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.

Roflumilast cream appears safe, effective for children with psoriasis, researchers report

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Changed
Fri, 08/11/2023 - 10:20

In patients aged 2-11 years, roflumilast cream was well tolerated and improved signs and symptoms of psoriasis over 4 weeks, according to results from a pair of phase two studies.

“Limited topical treatments are approved for children younger than 12 years old with psoriasis,” researchers led by Adelaide A. Hebert, MD, wrote in their abstract. The results were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.

Roflumilast cream 0.3% (Zoryve) is a once-daily, topical nonsteroidal treatment from Arcutis Biotherapeutics. A phosphodiesterase-4 inhibitor, it was approved by the Food and Drug Administration in 2022 for mild, moderate and severe psoriasis in individuals aged 12 and older, including intertriginous psoriasis.

For the analysis, Dr. Hebert, chief of pediatric dermatology at the University of Texas, Houston, and colleagues conducted two 4-week, phase 2, open-label safety studies of roflumilast cream 0.3%.

One, study 216, enrolled 10 children aged 2-5, and all but one were Black. The other, study 215, enrolled 20 children aged 6-11, and half were Black and nearly half were White. At baseline, patients had 2% or greater body surface area (BSA) involvement and an Investigator Global Assessment (IGA) score of at least mild.

Caregivers applied roflumilast cream to all affected areas once daily for 28 days. The researchers collected pharmacokinetic samples at week 2 and week 4. The primary endpoints were pharmacokinetic, safety, and tolerability.

Efficacy was evaluated as exploratory endpoints: An IGA of clear or almost clear plus a 2-grade or more improvement from baseline, a 50% or greater improvement and a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI-50 and PASI-75), a 4-point or greater reduction in the Worst Itch–Numeric Rating Scale (WI-NRS) in patients with a baseline score of 4 or greater, a mean change from baseline in BSA, and improvement in the Children’s Dermatology Life Quality Index (CDLQI).



At baseline, the mean BSA was similar for patients enrolled in studies 216 and 215 (9.6% and 8.8%, respectively), and 80% of all patients had baseline IGA of moderate. By week 2, the mean roflumilast and N-oxide predose plasma concentrations among patients in the younger group were 2.15 and 22.4 ng/mL, compared with 3.15 and 28.9 ng/mL among those in the older group. At week 4, the mean roflumilast and N-oxide predose concentrations were 2.04 and 15.8 ng/mL in the younger group (study 216), compared with 1.68 and 15.7 ng/mL in the older group (study 215).

As for efficacy, 90% and 40% of patients in studies 216 and 215 achieved IGA success at week 4, respectively, while 90% and 50% achieved PASI-75, 90% and 40% achieved WI-NRS success, and the mean BSA reductions at week 4 were 79.1% and 44.4%. Meanwhile, one younger patient in study 216 reported a treatment-emergent adverse event (TEAE) of headache, which was considered mild, while four older patients in study 215 reported 8 TEAEs, which were considered mild and ranged from back pain to nasal congestion.

“The rapid onset of action was surprising but exceedingly rewarding for the subjects enrolled in the study,” Dr. Hebert told this news organization after the meeting. “The PASI scores and itch scores were markedly improved at the end of the 4-week clinical trial. Patient and parents alike were pleased to use a steroid-free option with once-daily application and rapid onset of action to help control plaque psoriasis.”

In the poster abstract, she and her coauthors concluded that “under maximal use conditions in children aged 2-11 years, roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis with measured improvements in IGA score, PASI score, BSA involvement, CDLQI, and WI-NRS. Overall, pharmacokinetics, safety, tolerability, and efficacy in patients aged 2-11 years were consistent with prior results in adults and adolescents.”

The study was funded by Arcutis Biotherapeutics. Dr. Hebert reported that she is an investigator for Arcutis. About half the coauthors are employees of Arcutis, and the other half disclosed grants, research funding and/or honoraria from the company. Research grants from the company for this study were paid to the McGovern Medical School at the University of Texas.

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In patients aged 2-11 years, roflumilast cream was well tolerated and improved signs and symptoms of psoriasis over 4 weeks, according to results from a pair of phase two studies.

“Limited topical treatments are approved for children younger than 12 years old with psoriasis,” researchers led by Adelaide A. Hebert, MD, wrote in their abstract. The results were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.

Roflumilast cream 0.3% (Zoryve) is a once-daily, topical nonsteroidal treatment from Arcutis Biotherapeutics. A phosphodiesterase-4 inhibitor, it was approved by the Food and Drug Administration in 2022 for mild, moderate and severe psoriasis in individuals aged 12 and older, including intertriginous psoriasis.

For the analysis, Dr. Hebert, chief of pediatric dermatology at the University of Texas, Houston, and colleagues conducted two 4-week, phase 2, open-label safety studies of roflumilast cream 0.3%.

One, study 216, enrolled 10 children aged 2-5, and all but one were Black. The other, study 215, enrolled 20 children aged 6-11, and half were Black and nearly half were White. At baseline, patients had 2% or greater body surface area (BSA) involvement and an Investigator Global Assessment (IGA) score of at least mild.

Caregivers applied roflumilast cream to all affected areas once daily for 28 days. The researchers collected pharmacokinetic samples at week 2 and week 4. The primary endpoints were pharmacokinetic, safety, and tolerability.

Efficacy was evaluated as exploratory endpoints: An IGA of clear or almost clear plus a 2-grade or more improvement from baseline, a 50% or greater improvement and a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI-50 and PASI-75), a 4-point or greater reduction in the Worst Itch–Numeric Rating Scale (WI-NRS) in patients with a baseline score of 4 or greater, a mean change from baseline in BSA, and improvement in the Children’s Dermatology Life Quality Index (CDLQI).



At baseline, the mean BSA was similar for patients enrolled in studies 216 and 215 (9.6% and 8.8%, respectively), and 80% of all patients had baseline IGA of moderate. By week 2, the mean roflumilast and N-oxide predose plasma concentrations among patients in the younger group were 2.15 and 22.4 ng/mL, compared with 3.15 and 28.9 ng/mL among those in the older group. At week 4, the mean roflumilast and N-oxide predose concentrations were 2.04 and 15.8 ng/mL in the younger group (study 216), compared with 1.68 and 15.7 ng/mL in the older group (study 215).

As for efficacy, 90% and 40% of patients in studies 216 and 215 achieved IGA success at week 4, respectively, while 90% and 50% achieved PASI-75, 90% and 40% achieved WI-NRS success, and the mean BSA reductions at week 4 were 79.1% and 44.4%. Meanwhile, one younger patient in study 216 reported a treatment-emergent adverse event (TEAE) of headache, which was considered mild, while four older patients in study 215 reported 8 TEAEs, which were considered mild and ranged from back pain to nasal congestion.

“The rapid onset of action was surprising but exceedingly rewarding for the subjects enrolled in the study,” Dr. Hebert told this news organization after the meeting. “The PASI scores and itch scores were markedly improved at the end of the 4-week clinical trial. Patient and parents alike were pleased to use a steroid-free option with once-daily application and rapid onset of action to help control plaque psoriasis.”

In the poster abstract, she and her coauthors concluded that “under maximal use conditions in children aged 2-11 years, roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis with measured improvements in IGA score, PASI score, BSA involvement, CDLQI, and WI-NRS. Overall, pharmacokinetics, safety, tolerability, and efficacy in patients aged 2-11 years were consistent with prior results in adults and adolescents.”

The study was funded by Arcutis Biotherapeutics. Dr. Hebert reported that she is an investigator for Arcutis. About half the coauthors are employees of Arcutis, and the other half disclosed grants, research funding and/or honoraria from the company. Research grants from the company for this study were paid to the McGovern Medical School at the University of Texas.

In patients aged 2-11 years, roflumilast cream was well tolerated and improved signs and symptoms of psoriasis over 4 weeks, according to results from a pair of phase two studies.

“Limited topical treatments are approved for children younger than 12 years old with psoriasis,” researchers led by Adelaide A. Hebert, MD, wrote in their abstract. The results were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.

Roflumilast cream 0.3% (Zoryve) is a once-daily, topical nonsteroidal treatment from Arcutis Biotherapeutics. A phosphodiesterase-4 inhibitor, it was approved by the Food and Drug Administration in 2022 for mild, moderate and severe psoriasis in individuals aged 12 and older, including intertriginous psoriasis.

For the analysis, Dr. Hebert, chief of pediatric dermatology at the University of Texas, Houston, and colleagues conducted two 4-week, phase 2, open-label safety studies of roflumilast cream 0.3%.

One, study 216, enrolled 10 children aged 2-5, and all but one were Black. The other, study 215, enrolled 20 children aged 6-11, and half were Black and nearly half were White. At baseline, patients had 2% or greater body surface area (BSA) involvement and an Investigator Global Assessment (IGA) score of at least mild.

Caregivers applied roflumilast cream to all affected areas once daily for 28 days. The researchers collected pharmacokinetic samples at week 2 and week 4. The primary endpoints were pharmacokinetic, safety, and tolerability.

Efficacy was evaluated as exploratory endpoints: An IGA of clear or almost clear plus a 2-grade or more improvement from baseline, a 50% or greater improvement and a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI-50 and PASI-75), a 4-point or greater reduction in the Worst Itch–Numeric Rating Scale (WI-NRS) in patients with a baseline score of 4 or greater, a mean change from baseline in BSA, and improvement in the Children’s Dermatology Life Quality Index (CDLQI).



At baseline, the mean BSA was similar for patients enrolled in studies 216 and 215 (9.6% and 8.8%, respectively), and 80% of all patients had baseline IGA of moderate. By week 2, the mean roflumilast and N-oxide predose plasma concentrations among patients in the younger group were 2.15 and 22.4 ng/mL, compared with 3.15 and 28.9 ng/mL among those in the older group. At week 4, the mean roflumilast and N-oxide predose concentrations were 2.04 and 15.8 ng/mL in the younger group (study 216), compared with 1.68 and 15.7 ng/mL in the older group (study 215).

As for efficacy, 90% and 40% of patients in studies 216 and 215 achieved IGA success at week 4, respectively, while 90% and 50% achieved PASI-75, 90% and 40% achieved WI-NRS success, and the mean BSA reductions at week 4 were 79.1% and 44.4%. Meanwhile, one younger patient in study 216 reported a treatment-emergent adverse event (TEAE) of headache, which was considered mild, while four older patients in study 215 reported 8 TEAEs, which were considered mild and ranged from back pain to nasal congestion.

“The rapid onset of action was surprising but exceedingly rewarding for the subjects enrolled in the study,” Dr. Hebert told this news organization after the meeting. “The PASI scores and itch scores were markedly improved at the end of the 4-week clinical trial. Patient and parents alike were pleased to use a steroid-free option with once-daily application and rapid onset of action to help control plaque psoriasis.”

In the poster abstract, she and her coauthors concluded that “under maximal use conditions in children aged 2-11 years, roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis with measured improvements in IGA score, PASI score, BSA involvement, CDLQI, and WI-NRS. Overall, pharmacokinetics, safety, tolerability, and efficacy in patients aged 2-11 years were consistent with prior results in adults and adolescents.”

The study was funded by Arcutis Biotherapeutics. Dr. Hebert reported that she is an investigator for Arcutis. About half the coauthors are employees of Arcutis, and the other half disclosed grants, research funding and/or honoraria from the company. Research grants from the company for this study were paid to the McGovern Medical School at the University of Texas.

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Study evaluating in utero treatment for hypohidrotic ectodermal dysplasia seeks enrollees

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Changed
Wed, 08/02/2023 - 10:43

A multicenter, international phase 2 trial known as EDELIFE is underway to investigate the safety and efficacy of an in utero treatment for developing males with X-linked hypohidrotic ectodermal dysplasia (XLHED).

This condition is caused by mutations in the gene coding for ectodysplasin A (EDA), a protein that signals the epithelial-mesenchymal transition during embryogenesis. EDA loss or dysfunction precludes binding to its endogenous EDA1 receptor (EDAR), and downstream development of teeth, hair, nails, and skin adnexae, most notably eccrine glands.

pregnant woman in doctors office
shironosov/Getty Images

The treatment, ER004, is a first-in-class signaling protein EDA replacement molecule now under investigation by the EspeRare Foundation, with support from the Pierre Fabre Foundation. The pioneering clinical trial is evaluating the delivery of ER004 protein replacement in utero to affected fetuses, allowing antenatal binding to the EDAR. According to the EDELIFE web site, when ER004 is administered to XLHED-affected males in utero, it “should act as a replacement for the missing EDA and trigger the process that leads to the normal development of a baby’s skin, teeth, hair, and sweat glands, leading to better formation of these structures.”

The protein is delivered into the amniotic fluid via a needle and syringe under ultrasound guidance. In a report on this treatment used in a pair of affected twins and a third XLHED-affected male published in 2018, the authors reported that the three babies were able to sweat normally after birth, “and XLHED-related illness had not developed by 14-22 months of age.”



The goal of the prospective, open-label, genotype match–controlled EDELIFE trial is to confirm the efficacy and safety results for ER004 in a larger group of boys, and to determine if it can lead to robust, and long-lasting improvement in XLHED-associated defects.

In the United States, the first pregnant woman to join the study received the treatment in February 2023 at Washington University in St. Louis. Other clinical sites are located in France, Germany, Italy, Spain, and the United Kingdom. Led by principal investigator Holm Schneider, MD, of the University Erlanger-Nurnberg (Germany), researchers are seeking to enroll mothers aged 18 years and older who are genetically confirmed carriers of the XLHED mutation and pregnant with a boy or considering pregnancy. The control group will include XLHED-affected males, 6 months to 60 years old, who are blood relatives of the pregnant woman participating in the study.

Dr. Elaine Siegfried


“This is an unprecedented approach to preventing a significant morbidity affecting boys with XLHED, and a potential model for in utero correction of genetic defects involving embryogenesis,” Elaine Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, said in an interview. Dr. Siegfried, who has served on the scientific advisory board of the National Foundation for Ectodermal Dysplasias since 1997, added that many years of effort “has finally yielded sufficient funding and identified an international network of experts to support this ambitious trial. We are now seeking participation of the most important collaborators: mothers willing to help establish safety and efficacy of this approach.”

Mary Fete, MSN, RN, executive director of the NFED, said that the EDELIFE clinical trial “provides enormous hope for our families affected by XLHED. It’s extraordinary to think that the baby boys affected by XLHED who have received ER004 are sweating normally and have other improved symptoms. The NFED is proud to have begun and fostered the research for 30-plus years that developed ER004.”

Dr. Siegfried is a member of the independent data monitoring committee for the EDELIFE trial.

Clinicians treating affected families or potentially eligible subjects are encouraged to contact the trial investigators at this link.

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A multicenter, international phase 2 trial known as EDELIFE is underway to investigate the safety and efficacy of an in utero treatment for developing males with X-linked hypohidrotic ectodermal dysplasia (XLHED).

This condition is caused by mutations in the gene coding for ectodysplasin A (EDA), a protein that signals the epithelial-mesenchymal transition during embryogenesis. EDA loss or dysfunction precludes binding to its endogenous EDA1 receptor (EDAR), and downstream development of teeth, hair, nails, and skin adnexae, most notably eccrine glands.

pregnant woman in doctors office
shironosov/Getty Images

The treatment, ER004, is a first-in-class signaling protein EDA replacement molecule now under investigation by the EspeRare Foundation, with support from the Pierre Fabre Foundation. The pioneering clinical trial is evaluating the delivery of ER004 protein replacement in utero to affected fetuses, allowing antenatal binding to the EDAR. According to the EDELIFE web site, when ER004 is administered to XLHED-affected males in utero, it “should act as a replacement for the missing EDA and trigger the process that leads to the normal development of a baby’s skin, teeth, hair, and sweat glands, leading to better formation of these structures.”

The protein is delivered into the amniotic fluid via a needle and syringe under ultrasound guidance. In a report on this treatment used in a pair of affected twins and a third XLHED-affected male published in 2018, the authors reported that the three babies were able to sweat normally after birth, “and XLHED-related illness had not developed by 14-22 months of age.”



The goal of the prospective, open-label, genotype match–controlled EDELIFE trial is to confirm the efficacy and safety results for ER004 in a larger group of boys, and to determine if it can lead to robust, and long-lasting improvement in XLHED-associated defects.

In the United States, the first pregnant woman to join the study received the treatment in February 2023 at Washington University in St. Louis. Other clinical sites are located in France, Germany, Italy, Spain, and the United Kingdom. Led by principal investigator Holm Schneider, MD, of the University Erlanger-Nurnberg (Germany), researchers are seeking to enroll mothers aged 18 years and older who are genetically confirmed carriers of the XLHED mutation and pregnant with a boy or considering pregnancy. The control group will include XLHED-affected males, 6 months to 60 years old, who are blood relatives of the pregnant woman participating in the study.

Dr. Elaine Siegfried


“This is an unprecedented approach to preventing a significant morbidity affecting boys with XLHED, and a potential model for in utero correction of genetic defects involving embryogenesis,” Elaine Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, said in an interview. Dr. Siegfried, who has served on the scientific advisory board of the National Foundation for Ectodermal Dysplasias since 1997, added that many years of effort “has finally yielded sufficient funding and identified an international network of experts to support this ambitious trial. We are now seeking participation of the most important collaborators: mothers willing to help establish safety and efficacy of this approach.”

Mary Fete, MSN, RN, executive director of the NFED, said that the EDELIFE clinical trial “provides enormous hope for our families affected by XLHED. It’s extraordinary to think that the baby boys affected by XLHED who have received ER004 are sweating normally and have other improved symptoms. The NFED is proud to have begun and fostered the research for 30-plus years that developed ER004.”

Dr. Siegfried is a member of the independent data monitoring committee for the EDELIFE trial.

Clinicians treating affected families or potentially eligible subjects are encouraged to contact the trial investigators at this link.

A multicenter, international phase 2 trial known as EDELIFE is underway to investigate the safety and efficacy of an in utero treatment for developing males with X-linked hypohidrotic ectodermal dysplasia (XLHED).

This condition is caused by mutations in the gene coding for ectodysplasin A (EDA), a protein that signals the epithelial-mesenchymal transition during embryogenesis. EDA loss or dysfunction precludes binding to its endogenous EDA1 receptor (EDAR), and downstream development of teeth, hair, nails, and skin adnexae, most notably eccrine glands.

pregnant woman in doctors office
shironosov/Getty Images

The treatment, ER004, is a first-in-class signaling protein EDA replacement molecule now under investigation by the EspeRare Foundation, with support from the Pierre Fabre Foundation. The pioneering clinical trial is evaluating the delivery of ER004 protein replacement in utero to affected fetuses, allowing antenatal binding to the EDAR. According to the EDELIFE web site, when ER004 is administered to XLHED-affected males in utero, it “should act as a replacement for the missing EDA and trigger the process that leads to the normal development of a baby’s skin, teeth, hair, and sweat glands, leading to better formation of these structures.”

The protein is delivered into the amniotic fluid via a needle and syringe under ultrasound guidance. In a report on this treatment used in a pair of affected twins and a third XLHED-affected male published in 2018, the authors reported that the three babies were able to sweat normally after birth, “and XLHED-related illness had not developed by 14-22 months of age.”



The goal of the prospective, open-label, genotype match–controlled EDELIFE trial is to confirm the efficacy and safety results for ER004 in a larger group of boys, and to determine if it can lead to robust, and long-lasting improvement in XLHED-associated defects.

In the United States, the first pregnant woman to join the study received the treatment in February 2023 at Washington University in St. Louis. Other clinical sites are located in France, Germany, Italy, Spain, and the United Kingdom. Led by principal investigator Holm Schneider, MD, of the University Erlanger-Nurnberg (Germany), researchers are seeking to enroll mothers aged 18 years and older who are genetically confirmed carriers of the XLHED mutation and pregnant with a boy or considering pregnancy. The control group will include XLHED-affected males, 6 months to 60 years old, who are blood relatives of the pregnant woman participating in the study.

Dr. Elaine Siegfried


“This is an unprecedented approach to preventing a significant morbidity affecting boys with XLHED, and a potential model for in utero correction of genetic defects involving embryogenesis,” Elaine Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University, said in an interview. Dr. Siegfried, who has served on the scientific advisory board of the National Foundation for Ectodermal Dysplasias since 1997, added that many years of effort “has finally yielded sufficient funding and identified an international network of experts to support this ambitious trial. We are now seeking participation of the most important collaborators: mothers willing to help establish safety and efficacy of this approach.”

Mary Fete, MSN, RN, executive director of the NFED, said that the EDELIFE clinical trial “provides enormous hope for our families affected by XLHED. It’s extraordinary to think that the baby boys affected by XLHED who have received ER004 are sweating normally and have other improved symptoms. The NFED is proud to have begun and fostered the research for 30-plus years that developed ER004.”

Dr. Siegfried is a member of the independent data monitoring committee for the EDELIFE trial.

Clinicians treating affected families or potentially eligible subjects are encouraged to contact the trial investigators at this link.

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What factors cause multiple biologic failure in psoriasis?

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Wed, 08/02/2023 - 11:50

Female sex, hyperlipidemia, Medicaid insurance, earlier year of biologic initiation, shorter duration of psoriasis, and prior nonbiologic systemic therapy use were associated with multiple biologic failure in patients with psoriasis, results from a prospective cohort demonstrated.

“Prior cross-sectional and single-center studies have primarily analyzed therapeutic failure of a single biologic or biologics within one class,” researchers led by Wilson Liao, MD, professor and vice chair of research in the department of dermatology at the University of California, San Francisco, wrote in the study, published in the Journal of the American Academy of Dermatology. “However, failure of multiple biologics targeting different signaling pathways is common over the course of treatment. These ‘multiple biologic failure’ patients are not well-characterized, and the patterns of biologics attempted and sociodemographic or clinical features that may predict difficult treatment are incompletely studied.”

To bridge this gap, the researchers conducted a prospective cohort study from the CorEvitas Psoriasis Registry, which collected data from dermatologist-diagnosed patients with psoriasis who started or switched to a Food and Drug Administration (FDA)–approved systemic therapy for psoriasis during routine dermatology visits from April 15, 2015, to May 10, 2022. This period included data from 17,196 patients across 259 private and 209 academic sites from 580 physicians in the United States and Canada.

From this registry, Dr. Liao and colleagues identified 1,039 patients with 24 months or more of follow-up data, a confirmed index biologic start date, and valid baseline assessment data, and categorized them into three cohorts:

  • 490 (47.2%) with good response (GR), defined as patients with 24 months or more of continued index biologic use by the last registry visit.
  • 65 (6.3%) with multiple biologic failure (MBF), defined as patients administered two or more biologic agents of different mechanistic classes who discontinued these biologics because of physician-reported “inadequate initial response,” “failure to maintain initial response,” or “active disease” despite 90 or more days of use per biologic.
  • 484 (46.6%) categorized as “other,” defined as patients failed by one biologic or who discontinued treatment for nonmedical reasons.

The researchers used multivariable logistic regression to identify sociodemographic, clinical, and patient-reported outcomes that differed between the MBF and GR groups. The mean age of the patients in the study was 49.1 years, 44.2% were female, 77.9% were White, 9.7% were Hispanic, and the mean duration of psoriasis was 11.5 years.

On multivariable logistic regression, factors associated with MBF, compared with those with GR, included female at birth (odds ratio [OR] = 2.29; confidence interval [CI], 1.11-4.72), history of hyperlipidemia (OR = 3.14; CI, 1.35-7.30), Medicaid insurance (OR = 4.53; CI, 1.40-14.60), prior nonbiologic systemic therapy (OR = 2.47; CI, 1.16-5.25), higher psoriasis duration (OR = 0.60 per standard deviation [SD]; CI, 0.38-0.94), and later index biologic initiation (OR = 0.37 per year; CI, 0.27-0.52). Sensitivity analysis revealed that the duration of prior nonbiologic systemic therapy use was not associated with MBF (OR = 0.99; CI, 0.94-1.02; P = 0.56).

“Interestingly, health-related behaviors (e.g., smoking, alcohol use) and location/extent of psoriasis were not important differentiators between MBF and GR,” the authors noted. “We might suspect these features to correlate with MBF, as numerous observational studies found associations between health-related behaviors or psoriasis severity and presence at difficult-to-treat locations, which often relates to biologic use.”

They acknowledged certain limitations of their study, including underrepresentation of ethnoracial minorities and male sex at birth relative to reported psoriasis epidemiology, “possibly reflecting participation bias and reduced access to specialty care, given that patients were enrolled into the registry by dermatologists,” they wrote. “Patient adherence to prescribed biologic regimens between registry visits was not evaluated.”

Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that despite the rapid expansion in biologic therapies for psoriasis, “analysis of real-world use patterns and patient characteristics has been limited – particularly for those who have failed multiple treatments. These findings suggest that there indeed may be some key differences between patients who have had to cycle through multiple biologics versus those who have had a sustained satisfactory response on a single therapy, such as disease duration and previous nonbiologic treatments.”

Dr. Chovatiya
Dr. Raj Chovatiya


However, he added, “while this prospective study utilized a robust approach to gather standard-of-care data across multiple clinical sites, the absolute number of patients with multiple biologic failures was low, and additional data for these kinds of patients are still highly needed.”

The study was sponsored by CorEvitas and supported through a partnership between CorEvitas and the National Psoriasis Foundation. Dr. Liao disclosed that he has received research grant funding from AbbVie, Amgen, Janssen, Leo, Novartis, Pfizer, Regeneron, and TRex Bio. Dr. Chovatiya disclosed ties with several pharmaceutical companies.

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Female sex, hyperlipidemia, Medicaid insurance, earlier year of biologic initiation, shorter duration of psoriasis, and prior nonbiologic systemic therapy use were associated with multiple biologic failure in patients with psoriasis, results from a prospective cohort demonstrated.

“Prior cross-sectional and single-center studies have primarily analyzed therapeutic failure of a single biologic or biologics within one class,” researchers led by Wilson Liao, MD, professor and vice chair of research in the department of dermatology at the University of California, San Francisco, wrote in the study, published in the Journal of the American Academy of Dermatology. “However, failure of multiple biologics targeting different signaling pathways is common over the course of treatment. These ‘multiple biologic failure’ patients are not well-characterized, and the patterns of biologics attempted and sociodemographic or clinical features that may predict difficult treatment are incompletely studied.”

To bridge this gap, the researchers conducted a prospective cohort study from the CorEvitas Psoriasis Registry, which collected data from dermatologist-diagnosed patients with psoriasis who started or switched to a Food and Drug Administration (FDA)–approved systemic therapy for psoriasis during routine dermatology visits from April 15, 2015, to May 10, 2022. This period included data from 17,196 patients across 259 private and 209 academic sites from 580 physicians in the United States and Canada.

From this registry, Dr. Liao and colleagues identified 1,039 patients with 24 months or more of follow-up data, a confirmed index biologic start date, and valid baseline assessment data, and categorized them into three cohorts:

  • 490 (47.2%) with good response (GR), defined as patients with 24 months or more of continued index biologic use by the last registry visit.
  • 65 (6.3%) with multiple biologic failure (MBF), defined as patients administered two or more biologic agents of different mechanistic classes who discontinued these biologics because of physician-reported “inadequate initial response,” “failure to maintain initial response,” or “active disease” despite 90 or more days of use per biologic.
  • 484 (46.6%) categorized as “other,” defined as patients failed by one biologic or who discontinued treatment for nonmedical reasons.

The researchers used multivariable logistic regression to identify sociodemographic, clinical, and patient-reported outcomes that differed between the MBF and GR groups. The mean age of the patients in the study was 49.1 years, 44.2% were female, 77.9% were White, 9.7% were Hispanic, and the mean duration of psoriasis was 11.5 years.

On multivariable logistic regression, factors associated with MBF, compared with those with GR, included female at birth (odds ratio [OR] = 2.29; confidence interval [CI], 1.11-4.72), history of hyperlipidemia (OR = 3.14; CI, 1.35-7.30), Medicaid insurance (OR = 4.53; CI, 1.40-14.60), prior nonbiologic systemic therapy (OR = 2.47; CI, 1.16-5.25), higher psoriasis duration (OR = 0.60 per standard deviation [SD]; CI, 0.38-0.94), and later index biologic initiation (OR = 0.37 per year; CI, 0.27-0.52). Sensitivity analysis revealed that the duration of prior nonbiologic systemic therapy use was not associated with MBF (OR = 0.99; CI, 0.94-1.02; P = 0.56).

“Interestingly, health-related behaviors (e.g., smoking, alcohol use) and location/extent of psoriasis were not important differentiators between MBF and GR,” the authors noted. “We might suspect these features to correlate with MBF, as numerous observational studies found associations between health-related behaviors or psoriasis severity and presence at difficult-to-treat locations, which often relates to biologic use.”

They acknowledged certain limitations of their study, including underrepresentation of ethnoracial minorities and male sex at birth relative to reported psoriasis epidemiology, “possibly reflecting participation bias and reduced access to specialty care, given that patients were enrolled into the registry by dermatologists,” they wrote. “Patient adherence to prescribed biologic regimens between registry visits was not evaluated.”

Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that despite the rapid expansion in biologic therapies for psoriasis, “analysis of real-world use patterns and patient characteristics has been limited – particularly for those who have failed multiple treatments. These findings suggest that there indeed may be some key differences between patients who have had to cycle through multiple biologics versus those who have had a sustained satisfactory response on a single therapy, such as disease duration and previous nonbiologic treatments.”

Dr. Chovatiya
Dr. Raj Chovatiya


However, he added, “while this prospective study utilized a robust approach to gather standard-of-care data across multiple clinical sites, the absolute number of patients with multiple biologic failures was low, and additional data for these kinds of patients are still highly needed.”

The study was sponsored by CorEvitas and supported through a partnership between CorEvitas and the National Psoriasis Foundation. Dr. Liao disclosed that he has received research grant funding from AbbVie, Amgen, Janssen, Leo, Novartis, Pfizer, Regeneron, and TRex Bio. Dr. Chovatiya disclosed ties with several pharmaceutical companies.

Female sex, hyperlipidemia, Medicaid insurance, earlier year of biologic initiation, shorter duration of psoriasis, and prior nonbiologic systemic therapy use were associated with multiple biologic failure in patients with psoriasis, results from a prospective cohort demonstrated.

“Prior cross-sectional and single-center studies have primarily analyzed therapeutic failure of a single biologic or biologics within one class,” researchers led by Wilson Liao, MD, professor and vice chair of research in the department of dermatology at the University of California, San Francisco, wrote in the study, published in the Journal of the American Academy of Dermatology. “However, failure of multiple biologics targeting different signaling pathways is common over the course of treatment. These ‘multiple biologic failure’ patients are not well-characterized, and the patterns of biologics attempted and sociodemographic or clinical features that may predict difficult treatment are incompletely studied.”

To bridge this gap, the researchers conducted a prospective cohort study from the CorEvitas Psoriasis Registry, which collected data from dermatologist-diagnosed patients with psoriasis who started or switched to a Food and Drug Administration (FDA)–approved systemic therapy for psoriasis during routine dermatology visits from April 15, 2015, to May 10, 2022. This period included data from 17,196 patients across 259 private and 209 academic sites from 580 physicians in the United States and Canada.

From this registry, Dr. Liao and colleagues identified 1,039 patients with 24 months or more of follow-up data, a confirmed index biologic start date, and valid baseline assessment data, and categorized them into three cohorts:

  • 490 (47.2%) with good response (GR), defined as patients with 24 months or more of continued index biologic use by the last registry visit.
  • 65 (6.3%) with multiple biologic failure (MBF), defined as patients administered two or more biologic agents of different mechanistic classes who discontinued these biologics because of physician-reported “inadequate initial response,” “failure to maintain initial response,” or “active disease” despite 90 or more days of use per biologic.
  • 484 (46.6%) categorized as “other,” defined as patients failed by one biologic or who discontinued treatment for nonmedical reasons.

The researchers used multivariable logistic regression to identify sociodemographic, clinical, and patient-reported outcomes that differed between the MBF and GR groups. The mean age of the patients in the study was 49.1 years, 44.2% were female, 77.9% were White, 9.7% were Hispanic, and the mean duration of psoriasis was 11.5 years.

On multivariable logistic regression, factors associated with MBF, compared with those with GR, included female at birth (odds ratio [OR] = 2.29; confidence interval [CI], 1.11-4.72), history of hyperlipidemia (OR = 3.14; CI, 1.35-7.30), Medicaid insurance (OR = 4.53; CI, 1.40-14.60), prior nonbiologic systemic therapy (OR = 2.47; CI, 1.16-5.25), higher psoriasis duration (OR = 0.60 per standard deviation [SD]; CI, 0.38-0.94), and later index biologic initiation (OR = 0.37 per year; CI, 0.27-0.52). Sensitivity analysis revealed that the duration of prior nonbiologic systemic therapy use was not associated with MBF (OR = 0.99; CI, 0.94-1.02; P = 0.56).

“Interestingly, health-related behaviors (e.g., smoking, alcohol use) and location/extent of psoriasis were not important differentiators between MBF and GR,” the authors noted. “We might suspect these features to correlate with MBF, as numerous observational studies found associations between health-related behaviors or psoriasis severity and presence at difficult-to-treat locations, which often relates to biologic use.”

They acknowledged certain limitations of their study, including underrepresentation of ethnoracial minorities and male sex at birth relative to reported psoriasis epidemiology, “possibly reflecting participation bias and reduced access to specialty care, given that patients were enrolled into the registry by dermatologists,” they wrote. “Patient adherence to prescribed biologic regimens between registry visits was not evaluated.”

Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that despite the rapid expansion in biologic therapies for psoriasis, “analysis of real-world use patterns and patient characteristics has been limited – particularly for those who have failed multiple treatments. These findings suggest that there indeed may be some key differences between patients who have had to cycle through multiple biologics versus those who have had a sustained satisfactory response on a single therapy, such as disease duration and previous nonbiologic treatments.”

Dr. Chovatiya
Dr. Raj Chovatiya


However, he added, “while this prospective study utilized a robust approach to gather standard-of-care data across multiple clinical sites, the absolute number of patients with multiple biologic failures was low, and additional data for these kinds of patients are still highly needed.”

The study was sponsored by CorEvitas and supported through a partnership between CorEvitas and the National Psoriasis Foundation. Dr. Liao disclosed that he has received research grant funding from AbbVie, Amgen, Janssen, Leo, Novartis, Pfizer, Regeneron, and TRex Bio. Dr. Chovatiya disclosed ties with several pharmaceutical companies.

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FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

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Study examines burden of vitiligo in the U.S.

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Tue, 07/25/2023 - 10:46

Asian American, Hispanic/Latino, and older individuals appear to have the greatest burden of vitiligo in the United States, according to the results of a cross sectional study.

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 .

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Asian American, Hispanic/Latino, and older individuals appear to have the greatest burden of vitiligo in the United States, according to the results of a cross sectional study.

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 .

Asian American, Hispanic/Latino, and older individuals appear to have the greatest burden of vitiligo in the United States, according to the results of a cross sectional study.

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 .

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FDA approves cantharidin for molluscum contagiosum

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Mon, 07/24/2023 - 11:46

On July 21, 2023, topical cantharidin became the first Food and Drug Administration–approved treatment of molluscum contagiosum (molluscum), for adults and pediatric patients 2 years of age and older.

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.

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On July 21, 2023, topical cantharidin became the first Food and Drug Administration–approved treatment of molluscum contagiosum (molluscum), for adults and pediatric patients 2 years of age and older.

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, topical cantharidin became the first Food and Drug Administration–approved treatment of molluscum contagiosum (molluscum), for adults and pediatric patients 2 years of age and older.

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.

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Study examines pediatric skin biopsy trends at a tertiary care center

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Fri, 07/21/2023 - 15:28

Among more than 1,000 skin biopsies performed over the last 6 years by pediatric dermatologists at the University of California, San Francisco (UCSF), the three most common biopsy results were compound nevus, pyogenic granuloma, and spongiotic dermatitis.

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.

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Among more than 1,000 skin biopsies performed over the last 6 years by pediatric dermatologists at the University of California, San Francisco (UCSF), the three most common biopsy results were compound nevus, pyogenic granuloma, and spongiotic dermatitis.

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.

Among more than 1,000 skin biopsies performed over the last 6 years by pediatric dermatologists at the University of California, San Francisco (UCSF), the three most common biopsy results were compound nevus, pyogenic granuloma, and spongiotic dermatitis.

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.

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EU agency issues positive opinion on ritlecitinib

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Fri, 07/21/2023 - 13:43

The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for ritlecitinib, a once-daily 50-mg oral treatment for severe alopecia areata, 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.






 

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The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for ritlecitinib, a once-daily 50-mg oral treatment for severe alopecia areata, 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.






 

The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for ritlecitinib, a once-daily 50-mg oral treatment for severe alopecia areata, 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.






 

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What makes teens choose to use sunscreen?

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Fri, 07/21/2023 - 13:22

Among U.S. high school students, males and non-Whites are at greatest risk for not using 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.”  

Carly R. Stevens

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.

Wavebreakmedia Ltd/Thinkstock

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.

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Among U.S. high school students, males and non-Whites are at greatest risk for not using 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.”  

Carly R. Stevens

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.

Wavebreakmedia Ltd/Thinkstock

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.

Among U.S. high school students, males and non-Whites are at greatest risk for not using 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.”  

Carly R. Stevens

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.

Wavebreakmedia Ltd/Thinkstock

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.

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Indian Health Service dermatologist: ‘I saw a real need to be of service’

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Thu, 11/16/2023 - 11:52

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, Captain Bengson is still providing dermatologic care as the only full-time dermatologist in the entire Indian Health Service (IHS), the federal health program for American Indians and Alaska Natives.

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.

Courtesy Dr. Bengson
Dr. Christopher Bengson of Phoenix Indian Medical Center (right) and his longtime colleague Tashiya Whitey, CMA.

“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.”

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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, Captain Bengson is still providing dermatologic care as the only full-time dermatologist in the entire Indian Health Service (IHS), the federal health program for American Indians and Alaska Natives.

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.

Courtesy Dr. Bengson
Dr. Christopher Bengson of Phoenix Indian Medical Center (right) and his longtime colleague Tashiya Whitey, CMA.

“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, Captain Bengson is still providing dermatologic care as the only full-time dermatologist in the entire Indian Health Service (IHS), the federal health program for American Indians and Alaska Natives.

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.

Courtesy Dr. Bengson
Dr. Christopher Bengson of Phoenix Indian Medical Center (right) and his longtime colleague Tashiya Whitey, CMA.

“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.”

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Dermatologic care in Indian Country marked by unique challenges, opportunities

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Fri, 07/21/2023 - 13:51

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.”

Photo courtesy Tara Fanning
A portion of Badlands National Park is located near the Hicks family ranch in Pine Ridge, S.D.

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.

Drew Hicks

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.

Courtesy Dr. Lucinda Kohn
Dr. Lucinda Kohn

“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.

Courtesy Dr. Stephanie Klein
Dr. Stephanie Klein (right) and Dr. Lowell Nicholson

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.”

Courtesy Dr. Stephanie Klein
Dr. Lowell Nicholson poses in front of the sign for Montezuma Creek Community Health Center.


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.”
amadeustx/Shutterstock
An old windmill at an abandoned farm in Montezuma Creek, Utah.

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.

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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.”

Photo courtesy Tara Fanning
A portion of Badlands National Park is located near the Hicks family ranch in Pine Ridge, S.D.

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.

Drew Hicks

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.

Courtesy Dr. Lucinda Kohn
Dr. Lucinda Kohn

“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.

Courtesy Dr. Stephanie Klein
Dr. Stephanie Klein (right) and Dr. Lowell Nicholson

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.”

Courtesy Dr. Stephanie Klein
Dr. Lowell Nicholson poses in front of the sign for Montezuma Creek Community Health Center.


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.”
amadeustx/Shutterstock
An old windmill at an abandoned farm in Montezuma Creek, Utah.

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.”

Photo courtesy Tara Fanning
A portion of Badlands National Park is located near the Hicks family ranch in Pine Ridge, S.D.

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.

Drew Hicks

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.

Courtesy Dr. Lucinda Kohn
Dr. Lucinda Kohn

“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.

Courtesy Dr. Stephanie Klein
Dr. Stephanie Klein (right) and Dr. Lowell Nicholson

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.”

Courtesy Dr. Stephanie Klein
Dr. Lowell Nicholson poses in front of the sign for Montezuma Creek Community Health Center.


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.”
amadeustx/Shutterstock
An old windmill at an abandoned farm in Montezuma Creek, Utah.

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.

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