Dermatology News

SAN DIEGO — 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.”

Dr. 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.”

Dr. 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.

SAN DIEGO — 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.”

Dr. 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.”

Dr. 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.

SAN DIEGO — 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.”

Dr. 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.”

Dr. 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.

TOPLINE:

Infants with port-wine birthmarks (PWB) achieved near-total or total clearance with weekly pulsed dye laser (PDL) treatments in a case-series of 10 infants.

METHODOLOGY:

• Early intervention of PWB in infants can significantly improve outcomes, and some studies suggest shorter intervals between laser treatments may be more effective. While laser treatment with PDL is the gold standard, the optimal treatment interval has not been determined.
• Researchers evaluated the records of 10 infants with PWB who received weekly PDL treatments from 2022 to 2023 at a single center. Treatment was initiated when the infants were 6 months old or younger, with the median age at the first treatment being 4 weeks. Of the 10 infants, eight had Fitzpatrick skin types I-III and two had skin type IV.
• Two dermatologists assessed photographs taken before and after laser treatment, and the primary outcome was the percentage improvement of PWB.

TAKEAWAY:

• Of the 10 patients, six achieved near-total (76%-95%) clearance, and one achieved total (96%-100%) clearance of PWB at a mean of 2 months after the first treatment.
• Marked improvement (51%-75%) in PWB was observed in the remaining three patients, who achieved near-total clearance with additional treatments.
• The median duration of treatment was 2 months (range, 0.2-5.1), and a median of eight treatments (range, 2-20) were needed to achieve near total or total clearance.
• No adverse events were reported, including pigmentary changes, scarring, burns, erosions, or infections.

IN PRACTICE:

The outcomes in the case series, the authors concluded, “are compelling and warrant attention and further investigation into the possibility that this novel and decreased treatment interval of 1 week ... is associated with potential improvement in outcomes and shorter overall treatment duration.”

SOURCE:

This study was led by Shirin Bajaj, MD, of the Laser & Skin Surgery Center of New York, where the infants were treated, and was published online on April 17, 2024, in JAMA Dermatology.

LIMITATIONS:

A small sample size and the lack of a comparison arm limited the ability to draw any conclusions or make treatment recommendations based on the results.

DISCLOSURES:

The authors disclosed no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Infants with port-wine birthmarks (PWB) achieved near-total or total clearance with weekly pulsed dye laser (PDL) treatments in a case-series of 10 infants.

METHODOLOGY:

• Early intervention of PWB in infants can significantly improve outcomes, and some studies suggest shorter intervals between laser treatments may be more effective. While laser treatment with PDL is the gold standard, the optimal treatment interval has not been determined.
• Researchers evaluated the records of 10 infants with PWB who received weekly PDL treatments from 2022 to 2023 at a single center. Treatment was initiated when the infants were 6 months old or younger, with the median age at the first treatment being 4 weeks. Of the 10 infants, eight had Fitzpatrick skin types I-III and two had skin type IV.
• Two dermatologists assessed photographs taken before and after laser treatment, and the primary outcome was the percentage improvement of PWB.

TAKEAWAY:

• Of the 10 patients, six achieved near-total (76%-95%) clearance, and one achieved total (96%-100%) clearance of PWB at a mean of 2 months after the first treatment.
• Marked improvement (51%-75%) in PWB was observed in the remaining three patients, who achieved near-total clearance with additional treatments.
• The median duration of treatment was 2 months (range, 0.2-5.1), and a median of eight treatments (range, 2-20) were needed to achieve near total or total clearance.
• No adverse events were reported, including pigmentary changes, scarring, burns, erosions, or infections.

IN PRACTICE:

The outcomes in the case series, the authors concluded, “are compelling and warrant attention and further investigation into the possibility that this novel and decreased treatment interval of 1 week ... is associated with potential improvement in outcomes and shorter overall treatment duration.”

SOURCE:

This study was led by Shirin Bajaj, MD, of the Laser & Skin Surgery Center of New York, where the infants were treated, and was published online on April 17, 2024, in JAMA Dermatology.

LIMITATIONS:

A small sample size and the lack of a comparison arm limited the ability to draw any conclusions or make treatment recommendations based on the results.

DISCLOSURES:

The authors disclosed no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Infants with port-wine birthmarks (PWB) achieved near-total or total clearance with weekly pulsed dye laser (PDL) treatments in a case-series of 10 infants.

METHODOLOGY:

• Early intervention of PWB in infants can significantly improve outcomes, and some studies suggest shorter intervals between laser treatments may be more effective. While laser treatment with PDL is the gold standard, the optimal treatment interval has not been determined.
• Researchers evaluated the records of 10 infants with PWB who received weekly PDL treatments from 2022 to 2023 at a single center. Treatment was initiated when the infants were 6 months old or younger, with the median age at the first treatment being 4 weeks. Of the 10 infants, eight had Fitzpatrick skin types I-III and two had skin type IV.
• Two dermatologists assessed photographs taken before and after laser treatment, and the primary outcome was the percentage improvement of PWB.

TAKEAWAY:

• Of the 10 patients, six achieved near-total (76%-95%) clearance, and one achieved total (96%-100%) clearance of PWB at a mean of 2 months after the first treatment.
• Marked improvement (51%-75%) in PWB was observed in the remaining three patients, who achieved near-total clearance with additional treatments.
• The median duration of treatment was 2 months (range, 0.2-5.1), and a median of eight treatments (range, 2-20) were needed to achieve near total or total clearance.
• No adverse events were reported, including pigmentary changes, scarring, burns, erosions, or infections.

IN PRACTICE:

The outcomes in the case series, the authors concluded, “are compelling and warrant attention and further investigation into the possibility that this novel and decreased treatment interval of 1 week ... is associated with potential improvement in outcomes and shorter overall treatment duration.”

SOURCE:

This study was led by Shirin Bajaj, MD, of the Laser & Skin Surgery Center of New York, where the infants were treated, and was published online on April 17, 2024, in JAMA Dermatology.

LIMITATIONS:

A small sample size and the lack of a comparison arm limited the ability to draw any conclusions or make treatment recommendations based on the results.

DISCLOSURES:

The authors disclosed no conflicts of interest.
 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.

This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. 

Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release. 

“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. 

The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. 

The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.

Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.

This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. 

Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release. 

“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. 

The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. 

The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.

Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.

This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. 

Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release. 

“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. 

The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. 

The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.

Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson. 

A version of this article appeared on Medscape.com.

The photo of the patient’s foot, sent from his campsite, included a cheeky note: “I remember you telling me that getting in trouble doing something was better than getting in trouble doing nothing. This lets me get out there and know that I have feedback.”

The “this” was the patient’s “foot selfie,” an approach that allows patients at a risk for diabetic foot ulcers (DFUs) to snap a picture and send it to their healthcare providers for evaluation.

This particular patient had an extensive history of previous wounds. Some had essentially kept him house-bound in the past, as he was afraid to get another one.

This time, however, he got an all-clear to keep on camping, “and we scheduled him in on the following Tuesday [for follow-up],” said the camper’s physician David G. Armstrong, DPM, MD, PhD, professor of surgery and neurological surgery, USC Keck School of Medicine, Los Angeles.

Dr. Armstrong is one of the researchers evaluating the concept of foot selfies. It’s a welcome advance, he and others said, and has been shown to help heal wounds and reverse pre-ulcer lesions. Research on foot selfies continues, but much more is needed to solve the issue of DFUs, diabetic foot infections (DFIs), and the high rates of reinfection, experts know.

Worldwide, about 18.6 million people have a DFU each year, including 1.6 million in the United States. About 50%-60% of ulcers become infected, with 20% of moderate to severe infections requiring amputation of the limb. The 5-year mortality rate for DFUs is 30%, but it climbs to 70% after amputation. While about 40% of ulcers heal within 12 weeks, 42% recur at the 1-year mark, setting up a vicious and costly cycle. Healthcare costs for patients with diabetes and DFUs are five times as high as costs for patients with diabetes but no DFUs. The per capita cost to treat a DFU in America is $17,500.

While the statistics paint a grim picture, progress is being made on several fronts:

• US Food and Drug Administration (FDA) guidance on the development of drugs for DFUs, under evaluation, is forthcoming.
• New treatments are under study.
• A multidisciplinary team approach is known to improve outcomes.

Anatomy of a DFU

When neuropathy develops in those with diabetes, they no longer have what Dr. Armstrong calls the “gift” of pain perception. “They can wear a hole in their foot like you and I wear a hole in our sock or shoe,” he said. “That hole is called a diabetic foot ulcer.”

A DFU is an open wound on the foot, often occurring when bleeding develops beneath a callus and then the callus wears away. Deeper tissues of the foot are then exposed.

About half of the DFUs get infected, hence the FDA guidance, said Dr. Armstrong, who is also founding president of the American Limb Preservation Society, which aims to eliminate preventable amputations within the next generation. Every 20 seconds, Dr. Armstrong said, someone in the world loses a leg due to diabetes.
 

FDA Guidance on Drug Development for DFIs

In October, the FDA issued draft guidance for industry to articulate the design of clinical trials for developing antibacterial drugs to treat DFIs without concomitant bone and joint involvement. Comments closed on December 18. Among the points in the guidance, which is nonbinding, are to include DFIs of varying depths and extent in phase 3 trials and ideally to include only those patients who have not had prior antibacterial treatment for the current DFI.

According to an FDA spokesperson, “The agency is working to finalize the guidance. However, a timeline for its release has not yet been established.”

The good news about the upcoming FDA guidance, Dr. Armstrong said, is that the agency has realized the importance of treating the infections. Fully one third of direct costs of care for diabetes are spent on the lower extremities, he said. Keeping patients out of the hospital, uninfected, and “keeping legs on bodies” are all important goals, he said.

Pharmaceutical firms need to understand that “you aren’t dealing with a normal ulcer,” said Andrew J.M. Boulton, MD, professor of medicine at the University of Manchester and physician consultant at the Manchester Royal Infirmary, Manchester, England, and a visiting professor at the University of Miami. For research, “the most important thing is to take account of off-loading the ulcers,” he said. “Most ulcers will heal if put in a boot.”

Dr. Boulton, like Dr. Armstrong, a long-time expert in the field, contended that pharma has not understood this concept and has wasted millions over the last three decades doing studies that were poorly designed and controlled.
 

Treatments: Current, Under Study

Currently, DFIs are treated with antimicrobial therapy, without or without debridement, along with a clinical assessment for ischemia. If ischemia is found, care progresses to wound care and off-loading devices, such as healing sandals. Clinicians then assess the likelihood of improved outcomes with revascularization based on operative risks and distribution of lower extremity artery disease and proceed depending on the likelihood. If osteomyelitis testing shows it is present, providers proceed to wound debridement, limb-sparing amputation, and prolonged antimicrobials, as needed.

More options are needed, Dr. Armstrong said.

Among the many approaches under study:

• DFUs can be accurately detected by applying artificial intelligence to the “foot selfie” images taken by patients on smartphones, research by Dr.  and  has found.
• After a phase 3 study of  for DFUs originally intending to enroll 300 subjects was discontinued because of slow patient recruitment, an interim analysis was conducted on 44 participants. It showed a positive trend toward wound closure in the group receiving the injected gene therapy, VM202 (ENGENSIS), in their calf muscles. VM202 is a plasmid DNA-encoding human hepatocyte growth factor. While those in both the intervention and placebo groups showed wound-closing effects at month 6, in 23 patients with neuro-ischemic ulcers, the percentage of those reaching complete closure of the DFU was significantly higher in the treated group at months 3, 4, and 5 (P = .0391, .0391, and .0361, respectively). After excluding two outliers, the difference in months 3-6 became more significant (P = .03).
• An closed more DFUs than standard care after 12 weeks — 70% vs 34% (P = .00032). Of the 100 participants randomized, 50 per group, 42% of the treatment group and 56% of the control group experienced adverse events, with eight withdrawn due to serious adverse events (such as osteomyelitis).
• A closed more refractory DFUs over a 16-week study than standard sharp debridement, with 65% of water-treated ulcers healed but just 42% of the standard care group (P = .021, unadjusted).
• Researchers from UC Davis and VA Northern California Healthcare are evaluating timolol, a beta adrenergic receptor blocker already approved for topical administration for glaucoma, as a way to heal chronic DFUs faster. After demonstrating that the medication worked in animal models, researchers then launched a study to use it off-label for DFUs. While data are still being analyzed, researcher Roslyn (Rivkah) Isseroff, MD, of UC Davis and VA, said that data so far demonstrate that the timolol reduced transepidermal water loss in the healed wounds, and that is linked with a decrease in re-ulceration.

The Power of a Team

Multidisciplinary approaches to treatment are effective in reducing amputation, with one review of 33 studies finding the approach worked to decrease amputation in 94% of them. “The American Limb Preservation Society (ALPS) lists 30 programs,” said Dr. Armstrong, the founding president of the organization. “There may be as many as 100.”

Team compositions vary but usually include at least one medical specialty clinician, such as infectious disease, primary care, or endocrinology, and two or more specialty clinicians, such as vascular, podiatric, orthopedic, or plastic surgery. A shoe specialist is needed to prescribe and manage footwear. Other important team members include nutrition experts and behavioral health professionals to deal with associated depression.

Johns Hopkins’ Multidisciplinary Diabetic Foot and Wound Service launched in 2012 and includes vascular surgeons, surgical podiatrists, endocrinologists, wound care nurses, advanced practice staff, board-certified wound care specialists, orthopedic surgeons, infection disease experts, physical therapists, and certified orthotists.

“This interdisciplinary care model has been repeatedly validated by research as superior for limb salvage and wound healing,” said Nestoras Mathioudakis, MD, codirector of the service. “For instance, endocrinologists and diabetes educators are crucial for managing uncontrolled diabetes — a key factor in infection and delayed wound healing. Similarly, vascular surgeons play a vital role in addressing peripheral arterial disease to improve blood flow to the affected area.”

“Diabetic foot ulcers might require prolonged periods of specialized care, including meticulous wound management and off-loading, overseen by surgical podiatrists and wound care experts,” he said. “In cases where infection is present, particularly with multidrug resistant organisms or when standard antibiotics are contraindicated, the insight of an infectious disease specialist is invaluable.”

While the makeup of teams varies from location to location, he said “the hallmark of effective teams is their ability to comprehensively manage glycemic control, foot wounds, vascular disease, and infections.”

The power of teams, Dr. Armstrong said, is very much evident after his weekly “foot selfie rounds” conducted Mondays at 7 AM, with an “all feet on deck” approach. “Not a week goes by when we don’t stop a hospitalization,” he said of the team evaluating the photos, due to detecting issues early, while still in the manageable state.

Teams can trump technology, Dr. Armstrong said. A team of just a primary care doctor and a podiatrist can make a significant reduction in amputations, he said, just by a “Knock your socks off” approach. He reminds primary care doctors that observing the feet of their patients with diabetes can go a long way to reducing DFUs and the hospitalizations and amputations that can result.

Dr. Mathioudakis and Dr. Isseroff reported no disclosures. Dr. Boulton consults for Urgo Medical, Nevro Corporation, and AOT, Inc. Dr. Armstrong reported receiving consulting fees from Podimetrics; Molnlycke; Cardiovascular Systems, Inc.; Endo Pharmaceuticals; and Averitas Pharma (GRT US).

A version of this article first appeared on Medscape.com.

The photo of the patient’s foot, sent from his campsite, included a cheeky note: “I remember you telling me that getting in trouble doing something was better than getting in trouble doing nothing. This lets me get out there and know that I have feedback.”

The “this” was the patient’s “foot selfie,” an approach that allows patients at a risk for diabetic foot ulcers (DFUs) to snap a picture and send it to their healthcare providers for evaluation.

This particular patient had an extensive history of previous wounds. Some had essentially kept him house-bound in the past, as he was afraid to get another one.

This time, however, he got an all-clear to keep on camping, “and we scheduled him in on the following Tuesday [for follow-up],” said the camper’s physician David G. Armstrong, DPM, MD, PhD, professor of surgery and neurological surgery, USC Keck School of Medicine, Los Angeles.

Dr. Armstrong is one of the researchers evaluating the concept of foot selfies. It’s a welcome advance, he and others said, and has been shown to help heal wounds and reverse pre-ulcer lesions. Research on foot selfies continues, but much more is needed to solve the issue of DFUs, diabetic foot infections (DFIs), and the high rates of reinfection, experts know.

Worldwide, about 18.6 million people have a DFU each year, including 1.6 million in the United States. About 50%-60% of ulcers become infected, with 20% of moderate to severe infections requiring amputation of the limb. The 5-year mortality rate for DFUs is 30%, but it climbs to 70% after amputation. While about 40% of ulcers heal within 12 weeks, 42% recur at the 1-year mark, setting up a vicious and costly cycle. Healthcare costs for patients with diabetes and DFUs are five times as high as costs for patients with diabetes but no DFUs. The per capita cost to treat a DFU in America is $17,500.

While the statistics paint a grim picture, progress is being made on several fronts:

• US Food and Drug Administration (FDA) guidance on the development of drugs for DFUs, under evaluation, is forthcoming.
• New treatments are under study.
• A multidisciplinary team approach is known to improve outcomes.

Anatomy of a DFU

When neuropathy develops in those with diabetes, they no longer have what Dr. Armstrong calls the “gift” of pain perception. “They can wear a hole in their foot like you and I wear a hole in our sock or shoe,” he said. “That hole is called a diabetic foot ulcer.”

A DFU is an open wound on the foot, often occurring when bleeding develops beneath a callus and then the callus wears away. Deeper tissues of the foot are then exposed.

About half of the DFUs get infected, hence the FDA guidance, said Dr. Armstrong, who is also founding president of the American Limb Preservation Society, which aims to eliminate preventable amputations within the next generation. Every 20 seconds, Dr. Armstrong said, someone in the world loses a leg due to diabetes.
 

FDA Guidance on Drug Development for DFIs

In October, the FDA issued draft guidance for industry to articulate the design of clinical trials for developing antibacterial drugs to treat DFIs without concomitant bone and joint involvement. Comments closed on December 18. Among the points in the guidance, which is nonbinding, are to include DFIs of varying depths and extent in phase 3 trials and ideally to include only those patients who have not had prior antibacterial treatment for the current DFI.

According to an FDA spokesperson, “The agency is working to finalize the guidance. However, a timeline for its release has not yet been established.”

The good news about the upcoming FDA guidance, Dr. Armstrong said, is that the agency has realized the importance of treating the infections. Fully one third of direct costs of care for diabetes are spent on the lower extremities, he said. Keeping patients out of the hospital, uninfected, and “keeping legs on bodies” are all important goals, he said.

Pharmaceutical firms need to understand that “you aren’t dealing with a normal ulcer,” said Andrew J.M. Boulton, MD, professor of medicine at the University of Manchester and physician consultant at the Manchester Royal Infirmary, Manchester, England, and a visiting professor at the University of Miami. For research, “the most important thing is to take account of off-loading the ulcers,” he said. “Most ulcers will heal if put in a boot.”

Dr. Boulton, like Dr. Armstrong, a long-time expert in the field, contended that pharma has not understood this concept and has wasted millions over the last three decades doing studies that were poorly designed and controlled.
 

Treatments: Current, Under Study

Currently, DFIs are treated with antimicrobial therapy, without or without debridement, along with a clinical assessment for ischemia. If ischemia is found, care progresses to wound care and off-loading devices, such as healing sandals. Clinicians then assess the likelihood of improved outcomes with revascularization based on operative risks and distribution of lower extremity artery disease and proceed depending on the likelihood. If osteomyelitis testing shows it is present, providers proceed to wound debridement, limb-sparing amputation, and prolonged antimicrobials, as needed.

More options are needed, Dr. Armstrong said.

Among the many approaches under study:

• DFUs can be accurately detected by applying artificial intelligence to the “foot selfie” images taken by patients on smartphones, research by Dr.  and  has found.
• After a phase 3 study of  for DFUs originally intending to enroll 300 subjects was discontinued because of slow patient recruitment, an interim analysis was conducted on 44 participants. It showed a positive trend toward wound closure in the group receiving the injected gene therapy, VM202 (ENGENSIS), in their calf muscles. VM202 is a plasmid DNA-encoding human hepatocyte growth factor. While those in both the intervention and placebo groups showed wound-closing effects at month 6, in 23 patients with neuro-ischemic ulcers, the percentage of those reaching complete closure of the DFU was significantly higher in the treated group at months 3, 4, and 5 (P = .0391, .0391, and .0361, respectively). After excluding two outliers, the difference in months 3-6 became more significant (P = .03).
• An closed more DFUs than standard care after 12 weeks — 70% vs 34% (P = .00032). Of the 100 participants randomized, 50 per group, 42% of the treatment group and 56% of the control group experienced adverse events, with eight withdrawn due to serious adverse events (such as osteomyelitis).
• A closed more refractory DFUs over a 16-week study than standard sharp debridement, with 65% of water-treated ulcers healed but just 42% of the standard care group (P = .021, unadjusted).
• Researchers from UC Davis and VA Northern California Healthcare are evaluating timolol, a beta adrenergic receptor blocker already approved for topical administration for glaucoma, as a way to heal chronic DFUs faster. After demonstrating that the medication worked in animal models, researchers then launched a study to use it off-label for DFUs. While data are still being analyzed, researcher Roslyn (Rivkah) Isseroff, MD, of UC Davis and VA, said that data so far demonstrate that the timolol reduced transepidermal water loss in the healed wounds, and that is linked with a decrease in re-ulceration.

The Power of a Team

Multidisciplinary approaches to treatment are effective in reducing amputation, with one review of 33 studies finding the approach worked to decrease amputation in 94% of them. “The American Limb Preservation Society (ALPS) lists 30 programs,” said Dr. Armstrong, the founding president of the organization. “There may be as many as 100.”

Team compositions vary but usually include at least one medical specialty clinician, such as infectious disease, primary care, or endocrinology, and two or more specialty clinicians, such as vascular, podiatric, orthopedic, or plastic surgery. A shoe specialist is needed to prescribe and manage footwear. Other important team members include nutrition experts and behavioral health professionals to deal with associated depression.

Johns Hopkins’ Multidisciplinary Diabetic Foot and Wound Service launched in 2012 and includes vascular surgeons, surgical podiatrists, endocrinologists, wound care nurses, advanced practice staff, board-certified wound care specialists, orthopedic surgeons, infection disease experts, physical therapists, and certified orthotists.

“This interdisciplinary care model has been repeatedly validated by research as superior for limb salvage and wound healing,” said Nestoras Mathioudakis, MD, codirector of the service. “For instance, endocrinologists and diabetes educators are crucial for managing uncontrolled diabetes — a key factor in infection and delayed wound healing. Similarly, vascular surgeons play a vital role in addressing peripheral arterial disease to improve blood flow to the affected area.”

“Diabetic foot ulcers might require prolonged periods of specialized care, including meticulous wound management and off-loading, overseen by surgical podiatrists and wound care experts,” he said. “In cases where infection is present, particularly with multidrug resistant organisms or when standard antibiotics are contraindicated, the insight of an infectious disease specialist is invaluable.”

While the makeup of teams varies from location to location, he said “the hallmark of effective teams is their ability to comprehensively manage glycemic control, foot wounds, vascular disease, and infections.”

The power of teams, Dr. Armstrong said, is very much evident after his weekly “foot selfie rounds” conducted Mondays at 7 AM, with an “all feet on deck” approach. “Not a week goes by when we don’t stop a hospitalization,” he said of the team evaluating the photos, due to detecting issues early, while still in the manageable state.

Teams can trump technology, Dr. Armstrong said. A team of just a primary care doctor and a podiatrist can make a significant reduction in amputations, he said, just by a “Knock your socks off” approach. He reminds primary care doctors that observing the feet of their patients with diabetes can go a long way to reducing DFUs and the hospitalizations and amputations that can result.

Dr. Mathioudakis and Dr. Isseroff reported no disclosures. Dr. Boulton consults for Urgo Medical, Nevro Corporation, and AOT, Inc. Dr. Armstrong reported receiving consulting fees from Podimetrics; Molnlycke; Cardiovascular Systems, Inc.; Endo Pharmaceuticals; and Averitas Pharma (GRT US).

A version of this article first appeared on Medscape.com.

The photo of the patient’s foot, sent from his campsite, included a cheeky note: “I remember you telling me that getting in trouble doing something was better than getting in trouble doing nothing. This lets me get out there and know that I have feedback.”

The “this” was the patient’s “foot selfie,” an approach that allows patients at a risk for diabetic foot ulcers (DFUs) to snap a picture and send it to their healthcare providers for evaluation.

This particular patient had an extensive history of previous wounds. Some had essentially kept him house-bound in the past, as he was afraid to get another one.

This time, however, he got an all-clear to keep on camping, “and we scheduled him in on the following Tuesday [for follow-up],” said the camper’s physician David G. Armstrong, DPM, MD, PhD, professor of surgery and neurological surgery, USC Keck School of Medicine, Los Angeles.

Dr. Armstrong is one of the researchers evaluating the concept of foot selfies. It’s a welcome advance, he and others said, and has been shown to help heal wounds and reverse pre-ulcer lesions. Research on foot selfies continues, but much more is needed to solve the issue of DFUs, diabetic foot infections (DFIs), and the high rates of reinfection, experts know.

Worldwide, about 18.6 million people have a DFU each year, including 1.6 million in the United States. About 50%-60% of ulcers become infected, with 20% of moderate to severe infections requiring amputation of the limb. The 5-year mortality rate for DFUs is 30%, but it climbs to 70% after amputation. While about 40% of ulcers heal within 12 weeks, 42% recur at the 1-year mark, setting up a vicious and costly cycle. Healthcare costs for patients with diabetes and DFUs are five times as high as costs for patients with diabetes but no DFUs. The per capita cost to treat a DFU in America is $17,500.

While the statistics paint a grim picture, progress is being made on several fronts:

• US Food and Drug Administration (FDA) guidance on the development of drugs for DFUs, under evaluation, is forthcoming.
• New treatments are under study.
• A multidisciplinary team approach is known to improve outcomes.

Anatomy of a DFU

When neuropathy develops in those with diabetes, they no longer have what Dr. Armstrong calls the “gift” of pain perception. “They can wear a hole in their foot like you and I wear a hole in our sock or shoe,” he said. “That hole is called a diabetic foot ulcer.”

A DFU is an open wound on the foot, often occurring when bleeding develops beneath a callus and then the callus wears away. Deeper tissues of the foot are then exposed.

About half of the DFUs get infected, hence the FDA guidance, said Dr. Armstrong, who is also founding president of the American Limb Preservation Society, which aims to eliminate preventable amputations within the next generation. Every 20 seconds, Dr. Armstrong said, someone in the world loses a leg due to diabetes.
 

FDA Guidance on Drug Development for DFIs

In October, the FDA issued draft guidance for industry to articulate the design of clinical trials for developing antibacterial drugs to treat DFIs without concomitant bone and joint involvement. Comments closed on December 18. Among the points in the guidance, which is nonbinding, are to include DFIs of varying depths and extent in phase 3 trials and ideally to include only those patients who have not had prior antibacterial treatment for the current DFI.

According to an FDA spokesperson, “The agency is working to finalize the guidance. However, a timeline for its release has not yet been established.”

The good news about the upcoming FDA guidance, Dr. Armstrong said, is that the agency has realized the importance of treating the infections. Fully one third of direct costs of care for diabetes are spent on the lower extremities, he said. Keeping patients out of the hospital, uninfected, and “keeping legs on bodies” are all important goals, he said.

Pharmaceutical firms need to understand that “you aren’t dealing with a normal ulcer,” said Andrew J.M. Boulton, MD, professor of medicine at the University of Manchester and physician consultant at the Manchester Royal Infirmary, Manchester, England, and a visiting professor at the University of Miami. For research, “the most important thing is to take account of off-loading the ulcers,” he said. “Most ulcers will heal if put in a boot.”

Dr. Boulton, like Dr. Armstrong, a long-time expert in the field, contended that pharma has not understood this concept and has wasted millions over the last three decades doing studies that were poorly designed and controlled.
 

Treatments: Current, Under Study

Currently, DFIs are treated with antimicrobial therapy, without or without debridement, along with a clinical assessment for ischemia. If ischemia is found, care progresses to wound care and off-loading devices, such as healing sandals. Clinicians then assess the likelihood of improved outcomes with revascularization based on operative risks and distribution of lower extremity artery disease and proceed depending on the likelihood. If osteomyelitis testing shows it is present, providers proceed to wound debridement, limb-sparing amputation, and prolonged antimicrobials, as needed.

More options are needed, Dr. Armstrong said.

Among the many approaches under study:

• DFUs can be accurately detected by applying artificial intelligence to the “foot selfie” images taken by patients on smartphones, research by Dr.  and  has found.
• After a phase 3 study of  for DFUs originally intending to enroll 300 subjects was discontinued because of slow patient recruitment, an interim analysis was conducted on 44 participants. It showed a positive trend toward wound closure in the group receiving the injected gene therapy, VM202 (ENGENSIS), in their calf muscles. VM202 is a plasmid DNA-encoding human hepatocyte growth factor. While those in both the intervention and placebo groups showed wound-closing effects at month 6, in 23 patients with neuro-ischemic ulcers, the percentage of those reaching complete closure of the DFU was significantly higher in the treated group at months 3, 4, and 5 (P = .0391, .0391, and .0361, respectively). After excluding two outliers, the difference in months 3-6 became more significant (P = .03).
• An closed more DFUs than standard care after 12 weeks — 70% vs 34% (P = .00032). Of the 100 participants randomized, 50 per group, 42% of the treatment group and 56% of the control group experienced adverse events, with eight withdrawn due to serious adverse events (such as osteomyelitis).
• A closed more refractory DFUs over a 16-week study than standard sharp debridement, with 65% of water-treated ulcers healed but just 42% of the standard care group (P = .021, unadjusted).
• Researchers from UC Davis and VA Northern California Healthcare are evaluating timolol, a beta adrenergic receptor blocker already approved for topical administration for glaucoma, as a way to heal chronic DFUs faster. After demonstrating that the medication worked in animal models, researchers then launched a study to use it off-label for DFUs. While data are still being analyzed, researcher Roslyn (Rivkah) Isseroff, MD, of UC Davis and VA, said that data so far demonstrate that the timolol reduced transepidermal water loss in the healed wounds, and that is linked with a decrease in re-ulceration.

The Power of a Team

Multidisciplinary approaches to treatment are effective in reducing amputation, with one review of 33 studies finding the approach worked to decrease amputation in 94% of them. “The American Limb Preservation Society (ALPS) lists 30 programs,” said Dr. Armstrong, the founding president of the organization. “There may be as many as 100.”

Team compositions vary but usually include at least one medical specialty clinician, such as infectious disease, primary care, or endocrinology, and two or more specialty clinicians, such as vascular, podiatric, orthopedic, or plastic surgery. A shoe specialist is needed to prescribe and manage footwear. Other important team members include nutrition experts and behavioral health professionals to deal with associated depression.

Johns Hopkins’ Multidisciplinary Diabetic Foot and Wound Service launched in 2012 and includes vascular surgeons, surgical podiatrists, endocrinologists, wound care nurses, advanced practice staff, board-certified wound care specialists, orthopedic surgeons, infection disease experts, physical therapists, and certified orthotists.

“This interdisciplinary care model has been repeatedly validated by research as superior for limb salvage and wound healing,” said Nestoras Mathioudakis, MD, codirector of the service. “For instance, endocrinologists and diabetes educators are crucial for managing uncontrolled diabetes — a key factor in infection and delayed wound healing. Similarly, vascular surgeons play a vital role in addressing peripheral arterial disease to improve blood flow to the affected area.”

“Diabetic foot ulcers might require prolonged periods of specialized care, including meticulous wound management and off-loading, overseen by surgical podiatrists and wound care experts,” he said. “In cases where infection is present, particularly with multidrug resistant organisms or when standard antibiotics are contraindicated, the insight of an infectious disease specialist is invaluable.”

While the makeup of teams varies from location to location, he said “the hallmark of effective teams is their ability to comprehensively manage glycemic control, foot wounds, vascular disease, and infections.”

The power of teams, Dr. Armstrong said, is very much evident after his weekly “foot selfie rounds” conducted Mondays at 7 AM, with an “all feet on deck” approach. “Not a week goes by when we don’t stop a hospitalization,” he said of the team evaluating the photos, due to detecting issues early, while still in the manageable state.

Teams can trump technology, Dr. Armstrong said. A team of just a primary care doctor and a podiatrist can make a significant reduction in amputations, he said, just by a “Knock your socks off” approach. He reminds primary care doctors that observing the feet of their patients with diabetes can go a long way to reducing DFUs and the hospitalizations and amputations that can result.

Dr. Mathioudakis and Dr. Isseroff reported no disclosures. Dr. Boulton consults for Urgo Medical, Nevro Corporation, and AOT, Inc. Dr. Armstrong reported receiving consulting fees from Podimetrics; Molnlycke; Cardiovascular Systems, Inc.; Endo Pharmaceuticals; and Averitas Pharma (GRT US).

A version of this article first appeared on Medscape.com.

TOPLINE:

An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one-third demonstrated substantial clinical benefits at the time of approval.

METHODOLOGY:

• The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
• Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
• In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
• The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
• The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).

TAKEAWAY:

• The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
• Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
• Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
• Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.

IN PRACTICE:

“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”

SOURCE:

The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.

DISCLOSURES:

The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one-third demonstrated substantial clinical benefits at the time of approval.

METHODOLOGY:

• The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
• Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
• In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
• The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
• The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).

TAKEAWAY:

• The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
• Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
• Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
• Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.

IN PRACTICE:

“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”

SOURCE:

The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.

DISCLOSURES:

The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

An analysis of molecular-targeted cancer drug therapies recently approved in the United States found that fewer than one-third demonstrated substantial clinical benefits at the time of approval.

METHODOLOGY:

• The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
• Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
• In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
• The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
• The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).

TAKEAWAY:

• The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
• Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
• Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
• Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.

IN PRACTICE:

“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”

SOURCE:

The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.

LIMITATIONS:

The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.

DISCLOSURES:

The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

Physician practice ownership by corporations, including health insurers, private equity firms, and large pharmacy chains, reached 30.1% as of January for the first time surpassing ownership by hospitals and health systems (28.4%), according to a new report.

As a result, about three in five physician practices are now owned by nonphysicians.

In early 2020, corporations owned just about 17% of US medical practices, while hospitals and health systems owned about 25%, according to the report released Thursday by nonprofit Physician Advocacy Institute (PAI). But corporate ownership of medical groups surged during the pandemic.

These trends raise questions about how best to protect patients and physicians in a changing employment landscape, said Kelly Kenney, PAI’s chief executive officer, in a statement.

“Corporate entities are assuming control of physician practices and changing the face of medicine in the United States with little to no scrutiny from regulators,” Ms. Kenney said.

The research, conducted by consulting group Avalere for PAI, used the IQVIA OneKey database that contains physician and practice location information on hospital and health system ownership.

By 2022-2023, there was a 7.3% increase in the percentage of practices owned by hospitals and 5.9% increase in the percentage of physicians employed by these organizations, PAI said. In the same time frame, there was an 11% increase in the percentage of practices owned by corporations and a 3.0% increase in the percentage of physicians employed by these entities.

“Physicians have an ethical responsibility to their patients’ health,” Ms. Kenney said. “Corporate entities have a fiduciary responsibility to their shareholders and are motivated to put profits first…these interests can conflict with providing the best medical care to patients.”
 

Federal Scrutiny Increases

However, both federal and state regulators are paying more attention to what happens to patients and physicians when corporations acquire practices.

“Given recent trends, we are concerned that some transactions may generate profits for those firms at the expense of patients’ health, workers’ safety, quality of care, and affordable healthcare for patients and taxpayers,” said the Federal Trade Commission (FTC) and the Justice (DOJ) and Health and Human Services (HHS) departments.

This statement appears in those agencies’ joint request for information (RFI) announced in March. An RFI is a tool that federal agencies can use to gauge the level of both support and opposition they would face if they were to try to change policies. Public comments are due May 6.

Corporations and advocacy groups often submit detailed comments outlining reasons why the federal government should or should not act on an issue. But individuals also can make their case in this forum.

The FTC, DOJ, and HHS are looking broadly at consolidation in healthcare, but they also spell out potential concerns related to acquisition of physician practices.

For example, they asked clinicians and support staff to provide feedback about whether acquisitions lead to changes in:

• Take-home pay
• Staffing levels
• Workplace safety
• Compensation model (eg, from fixed salary to volume based)
• Policies regarding patient referrals
• Mix of patients
• The volume of patients
• The way providers practice medicine (eg, incentives, prescribing decisions, forced protocols, restrictions on time spent with patients, or mandatory coding practices)
• Administrative or managerial organization (eg, transition to a management services organization).

A version of this article appeared on Medscape.com.

BALTIMORE — Patients who have complications after dermatologic cosmetic procedures are prone to high rates of a host of mental health issues, ranging from anxiety disorder and depression to body dysmorphic disorder (BDD) and posttraumatic stress disorder (PTSD), according to a survey-based study of patients with dermatology-related complications. 

The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.

Taryn Murray, MD

“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
 

Rise in Mental Health Issues

The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results. 

Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.

“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”

Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”

The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).

The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).

Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.

“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
 

Take-Home Lesson

The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”

She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”

She said she hopes her findings lead to more research in the future.

Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”

She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.

The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”

Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.

A version of this article appeared on Medscape.com.

BALTIMORE — Patients who have complications after dermatologic cosmetic procedures are prone to high rates of a host of mental health issues, ranging from anxiety disorder and depression to body dysmorphic disorder (BDD) and posttraumatic stress disorder (PTSD), according to a survey-based study of patients with dermatology-related complications. 

The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.

Taryn Murray, MD

“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
 

Rise in Mental Health Issues

The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results. 

Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.

“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”

Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”

The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).

The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).

Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.

“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
 

Take-Home Lesson

The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”

She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”

She said she hopes her findings lead to more research in the future.

Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”

She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.

The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”

Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.

A version of this article appeared on Medscape.com.

BALTIMORE — Patients who have complications after dermatologic cosmetic procedures are prone to high rates of a host of mental health issues, ranging from anxiety disorder and depression to body dysmorphic disorder (BDD) and posttraumatic stress disorder (PTSD), according to a survey-based study of patients with dermatology-related complications. 

The study used an anonymous 40-question survey circulated to a Facebook cosmetic complication support group. Seventy-one of 100 individuals completed the questionnaire, reporting significantly higher rates of mental health issues after their complications than before. Results were presented at the annual conference of the American Society for Laser Medicine and Surgery (ASLMS). Almost all the survey respondents (99%) were female, with 61% aged 25-44 years and 34% aged 45-64 years.

Taryn Murray, MD

“Cosmetic procedures have increased over the past decade, with procedures being increasingly performed by an evolving variety of providers,” the study’s lead author, Taryn Murray, MD, a dermatologist at Cleveland Clinic, Cleveland, Ohio, told this news organization. “Appropriate patient assessment and counseling and proper procedure technique are important for obtaining safe and effective results. Complications may not only impact patients physically but can also be harmful to their mental health.”
 

Rise in Mental Health Issues

The study found that before respondents had the treatment that led to their complications, 16% reported a history of generalized anxiety disorder, 15% a history of depression, and 1% a history of either BDD or PTSD. Following the complication, 50% reported a positive depression screening, 63% a positive BDD Questionnaire – Dermatology Version, and 63% a positive Primary Care PTSD screen, Dr. Murray said. “Almost half of respondents (46%) reported thinking about their complication for more than 3 hours a day,” she said in presenting the results. 

Dr. Murray said the idea for the study grew out of her experience as a fellow working with Paul Friedman, MD, at the Dermatology and Laser Surgery Center at University of Texas Health in Houston.

“We were seeing a lot of complications,” Dr. Murray said in an interview. “Some of these were local. Some of these patients were flying in from out-of-state looking for help with the complication, and we could see what a mental and emotional burden this put on these patients. They were routinely in the office in tears saying it was interfering with their daily life, it was interfering with their job, saying they were going to lose their job, all because they were so distressed over what was happening to them.”

Yet, the research into psychological distress in patients with dermatologic complications is minimal, Dr. Murray added. “We think that body dysmorphic disorder is prevalent for patients seeking dermatology or plastic surgery services, but I don’t think either of the specialties do a great job in screening people for that when they come for treatment, so I think a lot of it goes undiagnosed. There’s been a trend looking at more at complications lately, but there’s been a gap in the literature.”

The treatments the patients in the survey had were microneedling with radiofrequency (29%), laser (24%), ultrasound for skin tightening (11%), radiofrequency for skin tightening (11%), microneedling (4%), chemical peel (3%), body contouring/sculpting (1%), and “other” (17%).

The study found that the largest share of procedures, 47%, were done by an esthetician/laser technician, followed by a nondermatologist physician (17%), a board-certified dermatologist (14%), an advanced practice provider (12%), and “other” (10%).

Self-reported complications included scarring (38%), hyperpigmentation (26%), erythema (24%), burn (23%), blisters (11%), and hypopigmentation (3%); 71% characterized their complications as “other,” and one respondent reported multiple complications.

“Respondents said they were satisfied with the previous cosmetic care they received,” Dr. Murray said during her presentation at the meeting. “And there was a consensus among the respondents that they did not feel adequately counseled on the risks of the procedure and that it did not meet their expectations and anticipated outcome.”
 

Take-Home Lesson

The lesson here is that practitioners who perform cosmetic procedures should be well-versed in the task and potential complications, Dr. Murray said in the interview. “If you’re going to be doing a procedure, make sure you know the proper techniques, the proper endpoints, and how to treat if you’re to have a complication,” she said. “If you don’t know how to treat a complication from the device, then you should think twice about using it.”

She also suggested screening patients for potentially undiagnosed mental health disorders. “It can play a role in the initial consultation and potentially any after-care they might need if there is a complication,” she said. “We may not have the adequate tools at this time to know how to best handle these patients and these scenarios, but hopefully my abstract will shed a little more light on it.”

She said she hopes her findings lead to more research in the future.

Asked to comment on the study, Jennifer Lin, MD, assistant professor of dermatology at Brigham and Women’s Hospital and Dana Farber Cancer Institute in Boston, Massachusetts, said one finding of the study stood out to her. “ I was very surprised from her dataset that patients think about it more than 3 hours a day,” she told this news organization. “That’s really significant. We talk about the side effects, but we don’t necessarily talk about the burden of how long the recovery will be or the psychological burden of potentially dealing with it.”

She noted that “there’s a bit of movement” toward developing guidelines for laser treatments, which would address the risk of complications. “That’s the goal: To have better guidelines to avoid these complications in the first place,” Dr. Lin said.

The study findings also point to a need for “premonitoring” individuals before procedures, she added. “We talked about patient selection and make sure someone doesn’t have body dysmorphic disorder, but we don’t formally screen for it,” she said. “We don’t our train our residents to screen for it. And I think doing more pre- and post-testing of how people are affected by laser treatment is going to become more important.”

Dr. Murray disclosed relationships with R2 Technologies. Dr. Lin had no relationships to disclose.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”

As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.

And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.

For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”

This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”

This stuff creeps into our medical notes because doctors are human, not AI — at least not yet — and our frustrations and biases are real. But could those frustrations and biases lead to medical errors? Even deaths? Stay with me.

We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.

In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.

Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.

Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.

Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.

Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.

Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”

As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.

And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.

For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”

This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”

This stuff creeps into our medical notes because doctors are human, not AI — at least not yet — and our frustrations and biases are real. But could those frustrations and biases lead to medical errors? Even deaths? Stay with me.

We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.

In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.

Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.

Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.

Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.

Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.

Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

When I was doing my nephrology training, I had an attending who would write notes that were, well, kind of funny. I remember one time we were seeing a patient whose first name was “Lucky.” He dryly opened his section of the consult note as follows: “This is a 56-year-old woman with an ironic name who presents with acute renal failure.”

As an exhausted renal fellow, I appreciated the bit of color amid the ongoing series of tragedies that was the consult service. But let’s be clear — writing like this in the medical record is not a good idea. It wasn’t a good idea then, when any record might end up disclosed during a malpractice suit, and it’s really not a good idea now, when patients have ready and automated access to all the notes we write about them.

And yet, worse language than that of my attending appears in hospital notes all the time; there is research about this. Specifically, I’m talking about language that does not have high clinical utility but telegraphs the biases of the person writing the note. This is known as “stigmatizing language” and it can be overt or subtle.

For example, a physician wrote “I listed several fictitious medication names and she reported she was taking them.”

This casts suspicions about the patient’s credibility, as does the more subtle statement, “he claims nicotine patches don’t work for him.” Stigmatizing language may cast the patient in a difficult light, like this note: “she persevered on the fact that ... ‘you wouldn’t understand.’ ”

This stuff creeps into our medical notes because doctors are human, not AI — at least not yet — and our frustrations and biases are real. But could those frustrations and biases lead to medical errors? Even deaths? Stay with me.

We are going to start by defining a very sick patient population: those admitted to the hospital and who, within 48 hours, have either been transferred to the intensive care unit or died. Because of the severity of illness in this population we’ve just defined, figuring out whether a diagnostic or other error was made would be extremely high yield; these can mean the difference between life and death.

In a letter appearing in JAMA Internal Medicine, researchers examined a group of more than 2300 patients just like this from 29 hospitals, scouring the medical records for evidence of these types of errors.

Nearly one in four (23.2%) had at least one diagnostic error, which could include a missed physical exam finding, failure to ask a key question on history taking, inadequate testing, and so on.

Understanding why we make these errors is clearly critical to improving care for these patients. The researchers hypothesized that stigmatizing language might lead to errors like this. For example, by demonstrating that you don’t find a patient credible, you may ignore statements that would help make a better diagnosis.

Just over 5% of these patients had evidence of stigmatizing language in their medical notes. Like earlier studies, this language was more common if the patient was Black or had unstable housing.

Critically, stigmatizing language was more likely to be found among those who had diagnostic errors — a rate of 8.2% vs 4.1%. After adjustment for factors like race, the presence of stigmatizing language was associated with roughly a doubling of the risk for diagnostic errors.

Now, I’m all for eliminating stigmatizing language from our medical notes. And, given the increased transparency of all medical notes these days, I expect that we’ll see less of this over time. But of course, the fact that a physician doesn’t write something that disparages the patient does not necessarily mean that they don’t retain that bias. That said, those comments have an effect on all the other team members who care for that patient as well; it sets a tone and can entrench an individual’s bias more broadly. We should strive to eliminate our biases when it comes to caring for patients. But perhaps the second best thing is to work to keep those biases to ourselves.
 

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Recent cases of botulism-like illness following neurotoxin injections in nonmedical settings have prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas.

In a press release issued on April 12, the ASDSA referenced investigations in Illinois and Tennessee in which suspected counterfeit neurotoxins were associated with individuals’ symptoms resembling botulism, including several that required hospitalization. These cases “emphasize the patient safety risks associated with receiving medical procedures in unlicensed, unapproved settings without proper oversight of medical care,” the release adds.

The cases also “highlight the need for increased public protection measures, like the recommendations in the ASDSA’s “Medical Spa Safety Act” to ensure patients’ safety,” according to the press release, which notes the increasing demand for facial fillers and neuromodulators in the United States.

Enforcement is needed to ensure that all patients receive US Food and Drug Administration (FDA)-approved products “and not counterfeit products or unsafe treatments,” ASDSA president Seth L. Matarasso, MD, who practices dermatology in San Francisco, said in the press release. “Lack of regulation and enforcement has enabled many to offer medical procedures for cosmetic purposes outside of their training and expertise,” he said.

Key Takeaways

All clinicians need to understand that aesthetic procedures are medical procedures and require a level of due diligence in patient evaluation and care before, during, and after the procedure, Pooja Sodha, MD, director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington, said in an interview.

Dr. Sodha

“FDA-approved medications should only be offered, and these should be obtained through well-defined sources to ensure their safety and purity,” she said.

However, some challenges to the enforcement of safety in medical spa settings persist, Dr. Sodha told this news organization. “To my knowledge, state and federal policies providing clear and up-to-date safety and legal guidelines for aesthetic procedures performed at medical spas by registered nurses, nurse practitioners, physician assistants, and physicians are limited, and in our current medical care structure, national oversight is challenging,” she said.

A pretreatment checklist assessment, she suggested, could be helpful “to ensure patient safety and help to standardize clinical practice in nonmedical settings.”

Other challenges include a lack of clear guidelines for aesthetic providers regarding initial assessment examinations, postprocedure follow-up, and evaluation for any future medical treatment, as well as “continued ambiguity on the exact meaning of physician oversight for those sites that delegate aesthetic services and appropriate and clear guidelines on what procedures require a licensed provider to perform versus oversee the treatment,” she said.
 

Additional Guidance, Actions Needed

As for additional guidance or actions, “we may be migrating towards a system that designates and assigns clearer licenses and authorizations to perform these services and care for patients,” said Dr. Sodha. A licensing process would entail academic understanding of anatomy, pharmacology, and tissue interactions, as well as practical hands-on training that emphasizes the importance of the preprocedure consultation and postprocedure follow-up and care, she said. “Experience in caring for the unintended outcomes is vital to delivering the best care we can,” she added.

D. Sodha had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

Recent cases of botulism-like illness following neurotoxin injections in nonmedical settings have prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas.

In a press release issued on April 12, the ASDSA referenced investigations in Illinois and Tennessee in which suspected counterfeit neurotoxins were associated with individuals’ symptoms resembling botulism, including several that required hospitalization. These cases “emphasize the patient safety risks associated with receiving medical procedures in unlicensed, unapproved settings without proper oversight of medical care,” the release adds.

The cases also “highlight the need for increased public protection measures, like the recommendations in the ASDSA’s “Medical Spa Safety Act” to ensure patients’ safety,” according to the press release, which notes the increasing demand for facial fillers and neuromodulators in the United States.

Enforcement is needed to ensure that all patients receive US Food and Drug Administration (FDA)-approved products “and not counterfeit products or unsafe treatments,” ASDSA president Seth L. Matarasso, MD, who practices dermatology in San Francisco, said in the press release. “Lack of regulation and enforcement has enabled many to offer medical procedures for cosmetic purposes outside of their training and expertise,” he said.

Key Takeaways

All clinicians need to understand that aesthetic procedures are medical procedures and require a level of due diligence in patient evaluation and care before, during, and after the procedure, Pooja Sodha, MD, director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington, said in an interview.

Dr. Sodha

“FDA-approved medications should only be offered, and these should be obtained through well-defined sources to ensure their safety and purity,” she said.

However, some challenges to the enforcement of safety in medical spa settings persist, Dr. Sodha told this news organization. “To my knowledge, state and federal policies providing clear and up-to-date safety and legal guidelines for aesthetic procedures performed at medical spas by registered nurses, nurse practitioners, physician assistants, and physicians are limited, and in our current medical care structure, national oversight is challenging,” she said.

A pretreatment checklist assessment, she suggested, could be helpful “to ensure patient safety and help to standardize clinical practice in nonmedical settings.”

Other challenges include a lack of clear guidelines for aesthetic providers regarding initial assessment examinations, postprocedure follow-up, and evaluation for any future medical treatment, as well as “continued ambiguity on the exact meaning of physician oversight for those sites that delegate aesthetic services and appropriate and clear guidelines on what procedures require a licensed provider to perform versus oversee the treatment,” she said.
 

Additional Guidance, Actions Needed

As for additional guidance or actions, “we may be migrating towards a system that designates and assigns clearer licenses and authorizations to perform these services and care for patients,” said Dr. Sodha. A licensing process would entail academic understanding of anatomy, pharmacology, and tissue interactions, as well as practical hands-on training that emphasizes the importance of the preprocedure consultation and postprocedure follow-up and care, she said. “Experience in caring for the unintended outcomes is vital to delivering the best care we can,” she added.

D. Sodha had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

Recent cases of botulism-like illness following neurotoxin injections in nonmedical settings have prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas.

In a press release issued on April 12, the ASDSA referenced investigations in Illinois and Tennessee in which suspected counterfeit neurotoxins were associated with individuals’ symptoms resembling botulism, including several that required hospitalization. These cases “emphasize the patient safety risks associated with receiving medical procedures in unlicensed, unapproved settings without proper oversight of medical care,” the release adds.

The cases also “highlight the need for increased public protection measures, like the recommendations in the ASDSA’s “Medical Spa Safety Act” to ensure patients’ safety,” according to the press release, which notes the increasing demand for facial fillers and neuromodulators in the United States.

Enforcement is needed to ensure that all patients receive US Food and Drug Administration (FDA)-approved products “and not counterfeit products or unsafe treatments,” ASDSA president Seth L. Matarasso, MD, who practices dermatology in San Francisco, said in the press release. “Lack of regulation and enforcement has enabled many to offer medical procedures for cosmetic purposes outside of their training and expertise,” he said.

Key Takeaways

All clinicians need to understand that aesthetic procedures are medical procedures and require a level of due diligence in patient evaluation and care before, during, and after the procedure, Pooja Sodha, MD, director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington, said in an interview.

Dr. Sodha

“FDA-approved medications should only be offered, and these should be obtained through well-defined sources to ensure their safety and purity,” she said.

However, some challenges to the enforcement of safety in medical spa settings persist, Dr. Sodha told this news organization. “To my knowledge, state and federal policies providing clear and up-to-date safety and legal guidelines for aesthetic procedures performed at medical spas by registered nurses, nurse practitioners, physician assistants, and physicians are limited, and in our current medical care structure, national oversight is challenging,” she said.

A pretreatment checklist assessment, she suggested, could be helpful “to ensure patient safety and help to standardize clinical practice in nonmedical settings.”

Other challenges include a lack of clear guidelines for aesthetic providers regarding initial assessment examinations, postprocedure follow-up, and evaluation for any future medical treatment, as well as “continued ambiguity on the exact meaning of physician oversight for those sites that delegate aesthetic services and appropriate and clear guidelines on what procedures require a licensed provider to perform versus oversee the treatment,” she said.
 

Additional Guidance, Actions Needed

As for additional guidance or actions, “we may be migrating towards a system that designates and assigns clearer licenses and authorizations to perform these services and care for patients,” said Dr. Sodha. A licensing process would entail academic understanding of anatomy, pharmacology, and tissue interactions, as well as practical hands-on training that emphasizes the importance of the preprocedure consultation and postprocedure follow-up and care, she said. “Experience in caring for the unintended outcomes is vital to delivering the best care we can,” she added.

D. Sodha had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

At least 19 people from nine states have reported serious reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in non-healthcare settings, such as homes and spas, according to an announcement of an investigation into these reports from the Centers for Disease Control and Prevention posted online April 15.

Reactions have included blurry vision, double vision, drooping eyelids, difficult swallowing or breathing, and other symptoms of botulism.

Of the 19 individuals — all of whom identified as female and had a mean age of 39 years — 9 (60%) were hospitalized and 4 (21%) were treated with botulism antitoxin because of concerns that the botulinum toxin could have spread beyond the injection site. Also, five were tested for botulism and their results were negative.

The CDC, several state and local health departments, and the US Food and Drug Administration (FDA) are investigating these reports, according to the announcement.

States reporting these cases include Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington. According to the CDC summary, some of the individuals “received injections with counterfeit products or products with unverified sources. Investigation into the sources of these products is ongoing.” All but one report involved receiving botulinum toxin injections for cosmetic purposes.

Recent cases of botulism-like illnesses possibly related to counterfeit botulinum toxin reported in Illinois and Tennessee, prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas, the ASDSA announced on April 12.

The CDC summary advises clinicians to consider the possibility of adverse effects from botulinum toxin injection, including for cosmetic reasons, when patients present with signs and symptoms consistent with botulism near the injection site. Symptoms of botulism include blurry or double vision, drooping eyelids, difficulty swallowing, difficulty breathing, and muscle weakness.

For people who are considering botulinum toxin for cosmetic or medical reasons, recommendations from the CDC include asking the provider and setting, such as a clinic or spa, if they are licensed and trained to provide these injections, and to ask if the product is approved by the FDA and from a reliable source, and, “if in doubt, don’t get the injection.”

This ‘Should Never Happen’

“The report of people getting botulism from botulinum toxin injections is frightening, and should never happen,” Lawrence J. Green, MD, clinical professor of dermatology, George Washington University, Washington, told this news organization.

Dr. Green

These reports show “how important it is to receive botulinum toxin injections only in a medical office, and from or under the direction of a qualified, trained, and licensed individual, like a board certified dermatologist,” added Dr. Green, who practices in Rockville, Maryland. “Other types of practitioners may not adhere to the same standards of professionalism, especially not always putting patient safety first.”

Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
 

For cases of suspected systemic botulism, the CDC recommends calling the local or state health department for consultation and antitoxin release (as well as information on reporting adverse events). Alternatively, the 24/7 phone number for the CDC clinical botulism service is 770-488-7100.

At least 19 people from nine states have reported serious reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in non-healthcare settings, such as homes and spas, according to an announcement of an investigation into these reports from the Centers for Disease Control and Prevention posted online April 15.

Reactions have included blurry vision, double vision, drooping eyelids, difficult swallowing or breathing, and other symptoms of botulism.

Of the 19 individuals — all of whom identified as female and had a mean age of 39 years — 9 (60%) were hospitalized and 4 (21%) were treated with botulism antitoxin because of concerns that the botulinum toxin could have spread beyond the injection site. Also, five were tested for botulism and their results were negative.

The CDC, several state and local health departments, and the US Food and Drug Administration (FDA) are investigating these reports, according to the announcement.

States reporting these cases include Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington. According to the CDC summary, some of the individuals “received injections with counterfeit products or products with unverified sources. Investigation into the sources of these products is ongoing.” All but one report involved receiving botulinum toxin injections for cosmetic purposes.

Recent cases of botulism-like illnesses possibly related to counterfeit botulinum toxin reported in Illinois and Tennessee, prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas, the ASDSA announced on April 12.

The CDC summary advises clinicians to consider the possibility of adverse effects from botulinum toxin injection, including for cosmetic reasons, when patients present with signs and symptoms consistent with botulism near the injection site. Symptoms of botulism include blurry or double vision, drooping eyelids, difficulty swallowing, difficulty breathing, and muscle weakness.

For people who are considering botulinum toxin for cosmetic or medical reasons, recommendations from the CDC include asking the provider and setting, such as a clinic or spa, if they are licensed and trained to provide these injections, and to ask if the product is approved by the FDA and from a reliable source, and, “if in doubt, don’t get the injection.”

This ‘Should Never Happen’

“The report of people getting botulism from botulinum toxin injections is frightening, and should never happen,” Lawrence J. Green, MD, clinical professor of dermatology, George Washington University, Washington, told this news organization.

Dr. Green

These reports show “how important it is to receive botulinum toxin injections only in a medical office, and from or under the direction of a qualified, trained, and licensed individual, like a board certified dermatologist,” added Dr. Green, who practices in Rockville, Maryland. “Other types of practitioners may not adhere to the same standards of professionalism, especially not always putting patient safety first.”

Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
 

For cases of suspected systemic botulism, the CDC recommends calling the local or state health department for consultation and antitoxin release (as well as information on reporting adverse events). Alternatively, the 24/7 phone number for the CDC clinical botulism service is 770-488-7100.

At least 19 people from nine states have reported serious reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in non-healthcare settings, such as homes and spas, according to an announcement of an investigation into these reports from the Centers for Disease Control and Prevention posted online April 15.

Reactions have included blurry vision, double vision, drooping eyelids, difficult swallowing or breathing, and other symptoms of botulism.

Of the 19 individuals — all of whom identified as female and had a mean age of 39 years — 9 (60%) were hospitalized and 4 (21%) were treated with botulism antitoxin because of concerns that the botulinum toxin could have spread beyond the injection site. Also, five were tested for botulism and their results were negative.

The CDC, several state and local health departments, and the US Food and Drug Administration (FDA) are investigating these reports, according to the announcement.

States reporting these cases include Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington. According to the CDC summary, some of the individuals “received injections with counterfeit products or products with unverified sources. Investigation into the sources of these products is ongoing.” All but one report involved receiving botulinum toxin injections for cosmetic purposes.

Recent cases of botulism-like illnesses possibly related to counterfeit botulinum toxin reported in Illinois and Tennessee, prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas, the ASDSA announced on April 12.

The CDC summary advises clinicians to consider the possibility of adverse effects from botulinum toxin injection, including for cosmetic reasons, when patients present with signs and symptoms consistent with botulism near the injection site. Symptoms of botulism include blurry or double vision, drooping eyelids, difficulty swallowing, difficulty breathing, and muscle weakness.

For people who are considering botulinum toxin for cosmetic or medical reasons, recommendations from the CDC include asking the provider and setting, such as a clinic or spa, if they are licensed and trained to provide these injections, and to ask if the product is approved by the FDA and from a reliable source, and, “if in doubt, don’t get the injection.”

This ‘Should Never Happen’

“The report of people getting botulism from botulinum toxin injections is frightening, and should never happen,” Lawrence J. Green, MD, clinical professor of dermatology, George Washington University, Washington, told this news organization.

Dr. Green

These reports show “how important it is to receive botulinum toxin injections only in a medical office, and from or under the direction of a qualified, trained, and licensed individual, like a board certified dermatologist,” added Dr. Green, who practices in Rockville, Maryland. “Other types of practitioners may not adhere to the same standards of professionalism, especially not always putting patient safety first.”

Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
 

For cases of suspected systemic botulism, the CDC recommends calling the local or state health department for consultation and antitoxin release (as well as information on reporting adverse events). Alternatively, the 24/7 phone number for the CDC clinical botulism service is 770-488-7100.