User login
Hope for Hidradenitis Suppurativa
In September 2015, the US Food and Drug Administration approved adalimumab, the well-known injectable tumor necrosis factor (TNF)–α inhibitor indicated for psoriasis and other inflammatory conditions, for treatment of moderate to severe hidradenitis suppurativa (HS), classifying it as the first and only US Food and Drug Administration–approved therapy for adults with HS.
Pivotal studies (PIONEER/HS-I and -II, phase 3, double-blind) evaluated 633 patients (307 in HS-I and 326 in HS-II) with moderate to severe HS who were randomized to adalimumab versus placebo for 12 weeks. There was significant clinical response (at least 50% reduction in abscess and inflammatory nodule count, defined as hidradenitis suppurativa clinical response, HiSCR) in the adalimumab group (42% vs 26% in HS-I, 59% vs. 28% in HS-II, P<.001), reduction in pain (significant in the HS-II trial, 45.7% vs 20.7%, P<.001; HS-I 27.9% vs 24.8%, P>.05), and no new safety concerns when compared to other adalimumab dosages and indications. Some HS-II study patients (19.3%) were permitted to use oral antibiotics during the study.
For the indication of adult HS (moderate to severe disease), adalimumab should be administered subcutaneously at a dosing regimen of 160 mg/4 syringes on day 1 (or 80 mg/2 syringes on days 1 and 2), followed by 80 mg/2 syringes on day 15, then 40 mg/1 syringe on day 29, and every 7 days thereafter for an indefinite treatment period.
What’s the Issue?
It sits well with dermatologists when the indications for a medication with which we have great familiarity are broadened to include new disease entities; it is even better when the new entity is a condition for which every dermatologist pines for efficacious treatment options. Despite the disease burden of HS, which can include pain, scarring, disfigurement, social exclusion, and/or embarrassment, as well as the wasteful and burdensome effect that HS has on health care resources, such as injudicious use of antibiotics and unnecessary emergency department visits and inpatient hospital stays,1 there is nonetheless a wide-open and inviting playing field for effective therapies.
Although a much higher dosage of adalimumab is required in the treatment of HS compared to what is indicated for psoriasis patients, its safety concerns and side effect profile were unchanged in HS, and therefore its monitoring guidelines remain the same. Not all patients in these studies showed a notable reduction in lesion count, but given that HS classically is unresponsive to most medication regimens, will you embrace this therapy option for your patients with HS?
Reference
1. Khalsa A, Liu G, Kirby JS. Increased utilization of emergency department and inpatient care by patients with hidradenitis suppurativa. J Am Acad Dermatol. 2015;73:609-614.
In September 2015, the US Food and Drug Administration approved adalimumab, the well-known injectable tumor necrosis factor (TNF)–α inhibitor indicated for psoriasis and other inflammatory conditions, for treatment of moderate to severe hidradenitis suppurativa (HS), classifying it as the first and only US Food and Drug Administration–approved therapy for adults with HS.
Pivotal studies (PIONEER/HS-I and -II, phase 3, double-blind) evaluated 633 patients (307 in HS-I and 326 in HS-II) with moderate to severe HS who were randomized to adalimumab versus placebo for 12 weeks. There was significant clinical response (at least 50% reduction in abscess and inflammatory nodule count, defined as hidradenitis suppurativa clinical response, HiSCR) in the adalimumab group (42% vs 26% in HS-I, 59% vs. 28% in HS-II, P<.001), reduction in pain (significant in the HS-II trial, 45.7% vs 20.7%, P<.001; HS-I 27.9% vs 24.8%, P>.05), and no new safety concerns when compared to other adalimumab dosages and indications. Some HS-II study patients (19.3%) were permitted to use oral antibiotics during the study.
For the indication of adult HS (moderate to severe disease), adalimumab should be administered subcutaneously at a dosing regimen of 160 mg/4 syringes on day 1 (or 80 mg/2 syringes on days 1 and 2), followed by 80 mg/2 syringes on day 15, then 40 mg/1 syringe on day 29, and every 7 days thereafter for an indefinite treatment period.
What’s the Issue?
It sits well with dermatologists when the indications for a medication with which we have great familiarity are broadened to include new disease entities; it is even better when the new entity is a condition for which every dermatologist pines for efficacious treatment options. Despite the disease burden of HS, which can include pain, scarring, disfigurement, social exclusion, and/or embarrassment, as well as the wasteful and burdensome effect that HS has on health care resources, such as injudicious use of antibiotics and unnecessary emergency department visits and inpatient hospital stays,1 there is nonetheless a wide-open and inviting playing field for effective therapies.
Although a much higher dosage of adalimumab is required in the treatment of HS compared to what is indicated for psoriasis patients, its safety concerns and side effect profile were unchanged in HS, and therefore its monitoring guidelines remain the same. Not all patients in these studies showed a notable reduction in lesion count, but given that HS classically is unresponsive to most medication regimens, will you embrace this therapy option for your patients with HS?
In September 2015, the US Food and Drug Administration approved adalimumab, the well-known injectable tumor necrosis factor (TNF)–α inhibitor indicated for psoriasis and other inflammatory conditions, for treatment of moderate to severe hidradenitis suppurativa (HS), classifying it as the first and only US Food and Drug Administration–approved therapy for adults with HS.
Pivotal studies (PIONEER/HS-I and -II, phase 3, double-blind) evaluated 633 patients (307 in HS-I and 326 in HS-II) with moderate to severe HS who were randomized to adalimumab versus placebo for 12 weeks. There was significant clinical response (at least 50% reduction in abscess and inflammatory nodule count, defined as hidradenitis suppurativa clinical response, HiSCR) in the adalimumab group (42% vs 26% in HS-I, 59% vs. 28% in HS-II, P<.001), reduction in pain (significant in the HS-II trial, 45.7% vs 20.7%, P<.001; HS-I 27.9% vs 24.8%, P>.05), and no new safety concerns when compared to other adalimumab dosages and indications. Some HS-II study patients (19.3%) were permitted to use oral antibiotics during the study.
For the indication of adult HS (moderate to severe disease), adalimumab should be administered subcutaneously at a dosing regimen of 160 mg/4 syringes on day 1 (or 80 mg/2 syringes on days 1 and 2), followed by 80 mg/2 syringes on day 15, then 40 mg/1 syringe on day 29, and every 7 days thereafter for an indefinite treatment period.
What’s the Issue?
It sits well with dermatologists when the indications for a medication with which we have great familiarity are broadened to include new disease entities; it is even better when the new entity is a condition for which every dermatologist pines for efficacious treatment options. Despite the disease burden of HS, which can include pain, scarring, disfigurement, social exclusion, and/or embarrassment, as well as the wasteful and burdensome effect that HS has on health care resources, such as injudicious use of antibiotics and unnecessary emergency department visits and inpatient hospital stays,1 there is nonetheless a wide-open and inviting playing field for effective therapies.
Although a much higher dosage of adalimumab is required in the treatment of HS compared to what is indicated for psoriasis patients, its safety concerns and side effect profile were unchanged in HS, and therefore its monitoring guidelines remain the same. Not all patients in these studies showed a notable reduction in lesion count, but given that HS classically is unresponsive to most medication regimens, will you embrace this therapy option for your patients with HS?
Reference
1. Khalsa A, Liu G, Kirby JS. Increased utilization of emergency department and inpatient care by patients with hidradenitis suppurativa. J Am Acad Dermatol. 2015;73:609-614.
Reference
1. Khalsa A, Liu G, Kirby JS. Increased utilization of emergency department and inpatient care by patients with hidradenitis suppurativa. J Am Acad Dermatol. 2015;73:609-614.
Individualized Melanoma Care
Melanoma has become more diverse in terms of the patients affected and the treatment course. Dr. Lorraine L. Rosamilia discusses individualized melanoma care from the early stages of diagnosis through treatment and follow-up. She explains clear margins from excisions and management based on tumor thickness. Coordinated care also is important to evaluate the best treatment course for the patient and favorable outcomes.
Melanoma has become more diverse in terms of the patients affected and the treatment course. Dr. Lorraine L. Rosamilia discusses individualized melanoma care from the early stages of diagnosis through treatment and follow-up. She explains clear margins from excisions and management based on tumor thickness. Coordinated care also is important to evaluate the best treatment course for the patient and favorable outcomes.
Melanoma has become more diverse in terms of the patients affected and the treatment course. Dr. Lorraine L. Rosamilia discusses individualized melanoma care from the early stages of diagnosis through treatment and follow-up. She explains clear margins from excisions and management based on tumor thickness. Coordinated care also is important to evaluate the best treatment course for the patient and favorable outcomes.
Individualizing Care for Melanoma Patients
What does your patient need to know at the first visit?
Melanoma patient visits and communications are complicated. When possible, you can preview the surgical and prognostic expectations with the patient when you see the lesion clinically for the first time, especially for a lesion that you’re sure is melanoma before it even hits the specimen cup. Sometimes you have to convey important biopsy and treatment information over the telephone, or sometimes you have the luxury of an extra clinic visit to discuss it with the patient and perhaps a family member in person.
During the first set of conversations, I explain the things that are tangible: the depth of the lesion, the relationship it has to prognosis, surgical options based on staging, further testing/referrals, and known risk factors. Then I wait. The digestion phase is critical before you hang up and schedule a surgery.
Probably the most important thing I tell patients is that melanoma is unpredictable. Not everyone has the same kind of “surgery,” we don’t say “remission,” we don’t have a certain “chemo” that we know will be best, and not everyone will need “CAT scans.” I tell patients that they’re stuck with me. Skin examinations, talk of sun protection, photography of nevi, upkeep of health maintenance visits with other specialists (eg, primary care physician, optometry/ophthalmology, gynecology, dentistry), and education of family members on melanoma risk factors will be the norm.
What are your go-to treatments?
In the past, surgical management was perhaps streamlined, but as we learn more about melanoma tumor biology, the less we can form generalizable guidelines for surgery, margin control, and lymph node perusal. Wide local excision is paramount, but the evidence that guidelines for 0.5-cm, 1-cm, and 2-cm margins or greater fit for all types of tumors is lacking, and many have challenged the recommended margins, particularly for lentigo maligna subtypes (Kunishige et al).
The 0.75-mm Breslow depth threshold guides my sentinel lymph node (SLN) discussion, with upstaging based on primary tumor mitotic index and/or ulceration. But SLN biopsy is always still a discussion and not a foregone conclusion because the risk-benefit ratio and prognostic/survival data are very difficult to dissect for some cases. Certainly, mention of SLN biopsy morbidity, including lymphedema, is warranted before the patient consents. Then there is further explanation that more invasive lymphadenectomy could occur based on SLN findings. If applicable in advanced cases, options for imaging and adjuvant therapy are introduced by us but then primarily led by oncologists.
Patients are generally pleased that the approach to melanoma surgery, reconstruction, SLN biopsy, and oncologic care is increasingly becoming (almost) harmoniously multidisciplinary. Larger institutions have streamlined their melanoma providers into shared clinics or at least regional networks—dermatologists, plastic/otolaryngology/oncologic surgeons, oncologists, and radiation oncologists, for instance—and simplified patient access based on individual tumor treatment plans. Dr. Christopher J. Miller at Penn Medicine (Philadelphia, Pennsylvania) is excelling at a collaborative surgical approach for melanoma between dermatologic surgery and specialties such as otolaryngology and also spearheading the Mohs micrographic surgery approach for primary melanoma as possible standard of care for some cases (Etzkorn et al).
Also evolving is the access to clinical trials and care coordination regarding the most novel metastatic melanoma therapies, which can now be a short drive away for most patients as the National Cancer Institute broadens its clinical trial reach.
After the diagnosis of melanoma is made, care is becoming much more individualized for surgery and beyond, but true morbidity and mortality benefit for the more complicated regimens has become anybody’s guess as this research field grossly and rapidly swells. Then these discussions with the patient become longer and more open-ended.
How do you keep patients compliant with treatment?
Initial surgery and multidisciplinary management requires meticulous communication between providers to ensure that pathology reports, surgical findings, imaging, wound care, and follow-up are transparent. The easier it is for patients to navigate the medical system(s), the more likely they are to comply. Voicemail, e-mails, text messages, and/or mailings are standard for different offices for reminders, but an old-fashioned telephone call goes a long way for a patient who has melanoma on his/her mind. Adherence to sun protection, health maintenance, and skin examination appointments is then the challenge.
Sun protection strategies were well-represented in the Cutis July issue’s Practical Pearls featuring Dr. Vincent A. DeLeo. My script for sunscreen-averse patients as I leave the room is “Take a mosey through the sunscreen aisle. You may be surprised at what you find.” And sporting goods stores are chock full of UPF (UV protection factor) clothing options. I’m not a scolder, but I do utilize the power of repetition/the squeaky wheel.
Patient delay or cancellation of skin checks requires other types of surveillance. Here at Geisinger Health System (State College, Pennsylvania), when melanoma patients check out, they are placed in a “priority appointment” slot, meaning that if they cancel, their names are automatically put on an electronic list that is compiled weekly by our schedulers to ensure that patients are called for another appointment. To avert telephone tag and delay of care, melanoma patients also get our direct nurses station extension and are encouraged to use our chart e-mail system to communicate with us if they notice a new or changing skin lesion.
What do you do if they refuse treatment?
Initial consent and compliance with melanoma wide local excision are rarely challenged by a well-informed patient, but what I find more common is delay in treatment and nonadherence to periodic skin examinations.
What resources do you recommend to patients for more information?
The National Comprehensive Cancer Network clini-cal practice guideline resource in oncology (melanoma) is the place to start, as their Web site is easily naviga-ble for patients and providers (http://www.nccn.org).
The American Academy of Dermatology (http://www.aad.org) and Skin Cancer Foundation (http://www.skincancer.org) Web sites also provide useful information, and there are always copies of their key melanoma and nevi surveillance pamphlets in our office.
Most recently, my melanoma patients have been inspired by another local patient and her cause: a 28-year-old woman with metastatic melanoma on a National Cancer Institute BRAF inhibitor clinical trial who plans to run an Ironman race this year (Thomason, Ames). Her motivation to maintain her baseline health and fitness while still reaching for this further remarkable goal gives fellow melanoma patients a source for enthusiasm and hope.
Inspiration and adherence come in all shapes and sizes for patients with melanoma. I find you need to throw multiple resources and strategies at them and see what sticks.
Suggested Readings
Ames C. Local runner fights cancer. WeAreCentralPA Web site. http://www.wearecentralpa.com/news/local-runner-fights -cancer#.VZw92-pJ2AU.mailto. Published June 30, 2015. Accessed August 14, 2015.
DeLeo VA. Patient compliance with photoprotection. Cutis. 2015;96:13-14.
Etzkorn JR, Sobanko JF, Elenitsas R, et al. Low recurrence rates for in situ and invasive melanomas using Mohs micrographic surgery with melanoma antigen recognized by T cells 1 (MART-1) immunostaining: tissue processing methodology to optimize pathologic staging and margin assessment. J Am Acad Dermatol. 2015;72:840-850.
Kunishige JH, Brodland DG, Zitelli JA. Larger surgical margins are required for lentigo maligna and other melanoma in situ. J Am Acad Dermatol. 2012;67:1069-1071.
NCCN clinical practice guidelines in oncology: melanoma. National Comprehensive Cancer Network Web site. http://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf. Updated March 11, 2015. Accessed August 14, 2015.
Thomason M. My story: April Salinas. Live In Our Skinz! Blog. http://blog.uvskinz.com/2015/01/30/my-story-april -salinas/#sthash.yvSRVglT.YGLDn95T.dpbs. Published January 30, 2015. Accessed August 14, 2015.
What does your patient need to know at the first visit?
Melanoma patient visits and communications are complicated. When possible, you can preview the surgical and prognostic expectations with the patient when you see the lesion clinically for the first time, especially for a lesion that you’re sure is melanoma before it even hits the specimen cup. Sometimes you have to convey important biopsy and treatment information over the telephone, or sometimes you have the luxury of an extra clinic visit to discuss it with the patient and perhaps a family member in person.
During the first set of conversations, I explain the things that are tangible: the depth of the lesion, the relationship it has to prognosis, surgical options based on staging, further testing/referrals, and known risk factors. Then I wait. The digestion phase is critical before you hang up and schedule a surgery.
Probably the most important thing I tell patients is that melanoma is unpredictable. Not everyone has the same kind of “surgery,” we don’t say “remission,” we don’t have a certain “chemo” that we know will be best, and not everyone will need “CAT scans.” I tell patients that they’re stuck with me. Skin examinations, talk of sun protection, photography of nevi, upkeep of health maintenance visits with other specialists (eg, primary care physician, optometry/ophthalmology, gynecology, dentistry), and education of family members on melanoma risk factors will be the norm.
What are your go-to treatments?
In the past, surgical management was perhaps streamlined, but as we learn more about melanoma tumor biology, the less we can form generalizable guidelines for surgery, margin control, and lymph node perusal. Wide local excision is paramount, but the evidence that guidelines for 0.5-cm, 1-cm, and 2-cm margins or greater fit for all types of tumors is lacking, and many have challenged the recommended margins, particularly for lentigo maligna subtypes (Kunishige et al).
The 0.75-mm Breslow depth threshold guides my sentinel lymph node (SLN) discussion, with upstaging based on primary tumor mitotic index and/or ulceration. But SLN biopsy is always still a discussion and not a foregone conclusion because the risk-benefit ratio and prognostic/survival data are very difficult to dissect for some cases. Certainly, mention of SLN biopsy morbidity, including lymphedema, is warranted before the patient consents. Then there is further explanation that more invasive lymphadenectomy could occur based on SLN findings. If applicable in advanced cases, options for imaging and adjuvant therapy are introduced by us but then primarily led by oncologists.
Patients are generally pleased that the approach to melanoma surgery, reconstruction, SLN biopsy, and oncologic care is increasingly becoming (almost) harmoniously multidisciplinary. Larger institutions have streamlined their melanoma providers into shared clinics or at least regional networks—dermatologists, plastic/otolaryngology/oncologic surgeons, oncologists, and radiation oncologists, for instance—and simplified patient access based on individual tumor treatment plans. Dr. Christopher J. Miller at Penn Medicine (Philadelphia, Pennsylvania) is excelling at a collaborative surgical approach for melanoma between dermatologic surgery and specialties such as otolaryngology and also spearheading the Mohs micrographic surgery approach for primary melanoma as possible standard of care for some cases (Etzkorn et al).
Also evolving is the access to clinical trials and care coordination regarding the most novel metastatic melanoma therapies, which can now be a short drive away for most patients as the National Cancer Institute broadens its clinical trial reach.
After the diagnosis of melanoma is made, care is becoming much more individualized for surgery and beyond, but true morbidity and mortality benefit for the more complicated regimens has become anybody’s guess as this research field grossly and rapidly swells. Then these discussions with the patient become longer and more open-ended.
How do you keep patients compliant with treatment?
Initial surgery and multidisciplinary management requires meticulous communication between providers to ensure that pathology reports, surgical findings, imaging, wound care, and follow-up are transparent. The easier it is for patients to navigate the medical system(s), the more likely they are to comply. Voicemail, e-mails, text messages, and/or mailings are standard for different offices for reminders, but an old-fashioned telephone call goes a long way for a patient who has melanoma on his/her mind. Adherence to sun protection, health maintenance, and skin examination appointments is then the challenge.
Sun protection strategies were well-represented in the Cutis July issue’s Practical Pearls featuring Dr. Vincent A. DeLeo. My script for sunscreen-averse patients as I leave the room is “Take a mosey through the sunscreen aisle. You may be surprised at what you find.” And sporting goods stores are chock full of UPF (UV protection factor) clothing options. I’m not a scolder, but I do utilize the power of repetition/the squeaky wheel.
Patient delay or cancellation of skin checks requires other types of surveillance. Here at Geisinger Health System (State College, Pennsylvania), when melanoma patients check out, they are placed in a “priority appointment” slot, meaning that if they cancel, their names are automatically put on an electronic list that is compiled weekly by our schedulers to ensure that patients are called for another appointment. To avert telephone tag and delay of care, melanoma patients also get our direct nurses station extension and are encouraged to use our chart e-mail system to communicate with us if they notice a new or changing skin lesion.
What do you do if they refuse treatment?
Initial consent and compliance with melanoma wide local excision are rarely challenged by a well-informed patient, but what I find more common is delay in treatment and nonadherence to periodic skin examinations.
What resources do you recommend to patients for more information?
The National Comprehensive Cancer Network clini-cal practice guideline resource in oncology (melanoma) is the place to start, as their Web site is easily naviga-ble for patients and providers (http://www.nccn.org).
The American Academy of Dermatology (http://www.aad.org) and Skin Cancer Foundation (http://www.skincancer.org) Web sites also provide useful information, and there are always copies of their key melanoma and nevi surveillance pamphlets in our office.
Most recently, my melanoma patients have been inspired by another local patient and her cause: a 28-year-old woman with metastatic melanoma on a National Cancer Institute BRAF inhibitor clinical trial who plans to run an Ironman race this year (Thomason, Ames). Her motivation to maintain her baseline health and fitness while still reaching for this further remarkable goal gives fellow melanoma patients a source for enthusiasm and hope.
Inspiration and adherence come in all shapes and sizes for patients with melanoma. I find you need to throw multiple resources and strategies at them and see what sticks.
What does your patient need to know at the first visit?
Melanoma patient visits and communications are complicated. When possible, you can preview the surgical and prognostic expectations with the patient when you see the lesion clinically for the first time, especially for a lesion that you’re sure is melanoma before it even hits the specimen cup. Sometimes you have to convey important biopsy and treatment information over the telephone, or sometimes you have the luxury of an extra clinic visit to discuss it with the patient and perhaps a family member in person.
During the first set of conversations, I explain the things that are tangible: the depth of the lesion, the relationship it has to prognosis, surgical options based on staging, further testing/referrals, and known risk factors. Then I wait. The digestion phase is critical before you hang up and schedule a surgery.
Probably the most important thing I tell patients is that melanoma is unpredictable. Not everyone has the same kind of “surgery,” we don’t say “remission,” we don’t have a certain “chemo” that we know will be best, and not everyone will need “CAT scans.” I tell patients that they’re stuck with me. Skin examinations, talk of sun protection, photography of nevi, upkeep of health maintenance visits with other specialists (eg, primary care physician, optometry/ophthalmology, gynecology, dentistry), and education of family members on melanoma risk factors will be the norm.
What are your go-to treatments?
In the past, surgical management was perhaps streamlined, but as we learn more about melanoma tumor biology, the less we can form generalizable guidelines for surgery, margin control, and lymph node perusal. Wide local excision is paramount, but the evidence that guidelines for 0.5-cm, 1-cm, and 2-cm margins or greater fit for all types of tumors is lacking, and many have challenged the recommended margins, particularly for lentigo maligna subtypes (Kunishige et al).
The 0.75-mm Breslow depth threshold guides my sentinel lymph node (SLN) discussion, with upstaging based on primary tumor mitotic index and/or ulceration. But SLN biopsy is always still a discussion and not a foregone conclusion because the risk-benefit ratio and prognostic/survival data are very difficult to dissect for some cases. Certainly, mention of SLN biopsy morbidity, including lymphedema, is warranted before the patient consents. Then there is further explanation that more invasive lymphadenectomy could occur based on SLN findings. If applicable in advanced cases, options for imaging and adjuvant therapy are introduced by us but then primarily led by oncologists.
Patients are generally pleased that the approach to melanoma surgery, reconstruction, SLN biopsy, and oncologic care is increasingly becoming (almost) harmoniously multidisciplinary. Larger institutions have streamlined their melanoma providers into shared clinics or at least regional networks—dermatologists, plastic/otolaryngology/oncologic surgeons, oncologists, and radiation oncologists, for instance—and simplified patient access based on individual tumor treatment plans. Dr. Christopher J. Miller at Penn Medicine (Philadelphia, Pennsylvania) is excelling at a collaborative surgical approach for melanoma between dermatologic surgery and specialties such as otolaryngology and also spearheading the Mohs micrographic surgery approach for primary melanoma as possible standard of care for some cases (Etzkorn et al).
Also evolving is the access to clinical trials and care coordination regarding the most novel metastatic melanoma therapies, which can now be a short drive away for most patients as the National Cancer Institute broadens its clinical trial reach.
After the diagnosis of melanoma is made, care is becoming much more individualized for surgery and beyond, but true morbidity and mortality benefit for the more complicated regimens has become anybody’s guess as this research field grossly and rapidly swells. Then these discussions with the patient become longer and more open-ended.
How do you keep patients compliant with treatment?
Initial surgery and multidisciplinary management requires meticulous communication between providers to ensure that pathology reports, surgical findings, imaging, wound care, and follow-up are transparent. The easier it is for patients to navigate the medical system(s), the more likely they are to comply. Voicemail, e-mails, text messages, and/or mailings are standard for different offices for reminders, but an old-fashioned telephone call goes a long way for a patient who has melanoma on his/her mind. Adherence to sun protection, health maintenance, and skin examination appointments is then the challenge.
Sun protection strategies were well-represented in the Cutis July issue’s Practical Pearls featuring Dr. Vincent A. DeLeo. My script for sunscreen-averse patients as I leave the room is “Take a mosey through the sunscreen aisle. You may be surprised at what you find.” And sporting goods stores are chock full of UPF (UV protection factor) clothing options. I’m not a scolder, but I do utilize the power of repetition/the squeaky wheel.
Patient delay or cancellation of skin checks requires other types of surveillance. Here at Geisinger Health System (State College, Pennsylvania), when melanoma patients check out, they are placed in a “priority appointment” slot, meaning that if they cancel, their names are automatically put on an electronic list that is compiled weekly by our schedulers to ensure that patients are called for another appointment. To avert telephone tag and delay of care, melanoma patients also get our direct nurses station extension and are encouraged to use our chart e-mail system to communicate with us if they notice a new or changing skin lesion.
What do you do if they refuse treatment?
Initial consent and compliance with melanoma wide local excision are rarely challenged by a well-informed patient, but what I find more common is delay in treatment and nonadherence to periodic skin examinations.
What resources do you recommend to patients for more information?
The National Comprehensive Cancer Network clini-cal practice guideline resource in oncology (melanoma) is the place to start, as their Web site is easily naviga-ble for patients and providers (http://www.nccn.org).
The American Academy of Dermatology (http://www.aad.org) and Skin Cancer Foundation (http://www.skincancer.org) Web sites also provide useful information, and there are always copies of their key melanoma and nevi surveillance pamphlets in our office.
Most recently, my melanoma patients have been inspired by another local patient and her cause: a 28-year-old woman with metastatic melanoma on a National Cancer Institute BRAF inhibitor clinical trial who plans to run an Ironman race this year (Thomason, Ames). Her motivation to maintain her baseline health and fitness while still reaching for this further remarkable goal gives fellow melanoma patients a source for enthusiasm and hope.
Inspiration and adherence come in all shapes and sizes for patients with melanoma. I find you need to throw multiple resources and strategies at them and see what sticks.
Suggested Readings
Ames C. Local runner fights cancer. WeAreCentralPA Web site. http://www.wearecentralpa.com/news/local-runner-fights -cancer#.VZw92-pJ2AU.mailto. Published June 30, 2015. Accessed August 14, 2015.
DeLeo VA. Patient compliance with photoprotection. Cutis. 2015;96:13-14.
Etzkorn JR, Sobanko JF, Elenitsas R, et al. Low recurrence rates for in situ and invasive melanomas using Mohs micrographic surgery with melanoma antigen recognized by T cells 1 (MART-1) immunostaining: tissue processing methodology to optimize pathologic staging and margin assessment. J Am Acad Dermatol. 2015;72:840-850.
Kunishige JH, Brodland DG, Zitelli JA. Larger surgical margins are required for lentigo maligna and other melanoma in situ. J Am Acad Dermatol. 2012;67:1069-1071.
NCCN clinical practice guidelines in oncology: melanoma. National Comprehensive Cancer Network Web site. http://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf. Updated March 11, 2015. Accessed August 14, 2015.
Thomason M. My story: April Salinas. Live In Our Skinz! Blog. http://blog.uvskinz.com/2015/01/30/my-story-april -salinas/#sthash.yvSRVglT.YGLDn95T.dpbs. Published January 30, 2015. Accessed August 14, 2015.
Suggested Readings
Ames C. Local runner fights cancer. WeAreCentralPA Web site. http://www.wearecentralpa.com/news/local-runner-fights -cancer#.VZw92-pJ2AU.mailto. Published June 30, 2015. Accessed August 14, 2015.
DeLeo VA. Patient compliance with photoprotection. Cutis. 2015;96:13-14.
Etzkorn JR, Sobanko JF, Elenitsas R, et al. Low recurrence rates for in situ and invasive melanomas using Mohs micrographic surgery with melanoma antigen recognized by T cells 1 (MART-1) immunostaining: tissue processing methodology to optimize pathologic staging and margin assessment. J Am Acad Dermatol. 2015;72:840-850.
Kunishige JH, Brodland DG, Zitelli JA. Larger surgical margins are required for lentigo maligna and other melanoma in situ. J Am Acad Dermatol. 2012;67:1069-1071.
NCCN clinical practice guidelines in oncology: melanoma. National Comprehensive Cancer Network Web site. http://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf. Updated March 11, 2015. Accessed August 14, 2015.
Thomason M. My story: April Salinas. Live In Our Skinz! Blog. http://blog.uvskinz.com/2015/01/30/my-story-april -salinas/#sthash.yvSRVglT.YGLDn95T.dpbs. Published January 30, 2015. Accessed August 14, 2015.
Three Cheers for B3?
At the recent American Society of Clinical Oncology Annual Meeting, Martin et al presented data from the Australian Oral Nicotinamide to Reduce Actinic Cancer (ONTRAC) study. This prospective double-blind, randomized, controlled trial examined 386 immunocompetent patients with 2 or more nonmelanoma skin cancers (NMSCs) in the last 5 years (average, 8). The patients were randomized to receive oral nicotinamide 500 mg twice daily or placebo for 1 year, resulting in significant reduction of new NMSCs (average rate 1.77 vs 2.42; relative rate reduction, 23%; P=.02), with similar results for basal and squamous cell carcinomas. Actinic keratosis counts were reduced throughout the year by up to 20%, peaking at 9 months. No differences in adverse events were noted between the treatment and placebo groups.
What’s the issue?
High-risk NMSC patients present a challenge to dermatologists, as their need for constant surveillance, field therapy for actinic keratoses, and revolving visits between skin examinations and procedural modalities such as Mohs micrographic surgery can be staggering. Chemopreventive strategies pose difficulties, especially for elderly patients, due to tolerability and adherence, skin irritation and cosmetic limitations of topical therapies such as 5-fluorouracil, and inadequacy or financial inaccessibility of oral therapies such as acitretin.
Nicotinamide is a confusing supplement, as it is also called niacinamide. One of the 2 forms of vitamin B3, nicotinic acid (or niacin) is the other form and can be converted to nicotinamide in the body. It has cholesterol and vasodilatory/flushing effects that nicotinamide itself does not. Therefore, these supplement subtypes are not generally interchangeable.
Nicotinamide is postulated to enhance DNA repair and reverse UV immunosuppression in NMSC patients and is a well-tolerated and inexpensive supplement (approximately $10 a month for the dosage in this study). Although the decrease in skin cancer number per year seems modest in this study, my patients would likely welcome at least 1 fewer surgery per year and much less cryotherapy or 5-fluorouracil cream, especially if it is as simple as buying the supplement at the grocery store as they do for their fish oil capsules and probiotics. Does vitamin B3 hold promise for your high-risk NMSC patients?
At the recent American Society of Clinical Oncology Annual Meeting, Martin et al presented data from the Australian Oral Nicotinamide to Reduce Actinic Cancer (ONTRAC) study. This prospective double-blind, randomized, controlled trial examined 386 immunocompetent patients with 2 or more nonmelanoma skin cancers (NMSCs) in the last 5 years (average, 8). The patients were randomized to receive oral nicotinamide 500 mg twice daily or placebo for 1 year, resulting in significant reduction of new NMSCs (average rate 1.77 vs 2.42; relative rate reduction, 23%; P=.02), with similar results for basal and squamous cell carcinomas. Actinic keratosis counts were reduced throughout the year by up to 20%, peaking at 9 months. No differences in adverse events were noted between the treatment and placebo groups.
What’s the issue?
High-risk NMSC patients present a challenge to dermatologists, as their need for constant surveillance, field therapy for actinic keratoses, and revolving visits between skin examinations and procedural modalities such as Mohs micrographic surgery can be staggering. Chemopreventive strategies pose difficulties, especially for elderly patients, due to tolerability and adherence, skin irritation and cosmetic limitations of topical therapies such as 5-fluorouracil, and inadequacy or financial inaccessibility of oral therapies such as acitretin.
Nicotinamide is a confusing supplement, as it is also called niacinamide. One of the 2 forms of vitamin B3, nicotinic acid (or niacin) is the other form and can be converted to nicotinamide in the body. It has cholesterol and vasodilatory/flushing effects that nicotinamide itself does not. Therefore, these supplement subtypes are not generally interchangeable.
Nicotinamide is postulated to enhance DNA repair and reverse UV immunosuppression in NMSC patients and is a well-tolerated and inexpensive supplement (approximately $10 a month for the dosage in this study). Although the decrease in skin cancer number per year seems modest in this study, my patients would likely welcome at least 1 fewer surgery per year and much less cryotherapy or 5-fluorouracil cream, especially if it is as simple as buying the supplement at the grocery store as they do for their fish oil capsules and probiotics. Does vitamin B3 hold promise for your high-risk NMSC patients?
At the recent American Society of Clinical Oncology Annual Meeting, Martin et al presented data from the Australian Oral Nicotinamide to Reduce Actinic Cancer (ONTRAC) study. This prospective double-blind, randomized, controlled trial examined 386 immunocompetent patients with 2 or more nonmelanoma skin cancers (NMSCs) in the last 5 years (average, 8). The patients were randomized to receive oral nicotinamide 500 mg twice daily or placebo for 1 year, resulting in significant reduction of new NMSCs (average rate 1.77 vs 2.42; relative rate reduction, 23%; P=.02), with similar results for basal and squamous cell carcinomas. Actinic keratosis counts were reduced throughout the year by up to 20%, peaking at 9 months. No differences in adverse events were noted between the treatment and placebo groups.
What’s the issue?
High-risk NMSC patients present a challenge to dermatologists, as their need for constant surveillance, field therapy for actinic keratoses, and revolving visits between skin examinations and procedural modalities such as Mohs micrographic surgery can be staggering. Chemopreventive strategies pose difficulties, especially for elderly patients, due to tolerability and adherence, skin irritation and cosmetic limitations of topical therapies such as 5-fluorouracil, and inadequacy or financial inaccessibility of oral therapies such as acitretin.
Nicotinamide is a confusing supplement, as it is also called niacinamide. One of the 2 forms of vitamin B3, nicotinic acid (or niacin) is the other form and can be converted to nicotinamide in the body. It has cholesterol and vasodilatory/flushing effects that nicotinamide itself does not. Therefore, these supplement subtypes are not generally interchangeable.
Nicotinamide is postulated to enhance DNA repair and reverse UV immunosuppression in NMSC patients and is a well-tolerated and inexpensive supplement (approximately $10 a month for the dosage in this study). Although the decrease in skin cancer number per year seems modest in this study, my patients would likely welcome at least 1 fewer surgery per year and much less cryotherapy or 5-fluorouracil cream, especially if it is as simple as buying the supplement at the grocery store as they do for their fish oil capsules and probiotics. Does vitamin B3 hold promise for your high-risk NMSC patients?
Momentous Melanoma Marker Modality?
Clarke et al published a study online on March 2 in the Journal of Cutaneous Pathology regarding a novel diagnostic test for melanoma. Using quantitative reverse transcriptase–polymerase chain reaction targeting 23 preselected genes, biopsy samples from a variety of melanocytic skin lesions—464 lesions in a training set and 437 lesions in a separate validation set—were analyzed. The test assigned a single numeric score favoring either benign or malignant with sensitivity and specificity of 89% and 93%, respectively (training set), and 90% and 91%, respectively (validation set), when compared to expert consensus dermatopathology review.
What’s the issue?
Any clinician who biopsies multiple melanocytic lesions per day daydreams about a modality that will consistently and accurately distinguish the neoplasms that haunt us the most: the ones with no clear diagnosis and the lesions where intra- and interdepartmental histopathology results vary across the board. In fact, a patient recently told me that I “missed” her “dangerous” melanoma when our dermatopathology and outside consultant opinions stated that the lesion was a dysplastic nevus. The patient personally took the slides to another institution where they were deemed an “evolving” melanoma in situ. Are they all correct? How do we know that something is evolving? Which tumors will eventually be the sinister ones? If we don’t know, then how can a patient understand his/her predicament? What’s a clinician to do?
Reassuringly, in perusing the exhibit hall at the 73rd Annual Meeting of the American Academy of Dermatology, the climate has shifted somewhat. A new zone of molecular and genetic technology has emerged between the rows of pharmaceutical innovation and office supply hardware. The reverse transcriptase–polymerase chain reaction melanoma diagnostic test distinguishes itself with its large study set and measurement parameters, as it quantifies gene expression. Other adjunctive diagnostic modalities have been proven useful in atypical melanocytic proliferations, such as fluorescence in situ hybridization, comparative genomic hybridization, and DNA microarray technology, with focus on physical chromosomal copy alterations; however, it seems as though this new test provides a functional measure and straightforward plus/minus result that may be more universally and objectively relevant and interpretable from a simple skin biopsy. Perhaps the diagnostic technology has now outpaced our limited and confusing vocabulary for melanocytic lesions. Nonetheless, further clinical follow-up, prospective prognostic data, and cost analysis will define its evolving role. How do you think this gene signature test will ultimately influence our interpretation of melanocytic biopsy results?
Clarke et al published a study online on March 2 in the Journal of Cutaneous Pathology regarding a novel diagnostic test for melanoma. Using quantitative reverse transcriptase–polymerase chain reaction targeting 23 preselected genes, biopsy samples from a variety of melanocytic skin lesions—464 lesions in a training set and 437 lesions in a separate validation set—were analyzed. The test assigned a single numeric score favoring either benign or malignant with sensitivity and specificity of 89% and 93%, respectively (training set), and 90% and 91%, respectively (validation set), when compared to expert consensus dermatopathology review.
What’s the issue?
Any clinician who biopsies multiple melanocytic lesions per day daydreams about a modality that will consistently and accurately distinguish the neoplasms that haunt us the most: the ones with no clear diagnosis and the lesions where intra- and interdepartmental histopathology results vary across the board. In fact, a patient recently told me that I “missed” her “dangerous” melanoma when our dermatopathology and outside consultant opinions stated that the lesion was a dysplastic nevus. The patient personally took the slides to another institution where they were deemed an “evolving” melanoma in situ. Are they all correct? How do we know that something is evolving? Which tumors will eventually be the sinister ones? If we don’t know, then how can a patient understand his/her predicament? What’s a clinician to do?
Reassuringly, in perusing the exhibit hall at the 73rd Annual Meeting of the American Academy of Dermatology, the climate has shifted somewhat. A new zone of molecular and genetic technology has emerged between the rows of pharmaceutical innovation and office supply hardware. The reverse transcriptase–polymerase chain reaction melanoma diagnostic test distinguishes itself with its large study set and measurement parameters, as it quantifies gene expression. Other adjunctive diagnostic modalities have been proven useful in atypical melanocytic proliferations, such as fluorescence in situ hybridization, comparative genomic hybridization, and DNA microarray technology, with focus on physical chromosomal copy alterations; however, it seems as though this new test provides a functional measure and straightforward plus/minus result that may be more universally and objectively relevant and interpretable from a simple skin biopsy. Perhaps the diagnostic technology has now outpaced our limited and confusing vocabulary for melanocytic lesions. Nonetheless, further clinical follow-up, prospective prognostic data, and cost analysis will define its evolving role. How do you think this gene signature test will ultimately influence our interpretation of melanocytic biopsy results?
Clarke et al published a study online on March 2 in the Journal of Cutaneous Pathology regarding a novel diagnostic test for melanoma. Using quantitative reverse transcriptase–polymerase chain reaction targeting 23 preselected genes, biopsy samples from a variety of melanocytic skin lesions—464 lesions in a training set and 437 lesions in a separate validation set—were analyzed. The test assigned a single numeric score favoring either benign or malignant with sensitivity and specificity of 89% and 93%, respectively (training set), and 90% and 91%, respectively (validation set), when compared to expert consensus dermatopathology review.
What’s the issue?
Any clinician who biopsies multiple melanocytic lesions per day daydreams about a modality that will consistently and accurately distinguish the neoplasms that haunt us the most: the ones with no clear diagnosis and the lesions where intra- and interdepartmental histopathology results vary across the board. In fact, a patient recently told me that I “missed” her “dangerous” melanoma when our dermatopathology and outside consultant opinions stated that the lesion was a dysplastic nevus. The patient personally took the slides to another institution where they were deemed an “evolving” melanoma in situ. Are they all correct? How do we know that something is evolving? Which tumors will eventually be the sinister ones? If we don’t know, then how can a patient understand his/her predicament? What’s a clinician to do?
Reassuringly, in perusing the exhibit hall at the 73rd Annual Meeting of the American Academy of Dermatology, the climate has shifted somewhat. A new zone of molecular and genetic technology has emerged between the rows of pharmaceutical innovation and office supply hardware. The reverse transcriptase–polymerase chain reaction melanoma diagnostic test distinguishes itself with its large study set and measurement parameters, as it quantifies gene expression. Other adjunctive diagnostic modalities have been proven useful in atypical melanocytic proliferations, such as fluorescence in situ hybridization, comparative genomic hybridization, and DNA microarray technology, with focus on physical chromosomal copy alterations; however, it seems as though this new test provides a functional measure and straightforward plus/minus result that may be more universally and objectively relevant and interpretable from a simple skin biopsy. Perhaps the diagnostic technology has now outpaced our limited and confusing vocabulary for melanocytic lesions. Nonetheless, further clinical follow-up, prospective prognostic data, and cost analysis will define its evolving role. How do you think this gene signature test will ultimately influence our interpretation of melanocytic biopsy results?
Eyes on Ivermectin
In December 2014, the US Food and Drug Administration approved ivermectin cream 1% (Soolantra) for the treatment of inflammatory lesions of rosacea. This approval follows several safety and efficacy trials, particularly a phase 3 investigator-blinded, parallel-group study, published online in the British Journal of Dermatology on September 16, 2014, comparing once-daily application of ivermectin cream 1% and twice-daily metronidazole cream 0.75% in 962 patients with papulopustular rosacea over 16 weeks. Ivermectin showed more favorable local tolerability and significant reduction in lesion count versus metronidazole (83% vs 73.7%; P<.001) starting at week 3 and persisting throughout the study.
What’s the issue?
How many patients do you encounter each week who apply metronidazole topical treatments for years with little objective evidence of rosacea improvement? These data suggest that topical ivermectin may be a slightly more effective and tolerable alternative for papulopustular rosacea than the long-standing but modestly efficacious gold standard. With the recent approval of brimonidine gel for the erythematous component of rosacea, it is groundbreaking to introduce novel topical mechanisms into our rosacea prescription armamentarium as we attempt to elucidate the disease’s complex pathophysiology. What is your experience with this topical, and how do you think it will fit into your prescribing routines for rosacea?
In December 2014, the US Food and Drug Administration approved ivermectin cream 1% (Soolantra) for the treatment of inflammatory lesions of rosacea. This approval follows several safety and efficacy trials, particularly a phase 3 investigator-blinded, parallel-group study, published online in the British Journal of Dermatology on September 16, 2014, comparing once-daily application of ivermectin cream 1% and twice-daily metronidazole cream 0.75% in 962 patients with papulopustular rosacea over 16 weeks. Ivermectin showed more favorable local tolerability and significant reduction in lesion count versus metronidazole (83% vs 73.7%; P<.001) starting at week 3 and persisting throughout the study.
What’s the issue?
How many patients do you encounter each week who apply metronidazole topical treatments for years with little objective evidence of rosacea improvement? These data suggest that topical ivermectin may be a slightly more effective and tolerable alternative for papulopustular rosacea than the long-standing but modestly efficacious gold standard. With the recent approval of brimonidine gel for the erythematous component of rosacea, it is groundbreaking to introduce novel topical mechanisms into our rosacea prescription armamentarium as we attempt to elucidate the disease’s complex pathophysiology. What is your experience with this topical, and how do you think it will fit into your prescribing routines for rosacea?
In December 2014, the US Food and Drug Administration approved ivermectin cream 1% (Soolantra) for the treatment of inflammatory lesions of rosacea. This approval follows several safety and efficacy trials, particularly a phase 3 investigator-blinded, parallel-group study, published online in the British Journal of Dermatology on September 16, 2014, comparing once-daily application of ivermectin cream 1% and twice-daily metronidazole cream 0.75% in 962 patients with papulopustular rosacea over 16 weeks. Ivermectin showed more favorable local tolerability and significant reduction in lesion count versus metronidazole (83% vs 73.7%; P<.001) starting at week 3 and persisting throughout the study.
What’s the issue?
How many patients do you encounter each week who apply metronidazole topical treatments for years with little objective evidence of rosacea improvement? These data suggest that topical ivermectin may be a slightly more effective and tolerable alternative for papulopustular rosacea than the long-standing but modestly efficacious gold standard. With the recent approval of brimonidine gel for the erythematous component of rosacea, it is groundbreaking to introduce novel topical mechanisms into our rosacea prescription armamentarium as we attempt to elucidate the disease’s complex pathophysiology. What is your experience with this topical, and how do you think it will fit into your prescribing routines for rosacea?
Nailing Down the Data: Topicals for Onychomycosis
In summer 2014, the US Food and Drug Administration (FDA) approved 2 new topical medications for onychomycosis. In recent months, the Journal of Clinical and Aesthetic Dermatology (2014;7:10-18) and Medscape provided review materials to assist in sifting through this topic. In summary, efinaconazole, a triazole antifungal in a 10% solution recommended for daily application for 48 weeks, exhibited 17.8% complete and 55.2% mycological cure rates compared to vehicle (5.5% and 16.9%, respectively). Tavaborole, an oxaborole antifungal in a 5% solution recommended for daily application for 48 weeks, displayed 9.1% complete and 35.9% mycological cure rates versus vehicle (1.5% and 12.2%, respectively). To complete the discussion, ciclopirox nail lacquer, FDA approved in 1999 for onychomycosis for daily application for 48 weeks, heralded 8.5% complete and 36% mycological cure rates compared to vehicle (0% and 9%, respectively). Ciclopirox requires nail debridement periodically, and the newer agents do not.
What’s the issue?
Do you agree that nary a day goes by without an e-mailed article or continuing medical education opportunity tasked at “getting to know” new topical onychomycosis therapies? That being said, how often have you summarily deleted them, assuming that topicals just don’t work? I know I have, though I paused this week after thinking to myself, “How often have I written a prescription for ciclopirox nail lacquer to appease a patient who would prefer nonsystemic therapy?” And then I read on. Based on the data above, perhaps these medications, particularly efinaconazole, at least deserve perusal compared to our current meager topical and systemic options. What has your experience been with these novel topicals, their insurance coverage, and their tolerability and efficacy in your practice?
In summer 2014, the US Food and Drug Administration (FDA) approved 2 new topical medications for onychomycosis. In recent months, the Journal of Clinical and Aesthetic Dermatology (2014;7:10-18) and Medscape provided review materials to assist in sifting through this topic. In summary, efinaconazole, a triazole antifungal in a 10% solution recommended for daily application for 48 weeks, exhibited 17.8% complete and 55.2% mycological cure rates compared to vehicle (5.5% and 16.9%, respectively). Tavaborole, an oxaborole antifungal in a 5% solution recommended for daily application for 48 weeks, displayed 9.1% complete and 35.9% mycological cure rates versus vehicle (1.5% and 12.2%, respectively). To complete the discussion, ciclopirox nail lacquer, FDA approved in 1999 for onychomycosis for daily application for 48 weeks, heralded 8.5% complete and 36% mycological cure rates compared to vehicle (0% and 9%, respectively). Ciclopirox requires nail debridement periodically, and the newer agents do not.
What’s the issue?
Do you agree that nary a day goes by without an e-mailed article or continuing medical education opportunity tasked at “getting to know” new topical onychomycosis therapies? That being said, how often have you summarily deleted them, assuming that topicals just don’t work? I know I have, though I paused this week after thinking to myself, “How often have I written a prescription for ciclopirox nail lacquer to appease a patient who would prefer nonsystemic therapy?” And then I read on. Based on the data above, perhaps these medications, particularly efinaconazole, at least deserve perusal compared to our current meager topical and systemic options. What has your experience been with these novel topicals, their insurance coverage, and their tolerability and efficacy in your practice?
In summer 2014, the US Food and Drug Administration (FDA) approved 2 new topical medications for onychomycosis. In recent months, the Journal of Clinical and Aesthetic Dermatology (2014;7:10-18) and Medscape provided review materials to assist in sifting through this topic. In summary, efinaconazole, a triazole antifungal in a 10% solution recommended for daily application for 48 weeks, exhibited 17.8% complete and 55.2% mycological cure rates compared to vehicle (5.5% and 16.9%, respectively). Tavaborole, an oxaborole antifungal in a 5% solution recommended for daily application for 48 weeks, displayed 9.1% complete and 35.9% mycological cure rates versus vehicle (1.5% and 12.2%, respectively). To complete the discussion, ciclopirox nail lacquer, FDA approved in 1999 for onychomycosis for daily application for 48 weeks, heralded 8.5% complete and 36% mycological cure rates compared to vehicle (0% and 9%, respectively). Ciclopirox requires nail debridement periodically, and the newer agents do not.
What’s the issue?
Do you agree that nary a day goes by without an e-mailed article or continuing medical education opportunity tasked at “getting to know” new topical onychomycosis therapies? That being said, how often have you summarily deleted them, assuming that topicals just don’t work? I know I have, though I paused this week after thinking to myself, “How often have I written a prescription for ciclopirox nail lacquer to appease a patient who would prefer nonsystemic therapy?” And then I read on. Based on the data above, perhaps these medications, particularly efinaconazole, at least deserve perusal compared to our current meager topical and systemic options. What has your experience been with these novel topicals, their insurance coverage, and their tolerability and efficacy in your practice?
At Last? Apremilast
In late September 2014, the US Food and Drug Administration approved the medication apremilast for treatment of moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy. It was previously approved for psoriatic arthritis in March 2014. Its mechanism includes selective inhibition of phosphodiesterase 4, resulting in increased intracellular cyclic adenosine monophosphate levels, indirectly mediating production of inflammatory mediators in many cell types, namely decreasing tumor necrosis factor α and IL-23 and increasing IL-10. Orally dosed at 30 mg twice daily, safety and efficacy was determined via 2 multicenter, randomized, double-blind, placebo-controlled trials—ESTEEM 1 and ESTEEM 2 (N=1257)—that highlighted a PASI-75 (psoriasis area severity index) in 30% of patients in the first 4 months and up to 88% of patients with PASI-75 in the first year (J Am Acad Dermatol. 2014;70(suppl 1):AB164). Additionally, according to results presented at a recent European Academy of Dermatology and Venereology meeting in early October 2014, pruritus and difficult areas such as the scalp, palmoplantar area, and nails showed significant improvement at week 16 (P<.0001). The most common side effects were diarrhea, nausea, upper respiratory infection, and headache, which occurred most often in the first 2 weeks of therapy. The medication does not require routine laboratory monitoring; however, because weight loss is possible, it is recommended that weight should be periodically checked. There are no contraindications aside from hypersensitivity to the drug itself, and caution should be taken in patients with unstable depression, suicidal ideation, or severe renal impairment. It is pregnancy category C.
What’s the issue?
Because it is administered orally; is dually indicated for plaque psoriasis and psoriatic arthritis; and does not require laboratory monitoring, alcohol consumption restrictions, category X classification, or immunosuppressive infection or cancer risk, the window-shopping appeal of this drug seems attractive compared to the veteran and contemporary pharmaceutical army of psoriasis therapy. However, based on the ESTEEM studies, meager apremilast PASI scores are not blowing us away like those of biologic medications. At a time when the evolution of medications for psoriasis seems like a revolving door for new products highlighting new mechanisms in new pathways in even newer cells in relationship to inflammation, how will this drug fit in?
In late September 2014, the US Food and Drug Administration approved the medication apremilast for treatment of moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy. It was previously approved for psoriatic arthritis in March 2014. Its mechanism includes selective inhibition of phosphodiesterase 4, resulting in increased intracellular cyclic adenosine monophosphate levels, indirectly mediating production of inflammatory mediators in many cell types, namely decreasing tumor necrosis factor α and IL-23 and increasing IL-10. Orally dosed at 30 mg twice daily, safety and efficacy was determined via 2 multicenter, randomized, double-blind, placebo-controlled trials—ESTEEM 1 and ESTEEM 2 (N=1257)—that highlighted a PASI-75 (psoriasis area severity index) in 30% of patients in the first 4 months and up to 88% of patients with PASI-75 in the first year (J Am Acad Dermatol. 2014;70(suppl 1):AB164). Additionally, according to results presented at a recent European Academy of Dermatology and Venereology meeting in early October 2014, pruritus and difficult areas such as the scalp, palmoplantar area, and nails showed significant improvement at week 16 (P<.0001). The most common side effects were diarrhea, nausea, upper respiratory infection, and headache, which occurred most often in the first 2 weeks of therapy. The medication does not require routine laboratory monitoring; however, because weight loss is possible, it is recommended that weight should be periodically checked. There are no contraindications aside from hypersensitivity to the drug itself, and caution should be taken in patients with unstable depression, suicidal ideation, or severe renal impairment. It is pregnancy category C.
What’s the issue?
Because it is administered orally; is dually indicated for plaque psoriasis and psoriatic arthritis; and does not require laboratory monitoring, alcohol consumption restrictions, category X classification, or immunosuppressive infection or cancer risk, the window-shopping appeal of this drug seems attractive compared to the veteran and contemporary pharmaceutical army of psoriasis therapy. However, based on the ESTEEM studies, meager apremilast PASI scores are not blowing us away like those of biologic medications. At a time when the evolution of medications for psoriasis seems like a revolving door for new products highlighting new mechanisms in new pathways in even newer cells in relationship to inflammation, how will this drug fit in?
In late September 2014, the US Food and Drug Administration approved the medication apremilast for treatment of moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy. It was previously approved for psoriatic arthritis in March 2014. Its mechanism includes selective inhibition of phosphodiesterase 4, resulting in increased intracellular cyclic adenosine monophosphate levels, indirectly mediating production of inflammatory mediators in many cell types, namely decreasing tumor necrosis factor α and IL-23 and increasing IL-10. Orally dosed at 30 mg twice daily, safety and efficacy was determined via 2 multicenter, randomized, double-blind, placebo-controlled trials—ESTEEM 1 and ESTEEM 2 (N=1257)—that highlighted a PASI-75 (psoriasis area severity index) in 30% of patients in the first 4 months and up to 88% of patients with PASI-75 in the first year (J Am Acad Dermatol. 2014;70(suppl 1):AB164). Additionally, according to results presented at a recent European Academy of Dermatology and Venereology meeting in early October 2014, pruritus and difficult areas such as the scalp, palmoplantar area, and nails showed significant improvement at week 16 (P<.0001). The most common side effects were diarrhea, nausea, upper respiratory infection, and headache, which occurred most often in the first 2 weeks of therapy. The medication does not require routine laboratory monitoring; however, because weight loss is possible, it is recommended that weight should be periodically checked. There are no contraindications aside from hypersensitivity to the drug itself, and caution should be taken in patients with unstable depression, suicidal ideation, or severe renal impairment. It is pregnancy category C.
What’s the issue?
Because it is administered orally; is dually indicated for plaque psoriasis and psoriatic arthritis; and does not require laboratory monitoring, alcohol consumption restrictions, category X classification, or immunosuppressive infection or cancer risk, the window-shopping appeal of this drug seems attractive compared to the veteran and contemporary pharmaceutical army of psoriasis therapy. However, based on the ESTEEM studies, meager apremilast PASI scores are not blowing us away like those of biologic medications. At a time when the evolution of medications for psoriasis seems like a revolving door for new products highlighting new mechanisms in new pathways in even newer cells in relationship to inflammation, how will this drug fit in?
Melanoma and Sildenafil: “Enhanced” Risk?
A recently published prospective cohort study reported that sildenafil use may increase the risk for melanoma (JAMA Intern Med. 2014;174:964-970). BRAF activation, which is pathogenic in some melanoma variants, downregulates phosphodiesterase 5A and sildenafil downregulates phosphodiesterase 5A, surmising that either one may enhance melanoma invasion. The Health Professionals’ Follow-up Study cohort was utilized, which has prospectively evaluated male health professionals’ nutrition and incidences of serious illnesses since 1986. In 2000, more than 25,000 men were interviewed about sildenafil use for erectile dysfunction, and the incidence of skin cancer was obtained by questionnaire every 2 years for 10 years. The questionnaire showed that 142 melanomas were diagnosed, and recent or prior sildenafil use (with no breakdown of frequency of dosing) was significantly associated with increased risk for melanoma (hazard ratio, 1.84 for recent use; 1.92 for ever use) adjusted for age, erectile dysfunction without sildenafil, and several skin-related and genetic melanoma risk factors. No other types of skin cancer exhibited this risk trend.
What’s the issue?
Vascular tone and manipulation of such is a contender as a hot topic in melanoma given that even aspirin has been implicated as a risk factor. Unfortunately, similar to the aspirin data, without a true continuum providing any sildenafil dosage or frequency relationship to the development of melanoma, especially for this very short half-life medication, we likely cannot consider sildenafil as a hazard in patients at high risk for melanoma as we do for smokers and oral contraceptives, or alcoholics and terbinafine. Because UV radiation is the only behavioral risk factor linked to melanoma and considering that so many of our male patients take this class of drug, in your opinion what percentage of your patients in this risk category follow strict sun protection? Should we mention this potential association to them?
A recently published prospective cohort study reported that sildenafil use may increase the risk for melanoma (JAMA Intern Med. 2014;174:964-970). BRAF activation, which is pathogenic in some melanoma variants, downregulates phosphodiesterase 5A and sildenafil downregulates phosphodiesterase 5A, surmising that either one may enhance melanoma invasion. The Health Professionals’ Follow-up Study cohort was utilized, which has prospectively evaluated male health professionals’ nutrition and incidences of serious illnesses since 1986. In 2000, more than 25,000 men were interviewed about sildenafil use for erectile dysfunction, and the incidence of skin cancer was obtained by questionnaire every 2 years for 10 years. The questionnaire showed that 142 melanomas were diagnosed, and recent or prior sildenafil use (with no breakdown of frequency of dosing) was significantly associated with increased risk for melanoma (hazard ratio, 1.84 for recent use; 1.92 for ever use) adjusted for age, erectile dysfunction without sildenafil, and several skin-related and genetic melanoma risk factors. No other types of skin cancer exhibited this risk trend.
What’s the issue?
Vascular tone and manipulation of such is a contender as a hot topic in melanoma given that even aspirin has been implicated as a risk factor. Unfortunately, similar to the aspirin data, without a true continuum providing any sildenafil dosage or frequency relationship to the development of melanoma, especially for this very short half-life medication, we likely cannot consider sildenafil as a hazard in patients at high risk for melanoma as we do for smokers and oral contraceptives, or alcoholics and terbinafine. Because UV radiation is the only behavioral risk factor linked to melanoma and considering that so many of our male patients take this class of drug, in your opinion what percentage of your patients in this risk category follow strict sun protection? Should we mention this potential association to them?
A recently published prospective cohort study reported that sildenafil use may increase the risk for melanoma (JAMA Intern Med. 2014;174:964-970). BRAF activation, which is pathogenic in some melanoma variants, downregulates phosphodiesterase 5A and sildenafil downregulates phosphodiesterase 5A, surmising that either one may enhance melanoma invasion. The Health Professionals’ Follow-up Study cohort was utilized, which has prospectively evaluated male health professionals’ nutrition and incidences of serious illnesses since 1986. In 2000, more than 25,000 men were interviewed about sildenafil use for erectile dysfunction, and the incidence of skin cancer was obtained by questionnaire every 2 years for 10 years. The questionnaire showed that 142 melanomas were diagnosed, and recent or prior sildenafil use (with no breakdown of frequency of dosing) was significantly associated with increased risk for melanoma (hazard ratio, 1.84 for recent use; 1.92 for ever use) adjusted for age, erectile dysfunction without sildenafil, and several skin-related and genetic melanoma risk factors. No other types of skin cancer exhibited this risk trend.
What’s the issue?
Vascular tone and manipulation of such is a contender as a hot topic in melanoma given that even aspirin has been implicated as a risk factor. Unfortunately, similar to the aspirin data, without a true continuum providing any sildenafil dosage or frequency relationship to the development of melanoma, especially for this very short half-life medication, we likely cannot consider sildenafil as a hazard in patients at high risk for melanoma as we do for smokers and oral contraceptives, or alcoholics and terbinafine. Because UV radiation is the only behavioral risk factor linked to melanoma and considering that so many of our male patients take this class of drug, in your opinion what percentage of your patients in this risk category follow strict sun protection? Should we mention this potential association to them?
The Asterisk
In early July, a media blast regarding the safety of spray sunscreens was disseminated. Consumer Reports commented on a US Food and Drug Administration (FDA) investigation of sunscreen in the spray vehicle, stating that consumers should not apply them on children until the safety of these agents is determined by an ongoing FDA analysis. The focus of FDA concern is the inhalation of nanoparticles in these products, particularly those containing titanium dioxide. The report also provided instructions for safe application of spray sunscreen in adults, such as avoiding the face and applying evenly for best results.
What’s the issue?
I read this consumer article with great interest and attention. I not only use spray sunscreen on my toddler and myself, but I also often recommend it to patients who despise the feel and inconvenience of cream-based sunscreens. Also, the ability to independently reach areas such as the mid-back provides ease of application in the spray form. That being said, I do note that these sunscreens should not be used on the face and should be applied outdoors to reduce inhalation. The age of nanomedicine provides an unknown risk, given the potential of new and more invasive chemical exposure. However, the aggressiveness with which this report was disseminated through the press was not well founded.
The FDA started this investigation in 2011, which was disclosed by Consumer Reports using a tiny asterisk in the July 2014 report. The FDA has not made any statements for or against spray sunscreens except to say that consumers should avoid open flames during application. In fact, the American Academy of Dermatology’s educational page on sunscreen has acknowledged the unknown risk of spray sunscreens since 2011. Given that this consumer “update,” which did not provide any new information, was released by the press in the throes of the summer sun, it has bolstered patient doubts about what dermatologists recommend regarding sunscreen and its safety. Do you use or recommend spray sunscreens? How do you feel about the manner in which the popular media depicts sunscreens in recent years?
We want to know your views! Tell us what you think.
Reader Comments
I usually ask our patients to apply sprays outside and directed so the spray is dispersed downwind if possible. This at the beach or golf course. I also ask them to hold their breaths to not inhale the mist. I still however ask to use a cream or lotion at home and use the sprays as a secondary application.
--Michael A. Scannon, MD
Darrel Rigel showed several years ago that most people use one quarter to one third the proper amount of sunscreen needed to attain the SPF on the label. Sprays encourage using even less. In a use test I performed for a sunscreen company several years ago, our subjects had white round patches of unburned skin among their sunburns. Uniform coverage is difficult to achieve.
--Christopher G. Nelson, MD
In early July, a media blast regarding the safety of spray sunscreens was disseminated. Consumer Reports commented on a US Food and Drug Administration (FDA) investigation of sunscreen in the spray vehicle, stating that consumers should not apply them on children until the safety of these agents is determined by an ongoing FDA analysis. The focus of FDA concern is the inhalation of nanoparticles in these products, particularly those containing titanium dioxide. The report also provided instructions for safe application of spray sunscreen in adults, such as avoiding the face and applying evenly for best results.
What’s the issue?
I read this consumer article with great interest and attention. I not only use spray sunscreen on my toddler and myself, but I also often recommend it to patients who despise the feel and inconvenience of cream-based sunscreens. Also, the ability to independently reach areas such as the mid-back provides ease of application in the spray form. That being said, I do note that these sunscreens should not be used on the face and should be applied outdoors to reduce inhalation. The age of nanomedicine provides an unknown risk, given the potential of new and more invasive chemical exposure. However, the aggressiveness with which this report was disseminated through the press was not well founded.
The FDA started this investigation in 2011, which was disclosed by Consumer Reports using a tiny asterisk in the July 2014 report. The FDA has not made any statements for or against spray sunscreens except to say that consumers should avoid open flames during application. In fact, the American Academy of Dermatology’s educational page on sunscreen has acknowledged the unknown risk of spray sunscreens since 2011. Given that this consumer “update,” which did not provide any new information, was released by the press in the throes of the summer sun, it has bolstered patient doubts about what dermatologists recommend regarding sunscreen and its safety. Do you use or recommend spray sunscreens? How do you feel about the manner in which the popular media depicts sunscreens in recent years?
We want to know your views! Tell us what you think.
Reader Comments
I usually ask our patients to apply sprays outside and directed so the spray is dispersed downwind if possible. This at the beach or golf course. I also ask them to hold their breaths to not inhale the mist. I still however ask to use a cream or lotion at home and use the sprays as a secondary application.
--Michael A. Scannon, MD
Darrel Rigel showed several years ago that most people use one quarter to one third the proper amount of sunscreen needed to attain the SPF on the label. Sprays encourage using even less. In a use test I performed for a sunscreen company several years ago, our subjects had white round patches of unburned skin among their sunburns. Uniform coverage is difficult to achieve.
--Christopher G. Nelson, MD
In early July, a media blast regarding the safety of spray sunscreens was disseminated. Consumer Reports commented on a US Food and Drug Administration (FDA) investigation of sunscreen in the spray vehicle, stating that consumers should not apply them on children until the safety of these agents is determined by an ongoing FDA analysis. The focus of FDA concern is the inhalation of nanoparticles in these products, particularly those containing titanium dioxide. The report also provided instructions for safe application of spray sunscreen in adults, such as avoiding the face and applying evenly for best results.
What’s the issue?
I read this consumer article with great interest and attention. I not only use spray sunscreen on my toddler and myself, but I also often recommend it to patients who despise the feel and inconvenience of cream-based sunscreens. Also, the ability to independently reach areas such as the mid-back provides ease of application in the spray form. That being said, I do note that these sunscreens should not be used on the face and should be applied outdoors to reduce inhalation. The age of nanomedicine provides an unknown risk, given the potential of new and more invasive chemical exposure. However, the aggressiveness with which this report was disseminated through the press was not well founded.
The FDA started this investigation in 2011, which was disclosed by Consumer Reports using a tiny asterisk in the July 2014 report. The FDA has not made any statements for or against spray sunscreens except to say that consumers should avoid open flames during application. In fact, the American Academy of Dermatology’s educational page on sunscreen has acknowledged the unknown risk of spray sunscreens since 2011. Given that this consumer “update,” which did not provide any new information, was released by the press in the throes of the summer sun, it has bolstered patient doubts about what dermatologists recommend regarding sunscreen and its safety. Do you use or recommend spray sunscreens? How do you feel about the manner in which the popular media depicts sunscreens in recent years?
We want to know your views! Tell us what you think.
Reader Comments
I usually ask our patients to apply sprays outside and directed so the spray is dispersed downwind if possible. This at the beach or golf course. I also ask them to hold their breaths to not inhale the mist. I still however ask to use a cream or lotion at home and use the sprays as a secondary application.
--Michael A. Scannon, MD
Darrel Rigel showed several years ago that most people use one quarter to one third the proper amount of sunscreen needed to attain the SPF on the label. Sprays encourage using even less. In a use test I performed for a sunscreen company several years ago, our subjects had white round patches of unburned skin among their sunburns. Uniform coverage is difficult to achieve.
--Christopher G. Nelson, MD