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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
Study examines burden of vitiligo in the U.S.
To investigate the incidence and prevalence of diagnosed vitiligo in the United States, researchers used a 15% random sample of electronic medical records from the IBM Explorys database. Two cohorts were included: 2,980,778 patients diagnosed with vitiligo between Jan. 1, 2015, and Dec. 31, 2019 (incidence analysis), and 1,057,534 patients diagnosed with vitiligo between Jan. 1 and Dec. 31, 2019 (prevalence analysis).The main outcomes were incidence (per 100,000 person-years) and prevalence of diagnosed vitiligo overall and by age, race/ethnicity, and sex. Amit Garg, MD, a dermatologist with Northwell Health, New Hyde Park, N.Y., led the study, which was published in JAMA Dermatology.
The age- and sex-adjusted overall incidence rate of diagnosed vitiligo was 22.6 per 100,000 person-years, and the prevalence was 0.16%, the authors reported. The sex-adjusted IR was highest among patients aged 60-69 years (25.3 per 100,000 person-years); prevalence was highest among patients aged 70 years or older (0.21%).
The highest age-adjusted IR was among Asian American patients (41.2 per 100,000 person-years), followed by Hispanic/Latino patients (37.3 per 100,000 PY), those reporting other or multiple races (31.1 per 100,000), Black patients (29.6 per 100,000 person-years), and White patients (18.7 per 100,000 person-years). The highest age-adjusted prevalence was among Hispanic/Latino patients (0.29%), followed by Asian American patients (0.27%), those reporting other or multiple races (0.24%), Black patients (0.22%), and White patients (0.13%).
The burden of vitiligo in the United States is poorly understood, and the findings “may support improving awareness of vitiligo disease burden in medical and public sectors, informing research agendas, improving enrollment of racial and ethnic minority populations in trials, and developing health policies,” the authors wrote.
Limitations of the study included that the analysis only captured patients who sought care in health systems included in the database, and there was the potential for underreporting, “since not all patients with vitiligo seek care,” the authors noted.
Dr. Garg reported being an adviser for and receiving honoraria from many pharmaceutical companies. He has also received research grants from AbbVie, UCB, the National Psoriasis Foundation, and the CHORD COUSIN Collaboration. No other disclosures were reported.
A version of this article first appeared on Medscape.com .
To investigate the incidence and prevalence of diagnosed vitiligo in the United States, researchers used a 15% random sample of electronic medical records from the IBM Explorys database. Two cohorts were included: 2,980,778 patients diagnosed with vitiligo between Jan. 1, 2015, and Dec. 31, 2019 (incidence analysis), and 1,057,534 patients diagnosed with vitiligo between Jan. 1 and Dec. 31, 2019 (prevalence analysis).The main outcomes were incidence (per 100,000 person-years) and prevalence of diagnosed vitiligo overall and by age, race/ethnicity, and sex. Amit Garg, MD, a dermatologist with Northwell Health, New Hyde Park, N.Y., led the study, which was published in JAMA Dermatology.
The age- and sex-adjusted overall incidence rate of diagnosed vitiligo was 22.6 per 100,000 person-years, and the prevalence was 0.16%, the authors reported. The sex-adjusted IR was highest among patients aged 60-69 years (25.3 per 100,000 person-years); prevalence was highest among patients aged 70 years or older (0.21%).
The highest age-adjusted IR was among Asian American patients (41.2 per 100,000 person-years), followed by Hispanic/Latino patients (37.3 per 100,000 PY), those reporting other or multiple races (31.1 per 100,000), Black patients (29.6 per 100,000 person-years), and White patients (18.7 per 100,000 person-years). The highest age-adjusted prevalence was among Hispanic/Latino patients (0.29%), followed by Asian American patients (0.27%), those reporting other or multiple races (0.24%), Black patients (0.22%), and White patients (0.13%).
The burden of vitiligo in the United States is poorly understood, and the findings “may support improving awareness of vitiligo disease burden in medical and public sectors, informing research agendas, improving enrollment of racial and ethnic minority populations in trials, and developing health policies,” the authors wrote.
Limitations of the study included that the analysis only captured patients who sought care in health systems included in the database, and there was the potential for underreporting, “since not all patients with vitiligo seek care,” the authors noted.
Dr. Garg reported being an adviser for and receiving honoraria from many pharmaceutical companies. He has also received research grants from AbbVie, UCB, the National Psoriasis Foundation, and the CHORD COUSIN Collaboration. No other disclosures were reported.
A version of this article first appeared on Medscape.com .
To investigate the incidence and prevalence of diagnosed vitiligo in the United States, researchers used a 15% random sample of electronic medical records from the IBM Explorys database. Two cohorts were included: 2,980,778 patients diagnosed with vitiligo between Jan. 1, 2015, and Dec. 31, 2019 (incidence analysis), and 1,057,534 patients diagnosed with vitiligo between Jan. 1 and Dec. 31, 2019 (prevalence analysis).The main outcomes were incidence (per 100,000 person-years) and prevalence of diagnosed vitiligo overall and by age, race/ethnicity, and sex. Amit Garg, MD, a dermatologist with Northwell Health, New Hyde Park, N.Y., led the study, which was published in JAMA Dermatology.
The age- and sex-adjusted overall incidence rate of diagnosed vitiligo was 22.6 per 100,000 person-years, and the prevalence was 0.16%, the authors reported. The sex-adjusted IR was highest among patients aged 60-69 years (25.3 per 100,000 person-years); prevalence was highest among patients aged 70 years or older (0.21%).
The highest age-adjusted IR was among Asian American patients (41.2 per 100,000 person-years), followed by Hispanic/Latino patients (37.3 per 100,000 PY), those reporting other or multiple races (31.1 per 100,000), Black patients (29.6 per 100,000 person-years), and White patients (18.7 per 100,000 person-years). The highest age-adjusted prevalence was among Hispanic/Latino patients (0.29%), followed by Asian American patients (0.27%), those reporting other or multiple races (0.24%), Black patients (0.22%), and White patients (0.13%).
The burden of vitiligo in the United States is poorly understood, and the findings “may support improving awareness of vitiligo disease burden in medical and public sectors, informing research agendas, improving enrollment of racial and ethnic minority populations in trials, and developing health policies,” the authors wrote.
Limitations of the study included that the analysis only captured patients who sought care in health systems included in the database, and there was the potential for underreporting, “since not all patients with vitiligo seek care,” the authors noted.
Dr. Garg reported being an adviser for and receiving honoraria from many pharmaceutical companies. He has also received research grants from AbbVie, UCB, the National Psoriasis Foundation, and the CHORD COUSIN Collaboration. No other disclosures were reported.
A version of this article first appeared on Medscape.com .
FROM JAMA DERMATOLOGY
FDA approves cantharidin for molluscum contagiosum
On July 21, 2023, .
The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.
The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).
A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.
The product will be marketed as Ycanth.
In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.
On July 21, 2023, .
The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.
The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).
A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.
The product will be marketed as Ycanth.
In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.
On July 21, 2023, .
The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.
The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).
A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.
The product will be marketed as Ycanth.
In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.
Study examines pediatric skin biopsy trends at a tertiary care center
.
In addition, fewer biopsies were performed in the first 3 years of the global COVID-19 pandemic than in the previous 3 years.
These findings from a retrospective analysis were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology. The analysis set out to evaluate which patients required biopsy, which skin conditions were sampled, and if practice patterns changed following the start of the COVID-19 pandemic.
“The work is important because very few pediatric patients, relative to adult patients seen in dermatology clinics, have a biopsy done,” Kelly M. Cordoro, MD, one of the study authors, told this news organization.
“Approximately 1%-4% of pediatric patients visiting a dermatology clinic will have a biopsy done as compared to 30%-50% of adult patients. Understanding what is being biopsied in children sheds light on the medical decision-making required to decide when a biopsy is necessary,” said Dr. Cordoro, chief of pediatric dermatology at UCSF.
For the study, the researchers retrospectively reviewed 1,196 biopsy specimens from 1,080 unique patients that were performed by pediatric dermatologists at UCSF from 2017 to 2022. Half of the patients were female, their mean age was 11.5 years, and they ranged in age from 1 day to 61 years. Nearly half of biopsies (47%) were performed in patients aged 12-18 years and one-quarter (25.6%) were performed in those aged 6-11 years. In the remaining biopsies, 6.6% came from patients younger than 1 year, 5.8% of those aged 1-2 years, 7.3% from those aged 3-5 years, and 3.9% each in those aged 19-21 years and in those older than 21 years.
The five most common biopsy results were compound nevus (99 biopsies), pyogenic granuloma (96), spongiotic dermatitis (57), intradermal nevus (53), and pilomatricoma (40).
The researchers identified 30 malignant diagnoses in 28 unique patients, most commonly mycosis fungoides (in 16 patients with a median age of 12.5 years), basal cell carcinoma (in 5 patients with a median age of 9 years), and dermatofibrosarcoma protuberans (in 4 patients with a median age of 2 years).
There was no significant sex-based difference in the number of biopsies performed at a given age (P = .47), but Dr. Cordoro and colleagues noted a statistically significant decrease in the number of biopsies during the pandemic compared with the 3 years prior to the pandemic (P = .04).
“There was a slight uptick in 2022, although it remains to be seen whether this trend will continue,” they wrote in their abstract. “While the most common diagnoses in the years leading up to – versus following the start of the pandemic – were similar, there was one clear outlier. The histopathologic diagnosis of pernio spiked in 2020, reflecting the ‘COVID toes’ phenomenon”.
In an interview, Dr. Cordoro said that growths and rashes in children of all ages can, and should, be biopsied, but special considerations are necessary depending on the patient’s age and context.
“Our data showed that neoplastic conditions were biopsied more often than inflammatory conditions, with an emphasis on lesions that required removal (such as pyogenic granuloma), raised concerns for atypia (nevi), or had implications for systemic management (such as Langerhans cell histiocytosis and graft-versus-host disease). Importantly, cutaneous malignancies in children are rare but do occur, and a high index of suspicion is required when approaching any child with a complex neoplasm or rash.”
Dr. Cordoro characterized the medical decision making and rationale for biopsying skin lesions and rashes in children as “a complex process that involves weighing the risks of the biopsy itself against the benefit of the information it will provide; shared decision-making with the caregivers, the patient (if age-appropriate), and other members of the health care team; age of the child and clinical context; and whether the biopsy can be done at the bedside or requires sedation.”
Based on the study results, Dr. Cordoro said, the rationale to proceed with a biopsy boils down to three main goals: To make or confirm a diagnosis, to make decisions about management, and/or the biopsy itself is therapeutic.
UCSF dermatopathology fellow Suzanne W. Birmingham, MD, performed the study in collaboration with Dr. Cordoro and UCSF dermatopathologist Thaddeus W. Mully, MD. Additional analyses of this data set are in progress. The researchers reported having no relevant financial disclosures.
.
In addition, fewer biopsies were performed in the first 3 years of the global COVID-19 pandemic than in the previous 3 years.
These findings from a retrospective analysis were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology. The analysis set out to evaluate which patients required biopsy, which skin conditions were sampled, and if practice patterns changed following the start of the COVID-19 pandemic.
“The work is important because very few pediatric patients, relative to adult patients seen in dermatology clinics, have a biopsy done,” Kelly M. Cordoro, MD, one of the study authors, told this news organization.
“Approximately 1%-4% of pediatric patients visiting a dermatology clinic will have a biopsy done as compared to 30%-50% of adult patients. Understanding what is being biopsied in children sheds light on the medical decision-making required to decide when a biopsy is necessary,” said Dr. Cordoro, chief of pediatric dermatology at UCSF.
For the study, the researchers retrospectively reviewed 1,196 biopsy specimens from 1,080 unique patients that were performed by pediatric dermatologists at UCSF from 2017 to 2022. Half of the patients were female, their mean age was 11.5 years, and they ranged in age from 1 day to 61 years. Nearly half of biopsies (47%) were performed in patients aged 12-18 years and one-quarter (25.6%) were performed in those aged 6-11 years. In the remaining biopsies, 6.6% came from patients younger than 1 year, 5.8% of those aged 1-2 years, 7.3% from those aged 3-5 years, and 3.9% each in those aged 19-21 years and in those older than 21 years.
The five most common biopsy results were compound nevus (99 biopsies), pyogenic granuloma (96), spongiotic dermatitis (57), intradermal nevus (53), and pilomatricoma (40).
The researchers identified 30 malignant diagnoses in 28 unique patients, most commonly mycosis fungoides (in 16 patients with a median age of 12.5 years), basal cell carcinoma (in 5 patients with a median age of 9 years), and dermatofibrosarcoma protuberans (in 4 patients with a median age of 2 years).
There was no significant sex-based difference in the number of biopsies performed at a given age (P = .47), but Dr. Cordoro and colleagues noted a statistically significant decrease in the number of biopsies during the pandemic compared with the 3 years prior to the pandemic (P = .04).
“There was a slight uptick in 2022, although it remains to be seen whether this trend will continue,” they wrote in their abstract. “While the most common diagnoses in the years leading up to – versus following the start of the pandemic – were similar, there was one clear outlier. The histopathologic diagnosis of pernio spiked in 2020, reflecting the ‘COVID toes’ phenomenon”.
In an interview, Dr. Cordoro said that growths and rashes in children of all ages can, and should, be biopsied, but special considerations are necessary depending on the patient’s age and context.
“Our data showed that neoplastic conditions were biopsied more often than inflammatory conditions, with an emphasis on lesions that required removal (such as pyogenic granuloma), raised concerns for atypia (nevi), or had implications for systemic management (such as Langerhans cell histiocytosis and graft-versus-host disease). Importantly, cutaneous malignancies in children are rare but do occur, and a high index of suspicion is required when approaching any child with a complex neoplasm or rash.”
Dr. Cordoro characterized the medical decision making and rationale for biopsying skin lesions and rashes in children as “a complex process that involves weighing the risks of the biopsy itself against the benefit of the information it will provide; shared decision-making with the caregivers, the patient (if age-appropriate), and other members of the health care team; age of the child and clinical context; and whether the biopsy can be done at the bedside or requires sedation.”
Based on the study results, Dr. Cordoro said, the rationale to proceed with a biopsy boils down to three main goals: To make or confirm a diagnosis, to make decisions about management, and/or the biopsy itself is therapeutic.
UCSF dermatopathology fellow Suzanne W. Birmingham, MD, performed the study in collaboration with Dr. Cordoro and UCSF dermatopathologist Thaddeus W. Mully, MD. Additional analyses of this data set are in progress. The researchers reported having no relevant financial disclosures.
.
In addition, fewer biopsies were performed in the first 3 years of the global COVID-19 pandemic than in the previous 3 years.
These findings from a retrospective analysis were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology. The analysis set out to evaluate which patients required biopsy, which skin conditions were sampled, and if practice patterns changed following the start of the COVID-19 pandemic.
“The work is important because very few pediatric patients, relative to adult patients seen in dermatology clinics, have a biopsy done,” Kelly M. Cordoro, MD, one of the study authors, told this news organization.
“Approximately 1%-4% of pediatric patients visiting a dermatology clinic will have a biopsy done as compared to 30%-50% of adult patients. Understanding what is being biopsied in children sheds light on the medical decision-making required to decide when a biopsy is necessary,” said Dr. Cordoro, chief of pediatric dermatology at UCSF.
For the study, the researchers retrospectively reviewed 1,196 biopsy specimens from 1,080 unique patients that were performed by pediatric dermatologists at UCSF from 2017 to 2022. Half of the patients were female, their mean age was 11.5 years, and they ranged in age from 1 day to 61 years. Nearly half of biopsies (47%) were performed in patients aged 12-18 years and one-quarter (25.6%) were performed in those aged 6-11 years. In the remaining biopsies, 6.6% came from patients younger than 1 year, 5.8% of those aged 1-2 years, 7.3% from those aged 3-5 years, and 3.9% each in those aged 19-21 years and in those older than 21 years.
The five most common biopsy results were compound nevus (99 biopsies), pyogenic granuloma (96), spongiotic dermatitis (57), intradermal nevus (53), and pilomatricoma (40).
The researchers identified 30 malignant diagnoses in 28 unique patients, most commonly mycosis fungoides (in 16 patients with a median age of 12.5 years), basal cell carcinoma (in 5 patients with a median age of 9 years), and dermatofibrosarcoma protuberans (in 4 patients with a median age of 2 years).
There was no significant sex-based difference in the number of biopsies performed at a given age (P = .47), but Dr. Cordoro and colleagues noted a statistically significant decrease in the number of biopsies during the pandemic compared with the 3 years prior to the pandemic (P = .04).
“There was a slight uptick in 2022, although it remains to be seen whether this trend will continue,” they wrote in their abstract. “While the most common diagnoses in the years leading up to – versus following the start of the pandemic – were similar, there was one clear outlier. The histopathologic diagnosis of pernio spiked in 2020, reflecting the ‘COVID toes’ phenomenon”.
In an interview, Dr. Cordoro said that growths and rashes in children of all ages can, and should, be biopsied, but special considerations are necessary depending on the patient’s age and context.
“Our data showed that neoplastic conditions were biopsied more often than inflammatory conditions, with an emphasis on lesions that required removal (such as pyogenic granuloma), raised concerns for atypia (nevi), or had implications for systemic management (such as Langerhans cell histiocytosis and graft-versus-host disease). Importantly, cutaneous malignancies in children are rare but do occur, and a high index of suspicion is required when approaching any child with a complex neoplasm or rash.”
Dr. Cordoro characterized the medical decision making and rationale for biopsying skin lesions and rashes in children as “a complex process that involves weighing the risks of the biopsy itself against the benefit of the information it will provide; shared decision-making with the caregivers, the patient (if age-appropriate), and other members of the health care team; age of the child and clinical context; and whether the biopsy can be done at the bedside or requires sedation.”
Based on the study results, Dr. Cordoro said, the rationale to proceed with a biopsy boils down to three main goals: To make or confirm a diagnosis, to make decisions about management, and/or the biopsy itself is therapeutic.
UCSF dermatopathology fellow Suzanne W. Birmingham, MD, performed the study in collaboration with Dr. Cordoro and UCSF dermatopathologist Thaddeus W. Mully, MD. Additional analyses of this data set are in progress. The researchers reported having no relevant financial disclosures.
FROM SPD 2023
EU agency issues positive opinion on ritlecitinib
, paving the way for possible marketing authorization of the drug in the European Union for individuals 12 years of age and older. A final decision is expected in the coming months.
The development, which was announced by the manufacturer, Pfizer, on July 21, 2023, follows approval of ritlecitinib (Litfulo) for the treatment of severe alopecia areata in adults and adolescents 12 years and older by the Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare in June 2023. According to a press release from Pfizer, submissions to other regulatory agencies for the use of ritlecitinib in alopecia areata are ongoing.
The Marketing Authorization Application for ritlecitinib was based on results from a randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 study.
, paving the way for possible marketing authorization of the drug in the European Union for individuals 12 years of age and older. A final decision is expected in the coming months.
The development, which was announced by the manufacturer, Pfizer, on July 21, 2023, follows approval of ritlecitinib (Litfulo) for the treatment of severe alopecia areata in adults and adolescents 12 years and older by the Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare in June 2023. According to a press release from Pfizer, submissions to other regulatory agencies for the use of ritlecitinib in alopecia areata are ongoing.
The Marketing Authorization Application for ritlecitinib was based on results from a randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 study.
, paving the way for possible marketing authorization of the drug in the European Union for individuals 12 years of age and older. A final decision is expected in the coming months.
The development, which was announced by the manufacturer, Pfizer, on July 21, 2023, follows approval of ritlecitinib (Litfulo) for the treatment of severe alopecia areata in adults and adolescents 12 years and older by the Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare in June 2023. According to a press release from Pfizer, submissions to other regulatory agencies for the use of ritlecitinib in alopecia areata are ongoing.
The Marketing Authorization Application for ritlecitinib was based on results from a randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 study.
What makes teens choose to use sunscreen?
a cornerstone of skin cancer prevention, according to results from a systematic review.
“We know that skin cancer is one of the most common malignancies in the world, and sun protection methods such as sunscreen make it highly preventable,” first author Carly R. Stevens, a student at Tulane University, New Orleans, said in an interview. “This study demonstrates the adolescent populations that are most vulnerable to sun damage and how we can help mitigate their risk of developing skin cancer through education methods, such as Sun Protection Outreach Teaching by Students.” 
Ms. Stevens and coauthors presented the findings during a poster session at the annual meeting of the Society for Pediatric Dermatology.
To investigate predictors of sunscreen use among high school students, they searched PubMed, Embase, and Web of Science using the terms (“sunscreen” or “SPF” or “sun protection”) and (“high school” or “teen” or “teenager” or “adolescent”) and limited the analysis to English studies reporting data on sunscreen use in U.S. high school students up to November 2021.
A total of 20 studies were included in the final review. The study populations ranged in number from 208 to 24,645. Of 11 studies that examined gender, all showed increased sunscreen use in females compared with males. Of five studies that examined age, all showed increased sunscreen use in younger adolescents, compared with their older counterparts.
Of four studies that examined the role of ethnicity on sunscreen use, White students were more likely to use sunscreen, compared with their peers of other ethnicities. “This may be due to perceived sun sensitivity, as [these four studies] also showed increased sunscreen use in populations that believed were more susceptible to sun damage,” the researchers wrote in their abstract.
In other findings, two studies that examined perceived self-efficacy concluded that higher levels of sunscreen use correlated with higher self-efficacy, while four studies concluded that high school students were more likely to use sunscreen if their parents encouraged them the wear it or if the parent used it themselves.
“With 40%-50% of ultraviolet damage being done before the age of 20, it’s crucial that we find ways to educate adolescents on the importance of sunscreen use and target those populations who were found to rarely use sunscreen in our study,” Ms. Stevens said.
In one outreach program, Sun Protection Outreach Teaching by Students (SPOTS), medical students visit middle and high schools to educate them about the importance of practicing sun protection. The program began as a collaboration between Saint Louis University and Washington University in St. Louis, but has expanded nationwide. Ms. Stevens described SPOTS as “a great way for medical students to present the information to middle and high school students in a way that is engaging and interactive.”
The researchers reported having no disclosures.
a cornerstone of skin cancer prevention, according to results from a systematic review.
“We know that skin cancer is one of the most common malignancies in the world, and sun protection methods such as sunscreen make it highly preventable,” first author Carly R. Stevens, a student at Tulane University, New Orleans, said in an interview. “This study demonstrates the adolescent populations that are most vulnerable to sun damage and how we can help mitigate their risk of developing skin cancer through education methods, such as Sun Protection Outreach Teaching by Students.”
Ms. Stevens and coauthors presented the findings during a poster session at the annual meeting of the Society for Pediatric Dermatology.
To investigate predictors of sunscreen use among high school students, they searched PubMed, Embase, and Web of Science using the terms (“sunscreen” or “SPF” or “sun protection”) and (“high school” or “teen” or “teenager” or “adolescent”) and limited the analysis to English studies reporting data on sunscreen use in U.S. high school students up to November 2021.
A total of 20 studies were included in the final review. The study populations ranged in number from 208 to 24,645. Of 11 studies that examined gender, all showed increased sunscreen use in females compared with males. Of five studies that examined age, all showed increased sunscreen use in younger adolescents, compared with their older counterparts.
Of four studies that examined the role of ethnicity on sunscreen use, White students were more likely to use sunscreen, compared with their peers of other ethnicities. “This may be due to perceived sun sensitivity, as [these four studies] also showed increased sunscreen use in populations that believed were more susceptible to sun damage,” the researchers wrote in their abstract.
In other findings, two studies that examined perceived self-efficacy concluded that higher levels of sunscreen use correlated with higher self-efficacy, while four studies concluded that high school students were more likely to use sunscreen if their parents encouraged them the wear it or if the parent used it themselves.
“With 40%-50% of ultraviolet damage being done before the age of 20, it’s crucial that we find ways to educate adolescents on the importance of sunscreen use and target those populations who were found to rarely use sunscreen in our study,” Ms. Stevens said.
In one outreach program, Sun Protection Outreach Teaching by Students (SPOTS), medical students visit middle and high schools to educate them about the importance of practicing sun protection. The program began as a collaboration between Saint Louis University and Washington University in St. Louis, but has expanded nationwide. Ms. Stevens described SPOTS as “a great way for medical students to present the information to middle and high school students in a way that is engaging and interactive.”
The researchers reported having no disclosures.
a cornerstone of skin cancer prevention, according to results from a systematic review.
“We know that skin cancer is one of the most common malignancies in the world, and sun protection methods such as sunscreen make it highly preventable,” first author Carly R. Stevens, a student at Tulane University, New Orleans, said in an interview. “This study demonstrates the adolescent populations that are most vulnerable to sun damage and how we can help mitigate their risk of developing skin cancer through education methods, such as Sun Protection Outreach Teaching by Students.”
Ms. Stevens and coauthors presented the findings during a poster session at the annual meeting of the Society for Pediatric Dermatology.
To investigate predictors of sunscreen use among high school students, they searched PubMed, Embase, and Web of Science using the terms (“sunscreen” or “SPF” or “sun protection”) and (“high school” or “teen” or “teenager” or “adolescent”) and limited the analysis to English studies reporting data on sunscreen use in U.S. high school students up to November 2021.
A total of 20 studies were included in the final review. The study populations ranged in number from 208 to 24,645. Of 11 studies that examined gender, all showed increased sunscreen use in females compared with males. Of five studies that examined age, all showed increased sunscreen use in younger adolescents, compared with their older counterparts.
Of four studies that examined the role of ethnicity on sunscreen use, White students were more likely to use sunscreen, compared with their peers of other ethnicities. “This may be due to perceived sun sensitivity, as [these four studies] also showed increased sunscreen use in populations that believed were more susceptible to sun damage,” the researchers wrote in their abstract.
In other findings, two studies that examined perceived self-efficacy concluded that higher levels of sunscreen use correlated with higher self-efficacy, while four studies concluded that high school students were more likely to use sunscreen if their parents encouraged them the wear it or if the parent used it themselves.
“With 40%-50% of ultraviolet damage being done before the age of 20, it’s crucial that we find ways to educate adolescents on the importance of sunscreen use and target those populations who were found to rarely use sunscreen in our study,” Ms. Stevens said.
In one outreach program, Sun Protection Outreach Teaching by Students (SPOTS), medical students visit middle and high schools to educate them about the importance of practicing sun protection. The program began as a collaboration between Saint Louis University and Washington University in St. Louis, but has expanded nationwide. Ms. Stevens described SPOTS as “a great way for medical students to present the information to middle and high school students in a way that is engaging and interactive.”
The researchers reported having no disclosures.
FROM SPD 2023
Indian Health Service dermatologist: ‘I saw a real need to be of service’
After completing his dermatology residency at Johns Hopkins Hospital in 2010, Christopher Bengson, MD, MHS, then a Lieutenant Commander in the U.S. Public Health Service, accepted an offer to become a full-time dermatologist at Phoenix Indian Medical Center (PIMC) in Arizona, fulfilling a long desire to provide care for underserved individuals. Thirteen years later, .
As one of the largest hospitals in the IHS system, PIMC provides direct health care services to a population of more than 156,000, including tribal members from The Fort McDowell Yavapai Nation, the Salt River Pima-Maricopa Indian Community, and the San Lucy District of the Tohono O’odham Nation, the Tonto Apache Tribe, the Yavapai-Apache Indian Tribe, and the Yavapai-Prescott Indian Tribe. Dr. Bengson also cares for tribal members who travel to PIMC from as far away as Washington State and Hawaii to receive dermatologic care.
“There is a disproportionate number of Native American patients that come in with severe psoriasis, hidradenitis suppurativa, and dissecting cellulitis of the scalp compared to the general U.S. population, and I’ve been surprised by how many have nonmelanoma skin cancers and autoimmune connective tissue diseases like lupus, as the prevailing sentiment among his patients is that Native people do not get skin cancer,” he said in an interview. “Those who travel great distances are those who come see me for the surgical removal of skin cancers.”
Interesting cases he’s seen in his nearly 13 years on the job include Epstein-Barr virus-induced NK/T-cell lymphoma, anaplastic large cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, and necrobiotic xanthogranuloma, “tumors that have generally gone to tertiary care facilities for treatment, but we’ve been able to manage here.”
In 2017, Dr. Bengson was appointed as the IHS’s first chief clinical consultant for dermatology, a post that provides him the opportunity to interface with Native people and IHS-affiliated clinicians nationwide regarding skin-related questions and concerns. As the only full-time dermatologist employed by the IHS, he also views his role as providing an opportunity to change the perception that some Native Americans may still hold about federally delivered health care, “where there may be a cultural distrust of government health care in indigenous communities, driven by generational historical traumas that have come out of boarding schools, population relocation to desolate and isolated areas of the country, and contracts that were simply not honored,” he explained.
“While none of these issues are new, what has been great for me is that I’m going on 13 years of being at the same facility, and I’ve treated family members, their kids, and even their grandkids. In some ways the primary barrier of continuity of care – at least at PIMC – has been eliminated by me just being here for a long period of time.”
In Dr. Bengson’s opinion, efforts to improve access to attract more Native Americans to dermatology are laudable, including the American Academy of Dermatology’s Pathways Program, which aims to increase the number of dermatology residents from Black, Latino, and indigenous communities from approximately 100 residents to 250 residents by 2027, or by over 150%, through community-based engagement strategies that begin in high school.
“To have an objective benchmark is encouraging,” he said. However, he encourages dermatology residency program directors to rethink how they recruit Native Americans, many of whom hail from rural areas. “If you’re recruiting primarily from urban settings, you’re very unlikely to include Native Americans as a larger group of minorities,” he said. “When you look at the number of department chairs who are Native American, it’s on the order of 0.1%, [so] it’s no surprise that dermatologists coming out of a residency program don’t want to go to reservations to provide dermatologic care. We pay a lot of lip service to mentorship programs and things like that, but you need a mentor who follows you through the process – and it’s a long process.”
He believes that residency program directors should reconsider the metrics used to select dermatology residents and should consider the degree of adversity that a Native American applicant may have had to overcome to make it to the residency selection committees.
Despite obstacles to attracting young Native Americans to a career in medicine, Dr. Bengson sees encouraging signs ahead. Some of his Native American patients and family members of patients have enrolled in medical school and have asked to rotate with him at PIMC at the premedical and medical student level. “Some have moved on, not necessarily to dermatology, but to other specialties and careers in health care,” he said. “When you have such high rates of obesity, diabetes, hypertension, coronary artery disease, and stroke in Native American communities, nodulocystic acne and other skin conditions that are not threats to life and limb become less of a priority. We need to get more people in the pipeline to deliver medical services even if it may not be in dermatology, as the need for dedicated health care professionals is so great across all disciplines.”
After completing his dermatology residency at Johns Hopkins Hospital in 2010, Christopher Bengson, MD, MHS, then a Lieutenant Commander in the U.S. Public Health Service, accepted an offer to become a full-time dermatologist at Phoenix Indian Medical Center (PIMC) in Arizona, fulfilling a long desire to provide care for underserved individuals. Thirteen years later, .
As one of the largest hospitals in the IHS system, PIMC provides direct health care services to a population of more than 156,000, including tribal members from The Fort McDowell Yavapai Nation, the Salt River Pima-Maricopa Indian Community, and the San Lucy District of the Tohono O’odham Nation, the Tonto Apache Tribe, the Yavapai-Apache Indian Tribe, and the Yavapai-Prescott Indian Tribe. Dr. Bengson also cares for tribal members who travel to PIMC from as far away as Washington State and Hawaii to receive dermatologic care.
“There is a disproportionate number of Native American patients that come in with severe psoriasis, hidradenitis suppurativa, and dissecting cellulitis of the scalp compared to the general U.S. population, and I’ve been surprised by how many have nonmelanoma skin cancers and autoimmune connective tissue diseases like lupus, as the prevailing sentiment among his patients is that Native people do not get skin cancer,” he said in an interview. “Those who travel great distances are those who come see me for the surgical removal of skin cancers.”
Interesting cases he’s seen in his nearly 13 years on the job include Epstein-Barr virus-induced NK/T-cell lymphoma, anaplastic large cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, and necrobiotic xanthogranuloma, “tumors that have generally gone to tertiary care facilities for treatment, but we’ve been able to manage here.”
In 2017, Dr. Bengson was appointed as the IHS’s first chief clinical consultant for dermatology, a post that provides him the opportunity to interface with Native people and IHS-affiliated clinicians nationwide regarding skin-related questions and concerns. As the only full-time dermatologist employed by the IHS, he also views his role as providing an opportunity to change the perception that some Native Americans may still hold about federally delivered health care, “where there may be a cultural distrust of government health care in indigenous communities, driven by generational historical traumas that have come out of boarding schools, population relocation to desolate and isolated areas of the country, and contracts that were simply not honored,” he explained.
“While none of these issues are new, what has been great for me is that I’m going on 13 years of being at the same facility, and I’ve treated family members, their kids, and even their grandkids. In some ways the primary barrier of continuity of care – at least at PIMC – has been eliminated by me just being here for a long period of time.”
In Dr. Bengson’s opinion, efforts to improve access to attract more Native Americans to dermatology are laudable, including the American Academy of Dermatology’s Pathways Program, which aims to increase the number of dermatology residents from Black, Latino, and indigenous communities from approximately 100 residents to 250 residents by 2027, or by over 150%, through community-based engagement strategies that begin in high school.
“To have an objective benchmark is encouraging,” he said. However, he encourages dermatology residency program directors to rethink how they recruit Native Americans, many of whom hail from rural areas. “If you’re recruiting primarily from urban settings, you’re very unlikely to include Native Americans as a larger group of minorities,” he said. “When you look at the number of department chairs who are Native American, it’s on the order of 0.1%, [so] it’s no surprise that dermatologists coming out of a residency program don’t want to go to reservations to provide dermatologic care. We pay a lot of lip service to mentorship programs and things like that, but you need a mentor who follows you through the process – and it’s a long process.”
He believes that residency program directors should reconsider the metrics used to select dermatology residents and should consider the degree of adversity that a Native American applicant may have had to overcome to make it to the residency selection committees.
Despite obstacles to attracting young Native Americans to a career in medicine, Dr. Bengson sees encouraging signs ahead. Some of his Native American patients and family members of patients have enrolled in medical school and have asked to rotate with him at PIMC at the premedical and medical student level. “Some have moved on, not necessarily to dermatology, but to other specialties and careers in health care,” he said. “When you have such high rates of obesity, diabetes, hypertension, coronary artery disease, and stroke in Native American communities, nodulocystic acne and other skin conditions that are not threats to life and limb become less of a priority. We need to get more people in the pipeline to deliver medical services even if it may not be in dermatology, as the need for dedicated health care professionals is so great across all disciplines.”
After completing his dermatology residency at Johns Hopkins Hospital in 2010, Christopher Bengson, MD, MHS, then a Lieutenant Commander in the U.S. Public Health Service, accepted an offer to become a full-time dermatologist at Phoenix Indian Medical Center (PIMC) in Arizona, fulfilling a long desire to provide care for underserved individuals. Thirteen years later, .
As one of the largest hospitals in the IHS system, PIMC provides direct health care services to a population of more than 156,000, including tribal members from The Fort McDowell Yavapai Nation, the Salt River Pima-Maricopa Indian Community, and the San Lucy District of the Tohono O’odham Nation, the Tonto Apache Tribe, the Yavapai-Apache Indian Tribe, and the Yavapai-Prescott Indian Tribe. Dr. Bengson also cares for tribal members who travel to PIMC from as far away as Washington State and Hawaii to receive dermatologic care.
“There is a disproportionate number of Native American patients that come in with severe psoriasis, hidradenitis suppurativa, and dissecting cellulitis of the scalp compared to the general U.S. population, and I’ve been surprised by how many have nonmelanoma skin cancers and autoimmune connective tissue diseases like lupus, as the prevailing sentiment among his patients is that Native people do not get skin cancer,” he said in an interview. “Those who travel great distances are those who come see me for the surgical removal of skin cancers.”
Interesting cases he’s seen in his nearly 13 years on the job include Epstein-Barr virus-induced NK/T-cell lymphoma, anaplastic large cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, and necrobiotic xanthogranuloma, “tumors that have generally gone to tertiary care facilities for treatment, but we’ve been able to manage here.”
In 2017, Dr. Bengson was appointed as the IHS’s first chief clinical consultant for dermatology, a post that provides him the opportunity to interface with Native people and IHS-affiliated clinicians nationwide regarding skin-related questions and concerns. As the only full-time dermatologist employed by the IHS, he also views his role as providing an opportunity to change the perception that some Native Americans may still hold about federally delivered health care, “where there may be a cultural distrust of government health care in indigenous communities, driven by generational historical traumas that have come out of boarding schools, population relocation to desolate and isolated areas of the country, and contracts that were simply not honored,” he explained.
“While none of these issues are new, what has been great for me is that I’m going on 13 years of being at the same facility, and I’ve treated family members, their kids, and even their grandkids. In some ways the primary barrier of continuity of care – at least at PIMC – has been eliminated by me just being here for a long period of time.”
In Dr. Bengson’s opinion, efforts to improve access to attract more Native Americans to dermatology are laudable, including the American Academy of Dermatology’s Pathways Program, which aims to increase the number of dermatology residents from Black, Latino, and indigenous communities from approximately 100 residents to 250 residents by 2027, or by over 150%, through community-based engagement strategies that begin in high school.
“To have an objective benchmark is encouraging,” he said. However, he encourages dermatology residency program directors to rethink how they recruit Native Americans, many of whom hail from rural areas. “If you’re recruiting primarily from urban settings, you’re very unlikely to include Native Americans as a larger group of minorities,” he said. “When you look at the number of department chairs who are Native American, it’s on the order of 0.1%, [so] it’s no surprise that dermatologists coming out of a residency program don’t want to go to reservations to provide dermatologic care. We pay a lot of lip service to mentorship programs and things like that, but you need a mentor who follows you through the process – and it’s a long process.”
He believes that residency program directors should reconsider the metrics used to select dermatology residents and should consider the degree of adversity that a Native American applicant may have had to overcome to make it to the residency selection committees.
Despite obstacles to attracting young Native Americans to a career in medicine, Dr. Bengson sees encouraging signs ahead. Some of his Native American patients and family members of patients have enrolled in medical school and have asked to rotate with him at PIMC at the premedical and medical student level. “Some have moved on, not necessarily to dermatology, but to other specialties and careers in health care,” he said. “When you have such high rates of obesity, diabetes, hypertension, coronary artery disease, and stroke in Native American communities, nodulocystic acne and other skin conditions that are not threats to life and limb become less of a priority. We need to get more people in the pipeline to deliver medical services even if it may not be in dermatology, as the need for dedicated health care professionals is so great across all disciplines.”
Dermatologic care in Indian Country marked by unique challenges, opportunities
As a proud member of the Oglala Lakota Nation from the Pine Ridge Indian Reservation in southwestern South Dakota, Drew Hicks grew up with limited access to basic health care, let alone the luxury of scheduling an appointment with a dermatologist or another medical specialist.
The area – once home to the Lakota war leader Crazy Horse – encompasses nearly 47,000 residents scattered over about 2.2 million acres, larger than the size of Rhode Island, with land marked by rolling mixed grass prairie, sandhills, and badlands. Some of the Oglala Lakota people live in substandard housing and lack regular access to food, running water, and refrigeration, not to mention cell phone and Internet service. “It’s sparse,” said Mr. Hicks, the son of Tribal ranchers who now is a 3rd-year medical student at the Mayo Clinic College of Medicine and Science in Rochester, Minn., and has an early interest in pursuing dermatology. “There is a lot of territory and not a lot of health care serving the population.” From the Hicks home, the nearest place to receive health care is a family medicine practice in Martin, S.D. – about a 15-minute drive on gravel roads in the best of conditions, but in poor weather, it can be difficult, he said. “So, there are environmental challenges besides the limited number of health care providers.”
Clinicians in the practice “did have to be the point of care for everything from dermatologic issues to emergency medicine to delivering a baby, because the next-closest medical facility of any magnitude is 2 hours away,” he said.
Challenges of health literacy and limited access to comprehensive health care at Pine Ridge and other American Indian (AI) and Alaska Native (AN) reservations have long-term consequences. “My own mom struggled to control her blood pressure for years and now has chronic kidney disease,” Mr. Hicks said. “It’s not an uncommon story. Diabetes on the reservation is a big issue.” Then there’s his father, who survived two bouts with melanoma that was diagnosed at an advanced stage. “I think about how that has impacted him, and wonder, had we had a dermatologist who serviced our area, would we have caught things sooner?” he said. “I feel there is so much room for impactful health care deliveries to communities like Pine Ridge.” At the same time, he emphasized, “this isn’t poverty porn. We’re a resilient people. Any effort to engage with AIs or ANs should be from a perspective of a learner, having cultural humility, and seeking out community leaders to help lead you.”
According to the 2020 Census, there are 574 federally recognized sovereign tribal nations in the United States and federal- and state-recognized American Indian reservations in 35 states. AI/AN people make up about 2.9% of the total U.S. population, or 9.7 million, and their life expectancy is an average of 4.4 years less, compared with the general population (a mean of 73.7 vs. 78.1 years, respectively). Because of limited access to dermatologic care in these areas, the risk for developing significant skin conditions and diseases that may go undetected for long stretches of time is increased.
“That can mean advanced skin cancers like basal cell carcinomas that have become larger than what you would see in a typical metropolitan population,” said Lucinda Kohn, MD, assistant professor of dermatology in the Centers for American Indian and Alaska Native Health at the University of Colorado at Denver, Aurora, who spent part of her dermatology residency rotating at the Chinle (Ariz.) Service Unit, an Indian Health Service facility, in 2017 and now provides teledermatology and regular in-person dermatology care at that clinic. “The climate there is dry, so you can see bad eczema and dry skin. There’s also a lot of acne and hidradenitis suppurativa. I think the acne and HS is due to the hyperglycemic index diet from the food deserts. Skin disease reflects the climate, the food desert, and the lack of close specialty care.”
Acne scarring common
Some published evidence suggests that acne is more prevalent and severe in AI/AN individuals. In a survey of 158 AI/AN individuals with a mean age of 32 years, 79.1% reported a history of acne, 55.1% reported acne scarring, and 31% reported having active lesions. “Looking back on my experience in high school, I definitely see that in myself and in my peers,” Mr. Hicks said. And, while there are limited published studies about the incidence of melanoma in this population, an analysis from 2006 found that the incidence was 3.1 per 100,000 between 2001 and 2005, which was an increase from 1.6 per 100,000 reported between 1992 and 2000.
There’s a lot to unpack for dermatologists caring for the AI/AN population besides the raw health disparities: a long history of distrust between AI/AN people and the federal government, structural racism, geographic isolation, health literacy challenges, and high rates of poverty and unemployment. And while individuals from federally recognized tribes have a legal right to receive health care provided by the Indian Health Service, a component of the Department of Health & Human Services, the U.S. Government Accountability Office found that in 2017 per capita spending available to the IHS was $4,078, compared with $8,109 for Medicaid, $10,692 for the Veterans Health Administration, and $13,185 for Medicare.
“Everyone deserves healthy skin and good health,” said Dr. Kohn, whose husband is AI and works in AI law. “Knowing that there are pockets of people who lack that access to care really bothers me. I think the American Indians are frequently overlooked. They’re just not even counted for in certain surveys,” she added, noting that categories are usually defined as Black, Hispanic, Asian, or White.
According to Dr. Kohn, who coauthored a chapter titled “Dermatology on American Indian and Alaska Native Reservations,” for the 2021 book “Dermatology in Rural Settings”, 70% of AIs live in urban areas, “so it’s not just people who live on reservations, though the disparity is greatest there.” To help deliver dermatologic care in the rural areas “where you’re on tribal lands, you must partner with the tribes,” she added. “You must get their permission, operate under their laws and regulations and their rules, learn the local customs, learn about the culture, learn the people, and learn their resources before you practice. That’s the only ethical way to practice.” This also means appreciating the fact that some AI/AN individuals may not understand what a dermatologist could do for them. “One of the bigger hurdles to overcome,” she said, is educating the population that dermatologists can cure skin diseases and that there are good medications for treating the diseases.
Shortcomings of teledermatology
Some dermatologists perform teledermatology visits for tribes, often from an office located in a different time zone. “And, they don’t have a sense of what resources are available for the people they’re serving,” Dr. Kohn said. “For example, if they diagnose a potential skin cancer on the face and say, ‘you need a biopsy,’ but the closest dermatologist is 4 hours away, is that really serving the patient? Or, if you tell a patient, ‘I want you to go out and buy Vanicream for your skin,’ but Vanicream costs $17 and the patient can’t even afford to buy food, are you really doing them a service?”
In a survey-based study of 238 AI individuals that is scheduled to be published in late 2023, Dr. Kohn and colleagues asked respondents at two regional powwows in Denver if they would be open to teledermatology – either in their home or in a primary care clinic. Most respondents (70%) lived in urban areas, the rest in rural settings. Nearly half of respondents (42%) “did not want to do teledermatology, even though they couldn’t access in-person dermatology,” Dr. Kohn said. “So, for people who think teledermatology is the answer [to improving access], the respondents to our survey weren’t interested in pursuing that as a solution. I was surprised by that.” When the researchers broke down the responses by age, teenage respondents were even less interested in teledermatology than adults were. “I think there’s something about having someone see you in person, knowing who you are,” she said.
Partnerships with tribes
To foster more sustainable change in the delivery of skin care beyond remote teledermatology and periodic visits from volunteers, some dermatology residencies have established partnerships with tribes, including Massachusetts General Hospital’s teaching partnership with the Rosebud Sioux tribe in Rosebud, S.D., and the University of Utah dermatology department’s resident continuity clinic with Navajo Nation in Montezuma Creek, Utah. In 2016, officials from the Utah Navajo Health System reached out to the University of Utah’s dermatology department to inquire about the potential for creating a teledermatology clinic to serve patients who receive primary care at the Montezuma Creek Community Health Center, located in Southeastern Utah on the northern tip of the Navajo Nation.
Stephanie Klein, MD, associate professor of dermatology at the university, spearheaded the clinic’s launch but soon encountered obstacles that ranged from not being able to visualize the patient’s skin clearly on her computer screen to difficulty making a personal connection with patients despite help from Navajo translators. “It was hard to build a relationship,” she said. A few years later, she drove down to meet with officials of the health system and posed the question: “What is the ideal thing you would want from dermatology?”
Continuity, they told her. “They said that a lot of the services they receive in the form of outreach are rotational, where someone might come in for a day, or a week, or five people may rotate throughout the year,” which did not serve them well, said Dr. Klein, who subsequently collaborated with Utah Navajo Health System clinicians to establish a resident continuity clinic, which launched in January 2021.
The arrangement also serves as a continuity clinic for Dr. Klein as an attending physician. Each month, she and one dermatology resident drive 6.5 hours from Salt Lake City to Montezuma Creek, where they spend 1 or 2 full days seeing about 25 patients referred by the primary care clinicians who work there. About one-quarter of the time they fly, thanks to financial support from a private donor. The flight takes about an hour, then it’s an hour-long drive to the actual clinic. “It’s a commitment,” Dr. Klein said. “A resident can come with me if they commit to the clinic for at least 1 year. This enables us to have continuity of care; it allows us to build relationships with the patients and with the care team there.” As for the prior teledermatology visits she had with residents, “I still do those, but now I do them in between the in-person visits, so I’m not meeting people over telehealth; I’m just following up with them.”
Situated in the high desert among rock formations, the estimated population of Montezuma Creek is just over 320 people. “It’s a beautiful place with otherworldly buttes and mesas, and the Blue Mountains rising up in the distance,” said Lowell Nicholson, MD, a dermatology resident at the University of Utah who is in his second year of a 2-year commitment to the clinic. “But the landscape can be harsh, and it is underserved from an infrastructure perspective,” with large areas with no cell phone service and limited access to running water and refrigeration. “People in general travel quite far to get their medical care and most of the roads are dirt or gravel, so after a big snowstorm or if it’s been raining, they can become impassable.”
Dermatologic conditions they often encounter include vitiligo, photodermatoses, hidradenitis suppurativa, eczema, psoriasis, and severe acne, often with lots of acne-associated scarring. “In general, we tend to see dramatic or advanced presentations of general dermatology diagnoses,” Dr. Nicholson said. “We see a lot of really extensive psoriasis, which can be socially stigmatizing.”
He recalled one middle-aged man who isolated himself from others because his psoriasis became unbearable. The man refused to leave his house, visit family members, or attend tribal meetups. “He tried to see his regular doctor about it and was given topicals, but his disease was just too extensive,” said Dr. Nicholson, who suggested trying a biologic but learned that the man did not have regular access to refrigeration. “That wasn’t going to work, but we started him on an oral medication, apremilast, which has completely cleared his skin,” he said. “He’s doing great. The last time we saw him he was re-engaged with his family, and he told us he was going on dates. We really improved his quality of life.”
Dr. Klein recalled seeing a 6-year-old girl at the clinic with atopic dermatitis so severe that it caused her to miss several days of school. “When she was in school, she was so distracted by the itching – it was so overwhelming,” she said. She was struggling with topical medicines that weren’t effective, but Dr. Klein got her on dupilumab, and during a follow-up visit the girl told her, “This is the first time in my life I can think about things” other than itching.
According to Dr. Nicholson, some patients seen at the Montezuma Creek clinic are on Medicare or carry standard insurance. “Others have a mix, and others are getting all their medications through the Montezuma Creek clinic or through the IHS clinics,” he said. “I have been surprised at the formulary and our ability to get relatively expensive medications for our patients, like biologics and TNF inhibitors. But it takes some creativity to know what is going to work for your patients’ living situation.”
Training more AI/AN dermatologists key
While efforts to increase the culturally respectful and sustainable dermatologic care for AI/AN individuals continue through programs like the continuity clinic at Montezuma Creek, sources interviewed for this story emphasized the importance of training more AI/AN dermatologists. “Of the people who graduate from high school, AIs have the lowest rate of going on to college,” said Dr. Kohn, who serves as a mentor to Mr. Hicks. “Let’s say they get all the way to medical school; it’s about good mentorship and support in what they’re pursuing. We are seeing more AIs in medical school now, something that I personally notice, and I notice it from what Chinle Service Unit tells me. They have received many requests from Native medical students and premed students who want to rotate at Chinle. Native trainees want the experience of being there.”
According to the Association of American Medical Colleges, the number of AI/AN applicants to medical schools increased from 72 in 2020-2021 to 105 in 2021-2022 but dipped slightly to 94 in 2022-2023. Inspired by a passion to serve Pine Ridge or a community like it, Mr. Hicks decided to apply for medical school. While he doesn’t want to “close any doors” on which medical specialty he ultimately chooses to practice, the current front-runner is dermatology, he said, largely because of the influence of Dr. Kohn and two Mayo dermatologists who have become mentors: Molly Lohman, MD, and Hafsa M. Cantwell, MD. “I didn’t see anyone from my background who was a doctor, so having those role models is so important for Native kids to think, ‘I can do this, too,’ and to pursue it,” he said.
As a proud member of the Oglala Lakota Nation from the Pine Ridge Indian Reservation in southwestern South Dakota, Drew Hicks grew up with limited access to basic health care, let alone the luxury of scheduling an appointment with a dermatologist or another medical specialist.
The area – once home to the Lakota war leader Crazy Horse – encompasses nearly 47,000 residents scattered over about 2.2 million acres, larger than the size of Rhode Island, with land marked by rolling mixed grass prairie, sandhills, and badlands. Some of the Oglala Lakota people live in substandard housing and lack regular access to food, running water, and refrigeration, not to mention cell phone and Internet service. “It’s sparse,” said Mr. Hicks, the son of Tribal ranchers who now is a 3rd-year medical student at the Mayo Clinic College of Medicine and Science in Rochester, Minn., and has an early interest in pursuing dermatology. “There is a lot of territory and not a lot of health care serving the population.” From the Hicks home, the nearest place to receive health care is a family medicine practice in Martin, S.D. – about a 15-minute drive on gravel roads in the best of conditions, but in poor weather, it can be difficult, he said. “So, there are environmental challenges besides the limited number of health care providers.”
Clinicians in the practice “did have to be the point of care for everything from dermatologic issues to emergency medicine to delivering a baby, because the next-closest medical facility of any magnitude is 2 hours away,” he said.
Challenges of health literacy and limited access to comprehensive health care at Pine Ridge and other American Indian (AI) and Alaska Native (AN) reservations have long-term consequences. “My own mom struggled to control her blood pressure for years and now has chronic kidney disease,” Mr. Hicks said. “It’s not an uncommon story. Diabetes on the reservation is a big issue.” Then there’s his father, who survived two bouts with melanoma that was diagnosed at an advanced stage. “I think about how that has impacted him, and wonder, had we had a dermatologist who serviced our area, would we have caught things sooner?” he said. “I feel there is so much room for impactful health care deliveries to communities like Pine Ridge.” At the same time, he emphasized, “this isn’t poverty porn. We’re a resilient people. Any effort to engage with AIs or ANs should be from a perspective of a learner, having cultural humility, and seeking out community leaders to help lead you.”
According to the 2020 Census, there are 574 federally recognized sovereign tribal nations in the United States and federal- and state-recognized American Indian reservations in 35 states. AI/AN people make up about 2.9% of the total U.S. population, or 9.7 million, and their life expectancy is an average of 4.4 years less, compared with the general population (a mean of 73.7 vs. 78.1 years, respectively). Because of limited access to dermatologic care in these areas, the risk for developing significant skin conditions and diseases that may go undetected for long stretches of time is increased.
“That can mean advanced skin cancers like basal cell carcinomas that have become larger than what you would see in a typical metropolitan population,” said Lucinda Kohn, MD, assistant professor of dermatology in the Centers for American Indian and Alaska Native Health at the University of Colorado at Denver, Aurora, who spent part of her dermatology residency rotating at the Chinle (Ariz.) Service Unit, an Indian Health Service facility, in 2017 and now provides teledermatology and regular in-person dermatology care at that clinic. “The climate there is dry, so you can see bad eczema and dry skin. There’s also a lot of acne and hidradenitis suppurativa. I think the acne and HS is due to the hyperglycemic index diet from the food deserts. Skin disease reflects the climate, the food desert, and the lack of close specialty care.”
Acne scarring common
Some published evidence suggests that acne is more prevalent and severe in AI/AN individuals. In a survey of 158 AI/AN individuals with a mean age of 32 years, 79.1% reported a history of acne, 55.1% reported acne scarring, and 31% reported having active lesions. “Looking back on my experience in high school, I definitely see that in myself and in my peers,” Mr. Hicks said. And, while there are limited published studies about the incidence of melanoma in this population, an analysis from 2006 found that the incidence was 3.1 per 100,000 between 2001 and 2005, which was an increase from 1.6 per 100,000 reported between 1992 and 2000.
There’s a lot to unpack for dermatologists caring for the AI/AN population besides the raw health disparities: a long history of distrust between AI/AN people and the federal government, structural racism, geographic isolation, health literacy challenges, and high rates of poverty and unemployment. And while individuals from federally recognized tribes have a legal right to receive health care provided by the Indian Health Service, a component of the Department of Health & Human Services, the U.S. Government Accountability Office found that in 2017 per capita spending available to the IHS was $4,078, compared with $8,109 for Medicaid, $10,692 for the Veterans Health Administration, and $13,185 for Medicare.
“Everyone deserves healthy skin and good health,” said Dr. Kohn, whose husband is AI and works in AI law. “Knowing that there are pockets of people who lack that access to care really bothers me. I think the American Indians are frequently overlooked. They’re just not even counted for in certain surveys,” she added, noting that categories are usually defined as Black, Hispanic, Asian, or White.
According to Dr. Kohn, who coauthored a chapter titled “Dermatology on American Indian and Alaska Native Reservations,” for the 2021 book “Dermatology in Rural Settings”, 70% of AIs live in urban areas, “so it’s not just people who live on reservations, though the disparity is greatest there.” To help deliver dermatologic care in the rural areas “where you’re on tribal lands, you must partner with the tribes,” she added. “You must get their permission, operate under their laws and regulations and their rules, learn the local customs, learn about the culture, learn the people, and learn their resources before you practice. That’s the only ethical way to practice.” This also means appreciating the fact that some AI/AN individuals may not understand what a dermatologist could do for them. “One of the bigger hurdles to overcome,” she said, is educating the population that dermatologists can cure skin diseases and that there are good medications for treating the diseases.
Shortcomings of teledermatology
Some dermatologists perform teledermatology visits for tribes, often from an office located in a different time zone. “And, they don’t have a sense of what resources are available for the people they’re serving,” Dr. Kohn said. “For example, if they diagnose a potential skin cancer on the face and say, ‘you need a biopsy,’ but the closest dermatologist is 4 hours away, is that really serving the patient? Or, if you tell a patient, ‘I want you to go out and buy Vanicream for your skin,’ but Vanicream costs $17 and the patient can’t even afford to buy food, are you really doing them a service?”
In a survey-based study of 238 AI individuals that is scheduled to be published in late 2023, Dr. Kohn and colleagues asked respondents at two regional powwows in Denver if they would be open to teledermatology – either in their home or in a primary care clinic. Most respondents (70%) lived in urban areas, the rest in rural settings. Nearly half of respondents (42%) “did not want to do teledermatology, even though they couldn’t access in-person dermatology,” Dr. Kohn said. “So, for people who think teledermatology is the answer [to improving access], the respondents to our survey weren’t interested in pursuing that as a solution. I was surprised by that.” When the researchers broke down the responses by age, teenage respondents were even less interested in teledermatology than adults were. “I think there’s something about having someone see you in person, knowing who you are,” she said.
Partnerships with tribes
To foster more sustainable change in the delivery of skin care beyond remote teledermatology and periodic visits from volunteers, some dermatology residencies have established partnerships with tribes, including Massachusetts General Hospital’s teaching partnership with the Rosebud Sioux tribe in Rosebud, S.D., and the University of Utah dermatology department’s resident continuity clinic with Navajo Nation in Montezuma Creek, Utah. In 2016, officials from the Utah Navajo Health System reached out to the University of Utah’s dermatology department to inquire about the potential for creating a teledermatology clinic to serve patients who receive primary care at the Montezuma Creek Community Health Center, located in Southeastern Utah on the northern tip of the Navajo Nation.
Stephanie Klein, MD, associate professor of dermatology at the university, spearheaded the clinic’s launch but soon encountered obstacles that ranged from not being able to visualize the patient’s skin clearly on her computer screen to difficulty making a personal connection with patients despite help from Navajo translators. “It was hard to build a relationship,” she said. A few years later, she drove down to meet with officials of the health system and posed the question: “What is the ideal thing you would want from dermatology?”
Continuity, they told her. “They said that a lot of the services they receive in the form of outreach are rotational, where someone might come in for a day, or a week, or five people may rotate throughout the year,” which did not serve them well, said Dr. Klein, who subsequently collaborated with Utah Navajo Health System clinicians to establish a resident continuity clinic, which launched in January 2021.
The arrangement also serves as a continuity clinic for Dr. Klein as an attending physician. Each month, she and one dermatology resident drive 6.5 hours from Salt Lake City to Montezuma Creek, where they spend 1 or 2 full days seeing about 25 patients referred by the primary care clinicians who work there. About one-quarter of the time they fly, thanks to financial support from a private donor. The flight takes about an hour, then it’s an hour-long drive to the actual clinic. “It’s a commitment,” Dr. Klein said. “A resident can come with me if they commit to the clinic for at least 1 year. This enables us to have continuity of care; it allows us to build relationships with the patients and with the care team there.” As for the prior teledermatology visits she had with residents, “I still do those, but now I do them in between the in-person visits, so I’m not meeting people over telehealth; I’m just following up with them.”
Situated in the high desert among rock formations, the estimated population of Montezuma Creek is just over 320 people. “It’s a beautiful place with otherworldly buttes and mesas, and the Blue Mountains rising up in the distance,” said Lowell Nicholson, MD, a dermatology resident at the University of Utah who is in his second year of a 2-year commitment to the clinic. “But the landscape can be harsh, and it is underserved from an infrastructure perspective,” with large areas with no cell phone service and limited access to running water and refrigeration. “People in general travel quite far to get their medical care and most of the roads are dirt or gravel, so after a big snowstorm or if it’s been raining, they can become impassable.”
Dermatologic conditions they often encounter include vitiligo, photodermatoses, hidradenitis suppurativa, eczema, psoriasis, and severe acne, often with lots of acne-associated scarring. “In general, we tend to see dramatic or advanced presentations of general dermatology diagnoses,” Dr. Nicholson said. “We see a lot of really extensive psoriasis, which can be socially stigmatizing.”
He recalled one middle-aged man who isolated himself from others because his psoriasis became unbearable. The man refused to leave his house, visit family members, or attend tribal meetups. “He tried to see his regular doctor about it and was given topicals, but his disease was just too extensive,” said Dr. Nicholson, who suggested trying a biologic but learned that the man did not have regular access to refrigeration. “That wasn’t going to work, but we started him on an oral medication, apremilast, which has completely cleared his skin,” he said. “He’s doing great. The last time we saw him he was re-engaged with his family, and he told us he was going on dates. We really improved his quality of life.”
Dr. Klein recalled seeing a 6-year-old girl at the clinic with atopic dermatitis so severe that it caused her to miss several days of school. “When she was in school, she was so distracted by the itching – it was so overwhelming,” she said. She was struggling with topical medicines that weren’t effective, but Dr. Klein got her on dupilumab, and during a follow-up visit the girl told her, “This is the first time in my life I can think about things” other than itching.
According to Dr. Nicholson, some patients seen at the Montezuma Creek clinic are on Medicare or carry standard insurance. “Others have a mix, and others are getting all their medications through the Montezuma Creek clinic or through the IHS clinics,” he said. “I have been surprised at the formulary and our ability to get relatively expensive medications for our patients, like biologics and TNF inhibitors. But it takes some creativity to know what is going to work for your patients’ living situation.”
Training more AI/AN dermatologists key
While efforts to increase the culturally respectful and sustainable dermatologic care for AI/AN individuals continue through programs like the continuity clinic at Montezuma Creek, sources interviewed for this story emphasized the importance of training more AI/AN dermatologists. “Of the people who graduate from high school, AIs have the lowest rate of going on to college,” said Dr. Kohn, who serves as a mentor to Mr. Hicks. “Let’s say they get all the way to medical school; it’s about good mentorship and support in what they’re pursuing. We are seeing more AIs in medical school now, something that I personally notice, and I notice it from what Chinle Service Unit tells me. They have received many requests from Native medical students and premed students who want to rotate at Chinle. Native trainees want the experience of being there.”
According to the Association of American Medical Colleges, the number of AI/AN applicants to medical schools increased from 72 in 2020-2021 to 105 in 2021-2022 but dipped slightly to 94 in 2022-2023. Inspired by a passion to serve Pine Ridge or a community like it, Mr. Hicks decided to apply for medical school. While he doesn’t want to “close any doors” on which medical specialty he ultimately chooses to practice, the current front-runner is dermatology, he said, largely because of the influence of Dr. Kohn and two Mayo dermatologists who have become mentors: Molly Lohman, MD, and Hafsa M. Cantwell, MD. “I didn’t see anyone from my background who was a doctor, so having those role models is so important for Native kids to think, ‘I can do this, too,’ and to pursue it,” he said.
As a proud member of the Oglala Lakota Nation from the Pine Ridge Indian Reservation in southwestern South Dakota, Drew Hicks grew up with limited access to basic health care, let alone the luxury of scheduling an appointment with a dermatologist or another medical specialist.
The area – once home to the Lakota war leader Crazy Horse – encompasses nearly 47,000 residents scattered over about 2.2 million acres, larger than the size of Rhode Island, with land marked by rolling mixed grass prairie, sandhills, and badlands. Some of the Oglala Lakota people live in substandard housing and lack regular access to food, running water, and refrigeration, not to mention cell phone and Internet service. “It’s sparse,” said Mr. Hicks, the son of Tribal ranchers who now is a 3rd-year medical student at the Mayo Clinic College of Medicine and Science in Rochester, Minn., and has an early interest in pursuing dermatology. “There is a lot of territory and not a lot of health care serving the population.” From the Hicks home, the nearest place to receive health care is a family medicine practice in Martin, S.D. – about a 15-minute drive on gravel roads in the best of conditions, but in poor weather, it can be difficult, he said. “So, there are environmental challenges besides the limited number of health care providers.”
Clinicians in the practice “did have to be the point of care for everything from dermatologic issues to emergency medicine to delivering a baby, because the next-closest medical facility of any magnitude is 2 hours away,” he said.
Challenges of health literacy and limited access to comprehensive health care at Pine Ridge and other American Indian (AI) and Alaska Native (AN) reservations have long-term consequences. “My own mom struggled to control her blood pressure for years and now has chronic kidney disease,” Mr. Hicks said. “It’s not an uncommon story. Diabetes on the reservation is a big issue.” Then there’s his father, who survived two bouts with melanoma that was diagnosed at an advanced stage. “I think about how that has impacted him, and wonder, had we had a dermatologist who serviced our area, would we have caught things sooner?” he said. “I feel there is so much room for impactful health care deliveries to communities like Pine Ridge.” At the same time, he emphasized, “this isn’t poverty porn. We’re a resilient people. Any effort to engage with AIs or ANs should be from a perspective of a learner, having cultural humility, and seeking out community leaders to help lead you.”
According to the 2020 Census, there are 574 federally recognized sovereign tribal nations in the United States and federal- and state-recognized American Indian reservations in 35 states. AI/AN people make up about 2.9% of the total U.S. population, or 9.7 million, and their life expectancy is an average of 4.4 years less, compared with the general population (a mean of 73.7 vs. 78.1 years, respectively). Because of limited access to dermatologic care in these areas, the risk for developing significant skin conditions and diseases that may go undetected for long stretches of time is increased.
“That can mean advanced skin cancers like basal cell carcinomas that have become larger than what you would see in a typical metropolitan population,” said Lucinda Kohn, MD, assistant professor of dermatology in the Centers for American Indian and Alaska Native Health at the University of Colorado at Denver, Aurora, who spent part of her dermatology residency rotating at the Chinle (Ariz.) Service Unit, an Indian Health Service facility, in 2017 and now provides teledermatology and regular in-person dermatology care at that clinic. “The climate there is dry, so you can see bad eczema and dry skin. There’s also a lot of acne and hidradenitis suppurativa. I think the acne and HS is due to the hyperglycemic index diet from the food deserts. Skin disease reflects the climate, the food desert, and the lack of close specialty care.”
Acne scarring common
Some published evidence suggests that acne is more prevalent and severe in AI/AN individuals. In a survey of 158 AI/AN individuals with a mean age of 32 years, 79.1% reported a history of acne, 55.1% reported acne scarring, and 31% reported having active lesions. “Looking back on my experience in high school, I definitely see that in myself and in my peers,” Mr. Hicks said. And, while there are limited published studies about the incidence of melanoma in this population, an analysis from 2006 found that the incidence was 3.1 per 100,000 between 2001 and 2005, which was an increase from 1.6 per 100,000 reported between 1992 and 2000.
There’s a lot to unpack for dermatologists caring for the AI/AN population besides the raw health disparities: a long history of distrust between AI/AN people and the federal government, structural racism, geographic isolation, health literacy challenges, and high rates of poverty and unemployment. And while individuals from federally recognized tribes have a legal right to receive health care provided by the Indian Health Service, a component of the Department of Health & Human Services, the U.S. Government Accountability Office found that in 2017 per capita spending available to the IHS was $4,078, compared with $8,109 for Medicaid, $10,692 for the Veterans Health Administration, and $13,185 for Medicare.
“Everyone deserves healthy skin and good health,” said Dr. Kohn, whose husband is AI and works in AI law. “Knowing that there are pockets of people who lack that access to care really bothers me. I think the American Indians are frequently overlooked. They’re just not even counted for in certain surveys,” she added, noting that categories are usually defined as Black, Hispanic, Asian, or White.
According to Dr. Kohn, who coauthored a chapter titled “Dermatology on American Indian and Alaska Native Reservations,” for the 2021 book “Dermatology in Rural Settings”, 70% of AIs live in urban areas, “so it’s not just people who live on reservations, though the disparity is greatest there.” To help deliver dermatologic care in the rural areas “where you’re on tribal lands, you must partner with the tribes,” she added. “You must get their permission, operate under their laws and regulations and their rules, learn the local customs, learn about the culture, learn the people, and learn their resources before you practice. That’s the only ethical way to practice.” This also means appreciating the fact that some AI/AN individuals may not understand what a dermatologist could do for them. “One of the bigger hurdles to overcome,” she said, is educating the population that dermatologists can cure skin diseases and that there are good medications for treating the diseases.
Shortcomings of teledermatology
Some dermatologists perform teledermatology visits for tribes, often from an office located in a different time zone. “And, they don’t have a sense of what resources are available for the people they’re serving,” Dr. Kohn said. “For example, if they diagnose a potential skin cancer on the face and say, ‘you need a biopsy,’ but the closest dermatologist is 4 hours away, is that really serving the patient? Or, if you tell a patient, ‘I want you to go out and buy Vanicream for your skin,’ but Vanicream costs $17 and the patient can’t even afford to buy food, are you really doing them a service?”
In a survey-based study of 238 AI individuals that is scheduled to be published in late 2023, Dr. Kohn and colleagues asked respondents at two regional powwows in Denver if they would be open to teledermatology – either in their home or in a primary care clinic. Most respondents (70%) lived in urban areas, the rest in rural settings. Nearly half of respondents (42%) “did not want to do teledermatology, even though they couldn’t access in-person dermatology,” Dr. Kohn said. “So, for people who think teledermatology is the answer [to improving access], the respondents to our survey weren’t interested in pursuing that as a solution. I was surprised by that.” When the researchers broke down the responses by age, teenage respondents were even less interested in teledermatology than adults were. “I think there’s something about having someone see you in person, knowing who you are,” she said.
Partnerships with tribes
To foster more sustainable change in the delivery of skin care beyond remote teledermatology and periodic visits from volunteers, some dermatology residencies have established partnerships with tribes, including Massachusetts General Hospital’s teaching partnership with the Rosebud Sioux tribe in Rosebud, S.D., and the University of Utah dermatology department’s resident continuity clinic with Navajo Nation in Montezuma Creek, Utah. In 2016, officials from the Utah Navajo Health System reached out to the University of Utah’s dermatology department to inquire about the potential for creating a teledermatology clinic to serve patients who receive primary care at the Montezuma Creek Community Health Center, located in Southeastern Utah on the northern tip of the Navajo Nation.
Stephanie Klein, MD, associate professor of dermatology at the university, spearheaded the clinic’s launch but soon encountered obstacles that ranged from not being able to visualize the patient’s skin clearly on her computer screen to difficulty making a personal connection with patients despite help from Navajo translators. “It was hard to build a relationship,” she said. A few years later, she drove down to meet with officials of the health system and posed the question: “What is the ideal thing you would want from dermatology?”
Continuity, they told her. “They said that a lot of the services they receive in the form of outreach are rotational, where someone might come in for a day, or a week, or five people may rotate throughout the year,” which did not serve them well, said Dr. Klein, who subsequently collaborated with Utah Navajo Health System clinicians to establish a resident continuity clinic, which launched in January 2021.
The arrangement also serves as a continuity clinic for Dr. Klein as an attending physician. Each month, she and one dermatology resident drive 6.5 hours from Salt Lake City to Montezuma Creek, where they spend 1 or 2 full days seeing about 25 patients referred by the primary care clinicians who work there. About one-quarter of the time they fly, thanks to financial support from a private donor. The flight takes about an hour, then it’s an hour-long drive to the actual clinic. “It’s a commitment,” Dr. Klein said. “A resident can come with me if they commit to the clinic for at least 1 year. This enables us to have continuity of care; it allows us to build relationships with the patients and with the care team there.” As for the prior teledermatology visits she had with residents, “I still do those, but now I do them in between the in-person visits, so I’m not meeting people over telehealth; I’m just following up with them.”
Situated in the high desert among rock formations, the estimated population of Montezuma Creek is just over 320 people. “It’s a beautiful place with otherworldly buttes and mesas, and the Blue Mountains rising up in the distance,” said Lowell Nicholson, MD, a dermatology resident at the University of Utah who is in his second year of a 2-year commitment to the clinic. “But the landscape can be harsh, and it is underserved from an infrastructure perspective,” with large areas with no cell phone service and limited access to running water and refrigeration. “People in general travel quite far to get their medical care and most of the roads are dirt or gravel, so after a big snowstorm or if it’s been raining, they can become impassable.”
Dermatologic conditions they often encounter include vitiligo, photodermatoses, hidradenitis suppurativa, eczema, psoriasis, and severe acne, often with lots of acne-associated scarring. “In general, we tend to see dramatic or advanced presentations of general dermatology diagnoses,” Dr. Nicholson said. “We see a lot of really extensive psoriasis, which can be socially stigmatizing.”
He recalled one middle-aged man who isolated himself from others because his psoriasis became unbearable. The man refused to leave his house, visit family members, or attend tribal meetups. “He tried to see his regular doctor about it and was given topicals, but his disease was just too extensive,” said Dr. Nicholson, who suggested trying a biologic but learned that the man did not have regular access to refrigeration. “That wasn’t going to work, but we started him on an oral medication, apremilast, which has completely cleared his skin,” he said. “He’s doing great. The last time we saw him he was re-engaged with his family, and he told us he was going on dates. We really improved his quality of life.”
Dr. Klein recalled seeing a 6-year-old girl at the clinic with atopic dermatitis so severe that it caused her to miss several days of school. “When she was in school, she was so distracted by the itching – it was so overwhelming,” she said. She was struggling with topical medicines that weren’t effective, but Dr. Klein got her on dupilumab, and during a follow-up visit the girl told her, “This is the first time in my life I can think about things” other than itching.
According to Dr. Nicholson, some patients seen at the Montezuma Creek clinic are on Medicare or carry standard insurance. “Others have a mix, and others are getting all their medications through the Montezuma Creek clinic or through the IHS clinics,” he said. “I have been surprised at the formulary and our ability to get relatively expensive medications for our patients, like biologics and TNF inhibitors. But it takes some creativity to know what is going to work for your patients’ living situation.”
Training more AI/AN dermatologists key
While efforts to increase the culturally respectful and sustainable dermatologic care for AI/AN individuals continue through programs like the continuity clinic at Montezuma Creek, sources interviewed for this story emphasized the importance of training more AI/AN dermatologists. “Of the people who graduate from high school, AIs have the lowest rate of going on to college,” said Dr. Kohn, who serves as a mentor to Mr. Hicks. “Let’s say they get all the way to medical school; it’s about good mentorship and support in what they’re pursuing. We are seeing more AIs in medical school now, something that I personally notice, and I notice it from what Chinle Service Unit tells me. They have received many requests from Native medical students and premed students who want to rotate at Chinle. Native trainees want the experience of being there.”
According to the Association of American Medical Colleges, the number of AI/AN applicants to medical schools increased from 72 in 2020-2021 to 105 in 2021-2022 but dipped slightly to 94 in 2022-2023. Inspired by a passion to serve Pine Ridge or a community like it, Mr. Hicks decided to apply for medical school. While he doesn’t want to “close any doors” on which medical specialty he ultimately chooses to practice, the current front-runner is dermatology, he said, largely because of the influence of Dr. Kohn and two Mayo dermatologists who have become mentors: Molly Lohman, MD, and Hafsa M. Cantwell, MD. “I didn’t see anyone from my background who was a doctor, so having those role models is so important for Native kids to think, ‘I can do this, too,’ and to pursue it,” he said.
FDA adds safety-related information to its dermal filler webpage
On July 6, the .
Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.
“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.
The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”
Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.
Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.
Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment about the FDA update on dermal fillers, said that the agency “is doing its job by making consumers aware of all possible complications [common and uncommon], as it does when it creates a package insert for a medication. Fortunately, however, comprehensive reviews published in the peer-reviewed dermatology literature show delayed inflammation to be a very rare event. So, while it is important for dermatologists during informed consent – prior to filler – to discuss that redness and/or nodules after infection/vaccinations, etc. are possible, it is important to add that based on the data, they are also highly unlikely.”
Sue Ellen Cox, MD, a dermatologist who practices in Chapel Hill, N.C., said that she was glad to see separate sections of recommendations geared to patients and health care providers. For example, the website recommends that patients seek a physician in the field of dermatology or plastic surgery to perform procedures that use dermal fillers. “These are not procedures to be done in an unsupervised spa setting,” said Dr. Cox, a past president of the American Society for Dermatologic Surgery and one of the task force authors of recommendations on preventing and treating adverse events of injectable fillers.
“It also makes the point of using products that are acquired from FDA-approved manufacturers, not products sold online or bootlegged from other countries. Finally, it goes into detail about the importance of in-depth knowledge of anatomy, which is crucial for safe injections and reviews potential complications such as intravascular events and hypersensitivity reactions. The administering physician should have extensive knowledge regarding how to treat any potential problems that arise.”
Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies. Dr. Cox disclosed that she has been a clinical investigator for many injectable companies including AbbVie, Galderma, Revance, and Chroma.
Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.
On July 6, the .
Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.
“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.
The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”
Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.
Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.
Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment about the FDA update on dermal fillers, said that the agency “is doing its job by making consumers aware of all possible complications [common and uncommon], as it does when it creates a package insert for a medication. Fortunately, however, comprehensive reviews published in the peer-reviewed dermatology literature show delayed inflammation to be a very rare event. So, while it is important for dermatologists during informed consent – prior to filler – to discuss that redness and/or nodules after infection/vaccinations, etc. are possible, it is important to add that based on the data, they are also highly unlikely.”
Sue Ellen Cox, MD, a dermatologist who practices in Chapel Hill, N.C., said that she was glad to see separate sections of recommendations geared to patients and health care providers. For example, the website recommends that patients seek a physician in the field of dermatology or plastic surgery to perform procedures that use dermal fillers. “These are not procedures to be done in an unsupervised spa setting,” said Dr. Cox, a past president of the American Society for Dermatologic Surgery and one of the task force authors of recommendations on preventing and treating adverse events of injectable fillers.
“It also makes the point of using products that are acquired from FDA-approved manufacturers, not products sold online or bootlegged from other countries. Finally, it goes into detail about the importance of in-depth knowledge of anatomy, which is crucial for safe injections and reviews potential complications such as intravascular events and hypersensitivity reactions. The administering physician should have extensive knowledge regarding how to treat any potential problems that arise.”
Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies. Dr. Cox disclosed that she has been a clinical investigator for many injectable companies including AbbVie, Galderma, Revance, and Chroma.
Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.
On July 6, the .
Along with a list of common reactions such as bruising, redness, swelling, and pain, the webpage now includes language to inform the public and health care providers about reports of delayed-onset inflammation that have been reported to occur near the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. According to an FDA spokesperson, the update is based on several sources of information, including postmarketing data from adverse event–reporting databases, such as the Manufacturer and User Facility Device Experience (MAUDE) for devices and the Vaccine Adverse Event Reporting System (VAERS) for vaccines, published literature, and recommendations from federal agencies and professional societies.
“More specifically, the site was updated to include certain risks of using dermal fillers such as swelling and bruising as well as some less common risks such as inflammation – swelling or redness near the dermal filler injection site – following viral or bacterial illnesses or infections, vaccinations, or dental procedures,” the spokesperson said.
The announcement about the update also states that “typically, the reported inflammation is responsive to treatment or resolves on its own.”
Other less common risks from dermal filler use listed on the website include bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgical removal; infection; open or draining wounds; a sore at the injection site; allergic reactions; or necrosis.
Meanwhile, rare risks from dermal filler use that have been reported to the FDA include severe allergic reactions (anaphylactic shock) that require immediate emergency medical assistance; migration (movement of filler material from the site of injection); leakage or rupture of the filler material at the injection site or through the skin (which may result from a tissue reaction or an infection); the formation of permanent hard nodules; and injury to the blood supply after an unintentional injection into a blood vessel, resulting in necrosis, vision abnormalities (including blindness), or stroke.
Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment about the FDA update on dermal fillers, said that the agency “is doing its job by making consumers aware of all possible complications [common and uncommon], as it does when it creates a package insert for a medication. Fortunately, however, comprehensive reviews published in the peer-reviewed dermatology literature show delayed inflammation to be a very rare event. So, while it is important for dermatologists during informed consent – prior to filler – to discuss that redness and/or nodules after infection/vaccinations, etc. are possible, it is important to add that based on the data, they are also highly unlikely.”
Sue Ellen Cox, MD, a dermatologist who practices in Chapel Hill, N.C., said that she was glad to see separate sections of recommendations geared to patients and health care providers. For example, the website recommends that patients seek a physician in the field of dermatology or plastic surgery to perform procedures that use dermal fillers. “These are not procedures to be done in an unsupervised spa setting,” said Dr. Cox, a past president of the American Society for Dermatologic Surgery and one of the task force authors of recommendations on preventing and treating adverse events of injectable fillers.
“It also makes the point of using products that are acquired from FDA-approved manufacturers, not products sold online or bootlegged from other countries. Finally, it goes into detail about the importance of in-depth knowledge of anatomy, which is crucial for safe injections and reviews potential complications such as intravascular events and hypersensitivity reactions. The administering physician should have extensive knowledge regarding how to treat any potential problems that arise.”
Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies. Dr. Cox disclosed that she has been a clinical investigator for many injectable companies including AbbVie, Galderma, Revance, and Chroma.
Health care professionals, patients, and others can report adverse events related to dermal fillers and other medical devices to the FDA at 800-FDA-1088 or on the MAUDE website.
New guidelines for MTX use in pediatric inflammatory skin disease unveiled
While the typical dose of methotrexate (MTX) for inflammatory disease in pediatric patients varies in published studies, the maximum dose is considered to be 1 mg/kg and not to exceed 25 mg/week. In addition, test doses are not necessary for pediatric patients starting low dose (1 mg/kg or less) MTX for inflammatory skin disease, and the onset of efficacy with MTX may take 8-16 weeks.
and published online in Pediatric Dermatology.
“Methotrexate is a cost-effective, readily accessible, well-tolerated, useful, and time-honored option for children with a spectrum of inflammatory skin diseases,” project cochair Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, told this news organization. “Although considered an ‘immune suppressant’ by some, it is more accurately classified as an immune modulator and has been widely used for more than 50 years, and remains the standard of care when administered at very high doses and intrathecally in children with acute lymphoblastic leukemia – a practice that supports safety. But many details that support optimized treatment are not widely appreciated.”
In their guidelines document, Dr. Siegfried and her 22 coauthors noted that Food and Drug Administration labeling does not include approved indications for the use of MTX for many inflammatory skin diseases in pediatric patients, including morphea, psoriasis, atopic dermatitis, and alopecia areata. “Furthermore, some clinicians may be unfamiliar or uncomfortable prescribing medications off label for pediatric patients, causing delayed initiation, premature drug discontinuation, or use of less advantageous alternatives,” they wrote.
To address this unmet need, Dr. Siegfried and the other committee members used a modified Delphi process to reach agreement on recommendations related to five key topic areas: indications and contraindications, dosing, interactions with immunizations and medications, potential for and management of adverse effects, and monitoring needs. Consensus was predefined as at least 70% of participants rating a statement as 7-9 on the Likert scale. The effort to develop 46 recommendations has been a work in progress for almost 5 years, “somewhat delayed by the pandemic,” Dr. Siegfried, past president and director of the American Board of Dermatology, said in an interview. “But it remains relevant, despite the emergence of biologics and JAK inhibitors for treating inflammatory skin conditions in children. Although the mechanism-of-action of low-dose MTX is not clear, it may overlap with the newer small molecules.”
The guidelines contain several pearls to guide optimal dosing, including the following key points:
- MTX can be discontinued abruptly without adverse effects, other than the risk of disease worsening.
- Folic acid supplementation (starting at 1 mg/day, regardless of weight) is an effective approach to minimizing associated gastrointestinal adverse effects.
- Concomitant use of MTX and antibiotics (including trimethoprim-sulfamethoxazole) and NSAIDS are not contraindicated for most pediatric patients treated for inflammatory skin disease.
- Live virus vaccine boosters such as varicella-zoster virus (VZV) and measles, mumps, and rubella (MMR) are not contraindicated in patients taking MTX; there are insufficient data to make recommendations for or against primary immunization with MMR vaccine in patients taking MTX; inactivated vaccines should be given to patients taking MTX.
- Routine surveillance laboratory monitoring (i.e., CBC with differential, alanine transaminase, aspartate aminotransferase, creatinine) is recommended at baseline, after 1 month of treatment, and every 3-4 months thereafter.
- Transient transaminase elevation (≤ 3 upper limit normal for < 3 months) is not uncommon with low-dose MTX and does not usually require interruption of MTX. The most likely causes are concomitant viral infection, MTX dosing within 24 hours prior to phlebotomy, recent administration of other medications (such as acetaminophen), and/or recent alcohol consumption.
- Liver biopsy is not indicated for routine monitoring of pediatric patients taking low-dose MTX.
According to Dr. Siegfried, consensus of the committee members was lowest on the need for a test dose of MTX.
Overall, she said in the interview, helping to craft the guidelines caused her to reflect on how her approach to using MTX has evolved over the past 35 years, after treating “many hundreds” of patients. “I was gratified to confirm similar practice patterns among my colleagues,” she added.
The project’s other cochair was Heather Brandling-Bennett, MD, a dermatologist at Seattle Children’s Hospital. This work was supported by a grant from the Pediatric Dermatology Research Alliance (PeDRA), with additional funding from the National Eczema Association and the National Psoriasis Foundation. Dr. Siegfried disclosed ties with AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica. She has participated in contracted research for AI Therapeutics, and has served as principal investigator for Janssen. Many of the guideline coauthors disclosed having received grant support and other funding from pharmaceutical companies.
While the typical dose of methotrexate (MTX) for inflammatory disease in pediatric patients varies in published studies, the maximum dose is considered to be 1 mg/kg and not to exceed 25 mg/week. In addition, test doses are not necessary for pediatric patients starting low dose (1 mg/kg or less) MTX for inflammatory skin disease, and the onset of efficacy with MTX may take 8-16 weeks.
and published online in Pediatric Dermatology.
“Methotrexate is a cost-effective, readily accessible, well-tolerated, useful, and time-honored option for children with a spectrum of inflammatory skin diseases,” project cochair Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, told this news organization. “Although considered an ‘immune suppressant’ by some, it is more accurately classified as an immune modulator and has been widely used for more than 50 years, and remains the standard of care when administered at very high doses and intrathecally in children with acute lymphoblastic leukemia – a practice that supports safety. But many details that support optimized treatment are not widely appreciated.”
In their guidelines document, Dr. Siegfried and her 22 coauthors noted that Food and Drug Administration labeling does not include approved indications for the use of MTX for many inflammatory skin diseases in pediatric patients, including morphea, psoriasis, atopic dermatitis, and alopecia areata. “Furthermore, some clinicians may be unfamiliar or uncomfortable prescribing medications off label for pediatric patients, causing delayed initiation, premature drug discontinuation, or use of less advantageous alternatives,” they wrote.
To address this unmet need, Dr. Siegfried and the other committee members used a modified Delphi process to reach agreement on recommendations related to five key topic areas: indications and contraindications, dosing, interactions with immunizations and medications, potential for and management of adverse effects, and monitoring needs. Consensus was predefined as at least 70% of participants rating a statement as 7-9 on the Likert scale. The effort to develop 46 recommendations has been a work in progress for almost 5 years, “somewhat delayed by the pandemic,” Dr. Siegfried, past president and director of the American Board of Dermatology, said in an interview. “But it remains relevant, despite the emergence of biologics and JAK inhibitors for treating inflammatory skin conditions in children. Although the mechanism-of-action of low-dose MTX is not clear, it may overlap with the newer small molecules.”
The guidelines contain several pearls to guide optimal dosing, including the following key points:
- MTX can be discontinued abruptly without adverse effects, other than the risk of disease worsening.
- Folic acid supplementation (starting at 1 mg/day, regardless of weight) is an effective approach to minimizing associated gastrointestinal adverse effects.
- Concomitant use of MTX and antibiotics (including trimethoprim-sulfamethoxazole) and NSAIDS are not contraindicated for most pediatric patients treated for inflammatory skin disease.
- Live virus vaccine boosters such as varicella-zoster virus (VZV) and measles, mumps, and rubella (MMR) are not contraindicated in patients taking MTX; there are insufficient data to make recommendations for or against primary immunization with MMR vaccine in patients taking MTX; inactivated vaccines should be given to patients taking MTX.
- Routine surveillance laboratory monitoring (i.e., CBC with differential, alanine transaminase, aspartate aminotransferase, creatinine) is recommended at baseline, after 1 month of treatment, and every 3-4 months thereafter.
- Transient transaminase elevation (≤ 3 upper limit normal for < 3 months) is not uncommon with low-dose MTX and does not usually require interruption of MTX. The most likely causes are concomitant viral infection, MTX dosing within 24 hours prior to phlebotomy, recent administration of other medications (such as acetaminophen), and/or recent alcohol consumption.
- Liver biopsy is not indicated for routine monitoring of pediatric patients taking low-dose MTX.
According to Dr. Siegfried, consensus of the committee members was lowest on the need for a test dose of MTX.
Overall, she said in the interview, helping to craft the guidelines caused her to reflect on how her approach to using MTX has evolved over the past 35 years, after treating “many hundreds” of patients. “I was gratified to confirm similar practice patterns among my colleagues,” she added.
The project’s other cochair was Heather Brandling-Bennett, MD, a dermatologist at Seattle Children’s Hospital. This work was supported by a grant from the Pediatric Dermatology Research Alliance (PeDRA), with additional funding from the National Eczema Association and the National Psoriasis Foundation. Dr. Siegfried disclosed ties with AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica. She has participated in contracted research for AI Therapeutics, and has served as principal investigator for Janssen. Many of the guideline coauthors disclosed having received grant support and other funding from pharmaceutical companies.
While the typical dose of methotrexate (MTX) for inflammatory disease in pediatric patients varies in published studies, the maximum dose is considered to be 1 mg/kg and not to exceed 25 mg/week. In addition, test doses are not necessary for pediatric patients starting low dose (1 mg/kg or less) MTX for inflammatory skin disease, and the onset of efficacy with MTX may take 8-16 weeks.
and published online in Pediatric Dermatology.
“Methotrexate is a cost-effective, readily accessible, well-tolerated, useful, and time-honored option for children with a spectrum of inflammatory skin diseases,” project cochair Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, told this news organization. “Although considered an ‘immune suppressant’ by some, it is more accurately classified as an immune modulator and has been widely used for more than 50 years, and remains the standard of care when administered at very high doses and intrathecally in children with acute lymphoblastic leukemia – a practice that supports safety. But many details that support optimized treatment are not widely appreciated.”
In their guidelines document, Dr. Siegfried and her 22 coauthors noted that Food and Drug Administration labeling does not include approved indications for the use of MTX for many inflammatory skin diseases in pediatric patients, including morphea, psoriasis, atopic dermatitis, and alopecia areata. “Furthermore, some clinicians may be unfamiliar or uncomfortable prescribing medications off label for pediatric patients, causing delayed initiation, premature drug discontinuation, or use of less advantageous alternatives,” they wrote.
To address this unmet need, Dr. Siegfried and the other committee members used a modified Delphi process to reach agreement on recommendations related to five key topic areas: indications and contraindications, dosing, interactions with immunizations and medications, potential for and management of adverse effects, and monitoring needs. Consensus was predefined as at least 70% of participants rating a statement as 7-9 on the Likert scale. The effort to develop 46 recommendations has been a work in progress for almost 5 years, “somewhat delayed by the pandemic,” Dr. Siegfried, past president and director of the American Board of Dermatology, said in an interview. “But it remains relevant, despite the emergence of biologics and JAK inhibitors for treating inflammatory skin conditions in children. Although the mechanism-of-action of low-dose MTX is not clear, it may overlap with the newer small molecules.”
The guidelines contain several pearls to guide optimal dosing, including the following key points:
- MTX can be discontinued abruptly without adverse effects, other than the risk of disease worsening.
- Folic acid supplementation (starting at 1 mg/day, regardless of weight) is an effective approach to minimizing associated gastrointestinal adverse effects.
- Concomitant use of MTX and antibiotics (including trimethoprim-sulfamethoxazole) and NSAIDS are not contraindicated for most pediatric patients treated for inflammatory skin disease.
- Live virus vaccine boosters such as varicella-zoster virus (VZV) and measles, mumps, and rubella (MMR) are not contraindicated in patients taking MTX; there are insufficient data to make recommendations for or against primary immunization with MMR vaccine in patients taking MTX; inactivated vaccines should be given to patients taking MTX.
- Routine surveillance laboratory monitoring (i.e., CBC with differential, alanine transaminase, aspartate aminotransferase, creatinine) is recommended at baseline, after 1 month of treatment, and every 3-4 months thereafter.
- Transient transaminase elevation (≤ 3 upper limit normal for < 3 months) is not uncommon with low-dose MTX and does not usually require interruption of MTX. The most likely causes are concomitant viral infection, MTX dosing within 24 hours prior to phlebotomy, recent administration of other medications (such as acetaminophen), and/or recent alcohol consumption.
- Liver biopsy is not indicated for routine monitoring of pediatric patients taking low-dose MTX.
According to Dr. Siegfried, consensus of the committee members was lowest on the need for a test dose of MTX.
Overall, she said in the interview, helping to craft the guidelines caused her to reflect on how her approach to using MTX has evolved over the past 35 years, after treating “many hundreds” of patients. “I was gratified to confirm similar practice patterns among my colleagues,” she added.
The project’s other cochair was Heather Brandling-Bennett, MD, a dermatologist at Seattle Children’s Hospital. This work was supported by a grant from the Pediatric Dermatology Research Alliance (PeDRA), with additional funding from the National Eczema Association and the National Psoriasis Foundation. Dr. Siegfried disclosed ties with AbbVie, Boehringer Ingelheim, Incyte, LEO Pharma, Novan, Novartis, Pierre Fabre, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Verrica. She has participated in contracted research for AI Therapeutics, and has served as principal investigator for Janssen. Many of the guideline coauthors disclosed having received grant support and other funding from pharmaceutical companies.
FROM PEDIATRIC DERMATOLOGY
Study points to need to improve identification of culprit in SJS/TEN cases
demonstrated.
“Prompt identification and discontinuation of a culprit drug is critical to improving patient outcomes and preventing recurrence,” researchers led by Sherrie J. Divito, MD, PhD, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in the study, which was published online in JAMA Dermatology. “Identification is difficult because there is no laboratory test or other criterion standard (in the absence of rechallenge) to identify a culprit drug, and patients take on average six medications at the time of their reaction. Consequently, many patients may be labeled as allergic to multiple agents.”
Although failing to identify the culprit drug can have severe consequences, they added, “overlabeling” (labeling a patient as allergic to a drug or drugs that they can tolerate safely) “is not insignificant.” As a result of overlabeling, “the patient may receive a less efficacious, more toxic, and/or more expensive agent than necessary, and in some cases may be left without treatment for their underlying disease.”
To evaluate the outcomes of patients’ allergy lists, current approaches to identify culprit drugs such as the Algorithm for Drug Causality for Epidermal Necrolysis (ALDEN), which was published in 2010, and potential methods of improving culprit drug identification, the researchers performed a retrospective cohort study of 48 patients at Brigham and Women’s Hospital and Massachusetts General Hospital, with clinically and histologically confirmed cases of SJS/TEN between January 2000 and July 2018. Of the 48 patients, 26 had SJS/TEN overlap and 22 had TEN. Their median age at diagnosis was 40 years; 60.4% were female; and 52.1% were white, 12.5% were Black, 10.4% were Hispanic, and 8.3% were Asian. They took a median of 6.5 drugs in the 3 months prior to disease onset.
The researchers observed that all patients had at least one drug labeled as an allergy. A single culprit drug was labeled in 17 cases, but physicians communicated certainty in only 7 of those cases. Among all 48 patients, 104 drugs were labeled as allergies.
To identify a culprit drug, physicians appeared to mainly rely on two factors: drug notoriety and timing of exposure, compared with the onset of SJS/TEN. “Identifying high-risk medications seemed heuristic, with one or more drugs in question noted in the record as a common culprit without reference to published or vetted data regarding risk,” the researchers wrote. “Regarding timing, drug charts when present in medical records were incomplete, as they focused predominantly on high-notoriety drugs.”
In other findings, ALDEN scoring was discordant with physician-labeled lists in 28 cases. It labeled an additional 9 drugs missed by physicians and scored 43 drugs labeled as allergens by physicians as “unlikely.” The researchers also reported that 20 cases could have potentially benefited from human leukocyte antigen testing.
Their results “underscore the need for a laboratory test to identify culprit drugs,” but without such a test, “a systematic unbiased approach, such as ALDEN or the RegiSCAR database, with possibly HLA testing, should be considered to ensure the true culprit drug is not missed and exonerate as many nonculprit drugs as possible,” Dr. Divito and colleagues concluded.
They acknowledged certain limitations of the analysis, including its retrospective design and that many cases predated research advances in the topic area that took place during the 18-year study period.
Karl Saardi, MD, director of the inpatient dermatology service at George Washington University Hospital, Washington, who was asked to comment on the study, said that the findings “are consistent with clinical practice in that drug causality is usually determined by ‘gestalt’ rather than objective tools like the ALDEN algorithm.”
“The main limitation is the small size, which suggests the study sites are low-volume centers for SJS/TEN. The fact that the ALDEN score wasn’t developed until 2010 means that all the cases included prior to 2010 would not have applied the ALDEN algorithm, so I think the metric about how infrequently ALDEN was applied is not very meaningful.”
Still, he said that he was “surprised” by the number of medications that were added as allergies based on clinical impression, “and I’m glad this article does cast some light on the issue. In my experience, beta-lactam antibiotics are often – incorrectly – deemed to be the cause of SJS/TEN when further review of the patient’s medication history clearly shows they have tolerated these drugs multiple times in the past.”
Since 2000, he added, “our understanding of SJS/TEN has grown substantially including the identification of MIRM [mycoplasma-induced rash and mucositis]/RIME [reactive infections mucocutaneous eruptions] and GBFDE [generalized bullous fixed drug eruption] as mimickers.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was also asked to comment on the study, agreed that a limitation of the study is that it partially preceded development of the unbiased approaches to determining the cause of a medication reaction, such as the ALDEN system. “A strength of this study is the examination of heuristics in dermatology and how they relate to patient safety,” she added.
The study was funded by grants from the National Institutes of Health, a Dermatology Foundation Diversity Research Supplement Award, and by the German Research Foundation. Dr. Divito reported receiving personal fees from Adaptimmune and MEI Pharma and a provisional patent issued from Brigham and Women’s Hospital outside the submitted work. Neither Dr. Saardi nor Dr. Ko reported having relevant disclosures.
demonstrated.
“Prompt identification and discontinuation of a culprit drug is critical to improving patient outcomes and preventing recurrence,” researchers led by Sherrie J. Divito, MD, PhD, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in the study, which was published online in JAMA Dermatology. “Identification is difficult because there is no laboratory test or other criterion standard (in the absence of rechallenge) to identify a culprit drug, and patients take on average six medications at the time of their reaction. Consequently, many patients may be labeled as allergic to multiple agents.”
Although failing to identify the culprit drug can have severe consequences, they added, “overlabeling” (labeling a patient as allergic to a drug or drugs that they can tolerate safely) “is not insignificant.” As a result of overlabeling, “the patient may receive a less efficacious, more toxic, and/or more expensive agent than necessary, and in some cases may be left without treatment for their underlying disease.”
To evaluate the outcomes of patients’ allergy lists, current approaches to identify culprit drugs such as the Algorithm for Drug Causality for Epidermal Necrolysis (ALDEN), which was published in 2010, and potential methods of improving culprit drug identification, the researchers performed a retrospective cohort study of 48 patients at Brigham and Women’s Hospital and Massachusetts General Hospital, with clinically and histologically confirmed cases of SJS/TEN between January 2000 and July 2018. Of the 48 patients, 26 had SJS/TEN overlap and 22 had TEN. Their median age at diagnosis was 40 years; 60.4% were female; and 52.1% were white, 12.5% were Black, 10.4% were Hispanic, and 8.3% were Asian. They took a median of 6.5 drugs in the 3 months prior to disease onset.
The researchers observed that all patients had at least one drug labeled as an allergy. A single culprit drug was labeled in 17 cases, but physicians communicated certainty in only 7 of those cases. Among all 48 patients, 104 drugs were labeled as allergies.
To identify a culprit drug, physicians appeared to mainly rely on two factors: drug notoriety and timing of exposure, compared with the onset of SJS/TEN. “Identifying high-risk medications seemed heuristic, with one or more drugs in question noted in the record as a common culprit without reference to published or vetted data regarding risk,” the researchers wrote. “Regarding timing, drug charts when present in medical records were incomplete, as they focused predominantly on high-notoriety drugs.”
In other findings, ALDEN scoring was discordant with physician-labeled lists in 28 cases. It labeled an additional 9 drugs missed by physicians and scored 43 drugs labeled as allergens by physicians as “unlikely.” The researchers also reported that 20 cases could have potentially benefited from human leukocyte antigen testing.
Their results “underscore the need for a laboratory test to identify culprit drugs,” but without such a test, “a systematic unbiased approach, such as ALDEN or the RegiSCAR database, with possibly HLA testing, should be considered to ensure the true culprit drug is not missed and exonerate as many nonculprit drugs as possible,” Dr. Divito and colleagues concluded.
They acknowledged certain limitations of the analysis, including its retrospective design and that many cases predated research advances in the topic area that took place during the 18-year study period.
Karl Saardi, MD, director of the inpatient dermatology service at George Washington University Hospital, Washington, who was asked to comment on the study, said that the findings “are consistent with clinical practice in that drug causality is usually determined by ‘gestalt’ rather than objective tools like the ALDEN algorithm.”
“The main limitation is the small size, which suggests the study sites are low-volume centers for SJS/TEN. The fact that the ALDEN score wasn’t developed until 2010 means that all the cases included prior to 2010 would not have applied the ALDEN algorithm, so I think the metric about how infrequently ALDEN was applied is not very meaningful.”
Still, he said that he was “surprised” by the number of medications that were added as allergies based on clinical impression, “and I’m glad this article does cast some light on the issue. In my experience, beta-lactam antibiotics are often – incorrectly – deemed to be the cause of SJS/TEN when further review of the patient’s medication history clearly shows they have tolerated these drugs multiple times in the past.”
Since 2000, he added, “our understanding of SJS/TEN has grown substantially including the identification of MIRM [mycoplasma-induced rash and mucositis]/RIME [reactive infections mucocutaneous eruptions] and GBFDE [generalized bullous fixed drug eruption] as mimickers.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was also asked to comment on the study, agreed that a limitation of the study is that it partially preceded development of the unbiased approaches to determining the cause of a medication reaction, such as the ALDEN system. “A strength of this study is the examination of heuristics in dermatology and how they relate to patient safety,” she added.
The study was funded by grants from the National Institutes of Health, a Dermatology Foundation Diversity Research Supplement Award, and by the German Research Foundation. Dr. Divito reported receiving personal fees from Adaptimmune and MEI Pharma and a provisional patent issued from Brigham and Women’s Hospital outside the submitted work. Neither Dr. Saardi nor Dr. Ko reported having relevant disclosures.
demonstrated.
“Prompt identification and discontinuation of a culprit drug is critical to improving patient outcomes and preventing recurrence,” researchers led by Sherrie J. Divito, MD, PhD, of the department of dermatology at Brigham and Women’s Hospital, Boston, wrote in the study, which was published online in JAMA Dermatology. “Identification is difficult because there is no laboratory test or other criterion standard (in the absence of rechallenge) to identify a culprit drug, and patients take on average six medications at the time of their reaction. Consequently, many patients may be labeled as allergic to multiple agents.”
Although failing to identify the culprit drug can have severe consequences, they added, “overlabeling” (labeling a patient as allergic to a drug or drugs that they can tolerate safely) “is not insignificant.” As a result of overlabeling, “the patient may receive a less efficacious, more toxic, and/or more expensive agent than necessary, and in some cases may be left without treatment for their underlying disease.”
To evaluate the outcomes of patients’ allergy lists, current approaches to identify culprit drugs such as the Algorithm for Drug Causality for Epidermal Necrolysis (ALDEN), which was published in 2010, and potential methods of improving culprit drug identification, the researchers performed a retrospective cohort study of 48 patients at Brigham and Women’s Hospital and Massachusetts General Hospital, with clinically and histologically confirmed cases of SJS/TEN between January 2000 and July 2018. Of the 48 patients, 26 had SJS/TEN overlap and 22 had TEN. Their median age at diagnosis was 40 years; 60.4% were female; and 52.1% were white, 12.5% were Black, 10.4% were Hispanic, and 8.3% were Asian. They took a median of 6.5 drugs in the 3 months prior to disease onset.
The researchers observed that all patients had at least one drug labeled as an allergy. A single culprit drug was labeled in 17 cases, but physicians communicated certainty in only 7 of those cases. Among all 48 patients, 104 drugs were labeled as allergies.
To identify a culprit drug, physicians appeared to mainly rely on two factors: drug notoriety and timing of exposure, compared with the onset of SJS/TEN. “Identifying high-risk medications seemed heuristic, with one or more drugs in question noted in the record as a common culprit without reference to published or vetted data regarding risk,” the researchers wrote. “Regarding timing, drug charts when present in medical records were incomplete, as they focused predominantly on high-notoriety drugs.”
In other findings, ALDEN scoring was discordant with physician-labeled lists in 28 cases. It labeled an additional 9 drugs missed by physicians and scored 43 drugs labeled as allergens by physicians as “unlikely.” The researchers also reported that 20 cases could have potentially benefited from human leukocyte antigen testing.
Their results “underscore the need for a laboratory test to identify culprit drugs,” but without such a test, “a systematic unbiased approach, such as ALDEN or the RegiSCAR database, with possibly HLA testing, should be considered to ensure the true culprit drug is not missed and exonerate as many nonculprit drugs as possible,” Dr. Divito and colleagues concluded.
They acknowledged certain limitations of the analysis, including its retrospective design and that many cases predated research advances in the topic area that took place during the 18-year study period.
Karl Saardi, MD, director of the inpatient dermatology service at George Washington University Hospital, Washington, who was asked to comment on the study, said that the findings “are consistent with clinical practice in that drug causality is usually determined by ‘gestalt’ rather than objective tools like the ALDEN algorithm.”
“The main limitation is the small size, which suggests the study sites are low-volume centers for SJS/TEN. The fact that the ALDEN score wasn’t developed until 2010 means that all the cases included prior to 2010 would not have applied the ALDEN algorithm, so I think the metric about how infrequently ALDEN was applied is not very meaningful.”
Still, he said that he was “surprised” by the number of medications that were added as allergies based on clinical impression, “and I’m glad this article does cast some light on the issue. In my experience, beta-lactam antibiotics are often – incorrectly – deemed to be the cause of SJS/TEN when further review of the patient’s medication history clearly shows they have tolerated these drugs multiple times in the past.”
Since 2000, he added, “our understanding of SJS/TEN has grown substantially including the identification of MIRM [mycoplasma-induced rash and mucositis]/RIME [reactive infections mucocutaneous eruptions] and GBFDE [generalized bullous fixed drug eruption] as mimickers.”
Christine Ko, MD, professor of dermatology and pathology at Yale University, New Haven, Conn., who was also asked to comment on the study, agreed that a limitation of the study is that it partially preceded development of the unbiased approaches to determining the cause of a medication reaction, such as the ALDEN system. “A strength of this study is the examination of heuristics in dermatology and how they relate to patient safety,” she added.
The study was funded by grants from the National Institutes of Health, a Dermatology Foundation Diversity Research Supplement Award, and by the German Research Foundation. Dr. Divito reported receiving personal fees from Adaptimmune and MEI Pharma and a provisional patent issued from Brigham and Women’s Hospital outside the submitted work. Neither Dr. Saardi nor Dr. Ko reported having relevant disclosures.
FROM JAMA DERMATOLOGY