LayerRx Mapping ID
334
Slot System
Featured Buckets
Featured Buckets Admin

How Media Coverage of Oral Minoxidil for Hair Loss Has Impacted Prescribing Habits

Article Type
Changed
Fri, 06/14/2024 - 12:41
Display Headline
How Media Coverage of Oral Minoxidil for Hair Loss Has Impacted Prescribing Habits

Minoxidil, a potent vasodilator, was approved by the US Food and Drug Administration (FDA) in 1963 to treat high blood pressure. Its application as a hair loss treatment was discovered by accident—patients taking oral minoxidil for blood pressure noticed hair growth on their bodies as a side effect of the medication. In 1988, topical minoxidil (Rogaine [Johnson & Johnson Consumer Inc]) was approved by the FDA for the treatment of androgenetic alopecia in men, and then it was approved for the same indication in women in 1991. The mechanism of action by which minoxidil increases hair growth still has not been fully elucidated. When applied topically, it is thought to extend the anagen phase (or growth phase) of the hair cycle and increase hair follicle size. It also increases oxygen to the hair follicle through vasodilation and stimulates the production of vascular endothelial growth factor, which is thought to promote hair growth.1 Since its approval, topical minoxidil has become a first-line treatment of androgenetic alopecia in men and women.

In August 2022, The New York Times (NYT) published an article on dermatologists’ use of oral minoxidil at a fraction of the dose prescribed for blood pressure with profound results in hair regrowth.2 Several dermatologists quoted in the article endorsed that the decreased dose minimizes unwanted side effects such as hypertrichosis, hypotension, and other cardiac issues while still being effective for hair loss. Also, compared to topical minoxidil, low-dose oral minoxidil (LDOM) is relatively cheaper and easier to use; topicals are more cumbersome to apply and often leave the hair and scalp sticky, leading to noncompliance among patients.2 Currently, oral minoxidil is not approved by the FDA for use in hair loss, making it an off-label use.

Since the NYT article was published, we have observed an increase in patient questions and requests for LDOM as well as heightened use by fellow dermatologists in our community. As of November 2022, the NYT had approximately 9,330,000 total subscribers, solidifying its place as a newspaper of record in the United States and across the world.3 In April 2023, we conducted a survey of US-based board-certified dermatologists to investigate the impact of the NYT article on prescribing practices of LDOM for alopecia. The survey was conducted as a poll in a Facebook group for board-certified dermatologists and asked, “How did the NYT article on oral minoxidil for alopecia change your utilization of LDOM (low-dose oral minoxidil) for alopecia?” Three answer choices were given: (1) I started Rx’ing LDOM or increased the number of patients I manage with LDOM; (2) No change. I never Rx’d LDOM and/or no increase in utilization; and (3) I was already prescribing LDOM.

Of the 65 total respondents, 27 (42%) reported that the NYT article influenced their decision to start prescribing LDOM for alopecia. Nine respondents (14%) reported that the article did not influence their prescribing habits, and 27 (42%) responded that they were already prescribing the medication prior to the article’s publication.

Data from Epiphany Dermatology, a practice with more than 70 locations throughout the United States, showed that oral minoxidil was prescribed for alopecia 107 times in 2020 and 672 times in 2021 (Amy Hadley, Epiphany Dermatology, written communication, March 24, 2023). In 2022, prescriptions increased exponentially to 1626, and in the period of January 2023 to March 2023 alone, oral minoxidil was prescribed 510 times. Following publication of the NYT article in August 2022, LDOM was prescribed a total of 1377 times in the next 8 months.

Moreover, data from Summit Pharmacy, a retail pharmacy in Centennial, Colorado, showed an 1800% increase in LDOM prescriptions in the 7 months following the NYT article’s publication (August 2022 to March 2023) compared with the 7 months prior (January 2022 to August 2022)(Brandon Johnson, Summit Pharmacy, written communication, March 30, 2023). These data provide evidence for the influence of the NYT article on prescribing habits of dermatology providers in the United States.

The safety of oral minoxidil for use in hair loss has been established through several studies in the literature.4,5 These results show that LDOM may be a safe, readily accessible, and revolutionary treatment for hair loss. A retrospective multicenter study of 1404 patients treated with LDOM for any type of alopecia found that side effects were infrequent, and only 1.7% of patients discontinued treatment due to adverse effects. The most frequent adverse effect was hypertrichosis, occurring in 15.1% of patients but leading to treatment withdrawal in only 0.5% of patients.4 Similarly, Randolph and Tosti5 found that hypertrichosis of the face and body was the most common adverse effect observed, though it rarely resulted in discontinuation and likely was dose dependent: less than 10% of patients receiving 0.25 mg/d experienced hypertrichosis compared with more than 50% of those receiving 5 mg/d (N=634). They also described patients in whom topical minoxidil, though effective, posed major barriers to compliance due to the twice-daily application, changes to hair texture from the medication, and scalp irritation. A literature review of 17 studies with 634 patients on LDOM as a primary treatment for hair loss found that it was an effective, well-tolerated treatment and should be considered for healthy patients who have difficulty with topical formulations.5

In the age of media with data constantly at users’ fingertips, the art of practicing medicine also has changed. Although physicians pride themselves on evidence-based medicine, it appears that an NYT article had an impact on how physicians, particularly dermatologists, prescribe oral minoxidil. However, it is difficult to know if the article exposed dermatologists to another treatment in their armamentarium for hair loss or if it influenced patients to ask their health care provider about LDOM for hair loss. One thing is clear—since the article’s publication, the off-label use of LDOM for alopecia has produced what many may call “miracles” for patients with hair loss.5

References
  1. Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004;150:186-194. doi:10.1111/j.1365-2133.2004.05785.x
  2. Kolata G. An old medicine grows new hair for pennies a day, doctors say. The New York Times. August 18, 2022. Accessed May 20, 2024. https://www.nytimes.com/2022/08/18/health/minoxidil-hair-loss-pills.html
  3. The New York Times Company reports third-quarter 2022 results. Press release. The New York Times Company; November 2, 2022. Accessed May 20, 2024. https://nytco-assets.nytimes.com/2022/11/NYT-Press-Release-Q3-2022-Final-nM7GzWGr.pdf
  4. Vañó-Galván S, Pirmez R, Hermosa-Gelbard A, et al. Safety of low-dose oral minoxidil for hair loss: a multicenter study of 1404 patients. J Am Acad Dermatol. 2021;84:1644-1651. doi:10.1016/j.jaad.2021.02.054
  5. Randolph M, Tosti A. Oral minoxidil treatment for hair loss: a review of efficacy and safety. J Am Acad Dermatol. 2021;84:737-746. doi:10.1016/j.jaad.2020.06.1009
Article PDF
Author and Disclosure Information

 

Dr. Taylor is from Aspen Dermatology, Colorado. Drs. Michael and Nguyen are from Larkin Community Hospital Palm Springs Campus, Hialeah, Florida. Dr. Lauck is from Baylor University Medical Center Division of Dermatology, Dallas, Texas. Dr. Park is from Park Dermatology, Lake Forest, Illinois. Dr. Tolkachjov is from Epiphany Dermatology, Lewisville, Texas. Dr. Weiss is from Hollywood Dermatology & Cosmetic Specialists, Florida.

Drs. Taylor, Michael, Nguyen, Lauck, and Weiss report no conflict of interest. Dr. Park is a speaker for Castle Biosciences. Dr. Tolkachjov is a speaker for Boehringer Ingelheim, Castle Biosciences, and Kerecis.

Correspondence: Mary Michael, DO, Larkin Community Hospital Palm Springs Campus, 1475 W 49th Pl, Hialeah, FL 33012 (marymichael94@gmail.com).

Cutis. 2024 June;113(6):269-270. doi:10.12788/cutis.1033

Issue
Cutis - 113(6)
Publications
Topics
Page Number
269-270
Sections
Author and Disclosure Information

 

Dr. Taylor is from Aspen Dermatology, Colorado. Drs. Michael and Nguyen are from Larkin Community Hospital Palm Springs Campus, Hialeah, Florida. Dr. Lauck is from Baylor University Medical Center Division of Dermatology, Dallas, Texas. Dr. Park is from Park Dermatology, Lake Forest, Illinois. Dr. Tolkachjov is from Epiphany Dermatology, Lewisville, Texas. Dr. Weiss is from Hollywood Dermatology & Cosmetic Specialists, Florida.

Drs. Taylor, Michael, Nguyen, Lauck, and Weiss report no conflict of interest. Dr. Park is a speaker for Castle Biosciences. Dr. Tolkachjov is a speaker for Boehringer Ingelheim, Castle Biosciences, and Kerecis.

Correspondence: Mary Michael, DO, Larkin Community Hospital Palm Springs Campus, 1475 W 49th Pl, Hialeah, FL 33012 (marymichael94@gmail.com).

Cutis. 2024 June;113(6):269-270. doi:10.12788/cutis.1033

Author and Disclosure Information

 

Dr. Taylor is from Aspen Dermatology, Colorado. Drs. Michael and Nguyen are from Larkin Community Hospital Palm Springs Campus, Hialeah, Florida. Dr. Lauck is from Baylor University Medical Center Division of Dermatology, Dallas, Texas. Dr. Park is from Park Dermatology, Lake Forest, Illinois. Dr. Tolkachjov is from Epiphany Dermatology, Lewisville, Texas. Dr. Weiss is from Hollywood Dermatology & Cosmetic Specialists, Florida.

Drs. Taylor, Michael, Nguyen, Lauck, and Weiss report no conflict of interest. Dr. Park is a speaker for Castle Biosciences. Dr. Tolkachjov is a speaker for Boehringer Ingelheim, Castle Biosciences, and Kerecis.

Correspondence: Mary Michael, DO, Larkin Community Hospital Palm Springs Campus, 1475 W 49th Pl, Hialeah, FL 33012 (marymichael94@gmail.com).

Cutis. 2024 June;113(6):269-270. doi:10.12788/cutis.1033

Article PDF
Article PDF

Minoxidil, a potent vasodilator, was approved by the US Food and Drug Administration (FDA) in 1963 to treat high blood pressure. Its application as a hair loss treatment was discovered by accident—patients taking oral minoxidil for blood pressure noticed hair growth on their bodies as a side effect of the medication. In 1988, topical minoxidil (Rogaine [Johnson & Johnson Consumer Inc]) was approved by the FDA for the treatment of androgenetic alopecia in men, and then it was approved for the same indication in women in 1991. The mechanism of action by which minoxidil increases hair growth still has not been fully elucidated. When applied topically, it is thought to extend the anagen phase (or growth phase) of the hair cycle and increase hair follicle size. It also increases oxygen to the hair follicle through vasodilation and stimulates the production of vascular endothelial growth factor, which is thought to promote hair growth.1 Since its approval, topical minoxidil has become a first-line treatment of androgenetic alopecia in men and women.

In August 2022, The New York Times (NYT) published an article on dermatologists’ use of oral minoxidil at a fraction of the dose prescribed for blood pressure with profound results in hair regrowth.2 Several dermatologists quoted in the article endorsed that the decreased dose minimizes unwanted side effects such as hypertrichosis, hypotension, and other cardiac issues while still being effective for hair loss. Also, compared to topical minoxidil, low-dose oral minoxidil (LDOM) is relatively cheaper and easier to use; topicals are more cumbersome to apply and often leave the hair and scalp sticky, leading to noncompliance among patients.2 Currently, oral minoxidil is not approved by the FDA for use in hair loss, making it an off-label use.

Since the NYT article was published, we have observed an increase in patient questions and requests for LDOM as well as heightened use by fellow dermatologists in our community. As of November 2022, the NYT had approximately 9,330,000 total subscribers, solidifying its place as a newspaper of record in the United States and across the world.3 In April 2023, we conducted a survey of US-based board-certified dermatologists to investigate the impact of the NYT article on prescribing practices of LDOM for alopecia. The survey was conducted as a poll in a Facebook group for board-certified dermatologists and asked, “How did the NYT article on oral minoxidil for alopecia change your utilization of LDOM (low-dose oral minoxidil) for alopecia?” Three answer choices were given: (1) I started Rx’ing LDOM or increased the number of patients I manage with LDOM; (2) No change. I never Rx’d LDOM and/or no increase in utilization; and (3) I was already prescribing LDOM.

Of the 65 total respondents, 27 (42%) reported that the NYT article influenced their decision to start prescribing LDOM for alopecia. Nine respondents (14%) reported that the article did not influence their prescribing habits, and 27 (42%) responded that they were already prescribing the medication prior to the article’s publication.

Data from Epiphany Dermatology, a practice with more than 70 locations throughout the United States, showed that oral minoxidil was prescribed for alopecia 107 times in 2020 and 672 times in 2021 (Amy Hadley, Epiphany Dermatology, written communication, March 24, 2023). In 2022, prescriptions increased exponentially to 1626, and in the period of January 2023 to March 2023 alone, oral minoxidil was prescribed 510 times. Following publication of the NYT article in August 2022, LDOM was prescribed a total of 1377 times in the next 8 months.

Moreover, data from Summit Pharmacy, a retail pharmacy in Centennial, Colorado, showed an 1800% increase in LDOM prescriptions in the 7 months following the NYT article’s publication (August 2022 to March 2023) compared with the 7 months prior (January 2022 to August 2022)(Brandon Johnson, Summit Pharmacy, written communication, March 30, 2023). These data provide evidence for the influence of the NYT article on prescribing habits of dermatology providers in the United States.

The safety of oral minoxidil for use in hair loss has been established through several studies in the literature.4,5 These results show that LDOM may be a safe, readily accessible, and revolutionary treatment for hair loss. A retrospective multicenter study of 1404 patients treated with LDOM for any type of alopecia found that side effects were infrequent, and only 1.7% of patients discontinued treatment due to adverse effects. The most frequent adverse effect was hypertrichosis, occurring in 15.1% of patients but leading to treatment withdrawal in only 0.5% of patients.4 Similarly, Randolph and Tosti5 found that hypertrichosis of the face and body was the most common adverse effect observed, though it rarely resulted in discontinuation and likely was dose dependent: less than 10% of patients receiving 0.25 mg/d experienced hypertrichosis compared with more than 50% of those receiving 5 mg/d (N=634). They also described patients in whom topical minoxidil, though effective, posed major barriers to compliance due to the twice-daily application, changes to hair texture from the medication, and scalp irritation. A literature review of 17 studies with 634 patients on LDOM as a primary treatment for hair loss found that it was an effective, well-tolerated treatment and should be considered for healthy patients who have difficulty with topical formulations.5

In the age of media with data constantly at users’ fingertips, the art of practicing medicine also has changed. Although physicians pride themselves on evidence-based medicine, it appears that an NYT article had an impact on how physicians, particularly dermatologists, prescribe oral minoxidil. However, it is difficult to know if the article exposed dermatologists to another treatment in their armamentarium for hair loss or if it influenced patients to ask their health care provider about LDOM for hair loss. One thing is clear—since the article’s publication, the off-label use of LDOM for alopecia has produced what many may call “miracles” for patients with hair loss.5

Minoxidil, a potent vasodilator, was approved by the US Food and Drug Administration (FDA) in 1963 to treat high blood pressure. Its application as a hair loss treatment was discovered by accident—patients taking oral minoxidil for blood pressure noticed hair growth on their bodies as a side effect of the medication. In 1988, topical minoxidil (Rogaine [Johnson & Johnson Consumer Inc]) was approved by the FDA for the treatment of androgenetic alopecia in men, and then it was approved for the same indication in women in 1991. The mechanism of action by which minoxidil increases hair growth still has not been fully elucidated. When applied topically, it is thought to extend the anagen phase (or growth phase) of the hair cycle and increase hair follicle size. It also increases oxygen to the hair follicle through vasodilation and stimulates the production of vascular endothelial growth factor, which is thought to promote hair growth.1 Since its approval, topical minoxidil has become a first-line treatment of androgenetic alopecia in men and women.

In August 2022, The New York Times (NYT) published an article on dermatologists’ use of oral minoxidil at a fraction of the dose prescribed for blood pressure with profound results in hair regrowth.2 Several dermatologists quoted in the article endorsed that the decreased dose minimizes unwanted side effects such as hypertrichosis, hypotension, and other cardiac issues while still being effective for hair loss. Also, compared to topical minoxidil, low-dose oral minoxidil (LDOM) is relatively cheaper and easier to use; topicals are more cumbersome to apply and often leave the hair and scalp sticky, leading to noncompliance among patients.2 Currently, oral minoxidil is not approved by the FDA for use in hair loss, making it an off-label use.

Since the NYT article was published, we have observed an increase in patient questions and requests for LDOM as well as heightened use by fellow dermatologists in our community. As of November 2022, the NYT had approximately 9,330,000 total subscribers, solidifying its place as a newspaper of record in the United States and across the world.3 In April 2023, we conducted a survey of US-based board-certified dermatologists to investigate the impact of the NYT article on prescribing practices of LDOM for alopecia. The survey was conducted as a poll in a Facebook group for board-certified dermatologists and asked, “How did the NYT article on oral minoxidil for alopecia change your utilization of LDOM (low-dose oral minoxidil) for alopecia?” Three answer choices were given: (1) I started Rx’ing LDOM or increased the number of patients I manage with LDOM; (2) No change. I never Rx’d LDOM and/or no increase in utilization; and (3) I was already prescribing LDOM.

Of the 65 total respondents, 27 (42%) reported that the NYT article influenced their decision to start prescribing LDOM for alopecia. Nine respondents (14%) reported that the article did not influence their prescribing habits, and 27 (42%) responded that they were already prescribing the medication prior to the article’s publication.

Data from Epiphany Dermatology, a practice with more than 70 locations throughout the United States, showed that oral minoxidil was prescribed for alopecia 107 times in 2020 and 672 times in 2021 (Amy Hadley, Epiphany Dermatology, written communication, March 24, 2023). In 2022, prescriptions increased exponentially to 1626, and in the period of January 2023 to March 2023 alone, oral minoxidil was prescribed 510 times. Following publication of the NYT article in August 2022, LDOM was prescribed a total of 1377 times in the next 8 months.

Moreover, data from Summit Pharmacy, a retail pharmacy in Centennial, Colorado, showed an 1800% increase in LDOM prescriptions in the 7 months following the NYT article’s publication (August 2022 to March 2023) compared with the 7 months prior (January 2022 to August 2022)(Brandon Johnson, Summit Pharmacy, written communication, March 30, 2023). These data provide evidence for the influence of the NYT article on prescribing habits of dermatology providers in the United States.

The safety of oral minoxidil for use in hair loss has been established through several studies in the literature.4,5 These results show that LDOM may be a safe, readily accessible, and revolutionary treatment for hair loss. A retrospective multicenter study of 1404 patients treated with LDOM for any type of alopecia found that side effects were infrequent, and only 1.7% of patients discontinued treatment due to adverse effects. The most frequent adverse effect was hypertrichosis, occurring in 15.1% of patients but leading to treatment withdrawal in only 0.5% of patients.4 Similarly, Randolph and Tosti5 found that hypertrichosis of the face and body was the most common adverse effect observed, though it rarely resulted in discontinuation and likely was dose dependent: less than 10% of patients receiving 0.25 mg/d experienced hypertrichosis compared with more than 50% of those receiving 5 mg/d (N=634). They also described patients in whom topical minoxidil, though effective, posed major barriers to compliance due to the twice-daily application, changes to hair texture from the medication, and scalp irritation. A literature review of 17 studies with 634 patients on LDOM as a primary treatment for hair loss found that it was an effective, well-tolerated treatment and should be considered for healthy patients who have difficulty with topical formulations.5

In the age of media with data constantly at users’ fingertips, the art of practicing medicine also has changed. Although physicians pride themselves on evidence-based medicine, it appears that an NYT article had an impact on how physicians, particularly dermatologists, prescribe oral minoxidil. However, it is difficult to know if the article exposed dermatologists to another treatment in their armamentarium for hair loss or if it influenced patients to ask their health care provider about LDOM for hair loss. One thing is clear—since the article’s publication, the off-label use of LDOM for alopecia has produced what many may call “miracles” for patients with hair loss.5

References
  1. Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004;150:186-194. doi:10.1111/j.1365-2133.2004.05785.x
  2. Kolata G. An old medicine grows new hair for pennies a day, doctors say. The New York Times. August 18, 2022. Accessed May 20, 2024. https://www.nytimes.com/2022/08/18/health/minoxidil-hair-loss-pills.html
  3. The New York Times Company reports third-quarter 2022 results. Press release. The New York Times Company; November 2, 2022. Accessed May 20, 2024. https://nytco-assets.nytimes.com/2022/11/NYT-Press-Release-Q3-2022-Final-nM7GzWGr.pdf
  4. Vañó-Galván S, Pirmez R, Hermosa-Gelbard A, et al. Safety of low-dose oral minoxidil for hair loss: a multicenter study of 1404 patients. J Am Acad Dermatol. 2021;84:1644-1651. doi:10.1016/j.jaad.2021.02.054
  5. Randolph M, Tosti A. Oral minoxidil treatment for hair loss: a review of efficacy and safety. J Am Acad Dermatol. 2021;84:737-746. doi:10.1016/j.jaad.2020.06.1009
References
  1. Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004;150:186-194. doi:10.1111/j.1365-2133.2004.05785.x
  2. Kolata G. An old medicine grows new hair for pennies a day, doctors say. The New York Times. August 18, 2022. Accessed May 20, 2024. https://www.nytimes.com/2022/08/18/health/minoxidil-hair-loss-pills.html
  3. The New York Times Company reports third-quarter 2022 results. Press release. The New York Times Company; November 2, 2022. Accessed May 20, 2024. https://nytco-assets.nytimes.com/2022/11/NYT-Press-Release-Q3-2022-Final-nM7GzWGr.pdf
  4. Vañó-Galván S, Pirmez R, Hermosa-Gelbard A, et al. Safety of low-dose oral minoxidil for hair loss: a multicenter study of 1404 patients. J Am Acad Dermatol. 2021;84:1644-1651. doi:10.1016/j.jaad.2021.02.054
  5. Randolph M, Tosti A. Oral minoxidil treatment for hair loss: a review of efficacy and safety. J Am Acad Dermatol. 2021;84:737-746. doi:10.1016/j.jaad.2020.06.1009
Issue
Cutis - 113(6)
Issue
Cutis - 113(6)
Page Number
269-270
Page Number
269-270
Publications
Publications
Topics
Article Type
Display Headline
How Media Coverage of Oral Minoxidil for Hair Loss Has Impacted Prescribing Habits
Display Headline
How Media Coverage of Oral Minoxidil for Hair Loss Has Impacted Prescribing Habits
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>Taylor</fileName> <TBEID>0C02F812.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F812</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname>Commentary</storyname> <articleType>1</articleType> <TBLocation>Copyfitting-CT</TBLocation> <QCDate/> <firstPublished>20240614T094219</firstPublished> <LastPublished>20240614T094219</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240614T094219</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Drew Taylor, MD</byline> <bylineText>Drew Taylor, MD; Mary Michael, DO; Tam H. Nguyen, DO; Kyle Lauck, MD; Kelly K. Park, MD; Stanislav N. Tolkachjov, MD; Eduardo Weiss, MD</bylineText> <bylineFull>Drew Taylor, MD</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>Minoxidil, a potent vasodilator, was approved by the US Food and Drug Administration (FDA) in 1963 to treat high blood pressure. Its application as a hair loss </metaDescription> <articlePDF>301783</articlePDF> <teaserImage/> <title>How Media Coverage of Oral Minoxidil for Hair Loss Has Impacted Prescribing Habits</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>June</pubPubdateMonth> <pubPubdateDay/> <pubVolume>113</pubVolume> <pubNumber>6</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>8057</CMSID> <CMSID>2159</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>CT</publicationCode> <pubIssueName>June 2024</pubIssueName> <pubArticleType>Departments | 2159</pubArticleType> <pubTopics/> <pubCategories/> <pubSections> <pubSection>Commentary | 8057<pubSubsection/></pubSection> </pubSections> <journalTitle>Cutis</journalTitle> <journalFullTitle>Cutis</journalFullTitle> <copyrightStatement>Copyright 2015 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">12</term> </publications> <sections> <term canonical="true">52</term> </sections> <topics> <term canonical="true">219</term> </topics> <links> <link> <itemClass qcode="ninat:composite"/> <altRep contenttype="application/pdf">images/1800274e.pdf</altRep> <description role="drol:caption"/> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>How Media Coverage of Oral Minoxidil for Hair Loss Has Impacted Prescribing Habits</title> <deck/> </itemMeta> <itemContent> <p>Minoxidil, a potent vasodilator, was approved by the US Food and Drug Administration (FDA) in 1963 to treat high blood pressure. Its application as a hair loss treatment was discovered by accident—patients taking oral minoxidil for blood pressure noticed hair growth on their bodies as a side effect of the medication. In 1988, topical minoxidil (Rogaine [Johnson &amp; Johnson Consumer Inc]) was approved by the FDA for the treatment of androgenetic alopecia in men, and then it was approved for the same indication in women in 1991. The mechanism of action by which minoxidil increases hair growth still has not been fully elucidated. When applied topically, it is thought to extend the anagen phase (or growth phase) of the hair cycle and increase hair follicle size. It also increases oxygen to the hair follicle through vasodilation and stimulates the production of vascular endothelial growth factor, which is thought to promote hair growth.1 Since its approval, topical minoxidil has become a first-line treatment of androgenetic alopecia in men and women. </p> <p>In August 2022, <i>The New York Times</i> (NYT) published an article on dermatologists’ use of oral minoxidil at a fraction of the dose prescribed for blood pressure with profound results in hair regrowth.<sup>2</sup> Several dermatologists quoted in the article endorsed that the decreased dose minimizes unwanted side effects such as hypertrichosis, hypotension, and other cardiac issues while still being effective for hair loss. Also, compared to topical minoxidil, low-dose oral minoxidil (LDOM) is relatively cheaper and easier to use; topicals are more cumbersome to apply and often leave the hair and scalp sticky, leading to noncompliance among patients.<sup>2</sup> Currently, oral minoxidil is not approved by the FDA for use in hair loss, making it an off-label use. <br/><br/>Since the NYT article was published, we have observed an increase in patient questions and requests for LDOM as well as heightened use by fellow dermatologists in our community. As of November 2022, the NYT had approximately 9,330,000 total subscribers, solidifying its place as a newspaper of record in the United States and across the world.<sup>3</sup> In April 2023, we conducted a survey of US-based board-certified dermatologists to investigate the impact of the NYT article on prescribing practices of LDOM for alopecia. The survey was conducted as a poll in a Facebook group for board-certified dermatologists and asked, “How did the NYT article on oral minoxidil for alopecia change your utilization of LDOM (low-dose oral minoxidil) for alopecia?” Three answer choices were given: (1) I started Rx’ing LDOM or increased the number of patients I manage with LDOM; (2) No change. I never Rx’d LDOM and/or no increase in utilization; and (3) I was already prescribing LDOM. <br/><br/>Of the 65 total respondents, 27 (42%) reported that the NYT article influenced their decision to start prescribing LDOM for alopecia. Nine respondents (14%) reported that the article did not influence their prescribing habits, and 27 (42%) responded that they were already prescribing the medication prior to the article’s publication.<br/><br/>Data from Epiphany Dermatology, a practice with more than 70 locations throughout the United States, showed that oral minoxidil was prescribed for alopecia 107 times in 2020 and 672 times in 2021 (Amy Hadley, Epiphany Dermatology, written communication, March 24, 2023). In 2022, prescriptions increased exponentially to 1626, and in the period of January 2023 to March 2023 alone, oral minoxidil was prescribed 510 times. Following publication of the NYT article in August 2022, LDOM was prescribed a total of 1377 times in the next 8 months. <br/><br/>Moreover, data from Summit Pharmacy, a retail pharmacy in Centennial, Colorado, showed an 1800% increase in LDOM prescriptions in the 7 months following the NYT article’s publication (August 2022 to March 2023) compared with the 7 months prior (January 2022 to August 2022)(Brandon Johnson, Summit Pharmacy, written communication, March 30, 2023). These data provide evidence for the influence of the NYT article on prescribing habits of dermatology providers in the United States. <br/><br/>The safety of oral minoxidil for use in hair loss has been established through several studies in the literature.<sup>4,5</sup> These results show that LDOM may be a safe, readily accessible, and revolutionary treatment for hair loss. A retrospective multicenter study of 1404 patients treated with LDOM for any type of alopecia found that side effects were infrequent, and only 1.7% of patients discontinued treatment due to adverse effects. The most frequent adverse effect was hypertrichosis, occurring in 15.1% of patients but leading to treatment withdrawal in only 0.5% of patients.<sup>4</sup> Similarly, Randolph and Tosti<sup>5</sup> found that hypertrichosis of the face and body was the most common adverse effect observed, though it rarely resulted in discontinuation and likely was dose dependent: less than 10% of patients receiving 0.25 mg/d experienced hypertrichosis compared with more than 50% of those receiving 5 mg/d (N<span class="body">=</span>634). They also described patients in whom topical minoxidil, though effective, posed major barriers to compliance due to the twice-daily application, changes to hair texture from the medication, and scalp irritation. A literature review of 17 studies with 634 patients on LDOM as a primary treatment for hair loss found that it was an effective, well-tolerated treatment and should be considered for healthy patients who have difficulty with topical formulations.<sup>5</sup> <br/><br/>In the age of media with data constantly at users’ fingertips, the art of practicing medicine also has changed. Although physicians pride themselves on evidence-based medicine, it appears that an NYT article had an impact on how physicians, particularly dermatologists, prescribe oral minoxidil. However, it is difficult to know if the article exposed dermatologists to another treatment in their armamentarium for hair loss or if it influenced patients to ask their health care provider about LDOM for hair loss. One thing is clear—since the article’s publication, the off-label use of LDOM for alopecia has produced what many may call “miracles” for patients with hair loss.<sup>5</sup> </p> <h2>References</h2> <p class="reference"> 1. Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth.<i> Br J Dermatol. </i>2004;150:186-194. doi:10.1111/j.1365-2133.2004.05785.x<br/><br/> 2. Kolata G. An old medicine grows new hair for pennies a day, doctors say. <i>The New York Times.</i> August 18, 2022.<i> </i>Accessed May 20, 2024. https://www.nytimes.com/2022/08/18/health/minoxidil-hair-loss-pills.html</p> <p class="reference"> 3. The New York Times Company reports third-quarter 2022 results. Press release. The New York Times Company; November 2, 2022. Accessed May 20, 2024. https://nytco-assets.nytimes.com/2022/11/NYT-Press-Release-Q3-2022-Final-nM7GzWGr.pdf<br/><br/> 4. Vañó-Galván S, Pirmez R, Hermosa-Gelbard A, et al. Safety of low-dose oral minoxidil for hair loss: a multicenter study of 1404 patients. <i>J Am Acad Dermatol</i>. 2021;84:1644-1651. doi:10.1016/j.jaad.2021.02.054 <br/><br/> 5. Randolph M, Tosti A. Oral minoxidil treatment for hair loss: a review of efficacy and safety. <i>J Am Acad Dermatol</i>. 2021;84:737-746. doi:10.1016/j.jaad.2020.06.1009</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>bio</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p class="disclosure">Dr. Taylor is from Aspen Dermatology, Colorado. Drs. Michael and Nguyen are from Larkin Community Hospital Palm Springs Campus, Hialeah, Florida. Dr. Lauck is from Baylor University Medical Center Division of Dermatology, Dallas, Texas. Dr. Park is from Park Dermatology, Lake Forest, Illinois. Dr. Tolkachjov is from Epiphany Dermatology, Lewisville, Texas. Dr. Weiss is from Hollywood Dermatology &amp; Cosmetic Specialists, Florida.</p> <p class="disclosure">Drs. Taylor, Michael, Nguyen, Lauck, and Weiss report no conflict of interest. Dr. Park is a speaker for Castle Biosciences. Dr. Tolkachjov is a speaker for Boehringer Ingelheim, Castle Biosciences, and Kerecis.<br/><br/>Correspondence: Mary Michael, DO, Larkin Community Hospital Palm Springs Campus, 1475 W 49th Pl, Hialeah, FL 33012 (marymichael94@gmail.com).<br/><br/><i>Cutis</i>. 2024 June;113(6):269-270. doi:10.12788/cutis.1033</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>in</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p class="insidehead">Practice <strong>Points</strong></p> <ul class="insidebody"> <li>Low-dose oral minoxidil (LDOM) prescriptions have increased due to rising attention to its efficacy and safety. </li> <li>Media outlets can have a powerful effect on prescribing habits of physicians. </li> <li>Physicians should be aware of media trends to help direct patient education.</li> </ul> </itemContent> </newsItem> </itemSet></root>
Inside the Article

 

Practice Points

  • Low-dose oral minoxidil (LDOM) prescriptions have increased due to rising attention to its efficacy and safety.
  • Media outlets can have a powerful effect on prescribing habits of physicians.
  • Physicians should be aware of media trends to help direct patient education.
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media
Image
Disable zoom
Off

Central Centrifugal Cicatricial Alopecia in Males: Analysis of Time to Diagnosis and Disease Severity

Article Type
Changed
Fri, 06/14/2024 - 12:41
Display Headline
Central Centrifugal Cicatricial Alopecia in Males: Analysis of Time to Diagnosis and Disease Severity

To the Editor:

Central centrifugal cicatricial alopecia (CCCA) is a chronic progressive type of scarring alopecia that primarily affects women of African descent.1 The disorder rarely is reported in men, which may be due to misdiagnosis or delayed diagnosis. Early diagnosis and treatment are the cornerstones to slow or halt disease progression and prevent permanent damage to hair follicles. This study aimed to investigate the time to diagnosis and disease severity among males with CCCA.

We conducted a retrospective chart review of male patients older than 18 years seen in outpatient clinics at an academic dermatology department (Philadelphia, Pennsylvania) between January 2012 and December 2022. An electronic query using the International Classification of Diseases, Ninth and Tenth Revisions, code L66.9 (cicatricial alopecia, unspecified) was performed. Patients were included if they had a clinical diagnosis of CCCA, histologic evidence of CCCA, and scalp photographs from the initial dermatology visit. Patients with folliculitis decalvans, scalp biopsy features that limited characterization, or no scalp biopsy were excluded from the study. Onset of CCCA was defined as the patient-reported start time of hair loss and/or scalp symptoms. To determine alopecia severity, the degree of central scalp hair loss was independently assessed by 2 dermatologists (S.C.T., T.O.) using the central scalp alopecia photographic scale in African American women.2,3 This 6-point photographic scale displays images with grades ranging from 0 (normal) to 5 (bald scalp); higher grades indicate probable and more severe CCCA. The scale also divides the central hair loss in a frontal-accentuation or vertex-predominant pattern, which corresponds to the A or B designations, respectively; thus, a score of 5A indicates probable severe CCCA with a frontal accentuation pattern, while 5B indicates probable severe CCCA with hair loss focused on the vertex scalp. This study was approved by the University of Pennsylvania institutional review board (approval #850730).

Of 108 male patients, 12 met the eligibility criteria. Nearly all patients (91.7% [11/12]) had a CCCA severity grade of 3 or higher at the initial dermatology visit, indicating extensive hair loss (Table). The clinical appearance of severity grades 2 through 5 is demonstrated in the Figure. Among patients with a known disease duration prior to diagnosis, 72.7% (8/11) were diagnosed more than 1 year after onset of CCCA, and 45.4% (5/11) were diagnosed more than 5 years after onset. On average (SD), it took 6.4 (5.9) years for patients to receive a diagnosis of CCCA after the onset of scalp symptoms and/or hair loss.

Randomized controlled trials evaluating treatment of CCCA are lacking, and anecdotal evidence posits a better treatment response in early CCCA; however, our results suggest that most male patients present with advanced CCCA and receive a diagnosis years after disease onset. Similar research in alopecia areata has shown that 72.4% (105/145) of patients received their diagnosis within a year after onset of symptoms, and the mean time from onset of symptoms to diagnosis was 1 year.4 In contrast, male patients with CCCA experience considerable diagnostic delays. This disparity indicates the need for clinicians to increase recognition of CCCA in men and quickly refer them to a dermatologist for prompt treatment.

lafrucrehoshawovihathegotreclabusephabruclemavowrudecidijeshouogetrastipewracropemulepregusholetedafrunushudedechuuijocemaretopewrisiwujastaprustaclimuswaspouunekawoshisledicliclavicawastespome

hekochepruvagacewriducaswugagomopuchafranuhuvuuucrabedruclatostatoshistoswajapebresedocakicluhes
%3Cp%3EA%E2%80%93D%2C%20Clinical%20appearance%20of%20central%20centrifugal%20cicatricial%20alopecia%20grades%202A%2C%203A%2FB%2C%204B%2C%20and%205B%2C%20respectively%2C%20based%20on%20comparison%20of%20the%20patients%E2%80%99%20hair%20loss%20to%20the%20images%20in%20the%20scale.%3C%2Fp%3E

Androgenetic alopecia (AGA) commonly is at the top of the differential diagnosis for hair loss on the vertex of the scalp in males, but clinicians should maintain a high index of suspicion for CCCA, especially when scalp symptoms or atypical features of AGA are present.5 Androgenetic alopecia typically is asymptomatic, whereas the symptoms of CCCA may include itching, tenderness, and/or burning.6,7 Trichoscopy is useful to evaluate for scarring, and a scalp biopsy may reveal other features to lower AGA on the differential. Educating patients, barbers, and hairstylists about the importance of early intervention also may encourage earlier visits before the scarring process is advanced. Further exploration into factors impacting diagnosis and CCCA severity may uncover implications for prognosis and treatment.

This study was limited by a small sample size, retrospective design, and single-center analysis. Some patients had comorbid hair loss conditions, which could affect disease severity. Moreover, the central scalp alopecia photographic scale2 was not validated in men or designed for assessment of the nonclassical hair loss distributions noted in some of our patients. Nonetheless, we hope these data will support clinicians in efforts to advocate for early diagnosis and treatment in patients with CCCA to ultimately help improve outcomes.

References
  1. Ogunleye TA, McMichael A, Olsen EA. Central centrifugal cicatricial alopecia: what has been achieved, current clues for future research. Dermatol Clin. 2014;32:173-181. doi:10.1016/j.det.2013.12.005
  2. Olsen EA, Callender V, McMichael A, et al. Central hair loss in African American women: incidence and potential risk factors. J Am Acad Dermatol. 2011;64:245-252. doi:10.1016/j.jaad.2009.11.693
  3. Olsen EA, Callendar V, Sperling L, et al. Central scalp alopecia photographic scale in African American women. Dermatol Ther. 2008;21:264-267. doi:10.1111/j.1529-8019.2008.00208.x
  4. Andersen YMF, Nymand L, DeLozier AM, et al. Patient characteristics and disease burden of alopecia areata in the Danish Skin Cohort. BMJ Open. 2022;12:E053137. doi:10.1136/bmjopen-2021-053137
  5. Davis EC, Reid SD, Callender VD, et al. Differentiating central centrifugal cicatricial alopecia and androgenetic alopecia in African American men. J Clin Aesthetic Dermatol. 2012;5:37-40.
  6. Jackson TK, Sow Y, Ayoade KO, et al. Central centrifugal cicatricial alopecia in males. J Am Acad Dermatol. 2023;89:1136-1140. doi:10.1016/j.jaad.2023.07.1011
  7. Lawson CN, Bakayoko A, Callender VD. Central centrifugal cicatricial alopecia: challenges and treatments. Dermatol Clin. 2021;39:389-405. doi:10.1016/j.det.2021.03.004
Article PDF
Author and Disclosure Information

 

Dr. Jackson is from the University of Illinois College of Medicine, Peoria. Dr. Sow is from the Morehouse School of Medicine, Atlanta, Georgia. Drs. Taylor and Ogunleye are from the Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Drs. Jackson, Sow, and Ogunleye report no conflicts of interest. Dr. Taylor is an advisory board member, consultant, employee, investigator, and/or speaker for AbbVie; Allergan Aesthetics; Arcutis Biotherapeutics, Inc; Armis Biopharma; Avita Medical; Beiersdorf, Inc; Biorez, Inc; Bristol-Myers Squibb; Cara Therapeutics; Catalyst Medical Education LLC; Concert Pharmaceuticals/Sun Pharma; Croma-Pharma GmbH; Dior; Eli Lilly and Company; EPI Health; Evolus, Inc; Galderma Laboratories; GloGetter; Hugel America, Inc; Incyte; Johnson & Johnson Consumer Products Company; L’Oreal USA; Mercer Strategies; Pfizer; Piction Health; Sanofi; Scientis US; UCB; and Vichy Laboratoires.

Correspondence: Temitayo Ogunleye, MD, Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 7th Floor PCAM South, Room 773, Philadelphia, PA 19104-5162 (temitayo.ogunleye@pennmedicine.upenn.edu).

Cutis. 2024 June;113(6):246-248. doi:10.12788/cutis.1031

Issue
Cutis - 113(6)
Publications
Topics
Page Number
246-248
Sections
Author and Disclosure Information

 

Dr. Jackson is from the University of Illinois College of Medicine, Peoria. Dr. Sow is from the Morehouse School of Medicine, Atlanta, Georgia. Drs. Taylor and Ogunleye are from the Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Drs. Jackson, Sow, and Ogunleye report no conflicts of interest. Dr. Taylor is an advisory board member, consultant, employee, investigator, and/or speaker for AbbVie; Allergan Aesthetics; Arcutis Biotherapeutics, Inc; Armis Biopharma; Avita Medical; Beiersdorf, Inc; Biorez, Inc; Bristol-Myers Squibb; Cara Therapeutics; Catalyst Medical Education LLC; Concert Pharmaceuticals/Sun Pharma; Croma-Pharma GmbH; Dior; Eli Lilly and Company; EPI Health; Evolus, Inc; Galderma Laboratories; GloGetter; Hugel America, Inc; Incyte; Johnson & Johnson Consumer Products Company; L’Oreal USA; Mercer Strategies; Pfizer; Piction Health; Sanofi; Scientis US; UCB; and Vichy Laboratoires.

Correspondence: Temitayo Ogunleye, MD, Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 7th Floor PCAM South, Room 773, Philadelphia, PA 19104-5162 (temitayo.ogunleye@pennmedicine.upenn.edu).

Cutis. 2024 June;113(6):246-248. doi:10.12788/cutis.1031

Author and Disclosure Information

 

Dr. Jackson is from the University of Illinois College of Medicine, Peoria. Dr. Sow is from the Morehouse School of Medicine, Atlanta, Georgia. Drs. Taylor and Ogunleye are from the Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Drs. Jackson, Sow, and Ogunleye report no conflicts of interest. Dr. Taylor is an advisory board member, consultant, employee, investigator, and/or speaker for AbbVie; Allergan Aesthetics; Arcutis Biotherapeutics, Inc; Armis Biopharma; Avita Medical; Beiersdorf, Inc; Biorez, Inc; Bristol-Myers Squibb; Cara Therapeutics; Catalyst Medical Education LLC; Concert Pharmaceuticals/Sun Pharma; Croma-Pharma GmbH; Dior; Eli Lilly and Company; EPI Health; Evolus, Inc; Galderma Laboratories; GloGetter; Hugel America, Inc; Incyte; Johnson & Johnson Consumer Products Company; L’Oreal USA; Mercer Strategies; Pfizer; Piction Health; Sanofi; Scientis US; UCB; and Vichy Laboratoires.

Correspondence: Temitayo Ogunleye, MD, Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 7th Floor PCAM South, Room 773, Philadelphia, PA 19104-5162 (temitayo.ogunleye@pennmedicine.upenn.edu).

Cutis. 2024 June;113(6):246-248. doi:10.12788/cutis.1031

Article PDF
Article PDF

To the Editor:

Central centrifugal cicatricial alopecia (CCCA) is a chronic progressive type of scarring alopecia that primarily affects women of African descent.1 The disorder rarely is reported in men, which may be due to misdiagnosis or delayed diagnosis. Early diagnosis and treatment are the cornerstones to slow or halt disease progression and prevent permanent damage to hair follicles. This study aimed to investigate the time to diagnosis and disease severity among males with CCCA.

We conducted a retrospective chart review of male patients older than 18 years seen in outpatient clinics at an academic dermatology department (Philadelphia, Pennsylvania) between January 2012 and December 2022. An electronic query using the International Classification of Diseases, Ninth and Tenth Revisions, code L66.9 (cicatricial alopecia, unspecified) was performed. Patients were included if they had a clinical diagnosis of CCCA, histologic evidence of CCCA, and scalp photographs from the initial dermatology visit. Patients with folliculitis decalvans, scalp biopsy features that limited characterization, or no scalp biopsy were excluded from the study. Onset of CCCA was defined as the patient-reported start time of hair loss and/or scalp symptoms. To determine alopecia severity, the degree of central scalp hair loss was independently assessed by 2 dermatologists (S.C.T., T.O.) using the central scalp alopecia photographic scale in African American women.2,3 This 6-point photographic scale displays images with grades ranging from 0 (normal) to 5 (bald scalp); higher grades indicate probable and more severe CCCA. The scale also divides the central hair loss in a frontal-accentuation or vertex-predominant pattern, which corresponds to the A or B designations, respectively; thus, a score of 5A indicates probable severe CCCA with a frontal accentuation pattern, while 5B indicates probable severe CCCA with hair loss focused on the vertex scalp. This study was approved by the University of Pennsylvania institutional review board (approval #850730).

Of 108 male patients, 12 met the eligibility criteria. Nearly all patients (91.7% [11/12]) had a CCCA severity grade of 3 or higher at the initial dermatology visit, indicating extensive hair loss (Table). The clinical appearance of severity grades 2 through 5 is demonstrated in the Figure. Among patients with a known disease duration prior to diagnosis, 72.7% (8/11) were diagnosed more than 1 year after onset of CCCA, and 45.4% (5/11) were diagnosed more than 5 years after onset. On average (SD), it took 6.4 (5.9) years for patients to receive a diagnosis of CCCA after the onset of scalp symptoms and/or hair loss.

Randomized controlled trials evaluating treatment of CCCA are lacking, and anecdotal evidence posits a better treatment response in early CCCA; however, our results suggest that most male patients present with advanced CCCA and receive a diagnosis years after disease onset. Similar research in alopecia areata has shown that 72.4% (105/145) of patients received their diagnosis within a year after onset of symptoms, and the mean time from onset of symptoms to diagnosis was 1 year.4 In contrast, male patients with CCCA experience considerable diagnostic delays. This disparity indicates the need for clinicians to increase recognition of CCCA in men and quickly refer them to a dermatologist for prompt treatment.

lafrucrehoshawovihathegotreclabusephabruclemavowrudecidijeshouogetrastipewracropemulepregusholetedafrunushudedechuuijocemaretopewrisiwujastaprustaclimuswaspouunekawoshisledicliclavicawastespome

hekochepruvagacewriducaswugagomopuchafranuhuvuuucrabedruclatostatoshistoswajapebresedocakicluhes
%3Cp%3EA%E2%80%93D%2C%20Clinical%20appearance%20of%20central%20centrifugal%20cicatricial%20alopecia%20grades%202A%2C%203A%2FB%2C%204B%2C%20and%205B%2C%20respectively%2C%20based%20on%20comparison%20of%20the%20patients%E2%80%99%20hair%20loss%20to%20the%20images%20in%20the%20scale.%3C%2Fp%3E

Androgenetic alopecia (AGA) commonly is at the top of the differential diagnosis for hair loss on the vertex of the scalp in males, but clinicians should maintain a high index of suspicion for CCCA, especially when scalp symptoms or atypical features of AGA are present.5 Androgenetic alopecia typically is asymptomatic, whereas the symptoms of CCCA may include itching, tenderness, and/or burning.6,7 Trichoscopy is useful to evaluate for scarring, and a scalp biopsy may reveal other features to lower AGA on the differential. Educating patients, barbers, and hairstylists about the importance of early intervention also may encourage earlier visits before the scarring process is advanced. Further exploration into factors impacting diagnosis and CCCA severity may uncover implications for prognosis and treatment.

This study was limited by a small sample size, retrospective design, and single-center analysis. Some patients had comorbid hair loss conditions, which could affect disease severity. Moreover, the central scalp alopecia photographic scale2 was not validated in men or designed for assessment of the nonclassical hair loss distributions noted in some of our patients. Nonetheless, we hope these data will support clinicians in efforts to advocate for early diagnosis and treatment in patients with CCCA to ultimately help improve outcomes.

To the Editor:

Central centrifugal cicatricial alopecia (CCCA) is a chronic progressive type of scarring alopecia that primarily affects women of African descent.1 The disorder rarely is reported in men, which may be due to misdiagnosis or delayed diagnosis. Early diagnosis and treatment are the cornerstones to slow or halt disease progression and prevent permanent damage to hair follicles. This study aimed to investigate the time to diagnosis and disease severity among males with CCCA.

We conducted a retrospective chart review of male patients older than 18 years seen in outpatient clinics at an academic dermatology department (Philadelphia, Pennsylvania) between January 2012 and December 2022. An electronic query using the International Classification of Diseases, Ninth and Tenth Revisions, code L66.9 (cicatricial alopecia, unspecified) was performed. Patients were included if they had a clinical diagnosis of CCCA, histologic evidence of CCCA, and scalp photographs from the initial dermatology visit. Patients with folliculitis decalvans, scalp biopsy features that limited characterization, or no scalp biopsy were excluded from the study. Onset of CCCA was defined as the patient-reported start time of hair loss and/or scalp symptoms. To determine alopecia severity, the degree of central scalp hair loss was independently assessed by 2 dermatologists (S.C.T., T.O.) using the central scalp alopecia photographic scale in African American women.2,3 This 6-point photographic scale displays images with grades ranging from 0 (normal) to 5 (bald scalp); higher grades indicate probable and more severe CCCA. The scale also divides the central hair loss in a frontal-accentuation or vertex-predominant pattern, which corresponds to the A or B designations, respectively; thus, a score of 5A indicates probable severe CCCA with a frontal accentuation pattern, while 5B indicates probable severe CCCA with hair loss focused on the vertex scalp. This study was approved by the University of Pennsylvania institutional review board (approval #850730).

Of 108 male patients, 12 met the eligibility criteria. Nearly all patients (91.7% [11/12]) had a CCCA severity grade of 3 or higher at the initial dermatology visit, indicating extensive hair loss (Table). The clinical appearance of severity grades 2 through 5 is demonstrated in the Figure. Among patients with a known disease duration prior to diagnosis, 72.7% (8/11) were diagnosed more than 1 year after onset of CCCA, and 45.4% (5/11) were diagnosed more than 5 years after onset. On average (SD), it took 6.4 (5.9) years for patients to receive a diagnosis of CCCA after the onset of scalp symptoms and/or hair loss.

Randomized controlled trials evaluating treatment of CCCA are lacking, and anecdotal evidence posits a better treatment response in early CCCA; however, our results suggest that most male patients present with advanced CCCA and receive a diagnosis years after disease onset. Similar research in alopecia areata has shown that 72.4% (105/145) of patients received their diagnosis within a year after onset of symptoms, and the mean time from onset of symptoms to diagnosis was 1 year.4 In contrast, male patients with CCCA experience considerable diagnostic delays. This disparity indicates the need for clinicians to increase recognition of CCCA in men and quickly refer them to a dermatologist for prompt treatment.

lafrucrehoshawovihathegotreclabusephabruclemavowrudecidijeshouogetrastipewracropemulepregusholetedafrunushudedechuuijocemaretopewrisiwujastaprustaclimuswaspouunekawoshisledicliclavicawastespome

hekochepruvagacewriducaswugagomopuchafranuhuvuuucrabedruclatostatoshistoswajapebresedocakicluhes
%3Cp%3EA%E2%80%93D%2C%20Clinical%20appearance%20of%20central%20centrifugal%20cicatricial%20alopecia%20grades%202A%2C%203A%2FB%2C%204B%2C%20and%205B%2C%20respectively%2C%20based%20on%20comparison%20of%20the%20patients%E2%80%99%20hair%20loss%20to%20the%20images%20in%20the%20scale.%3C%2Fp%3E

Androgenetic alopecia (AGA) commonly is at the top of the differential diagnosis for hair loss on the vertex of the scalp in males, but clinicians should maintain a high index of suspicion for CCCA, especially when scalp symptoms or atypical features of AGA are present.5 Androgenetic alopecia typically is asymptomatic, whereas the symptoms of CCCA may include itching, tenderness, and/or burning.6,7 Trichoscopy is useful to evaluate for scarring, and a scalp biopsy may reveal other features to lower AGA on the differential. Educating patients, barbers, and hairstylists about the importance of early intervention also may encourage earlier visits before the scarring process is advanced. Further exploration into factors impacting diagnosis and CCCA severity may uncover implications for prognosis and treatment.

This study was limited by a small sample size, retrospective design, and single-center analysis. Some patients had comorbid hair loss conditions, which could affect disease severity. Moreover, the central scalp alopecia photographic scale2 was not validated in men or designed for assessment of the nonclassical hair loss distributions noted in some of our patients. Nonetheless, we hope these data will support clinicians in efforts to advocate for early diagnosis and treatment in patients with CCCA to ultimately help improve outcomes.

References
  1. Ogunleye TA, McMichael A, Olsen EA. Central centrifugal cicatricial alopecia: what has been achieved, current clues for future research. Dermatol Clin. 2014;32:173-181. doi:10.1016/j.det.2013.12.005
  2. Olsen EA, Callender V, McMichael A, et al. Central hair loss in African American women: incidence and potential risk factors. J Am Acad Dermatol. 2011;64:245-252. doi:10.1016/j.jaad.2009.11.693
  3. Olsen EA, Callendar V, Sperling L, et al. Central scalp alopecia photographic scale in African American women. Dermatol Ther. 2008;21:264-267. doi:10.1111/j.1529-8019.2008.00208.x
  4. Andersen YMF, Nymand L, DeLozier AM, et al. Patient characteristics and disease burden of alopecia areata in the Danish Skin Cohort. BMJ Open. 2022;12:E053137. doi:10.1136/bmjopen-2021-053137
  5. Davis EC, Reid SD, Callender VD, et al. Differentiating central centrifugal cicatricial alopecia and androgenetic alopecia in African American men. J Clin Aesthetic Dermatol. 2012;5:37-40.
  6. Jackson TK, Sow Y, Ayoade KO, et al. Central centrifugal cicatricial alopecia in males. J Am Acad Dermatol. 2023;89:1136-1140. doi:10.1016/j.jaad.2023.07.1011
  7. Lawson CN, Bakayoko A, Callender VD. Central centrifugal cicatricial alopecia: challenges and treatments. Dermatol Clin. 2021;39:389-405. doi:10.1016/j.det.2021.03.004
References
  1. Ogunleye TA, McMichael A, Olsen EA. Central centrifugal cicatricial alopecia: what has been achieved, current clues for future research. Dermatol Clin. 2014;32:173-181. doi:10.1016/j.det.2013.12.005
  2. Olsen EA, Callender V, McMichael A, et al. Central hair loss in African American women: incidence and potential risk factors. J Am Acad Dermatol. 2011;64:245-252. doi:10.1016/j.jaad.2009.11.693
  3. Olsen EA, Callendar V, Sperling L, et al. Central scalp alopecia photographic scale in African American women. Dermatol Ther. 2008;21:264-267. doi:10.1111/j.1529-8019.2008.00208.x
  4. Andersen YMF, Nymand L, DeLozier AM, et al. Patient characteristics and disease burden of alopecia areata in the Danish Skin Cohort. BMJ Open. 2022;12:E053137. doi:10.1136/bmjopen-2021-053137
  5. Davis EC, Reid SD, Callender VD, et al. Differentiating central centrifugal cicatricial alopecia and androgenetic alopecia in African American men. J Clin Aesthetic Dermatol. 2012;5:37-40.
  6. Jackson TK, Sow Y, Ayoade KO, et al. Central centrifugal cicatricial alopecia in males. J Am Acad Dermatol. 2023;89:1136-1140. doi:10.1016/j.jaad.2023.07.1011
  7. Lawson CN, Bakayoko A, Callender VD. Central centrifugal cicatricial alopecia: challenges and treatments. Dermatol Clin. 2021;39:389-405. doi:10.1016/j.det.2021.03.004
Issue
Cutis - 113(6)
Issue
Cutis - 113(6)
Page Number
246-248
Page Number
246-248
Publications
Publications
Topics
Article Type
Display Headline
Central Centrifugal Cicatricial Alopecia in Males: Analysis of Time to Diagnosis and Disease Severity
Display Headline
Central Centrifugal Cicatricial Alopecia in Males: Analysis of Time to Diagnosis and Disease Severity
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>Jackson</fileName> <TBEID>0C02F7C0.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F7C0</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname>Jackson</storyname> <articleType>1</articleType> <TBLocation>Copyfitting-CT</TBLocation> <QCDate/> <firstPublished>20240614T091251</firstPublished> <LastPublished>20240614T091251</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240614T091250</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Tiaranesha Jackson, MD, MPH</byline> <bylineText>Tiaranesha Jackson, MD, MPH; Yacine Sow, MD; Susan C. Taylor, MD; Temitayo Ogunleye, MD</bylineText> <bylineFull>Tiaranesha Jackson, MD, MPH</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange>246-248</pageRange> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>To the Editor:Central centrifugal cicatricial alopecia (CCCA) is a chronic progressive type of scarring alopecia that primarily affects women of African descent</metaDescription> <articlePDF>301774</articlePDF> <teaserImage/> <title>Central Centrifugal Cicatricial Alopecia in Males: Analysis of Time to Diagnosis and Disease Severity</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>June</pubPubdateMonth> <pubPubdateDay/> <pubVolume>113</pubVolume> <pubNumber>6</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>2161</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>CT</publicationCode> <pubIssueName>January 2019</pubIssueName> <pubArticleType>Original Articles | 2161</pubArticleType> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle>Cutis</journalTitle> <journalFullTitle>Cutis</journalFullTitle> <copyrightStatement>Copyright 2015 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">12</term> </publications> <sections> <term canonical="true">104</term> </sections> <topics> <term canonical="true">219</term> <term>66772</term> </topics> <links> <link> <itemClass qcode="ninat:composite"/> <altRep contenttype="application/pdf">images/18002745.pdf</altRep> <description role="drol:caption"/> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Central Centrifugal Cicatricial Alopecia in Males: Analysis of Time to Diagnosis and Disease Severity</title> <deck/> </itemMeta> <itemContent> <p>To the Editor:<br/><br/>Central centrifugal cicatricial alopecia (CCCA) is a chronic progressive type of scarring alopecia that primarily affects women of African descent.<sup>1</sup> The disorder rarely is reported in men, which may be due to misdiagnosis or delayed diagnosis. Early diagnosis and treatment are the cornerstones to slow or halt disease progression and prevent permanent damage to hair follicles. This study aimed to investigate the time to diagnosis and disease severity among males with CCCA.</p> <p>We conducted a retrospective chart review of male patients older than 18 years seen in outpatient clinics at an academic dermatology department (Philadelphia, Pennsylvania) between January 2012 and December 2022. An electronic query using the <i>International Classification of Diseases, Ninth </i>and<i> Tenth Revisions</i>, code L66.9 (cicatricial alopecia, unspecified) was performed. Patients were included if they had a clinical diagnosis of CCCA, histologic evidence of CCCA, and scalp photographs from the initial dermatology visit. Patients with folliculitis decalvans, scalp biopsy features that limited characterization, or no scalp biopsy were excluded from the study. Onset of CCCA was defined as the patient-reported start time of hair loss and/or scalp symptoms. To determine alopecia severity, the degree of central scalp hair loss was independently assessed by 2 dermatologists (S.C.T., T.O.) using the central scalp alopecia photographic scale in African American women.<sup>2,3</sup> This 6-point photographic scale displays images with grades ranging from 0 (normal) to 5 (bald scalp); higher grades indicate probable and more severe CCCA. The scale also divides the central hair loss in a frontal-accentuation or vertex-predominant pattern, which corresponds to the A or B designations, respectively; thus, a score of 5A indicates probable severe CCCA with a frontal accentuation pattern, while 5B indicates probable severe CCCA with hair loss focused on the vertex scalp. This study was approved by the University of Pennsylvania institutional review board (approval #850730). </p> <p>Of 108 male patients, 12 met the eligibility criteria. Nearly all patients (91.7% [11/12]) had a CCCA severity grade of 3 or higher at the initial dermatology visit, indicating extensive hair loss (Table). The clinical appearance of severity grades 2 through 5 is demonstrated in the Figure. Among patients with a known disease duration prior to diagnosis, 72.7% (8/11) were diagnosed more than 1 year after onset of CCCA, and 45.4% (5/11) were diagnosed more than 5 years after onset. On average (SD), it took 6.4 (5.9) years for patients to receive a diagnosis of CCCA after the onset of scalp symptoms and/or hair loss. <br/><br/>Randomized controlled trials evaluating treatment of CCCA are lacking, and anecdotal evidence posits a better treatment response in early CCCA; however, our results suggest that most male patients present with advanced CCCA and receive a diagnosis years after disease onset. Similar research in alopecia areata has shown that 72.4% (105/145) of patients received their diagnosis within a year after onset of symptoms, and the mean time from onset of symptoms to diagnosis was 1 year.<sup>4</sup> In contrast, male patients with CCCA experience considerable diagnostic delays. This disparity indicates the need for clinicians to increase recognition of CCCA in men and quickly refer them to a dermatologist for prompt treatment. <br/><br/>Androgenetic alopecia (AGA) commonly is at the top of the differential diagnosis for hair loss on the vertex of the scalp in males, but clinicians should maintain a high index of suspicion for CCCA, especially when scalp symptoms or atypical features of AGA are present.<sup>5 </sup>Androgenetic alopecia typically is asymptomatic, whereas the symptoms of CCCA may include itching, tenderness, and/or burning.<sup>6,7</sup> Trichoscopy is useful to evaluate for scarring, and a scalp biopsy may reveal other features to lower AGA on the differential. Educating patients, barbers, and hairstylists about the importance of early intervention also may encourage earlier visits before the scarring process is advanced. Further exploration into factors impacting diagnosis and CCCA severity may uncover implications for prognosis and treatment. <br/><br/>This study was limited by a small sample size, retrospective design, and single-center analysis. Some patients had comorbid hair loss conditions, which could affect disease severity. Moreover, the central scalp alopecia photographic scale<sup>2</sup> was not validated in men or designed for assessment of the nonclassical hair loss distributions noted in some of our patients. Nonetheless, we hope these data will support clinicians in efforts to advocate for early diagnosis and treatment in patients with CCCA to ultimately help improve outcomes.</p> <h2>References</h2> <p class="reference"> 1. Ogunleye TA, McMichael A, Olsen EA. Central centrifugal cicatricial alopecia: what has been achieved, current clues for future research. <i>Dermatol Clin</i>. 2014;32:173-181. doi:10.1016/j.det.2013.12.005<br/><br/> 2. Olsen EA, Callender V, McMichael A, et al. Central hair loss in African American women: incidence and potential risk factors. <i>J Am Acad Dermatol</i>. 2011;64:245-252. doi:10.1016/j.jaad.2009.11.693<br/><br/> 3. Olsen EA, Callendar V, Sperling L, et al. Central scalp alopecia photographic scale in African American women. <i>Dermatol Ther</i>. 2008;21:264-267. doi:10.1111/j.1529-8019.2008.00208.x<br/><br/> 4. Andersen YMF, Nymand L, DeLozier AM, et al. Patient characteristics and disease burden of alopecia areata in the Danish Skin Cohort. <i>BMJ Open</i>. 2022;12:E053137. doi:10.1136/bmjopen-2021-053137<br/><br/> 5. Davis EC, Reid SD, Callender VD, et al. Differentiating central centrifugal cicatricial alopecia and androgenetic alopecia in African American men. <i>J Clin Aesthetic Dermatol</i>. 2012;5:37-40.<br/><br/> 6. Jackson TK, Sow Y, Ayoade KO, et al. Central centrifugal cicatricial alopecia in males. <i>J Am Acad Dermatol</i>. 2023;89:1136-1140. doi:10.1016/j.jaad.2023.07.1011<br/><br/> 7. Lawson CN, Bakayoko A, Callender VD. Central centrifugal cicatricial alopecia: challenges and treatments. <i>Dermatol Clin</i>. 2021;39:389-405. doi:10.1016/j.det.2021.03.004</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>bio</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p class="disclosure">Dr. Jackson is from the University of Illinois College of Medicine, Peoria. Dr. Sow is from the Morehouse School of Medicine, Atlanta, Georgia. Drs. Taylor and Ogunleye are from the Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.</p> <p class="disclosure">Drs. Jackson, Sow, and Ogunleye report no conflicts of interest. Dr. Taylor is an advisory board member, consultant, employee, investigator, and/or speaker for AbbVie; Allergan Aesthetics; Arcutis Biotherapeutics, Inc; Armis Biopharma; Avita Medical; Beiersdorf, Inc; Biorez, Inc; Bristol-Myers Squibb; Cara Therapeutics; Catalyst Medical Education LLC; Concert Pharmaceuticals/Sun Pharma; Croma-Pharma GmbH; Dior; Eli Lilly and Company; EPI Health; Evolus, Inc; Galderma Laboratories; GloGetter; Hugel America, Inc; Incyte; Johnson &amp; Johnson Consumer Products Company; L’Oreal USA; Mercer Strategies; Pfizer; Piction Health; Sanofi; Scientis US; UCB; and Vichy Laboratoires.<br/><br/>Correspondence: Temitayo Ogunleye, MD, Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 7th Floor PCAM South, Room 773, Philadelphia, PA 19104-5162 (temitayo.ogunleye@pennmedicine.upenn.edu).<br/><br/><em>Cutis. </em>2024 June;113(6):246-248. doi:10.12788/cutis.1031</p> </itemContent> </newsItem> </itemSet></root>
Inside the Article

Practice Points

  • Most males with central centrifugal cicatricial alopecia (CCCA) experience considerable diagnostic delays and typically present to dermatology with late-stage disease.
  • Dermatologists should consider CCCA in the differential diagnosis for adult Black males with alopecia.
  • More research is needed to explore advanced CCCA in males, including factors limiting timely diagnosis and the impact on quality of life in this population.
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media
Image
Disable zoom
Off

Subungual Nodule in a Pediatric Patient

Article Type
Changed
Wed, 06/05/2024 - 16:09
Display Headline
Subungual Nodule in a Pediatric Patient

The Diagnosis: Subungual Exostosis

Subungual exostosis should be considered as a possible cause of an exophytic subungual nodule in a young active female. In our patient, the involvement of the great toe was a clue, as the hallux is the most common location of subungual exostosis. The patient’s age and sex also were supportive, as subungual exostosis is most common in female children and adolescents— particularly those who are active, as trauma is thought to play a possible role in development of this benign tumor.1-3 Radiography is the preferred modality for diagnosis; in our case, it showed a trabecular bony overgrowth (Figure 1), which confirmed the diagnosis. Subungual exostosis is a rare, benign, osteocartilaginous tumor of trabecular bone. The etiology is unknown but is hypothesized to be related to trauma, infection, or activation of a cartilaginous cyst.1,3 The subungual nodule may be asymptomatic or painful. Disruption and elevation of the nail plate is common.4 The differential diagnosis includes amelanotic melanoma, fibroma, fibrokeratoma, osteochondroma, pyogenic granuloma, squamous cell carcinoma, glomus tumor, and verruca vulgaris, among others.5

doswicubarasofrocheslosi
%3Cp%3E%3Cstrong%3EFIGURE%201.%3C%2Fstrong%3E%20Radiography%20demonstrated%20exostosis%20extending%20from%20the%20distal%20medial%20cortical%20surface%20of%20the%20left%20first%20distal%20phalanx%2C%20confirming%20the%20diagnosis%20of%20subungual%20exostosis.%3C%2Fp%3E

Physical examination demonstrates a firm, fixed, subungual nodule, often with an accompanying nail deformity. Further workup is required to confirm the benign nature of the lesion and exclude nail tumors such as melanoma or squamous cell carcinoma. Radiography is the gold standard for diagnosis, demonstrating a trabecular bony overgrowth.6 Performing a radiograph as the initial diagnostic test spares the patient from unnecessary procedures such as biopsy or expensive imaging techniques such as magnetic resonance imaging. Early lesions may not demonstrate sufficient bone formation shown on radiography. In these situations, a combination of dermoscopy and histopathologic examination may aid in diagnosis (Figure 2).4 Vascular ectasia, hyperkeratosis, onycholysis, and ulceration are the most common findings on dermoscopy (in ascending order).7 Histopathology typically demonstrates a base or stalk of normal-appearing trabecular bone with a fibrocartilage cap.8 However, initial clinical workup via radiography allows for the least-invasive and highest-yield intervention. Clinical suspicion for this condition is important, as it can be diagnosed with noninvasive inexpensive imaging rather than biopsy or more specialized imaging modalities. Appropriate recognition can save young patients from unnecessary and expensive procedures. Treatment typically involves surgical excision; to prevent regrowth, removal of the lesion at the base of the bone is recommended.2

degecuboviditrusifrokowujimeranujadasuhogufraslufrejatid
%3Cp%3E%3Cstrong%3EFIGURE%202.%3C%2Fstrong%3E%20Dermoscopy%20of%20a%20flesh-colored%2C%20sessile%2C%20subungual%20nodule%20that%20was%20diagnosed%20as%20subungual%20exostosis.%3C%2Fp%3E

Although amelanotic melanoma also can manifest as a subungual nail tumor, it would be unusual in a young child and would not be expected to show characteristic changes on radiography. A glomus tumor would be painful, is more common on the fingers than on the toes, and typically has a bluish hue.9 Verruca vulgaris can occur subungually but is more common around the nailfold and often has the characteristic dermoscopic finding of thrombosed capillaries. It also would not be expected to show characteristic radiographic findings. Osteochondroma can occur in young patients and can appear clinically similar to subungual exostosis; however, it typically is painful.10

References
  1. Pascoal D, Balaco I, Alves C, et al. Subungual exostosis—treatment results with preservation of the nail bed. J Pediatr Orthop B. 2020;29:382-386.
  2. Yousefian F, Davis B, Browning JC. Pediatric subungual exostosis. Cutis. 2021;108:256-257.
  3. Chiheb S, Slimani Y, Karam R, et al. Subungual exostosis: a case series of 48 patients. Skin Appendage Disord. 2021;7:475-479.
  4. Zhang W, Gu L, Fan H, et al. Subungual exostosis with an unusual dermoscopic feature. JAAD Case Rep. 2020;6:725-726.
  5. Demirdag HG, Tugrul Ayanoglu B, Akay BN. Dermoscopic features of subungual exostosis. Australas J Dermatol. 2019;60:E138-E141.
  6. Tritto M, Mirkin G, Hao X. Subungual exostosis on the right hallux. J Am Podiatr Med Assoc. 2021;111.
  7. Piccolo V, Argenziano G, Alessandrini AM, et al. Dermoscopy of subungual exostosis: a retrospective study of 10 patients. Dermatology. 2017;233:80-85.
  8. Lee SK, Jung MS, Lee YH, et al. Two distinctive subungual pathologies: subungual exostosis and subungual osteochondroma. Foot Ankle Int. 2007;28:595-601. doi:10.3113/FAI.2007.0595
  9. Samaniego E, Crespo A, Sanz A. Key diagnostic features and treatment of subungual glomus tumor. Actas Dermosifiliogr. 2009;100:875-882.
  10. Glick S. Subungual osteochondroma of the third toe. Consult.360. 2013;12.
Article PDF
Author and Disclosure Information

From the Mayo Clinic, Rochester, Minnesota. Rewan M. Abdelwahab is from the Alix School of Medicine, and Drs. Kim and Link are from the Department of Dermatology.

The authors report no conflict of interest.

Correspondence: Jenny L. Link, MD, Department of Dermatology, Mayo Clinic, 200 1st St SW, Rochester, MN 55905 (link.jenny@mayo.edu).

Issue
Cutis - 113(6)
Publications
Topics
Page Number
249-250
Sections
Author and Disclosure Information

From the Mayo Clinic, Rochester, Minnesota. Rewan M. Abdelwahab is from the Alix School of Medicine, and Drs. Kim and Link are from the Department of Dermatology.

The authors report no conflict of interest.

Correspondence: Jenny L. Link, MD, Department of Dermatology, Mayo Clinic, 200 1st St SW, Rochester, MN 55905 (link.jenny@mayo.edu).

Author and Disclosure Information

From the Mayo Clinic, Rochester, Minnesota. Rewan M. Abdelwahab is from the Alix School of Medicine, and Drs. Kim and Link are from the Department of Dermatology.

The authors report no conflict of interest.

Correspondence: Jenny L. Link, MD, Department of Dermatology, Mayo Clinic, 200 1st St SW, Rochester, MN 55905 (link.jenny@mayo.edu).

Article PDF
Article PDF

The Diagnosis: Subungual Exostosis

Subungual exostosis should be considered as a possible cause of an exophytic subungual nodule in a young active female. In our patient, the involvement of the great toe was a clue, as the hallux is the most common location of subungual exostosis. The patient’s age and sex also were supportive, as subungual exostosis is most common in female children and adolescents— particularly those who are active, as trauma is thought to play a possible role in development of this benign tumor.1-3 Radiography is the preferred modality for diagnosis; in our case, it showed a trabecular bony overgrowth (Figure 1), which confirmed the diagnosis. Subungual exostosis is a rare, benign, osteocartilaginous tumor of trabecular bone. The etiology is unknown but is hypothesized to be related to trauma, infection, or activation of a cartilaginous cyst.1,3 The subungual nodule may be asymptomatic or painful. Disruption and elevation of the nail plate is common.4 The differential diagnosis includes amelanotic melanoma, fibroma, fibrokeratoma, osteochondroma, pyogenic granuloma, squamous cell carcinoma, glomus tumor, and verruca vulgaris, among others.5

doswicubarasofrocheslosi
%3Cp%3E%3Cstrong%3EFIGURE%201.%3C%2Fstrong%3E%20Radiography%20demonstrated%20exostosis%20extending%20from%20the%20distal%20medial%20cortical%20surface%20of%20the%20left%20first%20distal%20phalanx%2C%20confirming%20the%20diagnosis%20of%20subungual%20exostosis.%3C%2Fp%3E

Physical examination demonstrates a firm, fixed, subungual nodule, often with an accompanying nail deformity. Further workup is required to confirm the benign nature of the lesion and exclude nail tumors such as melanoma or squamous cell carcinoma. Radiography is the gold standard for diagnosis, demonstrating a trabecular bony overgrowth.6 Performing a radiograph as the initial diagnostic test spares the patient from unnecessary procedures such as biopsy or expensive imaging techniques such as magnetic resonance imaging. Early lesions may not demonstrate sufficient bone formation shown on radiography. In these situations, a combination of dermoscopy and histopathologic examination may aid in diagnosis (Figure 2).4 Vascular ectasia, hyperkeratosis, onycholysis, and ulceration are the most common findings on dermoscopy (in ascending order).7 Histopathology typically demonstrates a base or stalk of normal-appearing trabecular bone with a fibrocartilage cap.8 However, initial clinical workup via radiography allows for the least-invasive and highest-yield intervention. Clinical suspicion for this condition is important, as it can be diagnosed with noninvasive inexpensive imaging rather than biopsy or more specialized imaging modalities. Appropriate recognition can save young patients from unnecessary and expensive procedures. Treatment typically involves surgical excision; to prevent regrowth, removal of the lesion at the base of the bone is recommended.2

degecuboviditrusifrokowujimeranujadasuhogufraslufrejatid
%3Cp%3E%3Cstrong%3EFIGURE%202.%3C%2Fstrong%3E%20Dermoscopy%20of%20a%20flesh-colored%2C%20sessile%2C%20subungual%20nodule%20that%20was%20diagnosed%20as%20subungual%20exostosis.%3C%2Fp%3E

Although amelanotic melanoma also can manifest as a subungual nail tumor, it would be unusual in a young child and would not be expected to show characteristic changes on radiography. A glomus tumor would be painful, is more common on the fingers than on the toes, and typically has a bluish hue.9 Verruca vulgaris can occur subungually but is more common around the nailfold and often has the characteristic dermoscopic finding of thrombosed capillaries. It also would not be expected to show characteristic radiographic findings. Osteochondroma can occur in young patients and can appear clinically similar to subungual exostosis; however, it typically is painful.10

The Diagnosis: Subungual Exostosis

Subungual exostosis should be considered as a possible cause of an exophytic subungual nodule in a young active female. In our patient, the involvement of the great toe was a clue, as the hallux is the most common location of subungual exostosis. The patient’s age and sex also were supportive, as subungual exostosis is most common in female children and adolescents— particularly those who are active, as trauma is thought to play a possible role in development of this benign tumor.1-3 Radiography is the preferred modality for diagnosis; in our case, it showed a trabecular bony overgrowth (Figure 1), which confirmed the diagnosis. Subungual exostosis is a rare, benign, osteocartilaginous tumor of trabecular bone. The etiology is unknown but is hypothesized to be related to trauma, infection, or activation of a cartilaginous cyst.1,3 The subungual nodule may be asymptomatic or painful. Disruption and elevation of the nail plate is common.4 The differential diagnosis includes amelanotic melanoma, fibroma, fibrokeratoma, osteochondroma, pyogenic granuloma, squamous cell carcinoma, glomus tumor, and verruca vulgaris, among others.5

doswicubarasofrocheslosi
%3Cp%3E%3Cstrong%3EFIGURE%201.%3C%2Fstrong%3E%20Radiography%20demonstrated%20exostosis%20extending%20from%20the%20distal%20medial%20cortical%20surface%20of%20the%20left%20first%20distal%20phalanx%2C%20confirming%20the%20diagnosis%20of%20subungual%20exostosis.%3C%2Fp%3E

Physical examination demonstrates a firm, fixed, subungual nodule, often with an accompanying nail deformity. Further workup is required to confirm the benign nature of the lesion and exclude nail tumors such as melanoma or squamous cell carcinoma. Radiography is the gold standard for diagnosis, demonstrating a trabecular bony overgrowth.6 Performing a radiograph as the initial diagnostic test spares the patient from unnecessary procedures such as biopsy or expensive imaging techniques such as magnetic resonance imaging. Early lesions may not demonstrate sufficient bone formation shown on radiography. In these situations, a combination of dermoscopy and histopathologic examination may aid in diagnosis (Figure 2).4 Vascular ectasia, hyperkeratosis, onycholysis, and ulceration are the most common findings on dermoscopy (in ascending order).7 Histopathology typically demonstrates a base or stalk of normal-appearing trabecular bone with a fibrocartilage cap.8 However, initial clinical workup via radiography allows for the least-invasive and highest-yield intervention. Clinical suspicion for this condition is important, as it can be diagnosed with noninvasive inexpensive imaging rather than biopsy or more specialized imaging modalities. Appropriate recognition can save young patients from unnecessary and expensive procedures. Treatment typically involves surgical excision; to prevent regrowth, removal of the lesion at the base of the bone is recommended.2

degecuboviditrusifrokowujimeranujadasuhogufraslufrejatid
%3Cp%3E%3Cstrong%3EFIGURE%202.%3C%2Fstrong%3E%20Dermoscopy%20of%20a%20flesh-colored%2C%20sessile%2C%20subungual%20nodule%20that%20was%20diagnosed%20as%20subungual%20exostosis.%3C%2Fp%3E

Although amelanotic melanoma also can manifest as a subungual nail tumor, it would be unusual in a young child and would not be expected to show characteristic changes on radiography. A glomus tumor would be painful, is more common on the fingers than on the toes, and typically has a bluish hue.9 Verruca vulgaris can occur subungually but is more common around the nailfold and often has the characteristic dermoscopic finding of thrombosed capillaries. It also would not be expected to show characteristic radiographic findings. Osteochondroma can occur in young patients and can appear clinically similar to subungual exostosis; however, it typically is painful.10

References
  1. Pascoal D, Balaco I, Alves C, et al. Subungual exostosis—treatment results with preservation of the nail bed. J Pediatr Orthop B. 2020;29:382-386.
  2. Yousefian F, Davis B, Browning JC. Pediatric subungual exostosis. Cutis. 2021;108:256-257.
  3. Chiheb S, Slimani Y, Karam R, et al. Subungual exostosis: a case series of 48 patients. Skin Appendage Disord. 2021;7:475-479.
  4. Zhang W, Gu L, Fan H, et al. Subungual exostosis with an unusual dermoscopic feature. JAAD Case Rep. 2020;6:725-726.
  5. Demirdag HG, Tugrul Ayanoglu B, Akay BN. Dermoscopic features of subungual exostosis. Australas J Dermatol. 2019;60:E138-E141.
  6. Tritto M, Mirkin G, Hao X. Subungual exostosis on the right hallux. J Am Podiatr Med Assoc. 2021;111.
  7. Piccolo V, Argenziano G, Alessandrini AM, et al. Dermoscopy of subungual exostosis: a retrospective study of 10 patients. Dermatology. 2017;233:80-85.
  8. Lee SK, Jung MS, Lee YH, et al. Two distinctive subungual pathologies: subungual exostosis and subungual osteochondroma. Foot Ankle Int. 2007;28:595-601. doi:10.3113/FAI.2007.0595
  9. Samaniego E, Crespo A, Sanz A. Key diagnostic features and treatment of subungual glomus tumor. Actas Dermosifiliogr. 2009;100:875-882.
  10. Glick S. Subungual osteochondroma of the third toe. Consult.360. 2013;12.
References
  1. Pascoal D, Balaco I, Alves C, et al. Subungual exostosis—treatment results with preservation of the nail bed. J Pediatr Orthop B. 2020;29:382-386.
  2. Yousefian F, Davis B, Browning JC. Pediatric subungual exostosis. Cutis. 2021;108:256-257.
  3. Chiheb S, Slimani Y, Karam R, et al. Subungual exostosis: a case series of 48 patients. Skin Appendage Disord. 2021;7:475-479.
  4. Zhang W, Gu L, Fan H, et al. Subungual exostosis with an unusual dermoscopic feature. JAAD Case Rep. 2020;6:725-726.
  5. Demirdag HG, Tugrul Ayanoglu B, Akay BN. Dermoscopic features of subungual exostosis. Australas J Dermatol. 2019;60:E138-E141.
  6. Tritto M, Mirkin G, Hao X. Subungual exostosis on the right hallux. J Am Podiatr Med Assoc. 2021;111.
  7. Piccolo V, Argenziano G, Alessandrini AM, et al. Dermoscopy of subungual exostosis: a retrospective study of 10 patients. Dermatology. 2017;233:80-85.
  8. Lee SK, Jung MS, Lee YH, et al. Two distinctive subungual pathologies: subungual exostosis and subungual osteochondroma. Foot Ankle Int. 2007;28:595-601. doi:10.3113/FAI.2007.0595
  9. Samaniego E, Crespo A, Sanz A. Key diagnostic features and treatment of subungual glomus tumor. Actas Dermosifiliogr. 2009;100:875-882.
  10. Glick S. Subungual osteochondroma of the third toe. Consult.360. 2013;12.
Issue
Cutis - 113(6)
Issue
Cutis - 113(6)
Page Number
249-250
Page Number
249-250
Publications
Publications
Topics
Article Type
Display Headline
Subungual Nodule in a Pediatric Patient
Display Headline
Subungual Nodule in a Pediatric Patient
Sections
Questionnaire Body

A 13-year-old girl presented to her pediatrician with a small pink bump under the left great toenail of 8 months’ duration that was slowly growing. Months later, she developed an ingrown nail on the same toe, which was treated with partial nail avulsion by the pediatrician. Given continued nail dystrophy and a visible bump under the nail, the patient was referred to dermatology. Physical examination revealed a subungual, flesh-colored, sessile nodule causing distortion of the nail plate on the left great toe with associated intermittent redness and swelling. She denied wearing new shoes or experiencing any pain, pruritus, or purulent drainage or bleeding from the lesion. She reported being physically active and playing tennis.

toslut

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Wed, 06/05/2024 - 09:15
Un-Gate On Date
Wed, 06/05/2024 - 09:15
Use ProPublica
CFC Schedule Remove Status
Wed, 06/05/2024 - 09:15
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media
Image
Disable zoom
Off

Dupilumab Evaluated as Treatment for Pediatric Alopecia Areata

Article Type
Changed
Tue, 06/04/2024 - 12:20

Children with concomitant atopic dermatitis (AD) and alopecia areata (AA) who were treated with dupilumab demonstrated significant hair regrowth over a mean of nearly 68 weeks, preliminary results from a small case series showed.

“We might be opening a new avenue for a safe, long-term treatment for our children with AA,” the study’s lead investigator, Emma Guttman-Yassky, MD, PhD, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York City, said in an interview during the annual meeting of the Society for Investigative Dermatology (SID), where the results were presented during a poster session. “I think AA is likely joining the atopic march, which may allow us to adapt some treatments from the atopy world to AA.”

When the original phase 2 and phase 3 trials of dupilumab for patients with moderate to severe AD were being conducted, Dr. Guttman-Yassky, one of the investigators, recalled observing that some patients who also had patch alopecia experienced hair regrowth. “I was scratching my head because, at the time, AA was considered to be only a Th1-driven disease,” she said. “I asked myself, ‘How can this happen?’ I looked in the literature and found many publications linking atopy in general to alopecia areata. The largest of the dermatologic publications showed that eczema and atopy in general are the highest comorbidities in alopecia areata.”

Guttman_Yassky_Emma_NYC_web.jpg
Dr. Emma Guttman-Yassky

“This and other findings such as IL [interleukin]-13 genetic linkage with AA and high IgE in patients with AA link AA with Th2 immune skewing, particularly in the setting of atopy,” she continued. In addition, she said, in a large biomarker study involving the scalp and blood of patients with AA, “we found increases in Th2 biomarkers that were associated with alopecia severity.”
 

Case Series of 20 Pediatric Patients

As part of a case series of children with both AD and AA, Dr. Guttman-Yassky and colleagues evaluated hair regrowth using the Severity of Alopecia Tool (SALT) in 20 pediatric patients (mean age, 10.8 years) who were being treated at Mount Sinai. They collected patient demographics, atopic history, immunoglobulin E (IgE) levels, and SALT scores at follow-up visits every 12-16 weeks for more than 72 weeks and performed Spearman correlations between clinical scores, demographics, and IgE levels.

At baseline, the mean SALT score was 54.4, the mean IgE level was 1567.7 IU/mL, and 75% of patients also had a family history of atopy. The mean follow-up was 67.6 weeks. The researchers observed a significant reduction in SALT scores at week 48 compared with baseline (a mean score of 20.4; P < .01) and continued improvement up to at least 72 weeks (P < .01 vs baseline). They also noted that patients who achieved a treatment response at week 24 had baseline IgE levels > 200 IU/mL.

In other findings, baseline IgE positively correlated with improvement in SALT scores at week 36 (P < .05), while baseline SALT scores positively correlated with disease duration (P < .01) and negatively correlated with improvement in SALT scores at weeks 24, 36, and 48 (P < .005). “The robustness of the response surprised me,” Dr. Guttman-Yassky said in the interview. “Dupilumab for AA takes time to work, but once it kicks in, it kicks in. It takes anywhere from 6 to 12 months to see hair regrowth.”

[embed:render:related:node:264415]

She acknowledged certain limitations of the analysis, including its small sample size and the fact that it was not a standardized trial. “But, based on our data and the adult data, we are very encouraged about the potential of using dupilumab for children with AA,” she said.

Mount Sinai recently announced that the National Institutes of Health awarded a $6.6 million, 5-year grant to Dr. Guttman-Yassky to further investigate dupilumab as a treatment for children with AA. She will lead a multicenter controlled trial of 76 children with alopecia affecting at least 30% of the scalp, who will be randomized 2:1 (dupilumab:placebo) for 48 weeks, followed by 48 weeks of open-label dupilumab for all participants, with 16 weeks of follow-up, for a total of 112 weeks. Participating sites include Mount Sinai, Yale University, Northwestern University, and the University of California, Irvine.

Dr. Guttman-Yassky disclosed that she is a consultant to many pharmaceutical companies, including dupilumab manufacturers Sanofi and Regeneron.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

Children with concomitant atopic dermatitis (AD) and alopecia areata (AA) who were treated with dupilumab demonstrated significant hair regrowth over a mean of nearly 68 weeks, preliminary results from a small case series showed.

“We might be opening a new avenue for a safe, long-term treatment for our children with AA,” the study’s lead investigator, Emma Guttman-Yassky, MD, PhD, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York City, said in an interview during the annual meeting of the Society for Investigative Dermatology (SID), where the results were presented during a poster session. “I think AA is likely joining the atopic march, which may allow us to adapt some treatments from the atopy world to AA.”

When the original phase 2 and phase 3 trials of dupilumab for patients with moderate to severe AD were being conducted, Dr. Guttman-Yassky, one of the investigators, recalled observing that some patients who also had patch alopecia experienced hair regrowth. “I was scratching my head because, at the time, AA was considered to be only a Th1-driven disease,” she said. “I asked myself, ‘How can this happen?’ I looked in the literature and found many publications linking atopy in general to alopecia areata. The largest of the dermatologic publications showed that eczema and atopy in general are the highest comorbidities in alopecia areata.”

Guttman_Yassky_Emma_NYC_web.jpg
Dr. Emma Guttman-Yassky

“This and other findings such as IL [interleukin]-13 genetic linkage with AA and high IgE in patients with AA link AA with Th2 immune skewing, particularly in the setting of atopy,” she continued. In addition, she said, in a large biomarker study involving the scalp and blood of patients with AA, “we found increases in Th2 biomarkers that were associated with alopecia severity.”
 

Case Series of 20 Pediatric Patients

As part of a case series of children with both AD and AA, Dr. Guttman-Yassky and colleagues evaluated hair regrowth using the Severity of Alopecia Tool (SALT) in 20 pediatric patients (mean age, 10.8 years) who were being treated at Mount Sinai. They collected patient demographics, atopic history, immunoglobulin E (IgE) levels, and SALT scores at follow-up visits every 12-16 weeks for more than 72 weeks and performed Spearman correlations between clinical scores, demographics, and IgE levels.

At baseline, the mean SALT score was 54.4, the mean IgE level was 1567.7 IU/mL, and 75% of patients also had a family history of atopy. The mean follow-up was 67.6 weeks. The researchers observed a significant reduction in SALT scores at week 48 compared with baseline (a mean score of 20.4; P < .01) and continued improvement up to at least 72 weeks (P < .01 vs baseline). They also noted that patients who achieved a treatment response at week 24 had baseline IgE levels > 200 IU/mL.

In other findings, baseline IgE positively correlated with improvement in SALT scores at week 36 (P < .05), while baseline SALT scores positively correlated with disease duration (P < .01) and negatively correlated with improvement in SALT scores at weeks 24, 36, and 48 (P < .005). “The robustness of the response surprised me,” Dr. Guttman-Yassky said in the interview. “Dupilumab for AA takes time to work, but once it kicks in, it kicks in. It takes anywhere from 6 to 12 months to see hair regrowth.”

[embed:render:related:node:264415]

She acknowledged certain limitations of the analysis, including its small sample size and the fact that it was not a standardized trial. “But, based on our data and the adult data, we are very encouraged about the potential of using dupilumab for children with AA,” she said.

Mount Sinai recently announced that the National Institutes of Health awarded a $6.6 million, 5-year grant to Dr. Guttman-Yassky to further investigate dupilumab as a treatment for children with AA. She will lead a multicenter controlled trial of 76 children with alopecia affecting at least 30% of the scalp, who will be randomized 2:1 (dupilumab:placebo) for 48 weeks, followed by 48 weeks of open-label dupilumab for all participants, with 16 weeks of follow-up, for a total of 112 weeks. Participating sites include Mount Sinai, Yale University, Northwestern University, and the University of California, Irvine.

Dr. Guttman-Yassky disclosed that she is a consultant to many pharmaceutical companies, including dupilumab manufacturers Sanofi and Regeneron.

A version of this article appeared on Medscape.com.

Children with concomitant atopic dermatitis (AD) and alopecia areata (AA) who were treated with dupilumab demonstrated significant hair regrowth over a mean of nearly 68 weeks, preliminary results from a small case series showed.

“We might be opening a new avenue for a safe, long-term treatment for our children with AA,” the study’s lead investigator, Emma Guttman-Yassky, MD, PhD, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York City, said in an interview during the annual meeting of the Society for Investigative Dermatology (SID), where the results were presented during a poster session. “I think AA is likely joining the atopic march, which may allow us to adapt some treatments from the atopy world to AA.”

When the original phase 2 and phase 3 trials of dupilumab for patients with moderate to severe AD were being conducted, Dr. Guttman-Yassky, one of the investigators, recalled observing that some patients who also had patch alopecia experienced hair regrowth. “I was scratching my head because, at the time, AA was considered to be only a Th1-driven disease,” she said. “I asked myself, ‘How can this happen?’ I looked in the literature and found many publications linking atopy in general to alopecia areata. The largest of the dermatologic publications showed that eczema and atopy in general are the highest comorbidities in alopecia areata.”

Guttman_Yassky_Emma_NYC_web.jpg
Dr. Emma Guttman-Yassky

“This and other findings such as IL [interleukin]-13 genetic linkage with AA and high IgE in patients with AA link AA with Th2 immune skewing, particularly in the setting of atopy,” she continued. In addition, she said, in a large biomarker study involving the scalp and blood of patients with AA, “we found increases in Th2 biomarkers that were associated with alopecia severity.”
 

Case Series of 20 Pediatric Patients

As part of a case series of children with both AD and AA, Dr. Guttman-Yassky and colleagues evaluated hair regrowth using the Severity of Alopecia Tool (SALT) in 20 pediatric patients (mean age, 10.8 years) who were being treated at Mount Sinai. They collected patient demographics, atopic history, immunoglobulin E (IgE) levels, and SALT scores at follow-up visits every 12-16 weeks for more than 72 weeks and performed Spearman correlations between clinical scores, demographics, and IgE levels.

At baseline, the mean SALT score was 54.4, the mean IgE level was 1567.7 IU/mL, and 75% of patients also had a family history of atopy. The mean follow-up was 67.6 weeks. The researchers observed a significant reduction in SALT scores at week 48 compared with baseline (a mean score of 20.4; P < .01) and continued improvement up to at least 72 weeks (P < .01 vs baseline). They also noted that patients who achieved a treatment response at week 24 had baseline IgE levels > 200 IU/mL.

In other findings, baseline IgE positively correlated with improvement in SALT scores at week 36 (P < .05), while baseline SALT scores positively correlated with disease duration (P < .01) and negatively correlated with improvement in SALT scores at weeks 24, 36, and 48 (P < .005). “The robustness of the response surprised me,” Dr. Guttman-Yassky said in the interview. “Dupilumab for AA takes time to work, but once it kicks in, it kicks in. It takes anywhere from 6 to 12 months to see hair regrowth.”

[embed:render:related:node:264415]

She acknowledged certain limitations of the analysis, including its small sample size and the fact that it was not a standardized trial. “But, based on our data and the adult data, we are very encouraged about the potential of using dupilumab for children with AA,” she said.

Mount Sinai recently announced that the National Institutes of Health awarded a $6.6 million, 5-year grant to Dr. Guttman-Yassky to further investigate dupilumab as a treatment for children with AA. She will lead a multicenter controlled trial of 76 children with alopecia affecting at least 30% of the scalp, who will be randomized 2:1 (dupilumab:placebo) for 48 weeks, followed by 48 weeks of open-label dupilumab for all participants, with 16 weeks of follow-up, for a total of 112 weeks. Participating sites include Mount Sinai, Yale University, Northwestern University, and the University of California, Irvine.

Dr. Guttman-Yassky disclosed that she is a consultant to many pharmaceutical companies, including dupilumab manufacturers Sanofi and Regeneron.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>168259</fileName> <TBEID>0C0505D0.SIG</TBEID> <TBUniqueIdentifier>MD_0C0505D0</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240604T120447</QCDate> <firstPublished>20240604T121442</firstPublished> <LastPublished>20240604T121442</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240604T121442</CMSDate> <articleSource>FROM SID 2024</articleSource> <facebookInfo/> <meetingNumber>3047-24</meetingNumber> <byline>Doug Brunk</byline> <bylineText>DOUG BRUNK</bylineText> <bylineFull>DOUG BRUNK</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Children with concomitant atopic dermatitis (AD) and alopecia areata (AA) who were treated with dupilumab demonstrated significant hair regrowth over a mean of </metaDescription> <articlePDF/> <teaserImage>265404</teaserImage> <title>Dupilumab Evaluated as Treatment for Pediatric Alopecia Areata</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>15</term> <term>25</term> </publications> <sections> <term>53</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">219</term> <term>271</term> <term>203</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/2400e691.jpg</altRep> <description role="drol:caption">Dr. Emma Guttman-Yassky</description> <description role="drol:credit">Courtesy Mount Sinai Health System</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Dupilumab Evaluated as Treatment for Pediatric Alopecia Areata</title> <deck/> </itemMeta> <itemContent> <p><span class="tag metaDescription">Children with concomitant atopic dermatitis (AD) and alopecia areata (AA) who were treated with dupilumab demonstrated significant hair regrowth over a mean of nearly 68 weeks, preliminary results from a small case series</span> showed.</p> <p>“We might be opening a new avenue for a safe, long-term treatment for our children with AA,” the study’s lead investigator, <a href="http://link.mediaoutreach.meltwater.com/ls/click?upn=u001.m0R2z8ZV0QgxQ4O1bqJYjbKLQUnRbUGy1-2BsHMhinRC6qE5TGkSKY9URNEzFg5n4bMAmPKJurYKIyToo3TOcX1A-3D-3DChog_-2BjG4A7jgdmAPtysNWHgZkOWY3gNolbdQtRf53NnRTPgKkwD1WKkfGrUv0rtQ-2FlPtg-2Fk-2BLXb76j1B-2BAK-2FJjiSLRFwocGSYvRY8P9s8p4DPcfe1wS3srMObWjwFGDP6CqS-2FC51mDAmL5hvKUTraRpr81XZRBBBO6hn9OHBh-2FBqDG0AG83iGIcokMG1nBJZWFJY8Bg-2F0HG56sP4AGms7OQi01ufKOzNt8lnGvds-2FegBYce4TT-2Bycu8wgjvRXj-2B-2Fgom0vaxvpBnTpAEEQBZCKYQyAY01AcEB1OCl-2BlHacFRPkz16yq2ojs8VChfaiImiRTdv1t8WHNOey597omd1fVCtsz7-2F16tvy4kDJCSFyj6K1Ko-2FZktS0JVDJgGISMLMv59y">Emma Guttman-Yassky, MD, PhD</a>, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York City, said in an interview during the annual meeting of the Society for Investigative Dermatology (SID), where the results were presented during a poster session. “I think AA is likely joining the atopic march, which may allow us to adapt some treatments from the atopy world to AA.”<br/><br/>When the original phase 2 and <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa1610020">phase 3</a> trials of dupilumab for patients with moderate to severe AD were being conducted, Dr. Guttman-Yassky, one of the investigators, recalled observing that some patients who also had patch alopecia experienced hair regrowth. “I was scratching my head because, at the time, AA was considered to be only a Th1-driven disease,” she said. “I asked myself, ‘How can this happen?’ I looked in the literature and found many publications <a href="https://jamanetwork.com/journals/jamadermatology/fullarticle/1690841">linking atopy</a> in general to alopecia areata. The largest of the dermatologic publications showed that eczema and atopy in general are the highest <a href="https://www.jaad.org/article/S0190-9622(10)01048-0/abstract">comorbidities in alopecia areata</a>.”<br/><br/>[[{"fid":"265404","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Emma Guttman-Yassky","field_file_image_credit[und][0][value]":"Courtesy Mount Sinai Health System","field_file_image_caption[und][0][value]":"Dr. Emma Guttman-Yassky"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]“This and other findings such as IL [interleukin]-13 <a href="https://www.jidonline.org/article/S0022-202X(15)35876-0/fulltext">genetic linkage</a> with AA and high IgE in patients with AA link AA with Th2 immune skewing, particularly in the setting of atopy,” she continued. In addition, she said, in a large biomarker study involving the scalp and blood of patients with AA, “we found increases in Th2 biomarkers that were associated with alopecia severity.”<br/><br/></p> <h2>Case Series of 20 Pediatric Patients</h2> <p>As part of a case series of children with both AD and AA, Dr. Guttman-Yassky and colleagues evaluated hair regrowth using the Severity of Alopecia Tool (SALT) in 20 pediatric patients (mean age, 10.8 years) who were being treated at Mount Sinai. They collected patient demographics, atopic history, immunoglobulin E (IgE) levels, and SALT scores at follow-up visits every 12-16 weeks for more than 72 weeks and performed Spearman correlations between clinical scores, demographics, and IgE levels.</p> <p>At baseline, the mean SALT score was 54.4, the mean IgE level was 1567.7 IU/mL, and 75% of patients also had a family history of atopy. The mean follow-up was 67.6 weeks. The researchers observed a significant reduction in SALT scores at week 48 compared with baseline (a mean score of 20.4; <em>P</em> &lt; .01) and continued improvement up to at least 72 weeks (<em>P</em> &lt; .01 vs baseline). They also noted that patients who achieved a treatment response at week 24 had baseline IgE levels &gt; 200 IU/mL.<br/><br/>In other findings, baseline IgE positively correlated with improvement in SALT scores at week 36 (<em>P</em> &lt; .05), while baseline SALT scores positively correlated with disease duration (<em>P</em> &lt; .01) and negatively correlated with improvement in SALT scores at weeks 24, 36, and 48 (<em>P</em> &lt; .005). “The robustness of the response surprised me,” Dr. Guttman-Yassky said in the interview. “Dupilumab for AA takes time to work, but once it kicks in, it kicks in. It takes anywhere from 6 to 12 months to see hair regrowth.”<br/><br/>She acknowledged certain limitations of the analysis, including its small sample size and the fact that it was not a standardized trial. “But, based on our data and the adult data, we are very encouraged about the potential of using dupilumab for children with AA,” she said.<br/><br/>Mount Sinai recently announced that the National Institutes of Health awarded a $6.6 million, <a href="https://www.mountsinai.org/about/newsroom/2024/mount-sinai-awarded-6-6-million-from-national-institutes-of-health-to-investigate-treatment-for-alopecia-areata-in-children">5-year grant</a> to Dr. Guttman-Yassky to further investigate dupilumab as a treatment for children with AA. She will lead a multicenter controlled trial of 76 children with alopecia affecting at least 30% of the scalp, who will be randomized 2:1 (dupilumab:placebo) for 48 weeks, followed by 48 weeks of open-label dupilumab for all participants, with 16 weeks of follow-up, for a total of 112 weeks. Participating sites include Mount Sinai, Yale University, Northwestern University, and the University of California, Irvine.<br/><br/>Dr. Guttman-Yassky disclosed that she is a consultant to many pharmaceutical companies, including dupilumab manufacturers Sanofi and Regeneron.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/dupilumab-associated-hair-growth-children-alopecia-areata-2024a1000a1s">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p>“We are very encouraged about the potential of using dupilumab for children with AA,” said Dr. Emma Guttman-Yassky.</p> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM SID 2024

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Frontal Fibrosing Alopecia: Study Finds Oral Contraceptive Use Modulates Risk In Women with Genetic Variant

Article Type
Changed
Mon, 06/03/2024 - 12:35

 

TOPLINE:

Investigators found that the use of oral contraceptives (OCs) may be associated with an increased risk for frontal fibrosing alopecia (FFA) in women with a common variant in the CYP1B1 gene.

METHODOLOGY:

  • OC use has been considered a possible factor behind the increased incidence of FFA because it was first documented in 1994, and a recent genome-wide association study of FFA identified a signal for an association with a variant in CYP1B1.
  • The same researchers conducted a gene-environment interaction study with a case-control design involving 489 White female patients (mean age, 65.8 years) with FFA and 34,254 controls, matched for age and genetic ancestry.
  • Data were collected from July 2015 to September 2017 and analyzed from October 2022 to December 2023.
  • The study aimed to investigate the modulatory effect of OC use on the CYP1B1 variant’s impact on FFA risk, using logistic regression models for analysis.

TAKEAWAY:

  • The use of OCs was associated with a 1.9 times greater risk for FFA in individuals with the specific CYP1B1 genetic variant, but there was no association among those with no history of OC use.
  • The study suggests a significant gene-environment interaction, indicating that OC use may influence FFA risk in genetically predisposed individuals.

IN PRACTICE:

“This gene-environment interaction analysis suggests that the protective effect of the CYPIB1 missense variant on FFA risk might be mediated by exposure” to OCs, the authors wrote. The study, they added, “underscores the importance of considering genetic predispositions and environmental factors, such as oral contraceptive use, in understanding and managing frontal fibrosing alopecia.”

[embed:render:related:node:268676]

SOURCE:

Tuntas Rayinda, MD, MSc, PhD, of St. John’s Institute of Dermatology, King’s College London, led the study, which was published online May 29, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s reliance on self-reported OC use may have introduced recall and differences in ascertainment of OC use between patient and control groups and could have affected the study’s findings. The study also did not collect information on the type of OC used, which could have influenced the observed interaction.

DISCLOSURES:

The study was supported by the British Skin Foundation Young Investigator Award. One investigator reported being a subinvestigator on an alopecia areata study funded by Pfizer. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. 

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

 

TOPLINE:

Investigators found that the use of oral contraceptives (OCs) may be associated with an increased risk for frontal fibrosing alopecia (FFA) in women with a common variant in the CYP1B1 gene.

METHODOLOGY:

  • OC use has been considered a possible factor behind the increased incidence of FFA because it was first documented in 1994, and a recent genome-wide association study of FFA identified a signal for an association with a variant in CYP1B1.
  • The same researchers conducted a gene-environment interaction study with a case-control design involving 489 White female patients (mean age, 65.8 years) with FFA and 34,254 controls, matched for age and genetic ancestry.
  • Data were collected from July 2015 to September 2017 and analyzed from October 2022 to December 2023.
  • The study aimed to investigate the modulatory effect of OC use on the CYP1B1 variant’s impact on FFA risk, using logistic regression models for analysis.

TAKEAWAY:

  • The use of OCs was associated with a 1.9 times greater risk for FFA in individuals with the specific CYP1B1 genetic variant, but there was no association among those with no history of OC use.
  • The study suggests a significant gene-environment interaction, indicating that OC use may influence FFA risk in genetically predisposed individuals.

IN PRACTICE:

“This gene-environment interaction analysis suggests that the protective effect of the CYPIB1 missense variant on FFA risk might be mediated by exposure” to OCs, the authors wrote. The study, they added, “underscores the importance of considering genetic predispositions and environmental factors, such as oral contraceptive use, in understanding and managing frontal fibrosing alopecia.”

[embed:render:related:node:268676]

SOURCE:

Tuntas Rayinda, MD, MSc, PhD, of St. John’s Institute of Dermatology, King’s College London, led the study, which was published online May 29, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s reliance on self-reported OC use may have introduced recall and differences in ascertainment of OC use between patient and control groups and could have affected the study’s findings. The study also did not collect information on the type of OC used, which could have influenced the observed interaction.

DISCLOSURES:

The study was supported by the British Skin Foundation Young Investigator Award. One investigator reported being a subinvestigator on an alopecia areata study funded by Pfizer. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. 

A version of this article appeared on Medscape.com.

 

TOPLINE:

Investigators found that the use of oral contraceptives (OCs) may be associated with an increased risk for frontal fibrosing alopecia (FFA) in women with a common variant in the CYP1B1 gene.

METHODOLOGY:

  • OC use has been considered a possible factor behind the increased incidence of FFA because it was first documented in 1994, and a recent genome-wide association study of FFA identified a signal for an association with a variant in CYP1B1.
  • The same researchers conducted a gene-environment interaction study with a case-control design involving 489 White female patients (mean age, 65.8 years) with FFA and 34,254 controls, matched for age and genetic ancestry.
  • Data were collected from July 2015 to September 2017 and analyzed from October 2022 to December 2023.
  • The study aimed to investigate the modulatory effect of OC use on the CYP1B1 variant’s impact on FFA risk, using logistic regression models for analysis.

TAKEAWAY:

  • The use of OCs was associated with a 1.9 times greater risk for FFA in individuals with the specific CYP1B1 genetic variant, but there was no association among those with no history of OC use.
  • The study suggests a significant gene-environment interaction, indicating that OC use may influence FFA risk in genetically predisposed individuals.

IN PRACTICE:

“This gene-environment interaction analysis suggests that the protective effect of the CYPIB1 missense variant on FFA risk might be mediated by exposure” to OCs, the authors wrote. The study, they added, “underscores the importance of considering genetic predispositions and environmental factors, such as oral contraceptive use, in understanding and managing frontal fibrosing alopecia.”

[embed:render:related:node:268676]

SOURCE:

Tuntas Rayinda, MD, MSc, PhD, of St. John’s Institute of Dermatology, King’s College London, led the study, which was published online May 29, 2024, in JAMA Dermatology.

LIMITATIONS:

The study’s reliance on self-reported OC use may have introduced recall and differences in ascertainment of OC use between patient and control groups and could have affected the study’s findings. The study also did not collect information on the type of OC used, which could have influenced the observed interaction.

DISCLOSURES:

The study was supported by the British Skin Foundation Young Investigator Award. One investigator reported being a subinvestigator on an alopecia areata study funded by Pfizer. No other disclosures were reported.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. 

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>168277</fileName> <TBEID>0C050625.SIG</TBEID> <TBUniqueIdentifier>MD_0C050625</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240603T120906</QCDate> <firstPublished>20240603T123128</firstPublished> <LastPublished>20240603T123128</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240603T123128</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>AI</byline> <bylineText>EDITED ELIZABETH MECHCATIE</bylineText> <bylineFull>EDITED ELIZABETH MECHCATIE</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>the use of oral contraceptives (OCs) may be associated with an increased risk for frontal fibrosing alopecia (FFA) in women with a common variant in the CYP1B1 </metaDescription> <articlePDF/> <teaserImage/> <teaser>The study suggests a significant gene-environment interaction, the authors wrote.</teaser> <title>Frontal Fibrosing Alopecia: Study Finds Oral Contraceptive Use Modulates Risk In Women with Genetic Variant</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>endo</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>ob</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>34</term> <term>15</term> <term>21</term> <term>23</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">219</term> <term>287</term> <term>203</term> <term>322</term> <term>200</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Frontal Fibrosing Alopecia: Study Finds Oral Contraceptive Use Modulates Risk In Women with Genetic Variant</title> <deck/> </itemMeta> <itemContent> <h2>TOPLINE:</h2> <p>Investigators found that <span class="tag metaDescription">the use of oral contraceptives (OCs) may be associated with an increased risk for frontal fibrosing alopecia (FFA) in women with a common variant in the <em>CYP1B1</em> gene</span>.</p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>OC use has been considered a possible factor behind the increased incidence of FFA because it was first documented in 1994, and a recent genome-wide association study of FFA identified a signal for an association with a variant in <em>CYP1B1</em>.</li> <li>The same researchers conducted a gene-environment interaction study with a case-control design involving 489 White female patients (mean age, 65.8 years) with FFA and 34,254 controls, matched for age and genetic ancestry.</li> <li>Data were collected from July 2015 to September 2017 and analyzed from October 2022 to December 2023.</li> <li>The study aimed to investigate the modulatory effect of OC use on the <em>CYP1B1</em> variant’s impact on FFA risk, using logistic regression models for analysis.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>The use of OCs was associated with a 1.9 times greater risk for FFA in individuals with the specific CYP1B1 genetic variant, but there was no association among those with no history of OC use.</li> <li>The study suggests a significant gene-environment interaction, indicating that OC use may influence FFA risk in genetically predisposed individuals.</li> </ul> <h2>IN PRACTICE:</h2> <p>“This gene-environment interaction analysis suggests that the protective effect of the <em>CYPIB</em>1 missense variant on FFA risk might be mediated by exposure” to OCs, the authors wrote. The study, they added, “underscores the importance of considering genetic predispositions and environmental factors, such as oral contraceptive use, in understanding and managing frontal fibrosing alopecia.”</p> <h2>SOURCE:</h2> <p>Tuntas Rayinda, MD, MSc, PhD, of St. John’s Institute of Dermatology, King’s College London, led the study, which was <a href="https://jamanetwork.com/journals/jamadermatology/article-abstract/2819419">published online</a> May 29, 2024, in <em>JAMA Dermatology</em>.</p> <h2>LIMITATIONS:</h2> <p>The study’s reliance on self-reported OC use may have introduced recall and differences in ascertainment of OC use between patient and control groups and could have affected the study’s findings. The study also did not collect information on the type of OC used, which could have influenced the observed interaction.</p> <h2>DISCLOSURES:</h2> <p>The study was supported by the British Skin Foundation Young Investigator Award. One investigator reported being a subinvestigator on an alopecia areata study funded by Pfizer. No other disclosures were reported.</p> <p>This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. </p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/oral-contraceptives-may-play-role-risk-frontal-fibrosing-2024a1000acd">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Recalcitrant Folliculitis Decalvans Treatment Outcomes With Biologics and Small Molecule Inhibitors

Article Type
Changed
Wed, 06/05/2024 - 12:27
Display Headline
Recalcitrant Folliculitis Decalvans Treatment Outcomes With Biologics and Small Molecule Inhibitors

Folliculitis decalvans (FD) is classified as a rare primary neutrophilic cicatricial alopecia occurring predominantly in middle-aged adults. Although the true etiology is still unknown, the pathogenesis behind the inflammatory follicular lesions stems from possible Staphylococcus aureus infection and an impaired host immune system in response to released superantigens. 1 The clinical severity of this inflammatory scalp disorder can range from mild to severe and debilitating. Multiple treatment regimens have been developed with the goal of maintaining full remission. We provide a summary of tumor necrosis factor (TNF) inhibitors, Janus kinase (JAK) inhibitors, phosphodiesterase 4 (PDE4) inhibitors, and monoclonal antibodies being utilized for patients with therapy-recalcitrant FD.

Methods

We conducted a PubMed, Medline, and Google Scholar search for the terms refractory FD, recalcitrant FD, or therapy-resistant FD to identify articles published in English from 1998 to 2022. Articles that reported recalcitrant cases and subsequent therapy with TNF inhibitors, JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies were included. Articles were excluded if recalcitrant cases were not clearly defined. Remission was defined as no recurrence in lesions or pustules or as a reduction in the inflammatory process with stabilization upon continuation or discontinuation of the therapy regimen. Two reviewers (T.F. and K.U.) independently searched for and screened each report.

Results 

Treatment of recalcitrant FD with biologics or small molecule inhibitors was discussed in 9 studies with a combined total of 35 patients.2-10 The treatment regimens included TNF inhibitors, JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies (Table).

stogoshogogirosinesiwuthumesoclipretratecriswestaswesweshiclofrocrojobrovuspinospiribrobestiphomotrothithigesalovospadisuwahamithacajireuahehaphojuwumastadruviwekewasus

The TNF inhibitors were utilized in 6 reports with a combined total of 29 patients. Treatments included adalimumab or biosimilar adalimumab (27/29 patients), infliximab (1/29 patients), and certolizumab pegol (1/29 patients). Remission was reported in 26 of 29 cases. There were 2 nonresponders to adalimumab and marked improvement with certolizumab pegol without complete resolution. The use of the JAK inhibitor baricitinib in 4 patients resulted in remission. In all 4 patients, baricitinib was used with concurrent treatments, and remission was achieved in an average of 2.25 months. The use of a PDE4 inhibitor, apremilast, was reported in 1 case; remission was achieved in 3 weeks. Secukinumab, a monoclonal antibody that targets IL-17, was utilized in 1 patient. Marked improvement was seen after 2 months, with complete remission in 7 months. 

Comment

Traditional treatment regimens for FD most often include a combination of topical and oral antibiotics; isotretinoin; and oral, topical, or intralesional corticosteroids. In the past, interventions typically were suppressive as opposed to curative; however, recent treatment advancements have shown promise in achieving lasting remission.

Most reports targeting treatment-resistant FD involved the use of TNF inhibitors, including adalimumab, biosimilar adalimumab, infliximab, and certolizumab pegol.  Adalimumab was the most frequently used TNF inhibitor, with 24 of 26 treated patients achieving remission. Adalimumab may have been used the most in the treatment of FD because TNF is pronounced in other neutrophilic dermatoses that have been successfully treated with TNF inhibitors. It has been reported that adalimumab needs to be continued, as stoppage or interruption led to relapse.3

Although there are few reports of the use of JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies for FD, these treatment modalities show promise, as their use led to marked improvement or lasting remission with ongoing treatment. The use of the PDE4 inhibitor apremilast displayed the most rapid improvement of any of the reviewed treatments, with remission achieved in just 3 weeks.9 The rapid success of apremilast may be attributed to the inhibitory effect on neutrophils.

Miguel-Gómez et al11 provided a therapeutic protocol for FD based on the severity of disease (N=60). The protocol included rifampicin plus clindamycin for the treatment of severe disease, as 90.5% (19/21) of resistant cases showed clinical response, with remission of 5 months’ duration. Although this may be acceptable for some patients, others may require an alternative approach. Tietze et al12 showed that rifampicin and clindamycin had the lowest success rate for long-term remission, with 8 of 10 patients relapsing within 2 to 4 months. In addition, the emergence of antimicrobial resistance remains a major concern in the treatment of FD. Upon the review of the most recent reports of successful treatment of ­therapy-resistant FD, biologics and small molecule inhibitors have shown remission extending through a 12-month follow-up period. We suggest considering the addition of biologics and small molecule inhibitors to the treatment protocol for severe or resistant disease.

Limitations—In the articles reviewed, the definition of remission was inconsistent among authors—some characterized it as no recurrence in lesions or pustules and some as a reduction in the inflammatory process. True duration of remission was difficult to assess from case reports, as follow-up periods varied prior to publication. The studies included in this review consisted mainly of small sample sizes owing to the rarity of FD, and consequently, strength of evidence is lacking. Inherent to the nature of systematic reviews, publication bias may have occurred. Lastly, several studies were impacted by difficulty in obtaining optimal treatment due to financial hardship, and regimens were adjusted accordingly.

Conclusion

The relapsing nature of FD leads to frustration and poor quality of life for patients. There is a paucity of data to guide treatment when FD remains recalcitrant to traditional therapy. Therapies such as TNF inhibitors, JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies have shown success in the treatment of this often ­difficult-to-treat disease. Small sample sizes in reports discussing treatment for resistant cases as well as conflicting results make it challenging to draw conclusions about treatment efficacy. Larger studies are needed to understand the long-term outcomes of treatment options. Regardless, disease severity, patient history, patient preferences, and treatment goals can guide the selection of therapeutic options.

References
  1. Otberg N, Kang H, Alzolibani AA, et al. Folliculitis decalvans. Dermatol Ther. 2008;21:238-244. doi:10.1111/j.1529-8019.2008.00204.x
  2. Shireen F, Sudhakar A. A case of isotretinoin therapy-refractory folliculitis decalvans treated successfully with biosimilar adalimumab (Exemptia). Int J Trichology. 2018;10:240-241.
  3. Iorizzo M, Starace M, Vano-Galvan S, et al. Refractory folliculitis decalvans treated with adalimumab: a case series of 23 patients. J Am Acad Dermatol. 2022;87:666-669. doi:10.1016/j.jaad.2022.02.044
  4. Kreutzer K, Effendy I. Therapy-resistant folliculitis decalvans and lichen planopilaris successfully treated with adalimumab. J Dtsch Dermatol Ges. 2014;12:74-76. doi:10.1111/ddg.12224
  5. Alhameedy MM, Alsantali AM. Therapy-recalcitrant folliculitis decalvans controlled successfully with adalimumab. Int J Trichology. 2019;11:241-243. doi:10.4103/ijt.ijt_92_19
  6. Mihaljevic´ N, von den Driesch P. Successful use of infliximab in a patient with recalcitrant folliculitis decalvans. J Dtsch Dermatol Ges. 2012;10:589-590. doi:10.1111/j.1610-0387.2012.07972.x
  7. Hoy M, Böhm M. Therapy-refractory folliculitis decalvans treated with certolizumab pegol. Int J Dermatol. 2022;61:e26-e28. doi:10.1111/ijd.15914
  8. Moussa A, Asfour L, Eisman S, et al. Successful treatment of folliculitis decalvans with baricitinib: a case series. Australas J Dermatol. 2022;63:279-281. doi:10.1111/ajd.13786
  9. Fässler M, Radonjic-Hoesli S, Feldmeyer L, et al. Successful treatment of refractory folliculitis decalvans with apremilast. JAAD Case Rep. 2020;6:1079-1081. doi:10.1016/j.jdcr.2020.08.019
  10. Ismail FF, Sinclair R. Successful treatment of refractory folliculitis decalvans with secukinumab. Australas J Dermatol. 2020;61:165-166. doi:10.1111/ajd.13190
  11. Miguel-Gómez L, Rodrigues-Barata AR, Molina-Ruiz A, et al. Folliculitis decalvans: effectiveness of therapies and prognostic factors in a multicenter series of 60 patients with long-term follow-up. J Am Acad Dermatol. 2018;79:878-883. doi:10.1016/j.jaad.2018.05.1240
  12. Tietze JK, Heppt MV, von Preußen A, et al. Oral isotretinoin as the most effective treatment in folliculitis decalvans: a retrospective comparison of different treatment regimens in 28 patients. J Eur Acad Dermatol Venereol. 2015;29:1816-1821. doi:10.1111/jdv.13052
Article PDF
Author and Disclosure Information

 

Dr. Fakhoury is from Lake Erie College of Osteopathic Medicine, Bradenton, Florida. Dr. Urban is from Prime West Consortium, Newport Beach, California. Drs. Ettefagh and Nami are from Island Dermatology, Newport Beach.

The authors report no conflict of interest.

Correspondence: Katelyn Urban, DO, Prime West Consortium, 360 San Miguel Dr, #501, Newport Beach, CA 92660 (KUrban19071@med.lecom.edu).

Cutis. 2024 May;113(5):E32-E34. doi:10.12788/cutis.1023

Issue
Cutis - 113(5)
Publications
Topics
Page Number
E32-E34
Sections
Author and Disclosure Information

 

Dr. Fakhoury is from Lake Erie College of Osteopathic Medicine, Bradenton, Florida. Dr. Urban is from Prime West Consortium, Newport Beach, California. Drs. Ettefagh and Nami are from Island Dermatology, Newport Beach.

The authors report no conflict of interest.

Correspondence: Katelyn Urban, DO, Prime West Consortium, 360 San Miguel Dr, #501, Newport Beach, CA 92660 (KUrban19071@med.lecom.edu).

Cutis. 2024 May;113(5):E32-E34. doi:10.12788/cutis.1023

Author and Disclosure Information

 

Dr. Fakhoury is from Lake Erie College of Osteopathic Medicine, Bradenton, Florida. Dr. Urban is from Prime West Consortium, Newport Beach, California. Drs. Ettefagh and Nami are from Island Dermatology, Newport Beach.

The authors report no conflict of interest.

Correspondence: Katelyn Urban, DO, Prime West Consortium, 360 San Miguel Dr, #501, Newport Beach, CA 92660 (KUrban19071@med.lecom.edu).

Cutis. 2024 May;113(5):E32-E34. doi:10.12788/cutis.1023

Article PDF
Article PDF

Folliculitis decalvans (FD) is classified as a rare primary neutrophilic cicatricial alopecia occurring predominantly in middle-aged adults. Although the true etiology is still unknown, the pathogenesis behind the inflammatory follicular lesions stems from possible Staphylococcus aureus infection and an impaired host immune system in response to released superantigens. 1 The clinical severity of this inflammatory scalp disorder can range from mild to severe and debilitating. Multiple treatment regimens have been developed with the goal of maintaining full remission. We provide a summary of tumor necrosis factor (TNF) inhibitors, Janus kinase (JAK) inhibitors, phosphodiesterase 4 (PDE4) inhibitors, and monoclonal antibodies being utilized for patients with therapy-recalcitrant FD.

Methods

We conducted a PubMed, Medline, and Google Scholar search for the terms refractory FD, recalcitrant FD, or therapy-resistant FD to identify articles published in English from 1998 to 2022. Articles that reported recalcitrant cases and subsequent therapy with TNF inhibitors, JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies were included. Articles were excluded if recalcitrant cases were not clearly defined. Remission was defined as no recurrence in lesions or pustules or as a reduction in the inflammatory process with stabilization upon continuation or discontinuation of the therapy regimen. Two reviewers (T.F. and K.U.) independently searched for and screened each report.

Results 

Treatment of recalcitrant FD with biologics or small molecule inhibitors was discussed in 9 studies with a combined total of 35 patients.2-10 The treatment regimens included TNF inhibitors, JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies (Table).

stogoshogogirosinesiwuthumesoclipretratecriswestaswesweshiclofrocrojobrovuspinospiribrobestiphomotrothithigesalovospadisuwahamithacajireuahehaphojuwumastadruviwekewasus

The TNF inhibitors were utilized in 6 reports with a combined total of 29 patients. Treatments included adalimumab or biosimilar adalimumab (27/29 patients), infliximab (1/29 patients), and certolizumab pegol (1/29 patients). Remission was reported in 26 of 29 cases. There were 2 nonresponders to adalimumab and marked improvement with certolizumab pegol without complete resolution. The use of the JAK inhibitor baricitinib in 4 patients resulted in remission. In all 4 patients, baricitinib was used with concurrent treatments, and remission was achieved in an average of 2.25 months. The use of a PDE4 inhibitor, apremilast, was reported in 1 case; remission was achieved in 3 weeks. Secukinumab, a monoclonal antibody that targets IL-17, was utilized in 1 patient. Marked improvement was seen after 2 months, with complete remission in 7 months. 

Comment

Traditional treatment regimens for FD most often include a combination of topical and oral antibiotics; isotretinoin; and oral, topical, or intralesional corticosteroids. In the past, interventions typically were suppressive as opposed to curative; however, recent treatment advancements have shown promise in achieving lasting remission.

Most reports targeting treatment-resistant FD involved the use of TNF inhibitors, including adalimumab, biosimilar adalimumab, infliximab, and certolizumab pegol.  Adalimumab was the most frequently used TNF inhibitor, with 24 of 26 treated patients achieving remission. Adalimumab may have been used the most in the treatment of FD because TNF is pronounced in other neutrophilic dermatoses that have been successfully treated with TNF inhibitors. It has been reported that adalimumab needs to be continued, as stoppage or interruption led to relapse.3

Although there are few reports of the use of JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies for FD, these treatment modalities show promise, as their use led to marked improvement or lasting remission with ongoing treatment. The use of the PDE4 inhibitor apremilast displayed the most rapid improvement of any of the reviewed treatments, with remission achieved in just 3 weeks.9 The rapid success of apremilast may be attributed to the inhibitory effect on neutrophils.

Miguel-Gómez et al11 provided a therapeutic protocol for FD based on the severity of disease (N=60). The protocol included rifampicin plus clindamycin for the treatment of severe disease, as 90.5% (19/21) of resistant cases showed clinical response, with remission of 5 months’ duration. Although this may be acceptable for some patients, others may require an alternative approach. Tietze et al12 showed that rifampicin and clindamycin had the lowest success rate for long-term remission, with 8 of 10 patients relapsing within 2 to 4 months. In addition, the emergence of antimicrobial resistance remains a major concern in the treatment of FD. Upon the review of the most recent reports of successful treatment of ­therapy-resistant FD, biologics and small molecule inhibitors have shown remission extending through a 12-month follow-up period. We suggest considering the addition of biologics and small molecule inhibitors to the treatment protocol for severe or resistant disease.

Limitations—In the articles reviewed, the definition of remission was inconsistent among authors—some characterized it as no recurrence in lesions or pustules and some as a reduction in the inflammatory process. True duration of remission was difficult to assess from case reports, as follow-up periods varied prior to publication. The studies included in this review consisted mainly of small sample sizes owing to the rarity of FD, and consequently, strength of evidence is lacking. Inherent to the nature of systematic reviews, publication bias may have occurred. Lastly, several studies were impacted by difficulty in obtaining optimal treatment due to financial hardship, and regimens were adjusted accordingly.

Conclusion

The relapsing nature of FD leads to frustration and poor quality of life for patients. There is a paucity of data to guide treatment when FD remains recalcitrant to traditional therapy. Therapies such as TNF inhibitors, JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies have shown success in the treatment of this often ­difficult-to-treat disease. Small sample sizes in reports discussing treatment for resistant cases as well as conflicting results make it challenging to draw conclusions about treatment efficacy. Larger studies are needed to understand the long-term outcomes of treatment options. Regardless, disease severity, patient history, patient preferences, and treatment goals can guide the selection of therapeutic options.

Folliculitis decalvans (FD) is classified as a rare primary neutrophilic cicatricial alopecia occurring predominantly in middle-aged adults. Although the true etiology is still unknown, the pathogenesis behind the inflammatory follicular lesions stems from possible Staphylococcus aureus infection and an impaired host immune system in response to released superantigens. 1 The clinical severity of this inflammatory scalp disorder can range from mild to severe and debilitating. Multiple treatment regimens have been developed with the goal of maintaining full remission. We provide a summary of tumor necrosis factor (TNF) inhibitors, Janus kinase (JAK) inhibitors, phosphodiesterase 4 (PDE4) inhibitors, and monoclonal antibodies being utilized for patients with therapy-recalcitrant FD.

Methods

We conducted a PubMed, Medline, and Google Scholar search for the terms refractory FD, recalcitrant FD, or therapy-resistant FD to identify articles published in English from 1998 to 2022. Articles that reported recalcitrant cases and subsequent therapy with TNF inhibitors, JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies were included. Articles were excluded if recalcitrant cases were not clearly defined. Remission was defined as no recurrence in lesions or pustules or as a reduction in the inflammatory process with stabilization upon continuation or discontinuation of the therapy regimen. Two reviewers (T.F. and K.U.) independently searched for and screened each report.

Results 

Treatment of recalcitrant FD with biologics or small molecule inhibitors was discussed in 9 studies with a combined total of 35 patients.2-10 The treatment regimens included TNF inhibitors, JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies (Table).

stogoshogogirosinesiwuthumesoclipretratecriswestaswesweshiclofrocrojobrovuspinospiribrobestiphomotrothithigesalovospadisuwahamithacajireuahehaphojuwumastadruviwekewasus

The TNF inhibitors were utilized in 6 reports with a combined total of 29 patients. Treatments included adalimumab or biosimilar adalimumab (27/29 patients), infliximab (1/29 patients), and certolizumab pegol (1/29 patients). Remission was reported in 26 of 29 cases. There were 2 nonresponders to adalimumab and marked improvement with certolizumab pegol without complete resolution. The use of the JAK inhibitor baricitinib in 4 patients resulted in remission. In all 4 patients, baricitinib was used with concurrent treatments, and remission was achieved in an average of 2.25 months. The use of a PDE4 inhibitor, apremilast, was reported in 1 case; remission was achieved in 3 weeks. Secukinumab, a monoclonal antibody that targets IL-17, was utilized in 1 patient. Marked improvement was seen after 2 months, with complete remission in 7 months. 

Comment

Traditional treatment regimens for FD most often include a combination of topical and oral antibiotics; isotretinoin; and oral, topical, or intralesional corticosteroids. In the past, interventions typically were suppressive as opposed to curative; however, recent treatment advancements have shown promise in achieving lasting remission.

Most reports targeting treatment-resistant FD involved the use of TNF inhibitors, including adalimumab, biosimilar adalimumab, infliximab, and certolizumab pegol.  Adalimumab was the most frequently used TNF inhibitor, with 24 of 26 treated patients achieving remission. Adalimumab may have been used the most in the treatment of FD because TNF is pronounced in other neutrophilic dermatoses that have been successfully treated with TNF inhibitors. It has been reported that adalimumab needs to be continued, as stoppage or interruption led to relapse.3

Although there are few reports of the use of JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies for FD, these treatment modalities show promise, as their use led to marked improvement or lasting remission with ongoing treatment. The use of the PDE4 inhibitor apremilast displayed the most rapid improvement of any of the reviewed treatments, with remission achieved in just 3 weeks.9 The rapid success of apremilast may be attributed to the inhibitory effect on neutrophils.

Miguel-Gómez et al11 provided a therapeutic protocol for FD based on the severity of disease (N=60). The protocol included rifampicin plus clindamycin for the treatment of severe disease, as 90.5% (19/21) of resistant cases showed clinical response, with remission of 5 months’ duration. Although this may be acceptable for some patients, others may require an alternative approach. Tietze et al12 showed that rifampicin and clindamycin had the lowest success rate for long-term remission, with 8 of 10 patients relapsing within 2 to 4 months. In addition, the emergence of antimicrobial resistance remains a major concern in the treatment of FD. Upon the review of the most recent reports of successful treatment of ­therapy-resistant FD, biologics and small molecule inhibitors have shown remission extending through a 12-month follow-up period. We suggest considering the addition of biologics and small molecule inhibitors to the treatment protocol for severe or resistant disease.

Limitations—In the articles reviewed, the definition of remission was inconsistent among authors—some characterized it as no recurrence in lesions or pustules and some as a reduction in the inflammatory process. True duration of remission was difficult to assess from case reports, as follow-up periods varied prior to publication. The studies included in this review consisted mainly of small sample sizes owing to the rarity of FD, and consequently, strength of evidence is lacking. Inherent to the nature of systematic reviews, publication bias may have occurred. Lastly, several studies were impacted by difficulty in obtaining optimal treatment due to financial hardship, and regimens were adjusted accordingly.

Conclusion

The relapsing nature of FD leads to frustration and poor quality of life for patients. There is a paucity of data to guide treatment when FD remains recalcitrant to traditional therapy. Therapies such as TNF inhibitors, JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies have shown success in the treatment of this often ­difficult-to-treat disease. Small sample sizes in reports discussing treatment for resistant cases as well as conflicting results make it challenging to draw conclusions about treatment efficacy. Larger studies are needed to understand the long-term outcomes of treatment options. Regardless, disease severity, patient history, patient preferences, and treatment goals can guide the selection of therapeutic options.

References
  1. Otberg N, Kang H, Alzolibani AA, et al. Folliculitis decalvans. Dermatol Ther. 2008;21:238-244. doi:10.1111/j.1529-8019.2008.00204.x
  2. Shireen F, Sudhakar A. A case of isotretinoin therapy-refractory folliculitis decalvans treated successfully with biosimilar adalimumab (Exemptia). Int J Trichology. 2018;10:240-241.
  3. Iorizzo M, Starace M, Vano-Galvan S, et al. Refractory folliculitis decalvans treated with adalimumab: a case series of 23 patients. J Am Acad Dermatol. 2022;87:666-669. doi:10.1016/j.jaad.2022.02.044
  4. Kreutzer K, Effendy I. Therapy-resistant folliculitis decalvans and lichen planopilaris successfully treated with adalimumab. J Dtsch Dermatol Ges. 2014;12:74-76. doi:10.1111/ddg.12224
  5. Alhameedy MM, Alsantali AM. Therapy-recalcitrant folliculitis decalvans controlled successfully with adalimumab. Int J Trichology. 2019;11:241-243. doi:10.4103/ijt.ijt_92_19
  6. Mihaljevic´ N, von den Driesch P. Successful use of infliximab in a patient with recalcitrant folliculitis decalvans. J Dtsch Dermatol Ges. 2012;10:589-590. doi:10.1111/j.1610-0387.2012.07972.x
  7. Hoy M, Böhm M. Therapy-refractory folliculitis decalvans treated with certolizumab pegol. Int J Dermatol. 2022;61:e26-e28. doi:10.1111/ijd.15914
  8. Moussa A, Asfour L, Eisman S, et al. Successful treatment of folliculitis decalvans with baricitinib: a case series. Australas J Dermatol. 2022;63:279-281. doi:10.1111/ajd.13786
  9. Fässler M, Radonjic-Hoesli S, Feldmeyer L, et al. Successful treatment of refractory folliculitis decalvans with apremilast. JAAD Case Rep. 2020;6:1079-1081. doi:10.1016/j.jdcr.2020.08.019
  10. Ismail FF, Sinclair R. Successful treatment of refractory folliculitis decalvans with secukinumab. Australas J Dermatol. 2020;61:165-166. doi:10.1111/ajd.13190
  11. Miguel-Gómez L, Rodrigues-Barata AR, Molina-Ruiz A, et al. Folliculitis decalvans: effectiveness of therapies and prognostic factors in a multicenter series of 60 patients with long-term follow-up. J Am Acad Dermatol. 2018;79:878-883. doi:10.1016/j.jaad.2018.05.1240
  12. Tietze JK, Heppt MV, von Preußen A, et al. Oral isotretinoin as the most effective treatment in folliculitis decalvans: a retrospective comparison of different treatment regimens in 28 patients. J Eur Acad Dermatol Venereol. 2015;29:1816-1821. doi:10.1111/jdv.13052
References
  1. Otberg N, Kang H, Alzolibani AA, et al. Folliculitis decalvans. Dermatol Ther. 2008;21:238-244. doi:10.1111/j.1529-8019.2008.00204.x
  2. Shireen F, Sudhakar A. A case of isotretinoin therapy-refractory folliculitis decalvans treated successfully with biosimilar adalimumab (Exemptia). Int J Trichology. 2018;10:240-241.
  3. Iorizzo M, Starace M, Vano-Galvan S, et al. Refractory folliculitis decalvans treated with adalimumab: a case series of 23 patients. J Am Acad Dermatol. 2022;87:666-669. doi:10.1016/j.jaad.2022.02.044
  4. Kreutzer K, Effendy I. Therapy-resistant folliculitis decalvans and lichen planopilaris successfully treated with adalimumab. J Dtsch Dermatol Ges. 2014;12:74-76. doi:10.1111/ddg.12224
  5. Alhameedy MM, Alsantali AM. Therapy-recalcitrant folliculitis decalvans controlled successfully with adalimumab. Int J Trichology. 2019;11:241-243. doi:10.4103/ijt.ijt_92_19
  6. Mihaljevic´ N, von den Driesch P. Successful use of infliximab in a patient with recalcitrant folliculitis decalvans. J Dtsch Dermatol Ges. 2012;10:589-590. doi:10.1111/j.1610-0387.2012.07972.x
  7. Hoy M, Böhm M. Therapy-refractory folliculitis decalvans treated with certolizumab pegol. Int J Dermatol. 2022;61:e26-e28. doi:10.1111/ijd.15914
  8. Moussa A, Asfour L, Eisman S, et al. Successful treatment of folliculitis decalvans with baricitinib: a case series. Australas J Dermatol. 2022;63:279-281. doi:10.1111/ajd.13786
  9. Fässler M, Radonjic-Hoesli S, Feldmeyer L, et al. Successful treatment of refractory folliculitis decalvans with apremilast. JAAD Case Rep. 2020;6:1079-1081. doi:10.1016/j.jdcr.2020.08.019
  10. Ismail FF, Sinclair R. Successful treatment of refractory folliculitis decalvans with secukinumab. Australas J Dermatol. 2020;61:165-166. doi:10.1111/ajd.13190
  11. Miguel-Gómez L, Rodrigues-Barata AR, Molina-Ruiz A, et al. Folliculitis decalvans: effectiveness of therapies and prognostic factors in a multicenter series of 60 patients with long-term follow-up. J Am Acad Dermatol. 2018;79:878-883. doi:10.1016/j.jaad.2018.05.1240
  12. Tietze JK, Heppt MV, von Preußen A, et al. Oral isotretinoin as the most effective treatment in folliculitis decalvans: a retrospective comparison of different treatment regimens in 28 patients. J Eur Acad Dermatol Venereol. 2015;29:1816-1821. doi:10.1111/jdv.13052
Issue
Cutis - 113(5)
Issue
Cutis - 113(5)
Page Number
E32-E34
Page Number
E32-E34
Publications
Publications
Topics
Article Type
Display Headline
Recalcitrant Folliculitis Decalvans Treatment Outcomes With Biologics and Small Molecule Inhibitors
Display Headline
Recalcitrant Folliculitis Decalvans Treatment Outcomes With Biologics and Small Molecule Inhibitors
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>Fakhoury</fileName> <TBEID>0C02F762.SIG</TBEID> <TBUniqueIdentifier>NJ_0C02F762</TBUniqueIdentifier> <newsOrJournal>Journal</newsOrJournal> <publisherName>Frontline Medical Communications Inc.</publisherName> <storyname>Fakhoury</storyname> <articleType>1</articleType> <TBLocation>Copyfitting-CT</TBLocation> <QCDate/> <firstPublished>20240530T115430</firstPublished> <LastPublished>20240530T115430</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240530T115430</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Tamara Fakhoury, DO</byline> <bylineText>Tamara Fakhoury, DO; Katelyn Urban, DO; Leila Ettefagh, MD; Navid Nami, DO</bylineText> <bylineFull>Tamara Fakhoury, DO</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange>E32-E34</pageRange> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:"> <name/> <rightsInfo> <copyrightHolder> <name/> </copyrightHolder> <copyrightNotice/> </rightsInfo> </provider> <abstract/> <metaDescription>F olliculitis decalvans (FD) is classified as a rare primary neutrophilic cicatricial alopecia occurring predominantly in middle-aged adults. Although the true </metaDescription> <articlePDF>301629</articlePDF> <teaserImage/> <title>Recalcitrant Folliculitis Decalvans Treatment Outcomes With Biologics and Small Molecule Inhibitors</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear>2024</pubPubdateYear> <pubPubdateMonth>May</pubPubdateMonth> <pubPubdateDay/> <pubVolume>113</pubVolume> <pubNumber>5</pubNumber> <wireChannels/> <primaryCMSID/> <CMSIDs> <CMSID>2161</CMSID> </CMSIDs> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>CT</publicationCode> <pubIssueName>July 2024</pubIssueName> <pubArticleType>Original Articles | 2161</pubArticleType> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle>Cutis</journalTitle> <journalFullTitle>Cutis</journalFullTitle> <copyrightStatement>Copyright 2015 Frontline Medical Communications Inc., Parsippany, NJ, USA. All rights reserved.</copyrightStatement> </publicationData> </publications_g> <publications> <term canonical="true">12</term> </publications> <sections> <term canonical="true">49</term> </sections> <topics> <term canonical="true">219</term> </topics> <links> <link> <itemClass qcode="ninat:composite"/> <altRep contenttype="application/pdf">images/1800273a.pdf</altRep> <description role="drol:caption"/> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Recalcitrant Folliculitis Decalvans Treatment Outcomes With Biologics and Small Molecule Inhibitors</title> <deck/> </itemMeta> <itemContent> <p class="abstract">Folliculitis decalvans (FD) is a rare primary neutrophilic cicatricial alopecia that commonly displays resistance to traditional therapies and remains challenging to treat. Currently, data are lacking with recommendations for therapy-recalcitrant FD. A systematic review was conducted to analyze biologics, small molecule inhibitors, tumor necrosis factor (TNF) inhibitors, Janus kinase (JAK) inhibitors, phosphodiesterase 4 (PDE4) inhibitors, and monoclonal antibodies<sup> </sup>utilized in the treatment of recalcitrant FD.</p> <p> <span class="body">F</span> olliculitis decalvans (FD) is classified as a rare primary neutrophilic cicatricial alopecia occurring predominantly in middle-aged adults. Although the true etiology is still unknown, the pathogenesis behind the inflammatory follicular lesions stems from possible <i>Staphylococcus aureus</i> infection and an impaired host immune system in response to released superantigens. <sup>1</sup> The clinical severity of this inflammatory scalp disorder can range from mild to severe and debilitating. Multiple treatment regimens have been developed with the goal of maintaining full remission. We provide a summary of tumor necrosis factor (TNF) inhibitors, Janus kinase (JAK) inhibitors, phosphodiesterase 4 (PDE4) inhibitors, and monoclonal antibodies being utilized for patients with therapy-recalcitrant FD. </p> <h3>Methods</h3> <p>We conducted a PubMed, Medline, and Google Scholar search for the terms <i>refractory FD</i>, <i>recalcitrant FD</i>, or <i>therapy-resistant FD</i> to identify articles published in English from 1998 to 2022. Articles that reported recalcitrant cases and subsequent therapy with TNF inhibitors, JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies were included. Articles were excluded if recalcitrant cases were not clearly defined. Remission was defined as no recurrence in lesions or pustules or as a reduction in the inflammatory process with stabilization upon continuation or discontinuation of the therapy regimen. Two reviewers (T.F. and K.U.) independently searched for and screened each report.</p> <h3>Results </h3> <p>Treatment of recalcitrant FD with biologics or small molecule inhibitors was discussed in 9 studies with a combined total of 35 patients.<sup>2-10</sup> The treatment regimens included TNF inhibitors, JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies (Table).</p> <p>The TNF inhibitors were utilized in 6 reports with a combined total of 29 patients. Treatments included adalimumab or biosimilar adalimumab (27/29 patients), infliximab (1/29 patients), and certolizumab pegol (1/29 patients). Remission was reported in 26 of 29 cases. There were 2 nonresponders to adalimumab and marked improvement with certolizumab pegol without complete resolution. The use of the JAK inhibitor baricitinib in 4 patients resulted in remission. In all 4 patients, baricitinib was used with concurrent treatments, and remission was achieved in an average of 2.25 months. The use of a PDE4 inhibitor, apremilast, was reported in 1 case; remission was achieved in 3 weeks. Secukinumab, a monoclonal antibody that targets IL-17, was utilized in 1 patient. Marked improvement was seen after 2 months, with complete remission in 7 months. </p> <h3>Comment</h3> <p>Traditional treatment regimens for FD most often include a combination of topical and oral antibiotics; isotretinoin; and oral, topical, or intralesional corticosteroids. In the past, interventions typically were suppressive as opposed to curative; however, recent treatment advancements have shown promise in achieving lasting remission.</p> <p>Most reports targeting treatment-resistant FD involved the use of TNF inhibitors, including adalimumab, biosimilar adalimumab, infliximab, and certolizumab pegol.  Adalimumab was the most frequently used TNF inhibitor, with 24 of 26 treated patients achieving remission. Adalimumab may have been used the most in the treatment of FD because TNF is pronounced in other neutrophilic dermatoses that have been successfully treated with TNF inhibitors. It has been reported that adalimumab needs to be continued, as stoppage or interruption led to relapse.<sup>3<br/><br/></sup>Although there are few reports of the use of JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies for FD, these treatment modalities show promise, as their use led to marked improvement or lasting remission with ongoing treatment. The use of the PDE4 inhibitor apremilast displayed the most rapid improvement of any of the reviewed treatments, with remission achieved in just 3 weeks.<sup>9</sup> The rapid success of apremilast may be attributed to the inhibitory effect on neutrophils. <br/><br/>Miguel-Gómez et al<sup>11</sup> provided a therapeutic protocol for FD based on the severity of disease (N<span class="body">=</span>60). The protocol included rifampicin plus clindamycin for the treatment of severe disease, as 90.5% (19/21) of resistant cases showed clinical response, with remission of 5 months’ duration. Although this may be acceptable for some patients, others may require an alternative approach. Tietze et al<sup>12</sup> showed that rifampicin and clindamycin had the lowest success rate for long-term remission, with 8 of 10 patients relapsing within 2 to 4 months. In addition, the emergence of antimicrobial resistance remains a major concern in the treatment of FD. Upon the review of the most recent reports of successful treatment of ­therapy-resistant FD, biologics and small molecule inhibitors have shown remission extending through a 12-month follow-up period. We suggest considering the addition of biologics and small molecule inhibitors to the treatment protocol for severe or resistant disease.<br/><br/><i>Limitations</i>—In the articles reviewed, the definition of remission was inconsistent among authors—some characterized it as no recurrence in lesions or pustules and some as a reduction in the inflammatory process. True duration of remission was difficult to assess from case reports, as follow-up periods varied prior to publication. The studies included in this review consisted mainly of small sample sizes owing to the rarity of FD, and consequently, strength of evidence is lacking. Inherent to the nature of systematic reviews, publication bias may have occurred. Lastly, several studies were impacted by difficulty in obtaining optimal treatment due to financial hardship, and regimens were adjusted accordingly. </p> <h3>Conclusion</h3> <p>The relapsing nature of FD leads to frustration and poor quality of life for patients. There is a paucity of data to guide treatment when FD remains recalcitrant to traditional therapy. Therapies such as TNF inhibitors, JAK inhibitors, PDE4 inhibitors, and monoclonal antibodies have shown success in the treatment of this often ­difficult-to-treat disease. Small sample sizes in reports discussing treatment for resistant cases as well as conflicting results make it challenging to draw conclusions about treatment efficacy. Larger studies are needed to understand the long-term outcomes of treatment options. Regardless, disease severity, patient history, patient preferences, and treatment goals can guide the selection of therapeutic options. </p> <h2>References </h2> <p class="reference"> 1. Otberg N, Kang H, Alzolibani AA, et al. Folliculitis decalvans. <i>Dermatol Ther</i>. 2008;21:238-244. doi:10.1111/j.1529-8019.2008.00204.x</p> <p class="reference"> 2. Shireen F, Sudhakar A. A case of isotretinoin therapy-refractory folliculitis decalvans treated successfully with biosimilar adalimumab (Exemptia). <i>Int J Trichology</i>. 2018;10:240-241.<br/><br/> 3. Iorizzo M, Starace M, Vano-Galvan S, et al. Refractory folliculitis decalvans treated with adalimumab: a case series of 23 patients. <i>J Am Acad Dermatol</i>. 2022;87:666-669. doi:10.1016/j.jaad.2022.02.044<br/><br/> 4. Kreutzer K, Effendy I. Therapy-resistant folliculitis decalvans and lichen planopilaris successfully treated with adalimumab. <i>J Dtsch Dermatol Ges</i>. 2014;12:74-76. doi:<a href="https://doi.org/10.1111/ddg.12224">10.1111/ddg.12224</a><br/><br/> 5. Alhameedy MM, Alsantali AM. Therapy-recalcitrant folliculitis decalvans controlled successfully with adalimumab<i>. Int J Trichology</i>. 2019;11:241-243. doi:<a href="https://doi.org/10.4103/ijt.ijt_92_19">10.4103/ijt.ijt_92_19</a><br/><br/> 6. Mihaljevic´ N, von den Driesch P. Successful use of infliximab in a patient with recalcitrant folliculitis decalvans. <i>J Dtsch Dermatol Ges</i>. 2012;10:589-590. doi:<a href="https://doi.org/10.1111/j.1610-0387.2012.07972.x">10.1111/j.1610-0387.2012.07972.x</a><br/><br/> 7. Hoy M, Böhm M. Therapy-refractory folliculitis decalvans treated with certolizumab pegol. <i>Int J Dermatol</i>. 2022;61:e26-e28. doi:<a href="https://doi.org/10.1111/ijd.15914">10.1111/ijd.15914</a><br/><br/> 8. Moussa A, Asfour L, Eisman S, et al. Successful treatment of folliculitis decalvans with baricitinib: a case series. <i>Australas J Dermatol</i>. 2022;63:279-281. doi:<a href="https://doi.org/10.1111/ajd.13786">10.1111/ajd.13786</a><br/><br/> 9. Fässler M, Radonjic-Hoesli S, Feldmeyer L, et al. Successful treatment of refractory folliculitis decalvans with apremilast. <i>JAAD Case Rep</i>. 2020;6:1079-1081. doi:<a href="https://doi.org/10.1016/j.jdcr.2020.08.019">10.1016/j.jdcr.2020.08.019</a><br/><br/>10. Ismail FF, Sinclair R. Successful treatment of refractory folliculitis decalvans with secukinumab. <i>Australas J Dermatol</i>. 2020;61:165-166. doi:<a href="https://doi.org/10.1111/ajd.13190">10.1111/ajd.13190</a><br/><br/>11. Miguel-Gómez L, Rodrigues-Barata AR, Molina-Ruiz A, et al. Folliculitis decalvans: effectiveness of therapies and prognostic factors in a multicenter series of 60 patients with long-term follow-up. <i>J Am Acad Dermatol</i>. 2018;79:878-883. doi:10.1016/j.jaad.2018.05.1240<br/><br/>12. Tietze JK, Heppt MV, von Preußen A, et al. Oral isotretinoin as the most effective treatment in folliculitis decalvans: a retrospective comparison of different treatment regimens in 28 patients. <i>J Eur Acad Dermatol Venereol</i>. 2015;29:1816-1821. doi:10.1111/jdv.13052</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>bio</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p class="disclosure">Dr. Fakhoury is from Lake Erie College of Osteopathic Medicine, Bradenton, Florida. Dr. Urban is from Prime West Consortium, Newport Beach, California. Drs. Ettefagh and Nami are from Island Dermatology, Newport Beach.</p> <p class="disclosure">The authors report no conflict of interest. <br/><br/>Correspondence: Katelyn Urban, DO, Prime West Consortium, 360 San Miguel Dr, #501, Newport Beach, CA 92660 (KUrban19071@med.lecom.edu).<br/><br/><em>Cutis</em>. 2024 May;113(5):E32-E34. doi:10.12788/cutis.1023</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>in</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p class="insidehead">Practice <strong>Points</strong></p> <ul class="insidebody"> <li>Tumor necrosis factor inhibitors, Janus kinase inhibitors, phosphodiesterase 4 inhibitors, and monoclonal antibodies have shown success in the treatment of folliculitis decalvans resistant to traditional therapies.</li> </ul> </itemContent> </newsItem> </itemSet></root>
Inside the Article

Practice Points

  • Tumor necrosis factor inhibitors, Janus kinase inhibitors, phosphodiesterase 4 inhibitors, and monoclonal antibodies have shown success in the treatment of folliculitis decalvans resistant to traditional therapies.
  • The true etiology of folliculitis decalvans is still unknown, but possible factors include Staphylococcus aureus infection and an impaired host immune system, which may benefit from treatment with biologics and small molecule inhibitors.
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media
Image
Disable zoom
Off

PCOS: Laser, Light Therapy Helpful for Hirsutism

Article Type
Changed
Mon, 04/22/2024 - 07:53

 

BY DEEPA VARMA

TOPLINE:

In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychological well-being in women, according to the results of a systematic review.

METHODOLOGY:

  • Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened depression.
  • The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.
  • Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.
  • The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.

TAKEAWAY:

  • Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).
  • Combined IPL (600 nm) and metformin therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).
  • Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).
  • Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).

IN PRACTICE:

Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.

SOURCE:

The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was published online in JAMA Dermatology.

LIMITATIONS:

Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.

DISCLOSURES:

The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

Publications
Topics
Sections

 

BY DEEPA VARMA

TOPLINE:

In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychological well-being in women, according to the results of a systematic review.

METHODOLOGY:

  • Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened depression.
  • The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.
  • Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.
  • The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.

TAKEAWAY:

  • Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).
  • Combined IPL (600 nm) and metformin therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).
  • Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).
  • Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).

IN PRACTICE:

Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.

SOURCE:

The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was published online in JAMA Dermatology.

LIMITATIONS:

Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.

DISCLOSURES:

The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

 

BY DEEPA VARMA

TOPLINE:

In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychological well-being in women, according to the results of a systematic review.

METHODOLOGY:

  • Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened depression.
  • The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.
  • Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.
  • The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.

TAKEAWAY:

  • Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).
  • Combined IPL (600 nm) and metformin therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).
  • Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).
  • Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).

IN PRACTICE:

Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.

SOURCE:

The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was published online in JAMA Dermatology.

LIMITATIONS:

Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.

DISCLOSURES:

The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167785</fileName> <TBEID>0C04FB50.SIG</TBEID> <TBUniqueIdentifier>MD_0C04FB50</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240419T154745</QCDate> <firstPublished>20240419T174716</firstPublished> <LastPublished>20240419T174716</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240419T174716</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Deepa Varma</byline> <bylineText/> <bylineFull/> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>In patients with polycystic ovary syndrome (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve hirsutism and psychol</metaDescription> <articlePDF/> <teaserImage/> <title>PCOS: Laser, Light Therapy Helpful for Hirsutism</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>endo</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>ob</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term>13</term> <term canonical="true">34</term> <term>15</term> <term>21</term> <term>23</term> <term>25</term> </publications> <sections> <term>27970</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">219</term> <term>177</term> <term>27442</term> <term>203</term> <term>322</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>PCOS: Laser, Light Therapy Helpful for Hirsutism</title> <deck/> </itemMeta> <itemContent> <p>BY DEEPA VARMA</p> <h2>TOPLINE:</h2> <p><span class="tag metaDescription">In patients with <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/256806-overview">polycystic ovary syndrome</a></span> (PCOS), laser and light therapies, alone or in combination with pharmacological agents, improve <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/121038-overview">hirsutism</a></span> and psychological well-being in women</span>, according to the results of a systematic review.</p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers, despite its significant psychological repercussions, including diminished self-esteem, reduced quality of life, and heightened <span class="Hyperlink">depression</span>.</li> <li>The 2023 international evidence-based PCOS guideline considers managing hirsutism a priority in women with PCOS.</li> <li>Researchers reviewed six studies (four randomized controlled trials and two cohort studies), which included 423 patients with PCOS who underwent laser or light-based hair reduction therapies, published through 2022.</li> <li>The studies evaluated the alexandrite laser, diode laser, and intense pulsed light (IPL) therapy, with and without pharmacological treatments. The main outcomes were hirsutism severity, psychological outcome, and adverse events.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>Alexandrite laser (wavelength, 755 nm) showed effective hair reduction and improved patient satisfaction (one study); high-fluence treatment yielded better outcomes than low-fluence treatment (one study). Alexandrite laser 755 nm also showed longer hair-free intervals and greater hair reduction than IPL therapy at 650-1000 nm (one study).</li> <li>Combined IPL (600 nm) and <span class="Hyperlink">metformin</span> therapy improved hirsutism and hair count reduction compared with IPL alone, but with more side effects (one study).</li> <li>Diode laser treatments (810 nm) with combined oral contraceptives improved hirsutism and related quality of life measures compared with diode laser alone or with metformin (one study).</li> <li>Comparing two diode lasers (wavelengths, 810 nm), low-fluence, high repetition laser showed superior hair width reduction and lower pain scores than high fluence, low-repetition laser (one study).</li> </ul> <h2>IN PRACTICE:</h2> <p>Laser and light treatments alone or combined with other treatments have demonstrated “encouraging results in reducing hirsutism severity, enhancing psychological well-being, and improving overall quality of life for affected individuals,” the authors wrote, noting that additional high-quality trials evaluating these treatments, which include more patients with different skin tones, are needed.</p> <h2>SOURCE:</h2> <p>The first author of the review is Katrina Tan, MD, Monash Health, Department of Dermatology, Melbourne, Victoria, Australia, and it was <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamadermatology/fullarticle/2817737?guestAccessKey=e026076a-a367-4779-9b77-19e79560182f&amp;utm_source=silverchair&amp;utm_medium=email&amp;utm_campaign=article_alert-jamadermatology&amp;utm_content=olf&amp;utm_term=041724&amp;adv=000003613421">published online</a> </span>in <em>JAMA Dermatology</em>.</p> <h2>LIMITATIONS:</h2> <p>Limitations include low certainty of evidence because of the observational nature of some of the studies, the small number of studies, and underrepresentation of darker skin types, limiting generalizability.</p> <h2>DISCLOSURES:</h2> <p>The review is part of an update to the PCOS guideline, which was funded by the Australian National Health and Medical Research Council through various organizations. Several authors reported receiving grants and personal fees outside this work. Dr. Tan was a member of the 2023 PCOS guideline evidence team. Other authors declared no conflicts of interest.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/review-highlights-benefits-laser-light-therapy-pcos-related-2024a10007i0?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p>Hirsutism, which affects 70%-80% of women with PCOS, is frequently marginalized as a cosmetic issue by healthcare providers.</p> </itemContent> </newsItem> </itemSet></root>
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Consensus Statement Aims to Guide Use of Low-Dose Oral Minoxidil for Hair Loss

Article Type
Changed
Wed, 04/24/2024 - 10:11

 

Compared with the use of topical minoxidil for hair loss, the used of low-dose oral minoxidil (LDOM) can be considered when topical minoxidil is more expensive or logistically challenging, has plateaued in efficacy, leaves unwanted product residue, causes skin irritation, or exacerbates the inflammatory process.

Those are among the key recommendations that resulted from a modified eDelphi consensus of experts who convened to develop guidelines for LDOM prescribing and monitoring.

“Topical minoxidil is safe, effective, over-the-counter, and FDA-approved to treat the most common form of hair loss, androgenetic alopecia,” one of the study authors, Jennifer Fu, MD, a dermatologist who directs the Hair Disorders Clinic at the University of California, San Francisco, told this news organization following the annual meeting of the American Academy of Dermatology. The results of the expert consensus were presented during a poster session at the meeting. “It is often used off label for other types of hair loss, yet clinicians who treat hair loss know that patient compliance with topical minoxidil can be poor for a variety of reasons,” she said. “Patients report that it can be difficult to apply and complicate hair styling. For many patients, topical minoxidil can be drying or cause irritant or allergic contact reactions.”

Fu_Jennifer_CA_web.jpg
Dr. Jennifer Fu

LDOM has become a popular alternative for patients for whom topical minoxidil is logistically challenging, irritating, or ineffective, she continued. Although oral minoxidil is no longer a first-line antihypertensive agent given the risk of cardiovascular adverse effects at higher antihypertensive dosing (10-40 mg daily), a growing number of small studies have documented the use of LDOM at doses ranging from 0.25 mg to 5 mg daily as a safe, effective option for various types of hair loss.

“Given the current absence of larger trials on this topic, our research group identified a need for expert-based guidelines for prescribing and monitoring LDOM use in hair loss patients,” Dr. Fu said. “Our goal was to provide clinicians who treat hair loss patients a road map for using LDOM effectively, maximizing hair growth, and minimizing potential cardiovascular adverse effects.”


 

Arriving at a Consensus

The process involved 43 hair loss specialists from 12 countries with an average of 6.29 years of experience with LDOM for hair loss, who participated in a multi-round modified Delphi process. They considered questions that addressed LDOM safety, efficacy, dosing, and monitoring for hair loss, and consensus was reached if at least 70% of participants indicated “agree” or “strongly agree” on a five-point Likert scale. Round 1 consisted of 180 open-ended, multiple-choice, or Likert-scale questions, while round 2 involved 121 Likert-scale questions, round 3 consisted of 16 Likert-scale questions, and round 4 included 11 Likert-scale questions. In all, 94 items achieved Likert-scale consensus.

Specifically, experts on the panel found a direct benefit of LDOM for androgenetic alopecia, age-related patterned thinning, alopecia areata, telogen effluvium, traction alopecia, persistent chemotherapy-induced alopecia, and endocrine therapy-induced alopecia. They found a supportive benefit of LDOM for lichen planopilaris, frontal fibrosing alopecia, central centrifugal alopecia, and fibrosing alopecia in a patterned distribution.

“LDOM can be considered when topical minoxidil is more expensive, logistically challenging, has plateaued in efficacy, results in undesirable product residue/skin irritation,” or exacerbates inflammatory processes (ie eczema, psoriasis), they added.

Contraindications to LDOM listed in the consensus recommendations include hypersensitivity to minoxidil, significant drug-drug interactions with LDOM, a history of pericardial effusion/tamponade, pericarditis, heart failure, pulmonary hypertension associated with mitral stenosis, pheochromocytoma, and pregnancy/breastfeeding. Cited precautions of LDOM use include a history of tachycardia or arrhythmia, hypotension, renal impairment, and being on dialysis.

Dr. Fu and colleagues noted that the earliest time point at which LDOM should be expected to demonstrate efficacy is 3-6 months. “Baseline testing is not routine but may be considered in case of identified precautions,” they wrote. They also noted that LDOM can possibly be co-administered with beta-blockers with a specialty consultation, and with spironolactone in biologic female or transgender female patients with hirsutism, acne, polycystic ovary syndrome (PCOS), and with lower extremity and facial edema.

According to the consensus statement, the most frequently prescribed LDOM dosing regimen in adult females aged 18 years and older includes a starting dose of 1.25 mg daily, with a dosing range between 0.625 mg and 5 mg daily. For adult males, the most frequently prescribed dosing regimen is a starting dose of 2.5 daily, with a dosing range between 1.25 mg and 5 mg daily. The most frequently prescribed LDOM dosing regimen in adolescent females aged 12-17 years is a starting dose of 0.625 mg daily, with a dosing range of 0.625 to 2.5 mg daily. For adolescent males, the recommended regimen is a starting dose of 1.25 mg daily, with a dosing range of 1.25 mg to 5 mg daily.

“We hope that this consensus statement will guide our colleagues who would like to use LDOM to treat hair loss in their adult and adolescent patients,” Dr. Fu told this news organization. “These recommendations may be used to inform clinical practice until additional evidence-based data becomes available.”

She acknowledged certain limitations of the effort, including the fact that the expert panel was underrepresented in treating hair loss in pediatric patients, “and therefore failed to reach consensus on LDOM pediatric use and dosing,” she said. “We encourage our pediatric dermatology colleagues to further research LDOM in pediatric patients.”

In an interview, Shari Lipner, MD, PhD, associate professor of clinical dermatology, Weill Cornell Medicine, New York, who was asked to comment, but was not involved with the work, characterized the consensus as a “helpful, concise reference guide for dermatologists.”

Lipner_Shari_R_NY_web.jpg
Dr. Shari R. Lipner

The advantages of the study are the standardized methods used, “and the experience of the panel,” she said. “Study limitations include the response rate, which was less than 60%, and the risk of potential side effects are not stratified by age, sex, or comorbidities,” she added.

Dr. Fu disclosed that she is a consultant to Pfizer. Dr. Lipner reported having no relevant disclosures.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

Compared with the use of topical minoxidil for hair loss, the used of low-dose oral minoxidil (LDOM) can be considered when topical minoxidil is more expensive or logistically challenging, has plateaued in efficacy, leaves unwanted product residue, causes skin irritation, or exacerbates the inflammatory process.

Those are among the key recommendations that resulted from a modified eDelphi consensus of experts who convened to develop guidelines for LDOM prescribing and monitoring.

“Topical minoxidil is safe, effective, over-the-counter, and FDA-approved to treat the most common form of hair loss, androgenetic alopecia,” one of the study authors, Jennifer Fu, MD, a dermatologist who directs the Hair Disorders Clinic at the University of California, San Francisco, told this news organization following the annual meeting of the American Academy of Dermatology. The results of the expert consensus were presented during a poster session at the meeting. “It is often used off label for other types of hair loss, yet clinicians who treat hair loss know that patient compliance with topical minoxidil can be poor for a variety of reasons,” she said. “Patients report that it can be difficult to apply and complicate hair styling. For many patients, topical minoxidil can be drying or cause irritant or allergic contact reactions.”

Fu_Jennifer_CA_web.jpg
Dr. Jennifer Fu

LDOM has become a popular alternative for patients for whom topical minoxidil is logistically challenging, irritating, or ineffective, she continued. Although oral minoxidil is no longer a first-line antihypertensive agent given the risk of cardiovascular adverse effects at higher antihypertensive dosing (10-40 mg daily), a growing number of small studies have documented the use of LDOM at doses ranging from 0.25 mg to 5 mg daily as a safe, effective option for various types of hair loss.

“Given the current absence of larger trials on this topic, our research group identified a need for expert-based guidelines for prescribing and monitoring LDOM use in hair loss patients,” Dr. Fu said. “Our goal was to provide clinicians who treat hair loss patients a road map for using LDOM effectively, maximizing hair growth, and minimizing potential cardiovascular adverse effects.”


 

Arriving at a Consensus

The process involved 43 hair loss specialists from 12 countries with an average of 6.29 years of experience with LDOM for hair loss, who participated in a multi-round modified Delphi process. They considered questions that addressed LDOM safety, efficacy, dosing, and monitoring for hair loss, and consensus was reached if at least 70% of participants indicated “agree” or “strongly agree” on a five-point Likert scale. Round 1 consisted of 180 open-ended, multiple-choice, or Likert-scale questions, while round 2 involved 121 Likert-scale questions, round 3 consisted of 16 Likert-scale questions, and round 4 included 11 Likert-scale questions. In all, 94 items achieved Likert-scale consensus.

Specifically, experts on the panel found a direct benefit of LDOM for androgenetic alopecia, age-related patterned thinning, alopecia areata, telogen effluvium, traction alopecia, persistent chemotherapy-induced alopecia, and endocrine therapy-induced alopecia. They found a supportive benefit of LDOM for lichen planopilaris, frontal fibrosing alopecia, central centrifugal alopecia, and fibrosing alopecia in a patterned distribution.

“LDOM can be considered when topical minoxidil is more expensive, logistically challenging, has plateaued in efficacy, results in undesirable product residue/skin irritation,” or exacerbates inflammatory processes (ie eczema, psoriasis), they added.

Contraindications to LDOM listed in the consensus recommendations include hypersensitivity to minoxidil, significant drug-drug interactions with LDOM, a history of pericardial effusion/tamponade, pericarditis, heart failure, pulmonary hypertension associated with mitral stenosis, pheochromocytoma, and pregnancy/breastfeeding. Cited precautions of LDOM use include a history of tachycardia or arrhythmia, hypotension, renal impairment, and being on dialysis.

Dr. Fu and colleagues noted that the earliest time point at which LDOM should be expected to demonstrate efficacy is 3-6 months. “Baseline testing is not routine but may be considered in case of identified precautions,” they wrote. They also noted that LDOM can possibly be co-administered with beta-blockers with a specialty consultation, and with spironolactone in biologic female or transgender female patients with hirsutism, acne, polycystic ovary syndrome (PCOS), and with lower extremity and facial edema.

According to the consensus statement, the most frequently prescribed LDOM dosing regimen in adult females aged 18 years and older includes a starting dose of 1.25 mg daily, with a dosing range between 0.625 mg and 5 mg daily. For adult males, the most frequently prescribed dosing regimen is a starting dose of 2.5 daily, with a dosing range between 1.25 mg and 5 mg daily. The most frequently prescribed LDOM dosing regimen in adolescent females aged 12-17 years is a starting dose of 0.625 mg daily, with a dosing range of 0.625 to 2.5 mg daily. For adolescent males, the recommended regimen is a starting dose of 1.25 mg daily, with a dosing range of 1.25 mg to 5 mg daily.

“We hope that this consensus statement will guide our colleagues who would like to use LDOM to treat hair loss in their adult and adolescent patients,” Dr. Fu told this news organization. “These recommendations may be used to inform clinical practice until additional evidence-based data becomes available.”

She acknowledged certain limitations of the effort, including the fact that the expert panel was underrepresented in treating hair loss in pediatric patients, “and therefore failed to reach consensus on LDOM pediatric use and dosing,” she said. “We encourage our pediatric dermatology colleagues to further research LDOM in pediatric patients.”

In an interview, Shari Lipner, MD, PhD, associate professor of clinical dermatology, Weill Cornell Medicine, New York, who was asked to comment, but was not involved with the work, characterized the consensus as a “helpful, concise reference guide for dermatologists.”

Lipner_Shari_R_NY_web.jpg
Dr. Shari R. Lipner

The advantages of the study are the standardized methods used, “and the experience of the panel,” she said. “Study limitations include the response rate, which was less than 60%, and the risk of potential side effects are not stratified by age, sex, or comorbidities,” she added.

Dr. Fu disclosed that she is a consultant to Pfizer. Dr. Lipner reported having no relevant disclosures.

 

Compared with the use of topical minoxidil for hair loss, the used of low-dose oral minoxidil (LDOM) can be considered when topical minoxidil is more expensive or logistically challenging, has plateaued in efficacy, leaves unwanted product residue, causes skin irritation, or exacerbates the inflammatory process.

Those are among the key recommendations that resulted from a modified eDelphi consensus of experts who convened to develop guidelines for LDOM prescribing and monitoring.

“Topical minoxidil is safe, effective, over-the-counter, and FDA-approved to treat the most common form of hair loss, androgenetic alopecia,” one of the study authors, Jennifer Fu, MD, a dermatologist who directs the Hair Disorders Clinic at the University of California, San Francisco, told this news organization following the annual meeting of the American Academy of Dermatology. The results of the expert consensus were presented during a poster session at the meeting. “It is often used off label for other types of hair loss, yet clinicians who treat hair loss know that patient compliance with topical minoxidil can be poor for a variety of reasons,” she said. “Patients report that it can be difficult to apply and complicate hair styling. For many patients, topical minoxidil can be drying or cause irritant or allergic contact reactions.”

Fu_Jennifer_CA_web.jpg
Dr. Jennifer Fu

LDOM has become a popular alternative for patients for whom topical minoxidil is logistically challenging, irritating, or ineffective, she continued. Although oral minoxidil is no longer a first-line antihypertensive agent given the risk of cardiovascular adverse effects at higher antihypertensive dosing (10-40 mg daily), a growing number of small studies have documented the use of LDOM at doses ranging from 0.25 mg to 5 mg daily as a safe, effective option for various types of hair loss.

“Given the current absence of larger trials on this topic, our research group identified a need for expert-based guidelines for prescribing and monitoring LDOM use in hair loss patients,” Dr. Fu said. “Our goal was to provide clinicians who treat hair loss patients a road map for using LDOM effectively, maximizing hair growth, and minimizing potential cardiovascular adverse effects.”


 

Arriving at a Consensus

The process involved 43 hair loss specialists from 12 countries with an average of 6.29 years of experience with LDOM for hair loss, who participated in a multi-round modified Delphi process. They considered questions that addressed LDOM safety, efficacy, dosing, and monitoring for hair loss, and consensus was reached if at least 70% of participants indicated “agree” or “strongly agree” on a five-point Likert scale. Round 1 consisted of 180 open-ended, multiple-choice, or Likert-scale questions, while round 2 involved 121 Likert-scale questions, round 3 consisted of 16 Likert-scale questions, and round 4 included 11 Likert-scale questions. In all, 94 items achieved Likert-scale consensus.

Specifically, experts on the panel found a direct benefit of LDOM for androgenetic alopecia, age-related patterned thinning, alopecia areata, telogen effluvium, traction alopecia, persistent chemotherapy-induced alopecia, and endocrine therapy-induced alopecia. They found a supportive benefit of LDOM for lichen planopilaris, frontal fibrosing alopecia, central centrifugal alopecia, and fibrosing alopecia in a patterned distribution.

“LDOM can be considered when topical minoxidil is more expensive, logistically challenging, has plateaued in efficacy, results in undesirable product residue/skin irritation,” or exacerbates inflammatory processes (ie eczema, psoriasis), they added.

Contraindications to LDOM listed in the consensus recommendations include hypersensitivity to minoxidil, significant drug-drug interactions with LDOM, a history of pericardial effusion/tamponade, pericarditis, heart failure, pulmonary hypertension associated with mitral stenosis, pheochromocytoma, and pregnancy/breastfeeding. Cited precautions of LDOM use include a history of tachycardia or arrhythmia, hypotension, renal impairment, and being on dialysis.

Dr. Fu and colleagues noted that the earliest time point at which LDOM should be expected to demonstrate efficacy is 3-6 months. “Baseline testing is not routine but may be considered in case of identified precautions,” they wrote. They also noted that LDOM can possibly be co-administered with beta-blockers with a specialty consultation, and with spironolactone in biologic female or transgender female patients with hirsutism, acne, polycystic ovary syndrome (PCOS), and with lower extremity and facial edema.

According to the consensus statement, the most frequently prescribed LDOM dosing regimen in adult females aged 18 years and older includes a starting dose of 1.25 mg daily, with a dosing range between 0.625 mg and 5 mg daily. For adult males, the most frequently prescribed dosing regimen is a starting dose of 2.5 daily, with a dosing range between 1.25 mg and 5 mg daily. The most frequently prescribed LDOM dosing regimen in adolescent females aged 12-17 years is a starting dose of 0.625 mg daily, with a dosing range of 0.625 to 2.5 mg daily. For adolescent males, the recommended regimen is a starting dose of 1.25 mg daily, with a dosing range of 1.25 mg to 5 mg daily.

“We hope that this consensus statement will guide our colleagues who would like to use LDOM to treat hair loss in their adult and adolescent patients,” Dr. Fu told this news organization. “These recommendations may be used to inform clinical practice until additional evidence-based data becomes available.”

She acknowledged certain limitations of the effort, including the fact that the expert panel was underrepresented in treating hair loss in pediatric patients, “and therefore failed to reach consensus on LDOM pediatric use and dosing,” she said. “We encourage our pediatric dermatology colleagues to further research LDOM in pediatric patients.”

In an interview, Shari Lipner, MD, PhD, associate professor of clinical dermatology, Weill Cornell Medicine, New York, who was asked to comment, but was not involved with the work, characterized the consensus as a “helpful, concise reference guide for dermatologists.”

Lipner_Shari_R_NY_web.jpg
Dr. Shari R. Lipner

The advantages of the study are the standardized methods used, “and the experience of the panel,” she said. “Study limitations include the response rate, which was less than 60%, and the risk of potential side effects are not stratified by age, sex, or comorbidities,” she added.

Dr. Fu disclosed that she is a consultant to Pfizer. Dr. Lipner reported having no relevant disclosures.

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167745</fileName> <TBEID>0C04FA3F.SIG</TBEID> <TBUniqueIdentifier>MD_0C04FA3F</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240418T164628</QCDate> <firstPublished>20240418T174041</firstPublished> <LastPublished>20240418T174042</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240418T174041</CMSDate> <articleSource>FROM AAD 2024 </articleSource> <facebookInfo/> <meetingNumber>2884-24</meetingNumber> <byline>Doug Brunk</byline> <bylineText>DOUG BRUNK</bylineText> <bylineFull>DOUG BRUNK</bylineFull> <bylineTitleText>MDedge News</bylineTitleText> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Compared with the use of topical minoxidil for hair loss, the used of low-dose oral minoxidil (LDOM) can be considered when topical minoxidil is more expensive </metaDescription> <articlePDF/> <teaserImage>301143</teaserImage> <teaser>The earliest time point at which LDOM should be expected to demonstrate efficacy is 3-6 months.</teaser> <title>Consensus Statement Aims to Guide Use of Low-Dose Oral Minoxidil for Hair Loss</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>15</term> <term>21</term> </publications> <sections> <term>53</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">219</term> <term>203</term> <term>177</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012852.jpg</altRep> <description role="drol:caption">Dr. Jennifer Fu</description> <description role="drol:credit">Dr. Fu</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24011b6b.jpg</altRep> <description role="drol:caption">Dr. Shari R. Lipner</description> <description role="drol:credit">Dr. Lipner</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Consensus Statement Aims to Guide Use of Low-Dose Oral Minoxidil for Hair Loss</title> <deck/> </itemMeta> <itemContent> <p><span class="dateline">SAN DIEGO </span>— <span class="tag metaDescription">Compared with the use of topical minoxidil for hair loss, the used of low-dose oral minoxidil (LDOM) can be considered when topical minoxidil is more expensive or logistically challenging, has plateaued in efficacy, leaves unwanted product residue, causes skin irritation, or exacerbates the inflammatory process</span>.</p> <p>Those are among the key recommendations that resulted from a modified eDelphi consensus of experts who convened to develop guidelines for LDOM prescribing and monitoring.<br/><br/>“Topical minoxidil is safe, effective, over-the-counter, and FDA-approved to treat the most common form of hair loss, androgenetic alopecia,” one of the study authors, <span class="Hyperlink"><a href="https://www.ucsfhealth.org/providers/dr-jennifer-fu">Jennifer Fu, MD</a></span>, a dermatologist who directs the Hair Disorders Clinic at the University of California, San Francisco, told this news organization following the annual meeting of the American Academy of Dermatology. The <span class="Hyperlink"><a href="https://aad-eposters.s3.amazonaws.com/AM2024/poster/50804/Low-Dose+Oral+Minoxidil+Initiation+and+Monitoring+LOMI+For+Hair+Loss+A+Modified+Delphi+Consensus+of+Experts.pdf">results</a> of the expert consensus</span> were presented during a poster session at the meeting. “It is often used off label for other types of hair loss, yet clinicians who treat hair loss know that patient compliance with topical minoxidil can be poor for a variety of reasons,” she said. “Patients report that it can be difficult to apply and complicate hair styling. For many patients, topical minoxidil can be drying or cause irritant or allergic contact reactions.”<br/><br/>[[{"fid":"301143","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Jennifer Fu, MD, director, hair disorders clinic, University of California, San Francisco","field_file_image_credit[und][0][value]":"Dr. Fu","field_file_image_caption[und][0][value]":"Dr. Jennifer Fu"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]LDOM has become a popular alternative for patients for whom <span class="Hyperlink">topical minoxidil</span> is logistically challenging, irritating, or ineffective, she continued. Although <span class="Hyperlink">oral minoxidil</span> is no longer a first-line antihypertensive agent given the risk of cardiovascular adverse effects at higher antihypertensive dosing (10-40 mg daily), a growing number of small studies have documented the use of LDOM at doses ranging from 0.25 mg to 5 mg daily as a safe, effective option for various types of hair loss.<br/><br/>“Given the current absence of larger trials on this topic, our research group identified a need for expert-based guidelines for prescribing and monitoring LDOM use in hair loss patients,” Dr. Fu said. “Our goal was to provide clinicians who treat hair loss patients a road map for using LDOM effectively, maximizing hair growth, and minimizing potential cardiovascular adverse effects.”<br/><br/><br/><br/></p> <h2>Arriving at a Consensus</h2> <p>The process involved 43 hair loss specialists from 12 countries with an average of 6.29 years of experience with LDOM for hair loss, who participated in a multi-round modified Delphi process. They considered questions that addressed LDOM safety, efficacy, dosing, and monitoring for hair loss, and consensus was reached if at least 70% of participants indicated “agree” or “strongly agree” on a five-point Likert scale. Round 1 consisted of 180 open-ended, multiple-choice, or Likert-scale questions, while round 2 involved 121 Likert-scale questions, round 3 consisted of 16 Likert-scale questions, and round 4 included 11 Likert-scale questions. In all, 94 items achieved Likert-scale consensus. </p> <p>Specifically, experts on the panel found a direct benefit of LDOM for androgenetic alopecia, age-related patterned thinning, alopecia areata, telogen effluvium, traction alopecia, persistent chemotherapy-induced alopecia, and endocrine therapy-induced alopecia. They found a supportive benefit of LDOM for lichen planopilaris, frontal fibrosing alopecia, central centrifugal alopecia, and fibrosing alopecia in a patterned distribution.<br/><br/>“LDOM can be considered when topical minoxidil is more expensive, logistically challenging, has plateaued in efficacy, results in undesirable product residue/skin irritation,” or exacerbates inflammatory processes (ie eczema, psoriasis), they added.<br/><br/>Contraindications to LDOM listed in the consensus recommendations include hypersensitivity to minoxidil, significant drug-drug interactions with LDOM, a history of pericardial effusion/tamponade, pericarditis, heart failure, pulmonary hypertension associated with mitral stenosis, pheochromocytoma, and pregnancy/breastfeeding. Cited precautions of LDOM use include a history of tachycardia or arrhythmia, hypotension, renal impairment, and being on dialysis.<br/><br/>Dr. Fu and colleagues noted that the earliest time point at which LDOM should be expected to demonstrate efficacy is 3-6 months. “Baseline testing is not routine but may be considered in case of identified precautions,” they wrote. They also noted that LDOM can possibly be co-administered with beta-blockers with a specialty consultation, and with spironolactone in biologic female or transgender female patients with hirsutism, acne, polycystic ovary syndrome (PCOS), and with lower extremity and facial edema.<br/><br/>According to the consensus statement, the most frequently prescribed LDOM dosing regimen in adult females aged 18 years and older includes a starting dose of 1.25 mg daily, with a dosing range between 0.625 mg and 5 mg daily. For adult males, the most frequently prescribed dosing regimen is a starting dose of 2.5 daily, with a dosing range between 1.25 mg and 5 mg daily. The most frequently prescribed LDOM dosing regimen in adolescent females aged 12-17 years is a starting dose of 0.625 mg daily, with a dosing range of 0.625 to 2.5 mg daily. For adolescent males, the recommended regimen is a starting dose of 1.25 mg daily, with a dosing range of 1.25 mg to 5 mg daily.<br/><br/>“We hope that this consensus statement will guide our colleagues who would like to use LDOM to treat hair loss in their adult and adolescent patients,” Dr. Fu told this news organization. “These recommendations may be used to inform clinical practice until additional evidence-based data becomes available.”<br/><br/>She acknowledged certain limitations of the effort, including the fact that the expert panel was underrepresented in treating hair loss in pediatric patients, “and therefore failed to reach consensus on LDOM pediatric use and dosing,” she said. “We encourage our pediatric dermatology colleagues to further research LDOM in pediatric patients.”<br/><br/><span class="Hyperlink">In an interview, <a href="https://weillcornell.org/slipner">Shari Lipner, MD, PhD</a></span>, associate professor of clinical dermatology, Weill Cornell Medicine, New York, who was asked to comment, but was not involved with the work, characterized the consensus as a “helpful, concise reference guide for dermatologists.” [[{"fid":"293977","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Shari R. Lipner, associate professor of clinical dermatology and director of the nail division at Weill Cornell Medicine, New York","field_file_image_credit[und][0][value]":"Dr. Lipner","field_file_image_caption[und][0][value]":"Dr. Shari R. Lipner"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]The advantages of the study are the standardized methods used, “and the experience of the panel,” she said. “Study limitations include the response rate, which was less than 60%, and the risk of potential side effects are not stratified by age, sex, or comorbidities,” she added.<br/><br/>Dr. Fu disclosed that she is a consultant to Pfizer. Dr. Lipner reported having no relevant disclosures.</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM AAD 2024

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Alopecia Areata: Late Responses Complicate Definition of JAK Inhibitor Failure

Article Type
Changed
Fri, 04/12/2024 - 12:03

In patients with alopecia areata (AA), the decision of when to give up on JAK inhibitors because of an inadequate response is being complicated by long-term follow-up showing that some patients accrue hair very slowly, according to late breaker data presented at the annual meeting of the American Academy of Dermatology.

Although the majority respond within months, response curves have so far climbed for as long as patients are followed, allowing many with disappointing early results to catch up, according to Rodney D. Sinclair, MD, professor of dermatology at the University of Melbourne, Australia.

His remarks were derived specifically from new long-term follow-up with baricitinib, the first JAK inhibitor approved for AA, but the pattern appears to be similar with ritlecitinib, the only other JAK inhibitor approved for AA, and for several if not all JAK inhibitors in phase 3 AA trials.

“We have had patients on baricitinib where not much was happening at 18 months, but now, at 4 years, they have a SALT score of zero,” Dr. Sinclair reported

A Severity of Alopecia Tool (SALT) score of 0 signifies complete hair regrowth. On a scale with a maximum score of 100 (complete hair loss), a SALT score of 20 or less, signaling clinical success, has been a primary endpoint in many JAK inhibitor trials, including those conducted with baricitinib.

Providing the most recent analysis in patients with severe AA participating in the phase 3 BRAVE-AA1 and BRAVE-AA2 trials of baricitinib, which were published together in 2022, Dr. Sinclair broke the data down into responders, mixed responders, and nonresponders at 52 weeks. The proportion of patients who responded with even longer follow-up were then tallied.

In the as-observed responses over time, the trajectory of response continued to climb through 76 weeks of follow-up in all three groups.

Relative to the 44.5% rate of overall response (SALT ≤ 20 ) at 52 weeks, there was some further growth in every group maintained on JAK inhibitor therapy over longer follow-up. In Dr. Sinclair’s late breaking analysis, this did not include nonresponders, who stopped therapy by week 52, but 78.4% of the combined responders and mixed responders who remained on treatment had reached treatment success at 76 weeks.
 

Response Curves Climb More Slowly With Severe Alopecia

While improvement in SALT scores was even seen in nonresponders over time as long as they remained on therapy, Dr. Sinclair reported that response curves tended to climb more slowly in those with more severe alopecia at baseline. Yet, they still climbed. For example, 28.1% of those with a baseline SALT score of 95 to 100 had reached treatment success at week 52, but the proportion had climbed to 35.4% by week 76.

The response curves climbed more quickly among those with a SALT score between 50 and 95 at baseline than among those with more severe alopecia, but the differences in SALT scores at 52 weeks and 76 weeks among patients in this range of baseline SALT scores were small.

Basically, “those with a SALT score of 94 did just as well as those with a SALT score of 51 when followed long-term,” he said, noting that this was among several findings that confounded expectations.

Duration of AA was found to be an important prognostic factor, with 4 years emerging as a general threshold separating those with a diminished likelihood of benefit relative to those with a shorter AA duration.

“When the duration of AA is more than 4 years, the response to any JAK inhibitor seems to fall off a cliff,” Dr. Sinclair said.

To clarify this observation, Dr. Sinclair made an analogy between acute and chronic urticaria. Chronicity appears to change the pathophysiology of both urticaria and AA, making durable remissions more difficult to achieve if the inflammatory response was persistently upregulated, he said.

The delayed responses in some patients “suggests that it is not enough to control inflammation for the hair to regrow. You actually have to activate the hair to grow as well as treat the inflammation,” Dr. Sinclair said.

This heterogeneity that has been observed in the speed of AA response to JAK inhibitors might be explained at least in part by the individual differences in hair growth activation. For ritlecitinib, the only other JAK inhibitor approved for AA to date, 62% were categorized as responders in the registration ALLEGRO trials, but only 44% were early responders, meaning SALT scores of ≤ 20 by week 24, according to a summary published last year. Of the remaining 16%, 11% were middle responders, meaning a SALT score of ≤ 20 reached at week 48, and 6% were late responders, meaning a SALT score of ≤ 20 reached at week 96.

In the context of late breaking 68-week data with deuruxolitinib, an oral JAK inhibitor currently under FDA review for treating moderate to severe AA, presented in the same AAD session as Dr. Sinclair’s baricitinib data, Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Connecticut, described similar long-term response curves. At 24 weeks, the SALT ≤ 20 response was achieved in 34.9% of patients, but climbed to 62.8% with continuous therapy over 68 weeks.

King_Brett_CONN_web.jpg
Dr. Brett King


The difference between AA and most other inflammatory conditions treated with a JAK inhibitor is that “it takes time to treat,” Dr. King said.


 

 

 

Time Factor Is Important for Response

“What we are learning is that patients keep getting better over time,” Dr. Sinclair said. Asked specifically how long he would treat a patient before giving up, he acknowledged that he used to consider 6 months adequate, but that he has now changed his mind.

“It might be that even 2 years is too short,” he said, although he conceded that a trial of therapy for this long “might be an issue for third-part payers.”

Asked to comment, Melissa Piliang, MD, chair of the department of dermatology at the Cleveland Clinic, agreed with the principle that early responses are not necessarily predictive of complete response.

Piliang_Melissa_OHIO_web.jpg
Dr. Melissa Piliang


“In my clinical experience, 6 months is not long enough to assess response,” she told this news organization. “Some patients have hair growth after 18 months to 2 years” of treatment. Additional studies to identify the characteristics and predictors of late response, she said, “would be very helpful, as would trials allowing multiple therapies to simulate real-world practice.”

Like Dr. Sinclair, Dr. Piliang is interested in the possibility of combining a JAK inhibitor with another therapy aimed specially at promoting hair regrowth.

“Using a secondary therapy to stimulate regrowth as an addition to an anti-inflammatory medicine like a JAK inhibitor might speed up response in some patients,” she speculated. Dr. Sinclair reports financial relationships with more than 30 pharmaceutical companies, including Eli Lilly, the manufacturer of baricitinib. Dr. King reports financial relationships with multiple companies, including Concert Pharmaceuticals (consultant and investigator), the manufacturer of deuruxolitinib. Dr. Piliang reports financial relationships with Eli Lilly, Pfizer, and Proctor & Gamble.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

In patients with alopecia areata (AA), the decision of when to give up on JAK inhibitors because of an inadequate response is being complicated by long-term follow-up showing that some patients accrue hair very slowly, according to late breaker data presented at the annual meeting of the American Academy of Dermatology.

Although the majority respond within months, response curves have so far climbed for as long as patients are followed, allowing many with disappointing early results to catch up, according to Rodney D. Sinclair, MD, professor of dermatology at the University of Melbourne, Australia.

His remarks were derived specifically from new long-term follow-up with baricitinib, the first JAK inhibitor approved for AA, but the pattern appears to be similar with ritlecitinib, the only other JAK inhibitor approved for AA, and for several if not all JAK inhibitors in phase 3 AA trials.

“We have had patients on baricitinib where not much was happening at 18 months, but now, at 4 years, they have a SALT score of zero,” Dr. Sinclair reported

A Severity of Alopecia Tool (SALT) score of 0 signifies complete hair regrowth. On a scale with a maximum score of 100 (complete hair loss), a SALT score of 20 or less, signaling clinical success, has been a primary endpoint in many JAK inhibitor trials, including those conducted with baricitinib.

Providing the most recent analysis in patients with severe AA participating in the phase 3 BRAVE-AA1 and BRAVE-AA2 trials of baricitinib, which were published together in 2022, Dr. Sinclair broke the data down into responders, mixed responders, and nonresponders at 52 weeks. The proportion of patients who responded with even longer follow-up were then tallied.

In the as-observed responses over time, the trajectory of response continued to climb through 76 weeks of follow-up in all three groups.

Relative to the 44.5% rate of overall response (SALT ≤ 20 ) at 52 weeks, there was some further growth in every group maintained on JAK inhibitor therapy over longer follow-up. In Dr. Sinclair’s late breaking analysis, this did not include nonresponders, who stopped therapy by week 52, but 78.4% of the combined responders and mixed responders who remained on treatment had reached treatment success at 76 weeks.
 

Response Curves Climb More Slowly With Severe Alopecia

While improvement in SALT scores was even seen in nonresponders over time as long as they remained on therapy, Dr. Sinclair reported that response curves tended to climb more slowly in those with more severe alopecia at baseline. Yet, they still climbed. For example, 28.1% of those with a baseline SALT score of 95 to 100 had reached treatment success at week 52, but the proportion had climbed to 35.4% by week 76.

The response curves climbed more quickly among those with a SALT score between 50 and 95 at baseline than among those with more severe alopecia, but the differences in SALT scores at 52 weeks and 76 weeks among patients in this range of baseline SALT scores were small.

Basically, “those with a SALT score of 94 did just as well as those with a SALT score of 51 when followed long-term,” he said, noting that this was among several findings that confounded expectations.

Duration of AA was found to be an important prognostic factor, with 4 years emerging as a general threshold separating those with a diminished likelihood of benefit relative to those with a shorter AA duration.

“When the duration of AA is more than 4 years, the response to any JAK inhibitor seems to fall off a cliff,” Dr. Sinclair said.

To clarify this observation, Dr. Sinclair made an analogy between acute and chronic urticaria. Chronicity appears to change the pathophysiology of both urticaria and AA, making durable remissions more difficult to achieve if the inflammatory response was persistently upregulated, he said.

The delayed responses in some patients “suggests that it is not enough to control inflammation for the hair to regrow. You actually have to activate the hair to grow as well as treat the inflammation,” Dr. Sinclair said.

This heterogeneity that has been observed in the speed of AA response to JAK inhibitors might be explained at least in part by the individual differences in hair growth activation. For ritlecitinib, the only other JAK inhibitor approved for AA to date, 62% were categorized as responders in the registration ALLEGRO trials, but only 44% were early responders, meaning SALT scores of ≤ 20 by week 24, according to a summary published last year. Of the remaining 16%, 11% were middle responders, meaning a SALT score of ≤ 20 reached at week 48, and 6% were late responders, meaning a SALT score of ≤ 20 reached at week 96.

In the context of late breaking 68-week data with deuruxolitinib, an oral JAK inhibitor currently under FDA review for treating moderate to severe AA, presented in the same AAD session as Dr. Sinclair’s baricitinib data, Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Connecticut, described similar long-term response curves. At 24 weeks, the SALT ≤ 20 response was achieved in 34.9% of patients, but climbed to 62.8% with continuous therapy over 68 weeks.

King_Brett_CONN_web.jpg
Dr. Brett King


The difference between AA and most other inflammatory conditions treated with a JAK inhibitor is that “it takes time to treat,” Dr. King said.


 

 

 

Time Factor Is Important for Response

“What we are learning is that patients keep getting better over time,” Dr. Sinclair said. Asked specifically how long he would treat a patient before giving up, he acknowledged that he used to consider 6 months adequate, but that he has now changed his mind.

“It might be that even 2 years is too short,” he said, although he conceded that a trial of therapy for this long “might be an issue for third-part payers.”

Asked to comment, Melissa Piliang, MD, chair of the department of dermatology at the Cleveland Clinic, agreed with the principle that early responses are not necessarily predictive of complete response.

Piliang_Melissa_OHIO_web.jpg
Dr. Melissa Piliang


“In my clinical experience, 6 months is not long enough to assess response,” she told this news organization. “Some patients have hair growth after 18 months to 2 years” of treatment. Additional studies to identify the characteristics and predictors of late response, she said, “would be very helpful, as would trials allowing multiple therapies to simulate real-world practice.”

Like Dr. Sinclair, Dr. Piliang is interested in the possibility of combining a JAK inhibitor with another therapy aimed specially at promoting hair regrowth.

“Using a secondary therapy to stimulate regrowth as an addition to an anti-inflammatory medicine like a JAK inhibitor might speed up response in some patients,” she speculated. Dr. Sinclair reports financial relationships with more than 30 pharmaceutical companies, including Eli Lilly, the manufacturer of baricitinib. Dr. King reports financial relationships with multiple companies, including Concert Pharmaceuticals (consultant and investigator), the manufacturer of deuruxolitinib. Dr. Piliang reports financial relationships with Eli Lilly, Pfizer, and Proctor & Gamble.

In patients with alopecia areata (AA), the decision of when to give up on JAK inhibitors because of an inadequate response is being complicated by long-term follow-up showing that some patients accrue hair very slowly, according to late breaker data presented at the annual meeting of the American Academy of Dermatology.

Although the majority respond within months, response curves have so far climbed for as long as patients are followed, allowing many with disappointing early results to catch up, according to Rodney D. Sinclair, MD, professor of dermatology at the University of Melbourne, Australia.

His remarks were derived specifically from new long-term follow-up with baricitinib, the first JAK inhibitor approved for AA, but the pattern appears to be similar with ritlecitinib, the only other JAK inhibitor approved for AA, and for several if not all JAK inhibitors in phase 3 AA trials.

“We have had patients on baricitinib where not much was happening at 18 months, but now, at 4 years, they have a SALT score of zero,” Dr. Sinclair reported

A Severity of Alopecia Tool (SALT) score of 0 signifies complete hair regrowth. On a scale with a maximum score of 100 (complete hair loss), a SALT score of 20 or less, signaling clinical success, has been a primary endpoint in many JAK inhibitor trials, including those conducted with baricitinib.

Providing the most recent analysis in patients with severe AA participating in the phase 3 BRAVE-AA1 and BRAVE-AA2 trials of baricitinib, which were published together in 2022, Dr. Sinclair broke the data down into responders, mixed responders, and nonresponders at 52 weeks. The proportion of patients who responded with even longer follow-up were then tallied.

In the as-observed responses over time, the trajectory of response continued to climb through 76 weeks of follow-up in all three groups.

Relative to the 44.5% rate of overall response (SALT ≤ 20 ) at 52 weeks, there was some further growth in every group maintained on JAK inhibitor therapy over longer follow-up. In Dr. Sinclair’s late breaking analysis, this did not include nonresponders, who stopped therapy by week 52, but 78.4% of the combined responders and mixed responders who remained on treatment had reached treatment success at 76 weeks.
 

Response Curves Climb More Slowly With Severe Alopecia

While improvement in SALT scores was even seen in nonresponders over time as long as they remained on therapy, Dr. Sinclair reported that response curves tended to climb more slowly in those with more severe alopecia at baseline. Yet, they still climbed. For example, 28.1% of those with a baseline SALT score of 95 to 100 had reached treatment success at week 52, but the proportion had climbed to 35.4% by week 76.

The response curves climbed more quickly among those with a SALT score between 50 and 95 at baseline than among those with more severe alopecia, but the differences in SALT scores at 52 weeks and 76 weeks among patients in this range of baseline SALT scores were small.

Basically, “those with a SALT score of 94 did just as well as those with a SALT score of 51 when followed long-term,” he said, noting that this was among several findings that confounded expectations.

Duration of AA was found to be an important prognostic factor, with 4 years emerging as a general threshold separating those with a diminished likelihood of benefit relative to those with a shorter AA duration.

“When the duration of AA is more than 4 years, the response to any JAK inhibitor seems to fall off a cliff,” Dr. Sinclair said.

To clarify this observation, Dr. Sinclair made an analogy between acute and chronic urticaria. Chronicity appears to change the pathophysiology of both urticaria and AA, making durable remissions more difficult to achieve if the inflammatory response was persistently upregulated, he said.

The delayed responses in some patients “suggests that it is not enough to control inflammation for the hair to regrow. You actually have to activate the hair to grow as well as treat the inflammation,” Dr. Sinclair said.

This heterogeneity that has been observed in the speed of AA response to JAK inhibitors might be explained at least in part by the individual differences in hair growth activation. For ritlecitinib, the only other JAK inhibitor approved for AA to date, 62% were categorized as responders in the registration ALLEGRO trials, but only 44% were early responders, meaning SALT scores of ≤ 20 by week 24, according to a summary published last year. Of the remaining 16%, 11% were middle responders, meaning a SALT score of ≤ 20 reached at week 48, and 6% were late responders, meaning a SALT score of ≤ 20 reached at week 96.

In the context of late breaking 68-week data with deuruxolitinib, an oral JAK inhibitor currently under FDA review for treating moderate to severe AA, presented in the same AAD session as Dr. Sinclair’s baricitinib data, Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Connecticut, described similar long-term response curves. At 24 weeks, the SALT ≤ 20 response was achieved in 34.9% of patients, but climbed to 62.8% with continuous therapy over 68 weeks.

King_Brett_CONN_web.jpg
Dr. Brett King


The difference between AA and most other inflammatory conditions treated with a JAK inhibitor is that “it takes time to treat,” Dr. King said.


 

 

 

Time Factor Is Important for Response

“What we are learning is that patients keep getting better over time,” Dr. Sinclair said. Asked specifically how long he would treat a patient before giving up, he acknowledged that he used to consider 6 months adequate, but that he has now changed his mind.

“It might be that even 2 years is too short,” he said, although he conceded that a trial of therapy for this long “might be an issue for third-part payers.”

Asked to comment, Melissa Piliang, MD, chair of the department of dermatology at the Cleveland Clinic, agreed with the principle that early responses are not necessarily predictive of complete response.

Piliang_Melissa_OHIO_web.jpg
Dr. Melissa Piliang


“In my clinical experience, 6 months is not long enough to assess response,” she told this news organization. “Some patients have hair growth after 18 months to 2 years” of treatment. Additional studies to identify the characteristics and predictors of late response, she said, “would be very helpful, as would trials allowing multiple therapies to simulate real-world practice.”

Like Dr. Sinclair, Dr. Piliang is interested in the possibility of combining a JAK inhibitor with another therapy aimed specially at promoting hair regrowth.

“Using a secondary therapy to stimulate regrowth as an addition to an anti-inflammatory medicine like a JAK inhibitor might speed up response in some patients,” she speculated. Dr. Sinclair reports financial relationships with more than 30 pharmaceutical companies, including Eli Lilly, the manufacturer of baricitinib. Dr. King reports financial relationships with multiple companies, including Concert Pharmaceuticals (consultant and investigator), the manufacturer of deuruxolitinib. Dr. Piliang reports financial relationships with Eli Lilly, Pfizer, and Proctor & Gamble.

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167622</fileName> <TBEID>0C04F75C.SIG</TBEID> <TBUniqueIdentifier>MD_0C04F75C</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname>Long-term JAKi for Alopecia</storyname> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240412T115533</QCDate> <firstPublished>20240412T120100</firstPublished> <LastPublished>20240412T120100</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240412T120059</CMSDate> <articleSource>FROM AAD 2024 </articleSource> <facebookInfo/> <meetingNumber>2884-24</meetingNumber> <byline>Ted Bosworth</byline> <bylineText>TED BOSWORTH</bylineText> <bylineFull>TED BOSWORTH</bylineFull> <bylineTitleText>MDedge News</bylineTitleText> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>In patients with alopecia areata (AA), the decision of when to give up on JAK inhibitors because of an inadequate response is being complicated by long-term fol</metaDescription> <articlePDF/> <teaserImage>301114</teaserImage> <teaser>Delayed but clinically significant responses are seen a year or more after starting JAK inhibitors for alopecia areata. </teaser> <title>Alopecia Areata: Late Responses Complicate Definition of JAK Inhibitor Failure</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> </publications> <sections> <term>53</term> <term canonical="true">39313</term> </sections> <topics> <term canonical="true">219</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012820.jpg</altRep> <description role="drol:caption">Dr. Brett King</description> <description role="drol:credit"/> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012821.jpg</altRep> <description role="drol:caption">Dr. Melissa Piliang</description> <description role="drol:credit">Dr. Piliang</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Alopecia Areata: Late Responses Complicate Definition of JAK Inhibitor Failure</title> <deck/> </itemMeta> <itemContent> <p><span class="dateline">SAN DIEGO</span> — <span class="tag metaDescription"> In patients with alopecia areata (AA), the decision of when to give up on JAK inhibitors because of an inadequate response is being complicated by long-term follow-up showing that some patients accrue hair very slowly</span>, according to late breaker data presented at the annual meeting of the American Academy of Dermatology.</p> <p>Although the majority respond within months, response curves have so far climbed for as long as patients are followed, allowing many with disappointing early results to catch up, according to <span class="Hyperlink"><a href="https://findanexpert.unimelb.edu.au/profile/2015-rodney-sinclair">Rodney D. Sinclair, MD</a></span>, professor of dermatology at the University of Melbourne, Australia.<br/><br/>His remarks were derived specifically from new long-term follow-up with <span class="Hyperlink"><a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207924s007lbl.pdf">baricitinib</a></span>, the first JAK inhibitor <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/975487">approved for AA</a></span>, but the pattern appears to be similar with <span class="Hyperlink"><a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215830s000lbl.pdf">ritlecitinib</a></span>, the only other JAK inhibitor <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/993663">approved for AA</a></span>, and for several if not all JAK inhibitors in phase 3 AA trials.<br/><br/>“We have had patients on baricitinib where not much was happening at 18 months, but now, at 4 years, they have a SALT score of zero,” Dr. Sinclair reported <br/><br/>A Severity of Alopecia Tool (SALT) score of 0 signifies complete hair regrowth. On a scale with a maximum score of 100 (complete hair loss), a SALT score of 20 or less, signaling clinical success, has been a primary endpoint in many JAK inhibitor trials, including those conducted with baricitinib.<br/><br/>Providing the most recent analysis in patients with severe AA participating in the phase 3 <span class="Hyperlink"><a href="https://clinicaltrials.gov/study/NCT03570749">BRAVE-AA1</a></span> and <span class="Hyperlink"><a href="https://clinicaltrials.gov/study/NCT03899259">BRAVE-AA2</a></span> trials of baricitinib, which were <span class="Hyperlink"><a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2110343">published together</a></span> in 2022, Dr. Sinclair broke the data down into responders, mixed responders, and nonresponders at 52 weeks. The proportion of patients who responded with even longer follow-up were then tallied. <br/><br/>In the as-observed responses over time, the trajectory of response continued to climb through 76 weeks of follow-up in all three groups. <br/><br/>Relative to the 44.5% rate of overall response (SALT ≤ 20 ) at 52 weeks, there was some further growth in every group maintained on JAK inhibitor therapy over longer follow-up. In Dr. Sinclair’s late breaking analysis, this did not include nonresponders, who stopped therapy by week 52, but 78.4% of the combined responders and mixed responders who remained on treatment had reached treatment success at 76 weeks. <br/><br/><br/><br/></p> <h2>Response Curves Climb More Slowly With Severe Alopecia</h2> <p>While improvement in SALT scores was even seen in nonresponders over time as long as they remained on therapy, Dr. Sinclair reported that response curves tended to climb more slowly in those with more severe alopecia at baseline. Yet, they still climbed. For example, 28.1% of those with a baseline SALT score of 95 to 100 had reached treatment success at week 52, but the proportion had climbed to 35.4% by week 76. </p> <p>The response curves climbed more quickly among those with a SALT score between 50 and 95 at baseline than among those with more severe alopecia, but the differences in SALT scores at 52 weeks and 76 weeks among patients in this range of baseline SALT scores were small. <br/><br/>Basically, “those with a SALT score of 94 did just as well as those with a SALT score of 51 when followed long-term,” he said, noting that this was among several findings that confounded expectations.<br/><br/>Duration of AA was found to be an important prognostic factor, with 4 years emerging as a general threshold separating those with a diminished likelihood of benefit relative to those with a shorter AA duration. <br/><br/>“When the duration of AA is more than 4 years, the response to any JAK inhibitor seems to fall off a cliff,” Dr. Sinclair said.<br/><br/>To clarify this observation, Dr. Sinclair made an analogy between acute and chronic urticaria. Chronicity appears to change the pathophysiology of both urticaria and AA, making durable remissions more difficult to achieve if the inflammatory response was persistently upregulated, he said. <br/><br/>The delayed responses in some patients “suggests that it is not enough to control inflammation for the hair to regrow. You actually have to activate the hair to grow as well as treat the inflammation,” Dr. Sinclair said.<br/><br/>This heterogeneity that has been observed in the speed of AA response to JAK inhibitors might be explained at least in part by the individual differences in hair growth activation. For ritlecitinib, the only other JAK inhibitor approved for AA to date, 62% were categorized as responders in the registration <span class="Hyperlink"><a href="https://clinicaltrials.gov/study/NCT03732807?term=NCT03732807&amp;rank=1&amp;tab=results">ALLEGRO</a></span> trials, but only 44% were early responders, meaning SALT scores of ≤ 20 by week 24, according to a <span class="Hyperlink"><a href="https://link.springer.com/article/10.1007/s40265-023-01928-y">summary</a></span> published last year. Of the remaining 16%, 11% were middle responders, meaning a SALT score of ≤ 20 reached at week 48, and 6% were late responders, meaning a SALT score of ≤ 20 reached at week 96.<br/><br/>In the context of late breaking 68-week data with <span class="Hyperlink">deuruxolitinib</span>, an oral JAK inhibitor currently under FDA review for treating moderate to severe AA, presented in the same AAD session as Dr. Sinclair’s baricitinib data, <span class="Hyperlink"><a href="https://medicine.yale.edu/profile/brett-king/">Brett King, MD, PhD</a></span>, associate professor of dermatology, Yale University, New Haven, Connecticut, described similar long-term response curves. At 24 weeks, the SALT ≤ 20 response was achieved in 34.9% of patients, but climbed to 62.8% with continuous therapy over 68 weeks.[[{"fid":"301114","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Brett King, Yale University School of Medicine, New Haven, CT","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Brett King"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]<br/><br/>The difference between AA and most other inflammatory conditions treated with a JAK inhibitor is that “it takes time to treat,” Dr. King said. <br/><br/><br/><br/></p> <h2>Time Factor Is Important for Response</h2> <p>“What we are learning is that patients keep getting better over time,” Dr. Sinclair said. Asked specifically how long he would treat a patient before giving up, he acknowledged that he used to consider 6 months adequate, but that he has now changed his mind.</p> <p>“It might be that even 2 years is too short,” he said, although he conceded that a trial of therapy for this long “might be an issue for third-part payers.”<br/><br/>Asked to comment, <span class="Hyperlink"><a href="https://my.clevelandclinic.org/staff/7887-melissa-piliang">Melissa Piliang, MD</a></span>, chair of the department of dermatology at the Cleveland Clinic, agreed with the principle that early responses are not necessarily predictive of complete response.[[{"fid":"301115","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Melissa Piliang, MD, Chair of Dermatology at the Cleveland Clinic, Cleveland, Ohio","field_file_image_credit[und][0][value]":"Dr. Piliang","field_file_image_caption[und][0][value]":"Dr. Melissa Piliang"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]<br/><br/>“In my clinical experience, 6 months is not long enough to assess response,” she told this news organization. “Some patients have hair growth after 18 months to 2 years” of treatment. Additional studies to identify the characteristics and predictors of late response, she said, “would be very helpful, as would trials allowing multiple therapies to simulate real-world practice.”<br/><br/>Like Dr. Sinclair, Dr. Piliang is interested in the possibility of combining a JAK inhibitor with another therapy aimed specially at promoting hair regrowth.<br/><br/>“Using a secondary therapy to stimulate regrowth as an addition to an anti-inflammatory medicine like a JAK inhibitor might speed up response in some patients,” she speculated. Dr. Sinclair reports financial relationships with more than 30 pharmaceutical companies, including Eli Lilly, the manufacturer of baricitinib. Dr. King reports financial relationships with multiple companies, including Concert Pharmaceuticals (consultant and investigator), the manufacturer of deuruxolitinib. Dr. Piliang reports financial relationships with Eli Lilly, Pfizer, and Proctor &amp; Gamble.</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM AAD 2024

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Androgenetic Alopecia: Study Finds Efficacy of Topical and Oral Minoxidil Similar

Article Type
Changed
Fri, 04/12/2024 - 07:25

A rigorously conducted trial in men with androgenetic alopecia found that low-dose oral minoxidil was as effective in promoting hair growth as was topical minoxidil.

Oral minoxidil, 5 mg once a day, “did not demonstrate superiority” over topical minoxidil, 5%, applied twice a day, after 24 weeks, reported Mariana Alvares Penha, MD, of the department of dermatology at São Paulo State University, in Botucatu, Brazil, and coauthors. Their randomized, controlled, double-blind study was published online in JAMA Dermatology.

Topical minoxidil is approved by the US Food and Drug Administration (FDA) for androgenetic alopecia (AGA), but there has been increasing interest worldwide in the use of low-dose oral minoxidil, a vasodilator approved as an antihypertensive, as an alternative treatment.

The trial “is important information that’s never been elucidated before,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview. The data, he added, can be used to reassure patients who do not want to take the oral form of the drug that a topical is just as effective.

“This study does let us counsel patients better and really give them the evidence,” said Shari Lipner, MD, PhD, associate professor of clinical dermatology at Weill Cornell Medicine, New York, who was also asked to comment on the results.

Both Dr. Lipner and Dr. Friedman said the study was well-designed.

[embed:render:related:node:264930]

The investigators enrolled 90 men aged 18-55; 68 completed the trial. Most had mild to moderate AGA. Men were excluded if they had received treatment for alopecia in the previous 6 months, a history of hair transplant, cardiopathy, nephropathy, dermatoses involving the scalp, any clinical conditions causing hair loss, or hypersensitivity to minoxidil.

They were randomized to receive either 5 mg of oral minoxidil a day, plus a placebo solution to apply to the scalp, or topical minoxidil solution (5%) applied twice a day plus placebo capsules. They were told to take a capsule at bedtime and to apply 1 mL of the solution to dry hair in the morning and at night.

The final analysis included 35 men in the topical group and 33 in the oral group (mean age, 36.6 years). Seven people in the topical group and 11 in the oral group were not able to attend the final appointment at 24 weeks. Three additional patients in the topical group dropped out for insomnia, hair shedding, and scalp eczema, while one dropped out of the oral group because of headache.

At 24 weeks, the percentage increase in terminal hair density in the oral minoxidil group was 27% higher (P = .005) in the vertex and 13% higher (P = .15) in the frontal scalp, compared with the topical-treated group.

Total hair density increased by 2% in the oral group compared with topical treatment in the vertex and decreased by 0.2% in the frontal area compared with topical treatment. None of these differences were statistically significant.

Three dermatologists blinded to the treatments, who analyzed photographs, determined that 60% of the men in the oral group and 48% in the topical group had clinical improvement in the frontal area, which was not statistically significant. More orally-treated patients had improvement in the vertex area: 70% compared with 46% of those on topical treatment (P = .04).

 

 

Hypertrichosis, Headache

Of the original 90 patients in the trial, more men taking oral minoxidil had hypertrichosis: 49% compared with 25% in the topical formulation group. Headache was also more common among those on oral minoxidil: six cases (14%) vs. one case (2%) among those on topical minoxidil. There was no difference in mean arterial blood pressure or resting heart rate between the two groups. Transient hair loss was more common with topical treatment, but it was not significant.

Dr. Friedman said that the study results would not change how he practices, but that it would give him data to use to inform patients who do not want to take oral minoxidil. He generally prescribes the oral form, unless patients do not want to take it or there is a medical contraindication, which he said is rare.

“I personally think oral is superior to topical,” mainly “because the patient’s actually using it,” said Dr. Friedman. “They’re more likely to take a pill a day versus apply something topically twice a day,” he added.

Both Dr. Lipner and Dr. Friedman said that they doubted that individuals could — or would want to — follow the twice-daily topical regimen used in the trial.

“In real life, not in the clinical trial scenario, it may be very hard for patients to comply with putting on the topical minoxidil twice a day or even once a day,” Dr. Lipner said.

However, she continues to prescribe more topical minoxidil than oral, because she believes “there’s less potential for side effects.” For patients who can adhere to the topical regimen, the study shows that they will get results, said Dr. Lipner.

Dr. Friedman, however, said that for patients who are looking at a lifetime of medication, “an oral will always win out on a topical to the scalp from an adherence perspective.”

The study was supported by the Brazilian Dermatology Society Support Fund. Dr. Penha reported receiving grants from the fund; no other disclosures were reported. Dr. Friedman and Dr. Lipner reported no conflicts related to minoxidil.

Publications
Topics
Sections

A rigorously conducted trial in men with androgenetic alopecia found that low-dose oral minoxidil was as effective in promoting hair growth as was topical minoxidil.

Oral minoxidil, 5 mg once a day, “did not demonstrate superiority” over topical minoxidil, 5%, applied twice a day, after 24 weeks, reported Mariana Alvares Penha, MD, of the department of dermatology at São Paulo State University, in Botucatu, Brazil, and coauthors. Their randomized, controlled, double-blind study was published online in JAMA Dermatology.

Topical minoxidil is approved by the US Food and Drug Administration (FDA) for androgenetic alopecia (AGA), but there has been increasing interest worldwide in the use of low-dose oral minoxidil, a vasodilator approved as an antihypertensive, as an alternative treatment.

The trial “is important information that’s never been elucidated before,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview. The data, he added, can be used to reassure patients who do not want to take the oral form of the drug that a topical is just as effective.

“This study does let us counsel patients better and really give them the evidence,” said Shari Lipner, MD, PhD, associate professor of clinical dermatology at Weill Cornell Medicine, New York, who was also asked to comment on the results.

Both Dr. Lipner and Dr. Friedman said the study was well-designed.

[embed:render:related:node:264930]

The investigators enrolled 90 men aged 18-55; 68 completed the trial. Most had mild to moderate AGA. Men were excluded if they had received treatment for alopecia in the previous 6 months, a history of hair transplant, cardiopathy, nephropathy, dermatoses involving the scalp, any clinical conditions causing hair loss, or hypersensitivity to minoxidil.

They were randomized to receive either 5 mg of oral minoxidil a day, plus a placebo solution to apply to the scalp, or topical minoxidil solution (5%) applied twice a day plus placebo capsules. They were told to take a capsule at bedtime and to apply 1 mL of the solution to dry hair in the morning and at night.

The final analysis included 35 men in the topical group and 33 in the oral group (mean age, 36.6 years). Seven people in the topical group and 11 in the oral group were not able to attend the final appointment at 24 weeks. Three additional patients in the topical group dropped out for insomnia, hair shedding, and scalp eczema, while one dropped out of the oral group because of headache.

At 24 weeks, the percentage increase in terminal hair density in the oral minoxidil group was 27% higher (P = .005) in the vertex and 13% higher (P = .15) in the frontal scalp, compared with the topical-treated group.

Total hair density increased by 2% in the oral group compared with topical treatment in the vertex and decreased by 0.2% in the frontal area compared with topical treatment. None of these differences were statistically significant.

Three dermatologists blinded to the treatments, who analyzed photographs, determined that 60% of the men in the oral group and 48% in the topical group had clinical improvement in the frontal area, which was not statistically significant. More orally-treated patients had improvement in the vertex area: 70% compared with 46% of those on topical treatment (P = .04).

 

 

Hypertrichosis, Headache

Of the original 90 patients in the trial, more men taking oral minoxidil had hypertrichosis: 49% compared with 25% in the topical formulation group. Headache was also more common among those on oral minoxidil: six cases (14%) vs. one case (2%) among those on topical minoxidil. There was no difference in mean arterial blood pressure or resting heart rate between the two groups. Transient hair loss was more common with topical treatment, but it was not significant.

Dr. Friedman said that the study results would not change how he practices, but that it would give him data to use to inform patients who do not want to take oral minoxidil. He generally prescribes the oral form, unless patients do not want to take it or there is a medical contraindication, which he said is rare.

“I personally think oral is superior to topical,” mainly “because the patient’s actually using it,” said Dr. Friedman. “They’re more likely to take a pill a day versus apply something topically twice a day,” he added.

Both Dr. Lipner and Dr. Friedman said that they doubted that individuals could — or would want to — follow the twice-daily topical regimen used in the trial.

“In real life, not in the clinical trial scenario, it may be very hard for patients to comply with putting on the topical minoxidil twice a day or even once a day,” Dr. Lipner said.

However, she continues to prescribe more topical minoxidil than oral, because she believes “there’s less potential for side effects.” For patients who can adhere to the topical regimen, the study shows that they will get results, said Dr. Lipner.

Dr. Friedman, however, said that for patients who are looking at a lifetime of medication, “an oral will always win out on a topical to the scalp from an adherence perspective.”

The study was supported by the Brazilian Dermatology Society Support Fund. Dr. Penha reported receiving grants from the fund; no other disclosures were reported. Dr. Friedman and Dr. Lipner reported no conflicts related to minoxidil.

A rigorously conducted trial in men with androgenetic alopecia found that low-dose oral minoxidil was as effective in promoting hair growth as was topical minoxidil.

Oral minoxidil, 5 mg once a day, “did not demonstrate superiority” over topical minoxidil, 5%, applied twice a day, after 24 weeks, reported Mariana Alvares Penha, MD, of the department of dermatology at São Paulo State University, in Botucatu, Brazil, and coauthors. Their randomized, controlled, double-blind study was published online in JAMA Dermatology.

Topical minoxidil is approved by the US Food and Drug Administration (FDA) for androgenetic alopecia (AGA), but there has been increasing interest worldwide in the use of low-dose oral minoxidil, a vasodilator approved as an antihypertensive, as an alternative treatment.

The trial “is important information that’s never been elucidated before,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview. The data, he added, can be used to reassure patients who do not want to take the oral form of the drug that a topical is just as effective.

“This study does let us counsel patients better and really give them the evidence,” said Shari Lipner, MD, PhD, associate professor of clinical dermatology at Weill Cornell Medicine, New York, who was also asked to comment on the results.

Both Dr. Lipner and Dr. Friedman said the study was well-designed.

[embed:render:related:node:264930]

The investigators enrolled 90 men aged 18-55; 68 completed the trial. Most had mild to moderate AGA. Men were excluded if they had received treatment for alopecia in the previous 6 months, a history of hair transplant, cardiopathy, nephropathy, dermatoses involving the scalp, any clinical conditions causing hair loss, or hypersensitivity to minoxidil.

They were randomized to receive either 5 mg of oral minoxidil a day, plus a placebo solution to apply to the scalp, or topical minoxidil solution (5%) applied twice a day plus placebo capsules. They were told to take a capsule at bedtime and to apply 1 mL of the solution to dry hair in the morning and at night.

The final analysis included 35 men in the topical group and 33 in the oral group (mean age, 36.6 years). Seven people in the topical group and 11 in the oral group were not able to attend the final appointment at 24 weeks. Three additional patients in the topical group dropped out for insomnia, hair shedding, and scalp eczema, while one dropped out of the oral group because of headache.

At 24 weeks, the percentage increase in terminal hair density in the oral minoxidil group was 27% higher (P = .005) in the vertex and 13% higher (P = .15) in the frontal scalp, compared with the topical-treated group.

Total hair density increased by 2% in the oral group compared with topical treatment in the vertex and decreased by 0.2% in the frontal area compared with topical treatment. None of these differences were statistically significant.

Three dermatologists blinded to the treatments, who analyzed photographs, determined that 60% of the men in the oral group and 48% in the topical group had clinical improvement in the frontal area, which was not statistically significant. More orally-treated patients had improvement in the vertex area: 70% compared with 46% of those on topical treatment (P = .04).

 

 

Hypertrichosis, Headache

Of the original 90 patients in the trial, more men taking oral minoxidil had hypertrichosis: 49% compared with 25% in the topical formulation group. Headache was also more common among those on oral minoxidil: six cases (14%) vs. one case (2%) among those on topical minoxidil. There was no difference in mean arterial blood pressure or resting heart rate between the two groups. Transient hair loss was more common with topical treatment, but it was not significant.

Dr. Friedman said that the study results would not change how he practices, but that it would give him data to use to inform patients who do not want to take oral minoxidil. He generally prescribes the oral form, unless patients do not want to take it or there is a medical contraindication, which he said is rare.

“I personally think oral is superior to topical,” mainly “because the patient’s actually using it,” said Dr. Friedman. “They’re more likely to take a pill a day versus apply something topically twice a day,” he added.

Both Dr. Lipner and Dr. Friedman said that they doubted that individuals could — or would want to — follow the twice-daily topical regimen used in the trial.

“In real life, not in the clinical trial scenario, it may be very hard for patients to comply with putting on the topical minoxidil twice a day or even once a day,” Dr. Lipner said.

However, she continues to prescribe more topical minoxidil than oral, because she believes “there’s less potential for side effects.” For patients who can adhere to the topical regimen, the study shows that they will get results, said Dr. Lipner.

Dr. Friedman, however, said that for patients who are looking at a lifetime of medication, “an oral will always win out on a topical to the scalp from an adherence perspective.”

The study was supported by the Brazilian Dermatology Society Support Fund. Dr. Penha reported receiving grants from the fund; no other disclosures were reported. Dr. Friedman and Dr. Lipner reported no conflicts related to minoxidil.

Publications
Publications
Topics
Article Type
Sections
Teambase XML
<?xml version="1.0" encoding="UTF-8"?>
<!--$RCSfile: InCopy_agile.xsl,v $ $Revision: 1.35 $-->
<!--$RCSfile: drupal.xsl,v $ $Revision: 1.7 $-->
<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167658</fileName> <TBEID>0C04F84C.SIG</TBEID> <TBUniqueIdentifier>MD_0C04F84C</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname>Oral equal to topical minoxidil</storyname> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240411T145629</QCDate> <firstPublished>20240411T153722</firstPublished> <LastPublished>20240411T153722</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240411T153722</CMSDate> <articleSource>FROM JAMA DERMATOLOGY</articleSource> <facebookInfo/> <meetingNumber/> <byline>Alicia Ault</byline> <bylineText>ALICIA AULT</bylineText> <bylineFull>ALICIA AULT</bylineFull> <bylineTitleText>MDedge News</bylineTitleText> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>A rigorously conducted trial in men with androgenetic alopecia found that low-dose oral minoxidil was as effective in promoting hair growth as was topical minox</metaDescription> <articlePDF/> <teaserImage/> <teaser>A randomized, controlled, blinded study finds little difference between the two forms of the drug in promoting hair growth in men.</teaser> <title>Androgenetic Alopecia: Study Finds Efficacy of Topical and Oral Minoxidil Similar</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>endo</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>34</term> <term>15</term> <term>21</term> </publications> <sections> <term canonical="true">39313</term> <term>27970</term> </sections> <topics> <term canonical="true">219</term> <term>27442</term> <term>203</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Androgenetic Alopecia: Study Finds Efficacy of Topical and Oral Minoxidil Similar</title> <deck/> </itemMeta> <itemContent> <p> <span class="tag metaDescription">A rigorously conducted trial in men with androgenetic alopecia found that low-dose oral minoxidil was as effective in promoting hair growth as was topical minoxidil.</span> </p> <p>Oral minoxidil, 5 mg once a day, “did not demonstrate superiority” over topical minoxidil, 5%, applied twice a day, after 24 weeks, reported Mariana Alvares Penha, MD, of the department of dermatology at São Paulo State University, in Botucatu, Brazil, and coauthors. Their randomized, controlled, double-blind <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamadermatology/fullarticle/2817326?guestAccessKey=8172339b-3874-4c33-9162-f391c430c263&amp;utm_source=silverchair&amp;utm_medium=email&amp;utm_campaign=article_alert-jamadermatology&amp;utm_content=olf&amp;utm_term=041024&amp;adv=000003613421">study</a></span> was published online in <em>JAMA Dermatology</em>.<br/><br/><span class="Hyperlink">Topical minoxidil</span> is approved by the US Food and Drug Administration (FDA) for androgenetic alopecia (AGA), but there has been <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/982317">increasing interest</a></span> worldwide in the use of low-dose oral minoxidil, a vasodilator approved as an antihypertensive, as an alternative treatment. <br/><br/>The trial “is important information that’s never been elucidated before,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview. The data, he added, can be used to reassure patients who do not want to take the oral form of the drug that a topical is just as effective.<br/><br/>“This study does let us counsel patients better and really give them the evidence,” said Shari Lipner, MD, PhD, associate professor of clinical dermatology at Weill Cornell Medicine, New York, who was also asked to comment on the results.<br/><br/>Both Dr. Lipner and Dr. Friedman said the study was well-designed.<br/><br/>The investigators enrolled 90 men aged 18-55; 68 completed the trial. Most had mild to moderate AGA. Men were excluded if they had received treatment for alopecia in the previous 6 months, a history of hair transplant, cardiopathy, nephropathy, dermatoses involving the scalp, any clinical conditions causing hair loss, or hypersensitivity to minoxidil.<br/><br/>They were randomized to receive either 5 mg of oral minoxidil a day, plus a placebo solution to apply to the scalp, or topical minoxidil solution (5%) applied twice a day plus placebo capsules. They were told to take a capsule at bedtime and to apply 1 mL of the solution to dry hair in the morning and at night. <br/><br/>The final analysis included 35 men in the topical group and 33 in the oral group (mean age, 36.6 years). Seven people in the topical group and 11 in the oral group were not able to attend the final appointment at 24 weeks. Three additional patients in the topical group dropped out for insomnia, hair shedding, and scalp eczema, while one dropped out of the oral group because of headache. <br/><br/>At 24 weeks, the percentage increase in terminal hair density in the oral minoxidil group was 27% higher (<em>P</em> = .005) in the vertex and 13% higher (<em>P</em> = .15) in the frontal scalp, compared with the topical-treated group.<br/><br/>Total hair density increased by 2% in the oral group compared with topical treatment in the vertex and decreased by 0.2% in the frontal area compared with topical treatment. None of these differences were statistically significant.<br/><br/>Three dermatologists blinded to the treatments, who analyzed photographs, determined that 60% of the men in the oral group and 48% in the topical group had clinical improvement in the frontal area, which was not statistically significant. More orally-treated patients had improvement in the vertex area: 70% compared with 46% of those on topical treatment (<em>P</em> = .04).<br/><br/></p> <h2>Hypertrichosis, Headache</h2> <p>Of the original 90 patients in the trial, more men taking oral minoxidil had hypertrichosis: 49% compared with 25% in the topical formulation group. Headache was also more common among those on oral minoxidil: six cases (14%) vs. one case (2%) among those on topical minoxidil. There was no difference in mean arterial blood pressure or resting heart rate between the two groups. Transient hair loss was more common with topical treatment, but it was not significant.</p> <p>Dr. Friedman said that the study results would not change how he practices, but that it would give him data to use to inform patients who do not want to take oral minoxidil. He generally prescribes the oral form, unless patients do not want to take it or there is a medical contraindication, which he said is rare.<br/><br/>“I personally think oral is superior to topical,” mainly “because the patient’s actually using it,” said Dr. Friedman. “They’re more likely to take a pill a day versus apply something topically twice a day,” he added.<br/><br/>Both Dr. Lipner and Dr. Friedman said that they doubted that individuals could — or would want to — follow the twice-daily topical regimen used in the trial.<br/><br/>“In real life, not in the clinical trial scenario, it may be very hard for patients to comply with putting on the topical minoxidil twice a day or even once a day,” Dr. Lipner said.<br/><br/>However, she continues to prescribe more topical minoxidil than oral, because she believes “there’s less potential for side effects.” For patients who can adhere to the topical regimen, the study shows that they will get results, said Dr. Lipner.<br/><br/>Dr. Friedman, however, said that for patients who are looking at a lifetime of medication, “an oral will always win out on a topical to the scalp from an adherence perspective.”<br/><br/>The study was supported by the Brazilian Dermatology Society Support Fund. Dr. Penha reported receiving grants from the fund; no other disclosures were reported. Dr. Friedman and Dr. Lipner reported no conflicts related to minoxidil.</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Article Source

FROM JAMA DERMATOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article