Dermatology

A significant number of patients with moderate-to-severe atopic dermatitis (AD) failed to achieve adequate disease control with systemic therapies over 12 months in a study of patient registry data, indicating a substantial degree of “therapeutic inertia,” the study’s lead author, Jonathan I. Silverberg, MD, PhD, MPH, reported.

The findings come from an analysis of real-world outcomes from the TARGET-DERM AD registry, which Dr. Silverberg, professor and director of clinical research and contact dermatitis in the department of dermatology at George Washington University, Washington, presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. He characterized the findings as “patients just getting stuck with a therapy and not advancing when they need to.”

TARGET-DERM AD is a longitudinal observational study of people with AD at 39 academic centers in the United States and Canada. Dr. Silverberg and his coinvestigators evaluated the proportion of patients who were experiencing an inadequate response after receiving systemic therapy and continuing on the same treatment for 3-12 months. “These are patients who are receiving their first or advanced systemic therapy, and the question is, how long did they stay on it, even if they’re not doing so well?” Dr. Silverberg said.

The researchers identified and compared the proportions of patients not achieving moderate or optimal clinician-reported outcome targets on patients with AD treated with their first systemic therapy. Advanced systemic therapy (AST) included abrocitinib, dupilumab, tralokinumab, or upadacitinib, while conventional systemic therapy (CST) included methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, and systemic corticosteroids.

Patients in TARGET-DERM AD were treated and maintained on their first systemic therapy (either advanced or conventional) for up to 12 months. They had a validated Investigator’s Global Assessment of AD (vIGA-AD) score of 3 or 4 less than 45 days prior to initiation of systemic therapy or up to 14 days afterward. They also had at least one vIGA-AD assessment 3-12 months after initiating treatment. Outcome measures included IGA (defined as a score of 2 or less, with an optional target of 0 or 1), BSA (defined as a 50% BSA improvement, with an optimal target BSA of 2% or less), and the Worst-Itch Numeric Rating Scale (defined as at least a 4-point reduction, with an optimal target of 1 or less).

The analysis included 445 patients with a mean age of 31 years at enrollment. More than half (62%) were female and 45% were non-Hispanic Whites. Most patients (92%) were on an AST, mainly dupilumab, with smaller proportions treated with either tralokinumab, upadacitinib, or abrocitinib. Fewer than 10% of patients in the registry were being treated with CSTs.

At 6 months, 37% and approximately 67% of the AST-treated patients had inadequate responses in terms of skin clearance and itch outcomes, respectively. At 12 months, these figures were about 30% and 66%, respectively. CST-treated patients showed a similar trend. For patients starting an AST on or after Sept. 21, 2021, when three additional AST options were available (tralokinumab, upadacitinib, and abrocitinib), the proportion of patients demonstrating an adequate response over 12 months was generally similar to the overall cohort of those on ASTs.

“These findings suggest a need for alternative therapies and management strategies in AD treatment,” concluded Dr. Silverberg, who chaired the RAD symposium.

Dr. Silverberg reported being a consultant and/or an adviser for many pharmaceutical companies, and has received grant or research support from Galderma and Pfizer. The TARGET-DERM study is sponsored by Target PharmaSolutions.

A significant number of patients with moderate-to-severe atopic dermatitis (AD) failed to achieve adequate disease control with systemic therapies over 12 months in a study of patient registry data, indicating a substantial degree of “therapeutic inertia,” the study’s lead author, Jonathan I. Silverberg, MD, PhD, MPH, reported.

The findings come from an analysis of real-world outcomes from the TARGET-DERM AD registry, which Dr. Silverberg, professor and director of clinical research and contact dermatitis in the department of dermatology at George Washington University, Washington, presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. He characterized the findings as “patients just getting stuck with a therapy and not advancing when they need to.”

TARGET-DERM AD is a longitudinal observational study of people with AD at 39 academic centers in the United States and Canada. Dr. Silverberg and his coinvestigators evaluated the proportion of patients who were experiencing an inadequate response after receiving systemic therapy and continuing on the same treatment for 3-12 months. “These are patients who are receiving their first or advanced systemic therapy, and the question is, how long did they stay on it, even if they’re not doing so well?” Dr. Silverberg said.

The researchers identified and compared the proportions of patients not achieving moderate or optimal clinician-reported outcome targets on patients with AD treated with their first systemic therapy. Advanced systemic therapy (AST) included abrocitinib, dupilumab, tralokinumab, or upadacitinib, while conventional systemic therapy (CST) included methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, and systemic corticosteroids.

Patients in TARGET-DERM AD were treated and maintained on their first systemic therapy (either advanced or conventional) for up to 12 months. They had a validated Investigator’s Global Assessment of AD (vIGA-AD) score of 3 or 4 less than 45 days prior to initiation of systemic therapy or up to 14 days afterward. They also had at least one vIGA-AD assessment 3-12 months after initiating treatment. Outcome measures included IGA (defined as a score of 2 or less, with an optional target of 0 or 1), BSA (defined as a 50% BSA improvement, with an optimal target BSA of 2% or less), and the Worst-Itch Numeric Rating Scale (defined as at least a 4-point reduction, with an optimal target of 1 or less).

The analysis included 445 patients with a mean age of 31 years at enrollment. More than half (62%) were female and 45% were non-Hispanic Whites. Most patients (92%) were on an AST, mainly dupilumab, with smaller proportions treated with either tralokinumab, upadacitinib, or abrocitinib. Fewer than 10% of patients in the registry were being treated with CSTs.

At 6 months, 37% and approximately 67% of the AST-treated patients had inadequate responses in terms of skin clearance and itch outcomes, respectively. At 12 months, these figures were about 30% and 66%, respectively. CST-treated patients showed a similar trend. For patients starting an AST on or after Sept. 21, 2021, when three additional AST options were available (tralokinumab, upadacitinib, and abrocitinib), the proportion of patients demonstrating an adequate response over 12 months was generally similar to the overall cohort of those on ASTs.

“These findings suggest a need for alternative therapies and management strategies in AD treatment,” concluded Dr. Silverberg, who chaired the RAD symposium.

Dr. Silverberg reported being a consultant and/or an adviser for many pharmaceutical companies, and has received grant or research support from Galderma and Pfizer. The TARGET-DERM study is sponsored by Target PharmaSolutions.

A significant number of patients with moderate-to-severe atopic dermatitis (AD) failed to achieve adequate disease control with systemic therapies over 12 months in a study of patient registry data, indicating a substantial degree of “therapeutic inertia,” the study’s lead author, Jonathan I. Silverberg, MD, PhD, MPH, reported.

The findings come from an analysis of real-world outcomes from the TARGET-DERM AD registry, which Dr. Silverberg, professor and director of clinical research and contact dermatitis in the department of dermatology at George Washington University, Washington, presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. He characterized the findings as “patients just getting stuck with a therapy and not advancing when they need to.”

TARGET-DERM AD is a longitudinal observational study of people with AD at 39 academic centers in the United States and Canada. Dr. Silverberg and his coinvestigators evaluated the proportion of patients who were experiencing an inadequate response after receiving systemic therapy and continuing on the same treatment for 3-12 months. “These are patients who are receiving their first or advanced systemic therapy, and the question is, how long did they stay on it, even if they’re not doing so well?” Dr. Silverberg said.

The researchers identified and compared the proportions of patients not achieving moderate or optimal clinician-reported outcome targets on patients with AD treated with their first systemic therapy. Advanced systemic therapy (AST) included abrocitinib, dupilumab, tralokinumab, or upadacitinib, while conventional systemic therapy (CST) included methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, and systemic corticosteroids.

Patients in TARGET-DERM AD were treated and maintained on their first systemic therapy (either advanced or conventional) for up to 12 months. They had a validated Investigator’s Global Assessment of AD (vIGA-AD) score of 3 or 4 less than 45 days prior to initiation of systemic therapy or up to 14 days afterward. They also had at least one vIGA-AD assessment 3-12 months after initiating treatment. Outcome measures included IGA (defined as a score of 2 or less, with an optional target of 0 or 1), BSA (defined as a 50% BSA improvement, with an optimal target BSA of 2% or less), and the Worst-Itch Numeric Rating Scale (defined as at least a 4-point reduction, with an optimal target of 1 or less).

The analysis included 445 patients with a mean age of 31 years at enrollment. More than half (62%) were female and 45% were non-Hispanic Whites. Most patients (92%) were on an AST, mainly dupilumab, with smaller proportions treated with either tralokinumab, upadacitinib, or abrocitinib. Fewer than 10% of patients in the registry were being treated with CSTs.

At 6 months, 37% and approximately 67% of the AST-treated patients had inadequate responses in terms of skin clearance and itch outcomes, respectively. At 12 months, these figures were about 30% and 66%, respectively. CST-treated patients showed a similar trend. For patients starting an AST on or after Sept. 21, 2021, when three additional AST options were available (tralokinumab, upadacitinib, and abrocitinib), the proportion of patients demonstrating an adequate response over 12 months was generally similar to the overall cohort of those on ASTs.

“These findings suggest a need for alternative therapies and management strategies in AD treatment,” concluded Dr. Silverberg, who chaired the RAD symposium.

Dr. Silverberg reported being a consultant and/or an adviser for many pharmaceutical companies, and has received grant or research support from Galderma and Pfizer. The TARGET-DERM study is sponsored by Target PharmaSolutions.

Individuals with severe acne were considered less attractive, less worthy of friendship, and less likely to be hired for a job, compared with those who did not have acne, based on survey responses from more than 1300 individuals.

JAMA Network, 2023 American Medical Association

Self-stigma among people with acne has been examined in previous studies; however, “little is known about the prevalence and magnitude of stigmatizing attitudes of the general public toward individuals with acne,” wrote Ali Shields of Drexel University, Philadelphia, Pennsylvania, and her coauthors.

In the study, recently published in JAMA Dermatology, they reviewed survey data from 1357 adults aged 18 years and older who were identified through an online national research registry (ResearchMatch). The mean age of the participants was 42.4 years range). 67.7% were female.

Participants were randomly shown 1 of 12 standardized portraits of individuals that varied in skin tone, sex, and acne severity. They responded to questions about stigmatizing attitudes with respect to the portrait, including stereotype endorsement and desire for social distance.

With regard to social distance, survey participants were significantly less comfortable being friends with people with severe acne, compared with those who did not have acne (adjusted coefficient [aC], -0.28, P = .003). Compared with people without acne, participants also reported significantly less comfort in hiring someone with severe acne (aC, -0.33; P < .001), having physical contact (aC, -0.26; P = .006), dating (aC, -0.44; P = .004), and posting photos with that person on social media (aC, -0.50; P < .001).

With regard to common acne stereotypes, survey participants also rated individuals with severe acne as significantly more likely than those without acne to have poor hygiene and to be unattractive, unintelligent, unlikeable, immature, and untrustworthy (aCs, -1.04, -0.89, -0.42, -0.36, -0.52, and -0.40, respectively; P < .001 for all).

In a linear regression analysis, the researchers found no evidence of association modification by sex of the portraits presented, but found evidence that “the effect size of association of acne with stereotype endorsement was greater for individuals with dark skin.”

The findings were limited by several factors including the potential differences in degree of severity between images after the addition of acne because the baseline images were not exact controls for each other: Therefore comparisons between image sets based on skin tone or sex should be interpreted cautiously, the researchers noted. Other limitations included the homogeneous population of survey respondents and the inability to account for all aspects of stigma, they said.

However, the results illustrate the persistent stigma associated with acne and “highlight the need to identify approaches to reduce stigmatizing attitudes in the community and for adequate access to care, which might prevent negative downstream effects related to these stigmatizing attitudes,” the authors concluded.

The study was supported by a grant from the National Institute of Arthritis and Musculoskeletal Diseases to corresponding author John S. Barbieri, MD. Coauthor Arash Mostaghimi, MD, disclosed personal fees from hims & hers, AbbVie, Sun Pharmaceutical Industries, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN Pharmaceuticals, Boehringer Ingelheim, Fig.1 Beauty, Acom Healthcare, and Olaplex outside the current study. Dr. Barbieri disclosed personal fees from Dexcel Pharma for consulting outside the current study.

Individuals with severe acne were considered less attractive, less worthy of friendship, and less likely to be hired for a job, compared with those who did not have acne, based on survey responses from more than 1300 individuals.

JAMA Network, 2023 American Medical Association

Self-stigma among people with acne has been examined in previous studies; however, “little is known about the prevalence and magnitude of stigmatizing attitudes of the general public toward individuals with acne,” wrote Ali Shields of Drexel University, Philadelphia, Pennsylvania, and her coauthors.

In the study, recently published in JAMA Dermatology, they reviewed survey data from 1357 adults aged 18 years and older who were identified through an online national research registry (ResearchMatch). The mean age of the participants was 42.4 years range). 67.7% were female.

Participants were randomly shown 1 of 12 standardized portraits of individuals that varied in skin tone, sex, and acne severity. They responded to questions about stigmatizing attitudes with respect to the portrait, including stereotype endorsement and desire for social distance.

With regard to social distance, survey participants were significantly less comfortable being friends with people with severe acne, compared with those who did not have acne (adjusted coefficient [aC], -0.28, P = .003). Compared with people without acne, participants also reported significantly less comfort in hiring someone with severe acne (aC, -0.33; P < .001), having physical contact (aC, -0.26; P = .006), dating (aC, -0.44; P = .004), and posting photos with that person on social media (aC, -0.50; P < .001).

With regard to common acne stereotypes, survey participants also rated individuals with severe acne as significantly more likely than those without acne to have poor hygiene and to be unattractive, unintelligent, unlikeable, immature, and untrustworthy (aCs, -1.04, -0.89, -0.42, -0.36, -0.52, and -0.40, respectively; P < .001 for all).

In a linear regression analysis, the researchers found no evidence of association modification by sex of the portraits presented, but found evidence that “the effect size of association of acne with stereotype endorsement was greater for individuals with dark skin.”

The findings were limited by several factors including the potential differences in degree of severity between images after the addition of acne because the baseline images were not exact controls for each other: Therefore comparisons between image sets based on skin tone or sex should be interpreted cautiously, the researchers noted. Other limitations included the homogeneous population of survey respondents and the inability to account for all aspects of stigma, they said.

However, the results illustrate the persistent stigma associated with acne and “highlight the need to identify approaches to reduce stigmatizing attitudes in the community and for adequate access to care, which might prevent negative downstream effects related to these stigmatizing attitudes,” the authors concluded.

The study was supported by a grant from the National Institute of Arthritis and Musculoskeletal Diseases to corresponding author John S. Barbieri, MD. Coauthor Arash Mostaghimi, MD, disclosed personal fees from hims & hers, AbbVie, Sun Pharmaceutical Industries, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN Pharmaceuticals, Boehringer Ingelheim, Fig.1 Beauty, Acom Healthcare, and Olaplex outside the current study. Dr. Barbieri disclosed personal fees from Dexcel Pharma for consulting outside the current study.

Individuals with severe acne were considered less attractive, less worthy of friendship, and less likely to be hired for a job, compared with those who did not have acne, based on survey responses from more than 1300 individuals.

JAMA Network, 2023 American Medical Association

Self-stigma among people with acne has been examined in previous studies; however, “little is known about the prevalence and magnitude of stigmatizing attitudes of the general public toward individuals with acne,” wrote Ali Shields of Drexel University, Philadelphia, Pennsylvania, and her coauthors.

In the study, recently published in JAMA Dermatology, they reviewed survey data from 1357 adults aged 18 years and older who were identified through an online national research registry (ResearchMatch). The mean age of the participants was 42.4 years range). 67.7% were female.

Participants were randomly shown 1 of 12 standardized portraits of individuals that varied in skin tone, sex, and acne severity. They responded to questions about stigmatizing attitudes with respect to the portrait, including stereotype endorsement and desire for social distance.

With regard to social distance, survey participants were significantly less comfortable being friends with people with severe acne, compared with those who did not have acne (adjusted coefficient [aC], -0.28, P = .003). Compared with people without acne, participants also reported significantly less comfort in hiring someone with severe acne (aC, -0.33; P < .001), having physical contact (aC, -0.26; P = .006), dating (aC, -0.44; P = .004), and posting photos with that person on social media (aC, -0.50; P < .001).

With regard to common acne stereotypes, survey participants also rated individuals with severe acne as significantly more likely than those without acne to have poor hygiene and to be unattractive, unintelligent, unlikeable, immature, and untrustworthy (aCs, -1.04, -0.89, -0.42, -0.36, -0.52, and -0.40, respectively; P < .001 for all).

In a linear regression analysis, the researchers found no evidence of association modification by sex of the portraits presented, but found evidence that “the effect size of association of acne with stereotype endorsement was greater for individuals with dark skin.”

The findings were limited by several factors including the potential differences in degree of severity between images after the addition of acne because the baseline images were not exact controls for each other: Therefore comparisons between image sets based on skin tone or sex should be interpreted cautiously, the researchers noted. Other limitations included the homogeneous population of survey respondents and the inability to account for all aspects of stigma, they said.

However, the results illustrate the persistent stigma associated with acne and “highlight the need to identify approaches to reduce stigmatizing attitudes in the community and for adequate access to care, which might prevent negative downstream effects related to these stigmatizing attitudes,” the authors concluded.

The study was supported by a grant from the National Institute of Arthritis and Musculoskeletal Diseases to corresponding author John S. Barbieri, MD. Coauthor Arash Mostaghimi, MD, disclosed personal fees from hims & hers, AbbVie, Sun Pharmaceutical Industries, Pfizer, Digital Diagnostics, Lilly, Equillium, ASLAN Pharmaceuticals, Boehringer Ingelheim, Fig.1 Beauty, Acom Healthcare, and Olaplex outside the current study. Dr. Barbieri disclosed personal fees from Dexcel Pharma for consulting outside the current study.

Following the initial presentation, the lesion was initially considered an acquired port wine stain and the child was referred for laser treatment. Upon reassessment during laser treatment a few months later, the lesion had progressed to hyper- and hypopigmented plaques with associated tissue sclerosis and bone atrophy on the mid forehead, nose, and scalp. Patches of alopecia and atrophy were observed on the frontal scalp. The diagnosis was revised to linear morphea en coup de sabre and the child was referred to pediatric rheumatology and commenced treatment with methotrexate and oral corticosteroids.

Linear morphea, a rare connective tissue disorder, primarily affects girls in the first 2 decades of life. Lesions can initially present in many ways. Usually, they present as hypo- or hyperpigmented patches, but may also present as lichenoid uncolored or pink plaques resembling lichen striatus. There may also be erythematous patches mimicking a capillary malformation, as seen in our patient. A recent article reviewing the progression of the lesions from erythematous patches to sclerosis suggests it occurs between 3 and 7 months of age. Subsequent stages manifest as significant atrophy, hypo- and hyperpigmentation, and in severe cases, bone atrophy and deformity, often causing substantial cosmetic disfigurement and functional impairment.

Pathophysiologically, linear morphea involves a complex interplay of immunologic, vascular, and fibrotic processes. While the initial triggers remain elusive, dysregulated immune responses leading to endothelial injury, subsequent activation of fibroblasts and myofibroblasts, and excessive collagen deposition are implicated. Angiogenic disturbances exacerbate tissue ischemia, perpetuating the fibrotic cascade. Alterations in cytokine signaling pathways, particularly TGF-beta and interleukin-6, play pivotal roles in promoting fibrosis and modulating the inflammatory milieu.

Diagnosis of linear morphea en coup de sabre relies on clinical examination, imaging (ultrasonography, MRI, CT scan), and skin biopsy for histopathological analysis. Imaging helps evaluate tissue involvement, while histology reveals characteristic dermal sclerosis, collagen deposition, and inflammation. Early-stage histology may show telangiectatic changes, complicating its differentiation from capillary malformation.

Treatment aims to mitigate symptoms, halt disease progression, and improve cosmesis and functionality. This involves a multidisciplinary approach with systemic medications, phototherapy, physical therapy, and surgical interventions in severe cases. Early identification is crucial for systemic treatments such as methotrexate and systemic corticosteroids to arrest disease progression. Other adjunctive therapies include topical corticosteroids, calcineurin inhibitors, and phototherapy. Surgical procedures like tissue expansion or autologous fat grafting may address tissue atrophy and deformities.

Linear morphea en coup de sabre presents diagnostic and therapeutic challenges because of its rarity and variable clinical course. Collaborative efforts among dermatologists, rheumatologists, radiologists, and surgeons are essential for accurate diagnosis, evaluation, and tailored management. Continued research into pathogenesis and novel therapeutic agents is pivotal to enhance understanding and improve outcomes for those affected by this enigmatic dermatologic condition.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

References

Gomez-Garcia LA et al. Pediatr Dermatol. 2022 Mar;39(2):275-80.

Ng SS, Tay YK. J Cosmet Laser Ther. 2015;17(5):277-80.

Nijhawan RI et al. J Am Acad Dermatol. 2011 Apr;64(4):779-82.

Following the initial presentation, the lesion was initially considered an acquired port wine stain and the child was referred for laser treatment. Upon reassessment during laser treatment a few months later, the lesion had progressed to hyper- and hypopigmented plaques with associated tissue sclerosis and bone atrophy on the mid forehead, nose, and scalp. Patches of alopecia and atrophy were observed on the frontal scalp. The diagnosis was revised to linear morphea en coup de sabre and the child was referred to pediatric rheumatology and commenced treatment with methotrexate and oral corticosteroids.

Linear morphea, a rare connective tissue disorder, primarily affects girls in the first 2 decades of life. Lesions can initially present in many ways. Usually, they present as hypo- or hyperpigmented patches, but may also present as lichenoid uncolored or pink plaques resembling lichen striatus. There may also be erythematous patches mimicking a capillary malformation, as seen in our patient. A recent article reviewing the progression of the lesions from erythematous patches to sclerosis suggests it occurs between 3 and 7 months of age. Subsequent stages manifest as significant atrophy, hypo- and hyperpigmentation, and in severe cases, bone atrophy and deformity, often causing substantial cosmetic disfigurement and functional impairment.

Pathophysiologically, linear morphea involves a complex interplay of immunologic, vascular, and fibrotic processes. While the initial triggers remain elusive, dysregulated immune responses leading to endothelial injury, subsequent activation of fibroblasts and myofibroblasts, and excessive collagen deposition are implicated. Angiogenic disturbances exacerbate tissue ischemia, perpetuating the fibrotic cascade. Alterations in cytokine signaling pathways, particularly TGF-beta and interleukin-6, play pivotal roles in promoting fibrosis and modulating the inflammatory milieu.

Diagnosis of linear morphea en coup de sabre relies on clinical examination, imaging (ultrasonography, MRI, CT scan), and skin biopsy for histopathological analysis. Imaging helps evaluate tissue involvement, while histology reveals characteristic dermal sclerosis, collagen deposition, and inflammation. Early-stage histology may show telangiectatic changes, complicating its differentiation from capillary malformation.

Treatment aims to mitigate symptoms, halt disease progression, and improve cosmesis and functionality. This involves a multidisciplinary approach with systemic medications, phototherapy, physical therapy, and surgical interventions in severe cases. Early identification is crucial for systemic treatments such as methotrexate and systemic corticosteroids to arrest disease progression. Other adjunctive therapies include topical corticosteroids, calcineurin inhibitors, and phototherapy. Surgical procedures like tissue expansion or autologous fat grafting may address tissue atrophy and deformities.

Linear morphea en coup de sabre presents diagnostic and therapeutic challenges because of its rarity and variable clinical course. Collaborative efforts among dermatologists, rheumatologists, radiologists, and surgeons are essential for accurate diagnosis, evaluation, and tailored management. Continued research into pathogenesis and novel therapeutic agents is pivotal to enhance understanding and improve outcomes for those affected by this enigmatic dermatologic condition.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

References

Gomez-Garcia LA et al. Pediatr Dermatol. 2022 Mar;39(2):275-80.

Ng SS, Tay YK. J Cosmet Laser Ther. 2015;17(5):277-80.

Nijhawan RI et al. J Am Acad Dermatol. 2011 Apr;64(4):779-82.

Following the initial presentation, the lesion was initially considered an acquired port wine stain and the child was referred for laser treatment. Upon reassessment during laser treatment a few months later, the lesion had progressed to hyper- and hypopigmented plaques with associated tissue sclerosis and bone atrophy on the mid forehead, nose, and scalp. Patches of alopecia and atrophy were observed on the frontal scalp. The diagnosis was revised to linear morphea en coup de sabre and the child was referred to pediatric rheumatology and commenced treatment with methotrexate and oral corticosteroids.

Linear morphea, a rare connective tissue disorder, primarily affects girls in the first 2 decades of life. Lesions can initially present in many ways. Usually, they present as hypo- or hyperpigmented patches, but may also present as lichenoid uncolored or pink plaques resembling lichen striatus. There may also be erythematous patches mimicking a capillary malformation, as seen in our patient. A recent article reviewing the progression of the lesions from erythematous patches to sclerosis suggests it occurs between 3 and 7 months of age. Subsequent stages manifest as significant atrophy, hypo- and hyperpigmentation, and in severe cases, bone atrophy and deformity, often causing substantial cosmetic disfigurement and functional impairment.

Pathophysiologically, linear morphea involves a complex interplay of immunologic, vascular, and fibrotic processes. While the initial triggers remain elusive, dysregulated immune responses leading to endothelial injury, subsequent activation of fibroblasts and myofibroblasts, and excessive collagen deposition are implicated. Angiogenic disturbances exacerbate tissue ischemia, perpetuating the fibrotic cascade. Alterations in cytokine signaling pathways, particularly TGF-beta and interleukin-6, play pivotal roles in promoting fibrosis and modulating the inflammatory milieu.

Diagnosis of linear morphea en coup de sabre relies on clinical examination, imaging (ultrasonography, MRI, CT scan), and skin biopsy for histopathological analysis. Imaging helps evaluate tissue involvement, while histology reveals characteristic dermal sclerosis, collagen deposition, and inflammation. Early-stage histology may show telangiectatic changes, complicating its differentiation from capillary malformation.

Treatment aims to mitigate symptoms, halt disease progression, and improve cosmesis and functionality. This involves a multidisciplinary approach with systemic medications, phototherapy, physical therapy, and surgical interventions in severe cases. Early identification is crucial for systemic treatments such as methotrexate and systemic corticosteroids to arrest disease progression. Other adjunctive therapies include topical corticosteroids, calcineurin inhibitors, and phototherapy. Surgical procedures like tissue expansion or autologous fat grafting may address tissue atrophy and deformities.

Linear morphea en coup de sabre presents diagnostic and therapeutic challenges because of its rarity and variable clinical course. Collaborative efforts among dermatologists, rheumatologists, radiologists, and surgeons are essential for accurate diagnosis, evaluation, and tailored management. Continued research into pathogenesis and novel therapeutic agents is pivotal to enhance understanding and improve outcomes for those affected by this enigmatic dermatologic condition.

Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.

References

Gomez-Garcia LA et al. Pediatr Dermatol. 2022 Mar;39(2):275-80.

Ng SS, Tay YK. J Cosmet Laser Ther. 2015;17(5):277-80.

Nijhawan RI et al. J Am Acad Dermatol. 2011 Apr;64(4):779-82.

Treatment with bimekizumab significantly improved symptoms in adults with palmoplantar pustulosis (PPP) and palmoplantar plaque psoriasis with pustules, in a case series of 21 individuals.

PPP is a type of pustular psoriasis that remains a treatment challenge, and available treatments for palmoplantar plaque psoriasis with pustules also “remain unsatisfactory,” according to Thierry Passeron, MD, PhD, of the dermatology service at Centre Hospitalier Universitaire de Nice (France), and colleagues. Bimekizumab, an anti-interleukin (IL)-17A and anti-IL-17F antibody therapy, has been used for psoriasis and psoriatic arthritis (PsA), but its effectiveness for PPP has not been studied, they said. In the United States, bimekizumab (Bimzelx), administered subcutaneously, was recently approved for treating moderate to severe plaque psoriasis in adults; in the European Union, it is approved for treating psoriasis, in addition to psoriatic arthritis, axial spondyloarthritis and ankylosing spondylitis.

In the case series published in JAMA Dermatology, Dr. Passeron and coinvestigators identified 11 adults with PPP and 10 with palmoplantar plaque psoriasis with pustules who were treated at one of seven tertiary dermatology centers in France from September 2022 through June 2023. PPP also has been associated with bone and joint inflammation in SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) syndrome.

All patients received bimekizumab for at least 3 months. The patients — 19 women and 2 men — ranged in age from 24 to 68 years (mean age, 46 years). The primary outcome was complete clearance, defined as an Investigator Global Assessment (IGA) score of 0.

A total of 17 patients achieved an IGA score of zero in 1-4 months. Over 3-6 months, three patients achieved an IGA score of 1 (almost clear), and one patient achieved an IGA score of 2 (mild).

Three patients with PPP also had acrodermatitis continua of Hallopeau; in these patients, nail involvement improved by 50%-70% after 4-6 months of bimekizumab use. Two patients with SAPHO experienced complete clearance of skin lesions associated with improvement in joint pain.

Four patients developed oral and genital candidiasis during treatment, but all were treated successfully with antifungals. None of the patients discontinued bimekizumab because of adverse events. “All patients are still receiving treatment, and their psoriatic lesions remain controlled,” the authors wrote.

“The rapid and consistent improvement observed in the present case series supports the effectiveness of bimekizumab therapy in managing PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome,” they said in their discussion.

The study findings were limited by several factors including the small sample size and short follow-up period, and by the inclusion of only patients with severe disease; and prospective, placebo-controlled studies are needed to confirm the results, the researchers noted.

However, the results suggest that bimekizumab could be a treatment approach for PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome, and warrant a prospective, randomized, placebo-controlled, randomized clinical trial to confirm the findings, they concluded.

Dr. Passeron disclosed fees from AbbVie, ACM Pharma, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Calypso, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte, Janssen, LEO Pharma, Eli Lilly, Novartis, Roivant Sciences, Sun Pharmaceuticals, and VYNE Therapeutics outside the current study; he is a cofounder of Yukin Therapeutics. Three authors disclosed receiving personal fees from UCB, manufacturer of bimekizumab, outside of the submitted work, another author disclosed receiving personal fees from UCB during the conduct of the study, and another reported receiving grants from UCB and several other companies, outside the submitted work.

The study findings were also presented at a meeting, Les Journées Dermatologiques de Paris 2023, on December 6, in Paris.

Treatment with bimekizumab significantly improved symptoms in adults with palmoplantar pustulosis (PPP) and palmoplantar plaque psoriasis with pustules, in a case series of 21 individuals.

PPP is a type of pustular psoriasis that remains a treatment challenge, and available treatments for palmoplantar plaque psoriasis with pustules also “remain unsatisfactory,” according to Thierry Passeron, MD, PhD, of the dermatology service at Centre Hospitalier Universitaire de Nice (France), and colleagues. Bimekizumab, an anti-interleukin (IL)-17A and anti-IL-17F antibody therapy, has been used for psoriasis and psoriatic arthritis (PsA), but its effectiveness for PPP has not been studied, they said. In the United States, bimekizumab (Bimzelx), administered subcutaneously, was recently approved for treating moderate to severe plaque psoriasis in adults; in the European Union, it is approved for treating psoriasis, in addition to psoriatic arthritis, axial spondyloarthritis and ankylosing spondylitis.

In the case series published in JAMA Dermatology, Dr. Passeron and coinvestigators identified 11 adults with PPP and 10 with palmoplantar plaque psoriasis with pustules who were treated at one of seven tertiary dermatology centers in France from September 2022 through June 2023. PPP also has been associated with bone and joint inflammation in SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) syndrome.

All patients received bimekizumab for at least 3 months. The patients — 19 women and 2 men — ranged in age from 24 to 68 years (mean age, 46 years). The primary outcome was complete clearance, defined as an Investigator Global Assessment (IGA) score of 0.

A total of 17 patients achieved an IGA score of zero in 1-4 months. Over 3-6 months, three patients achieved an IGA score of 1 (almost clear), and one patient achieved an IGA score of 2 (mild).

Three patients with PPP also had acrodermatitis continua of Hallopeau; in these patients, nail involvement improved by 50%-70% after 4-6 months of bimekizumab use. Two patients with SAPHO experienced complete clearance of skin lesions associated with improvement in joint pain.

Four patients developed oral and genital candidiasis during treatment, but all were treated successfully with antifungals. None of the patients discontinued bimekizumab because of adverse events. “All patients are still receiving treatment, and their psoriatic lesions remain controlled,” the authors wrote.

“The rapid and consistent improvement observed in the present case series supports the effectiveness of bimekizumab therapy in managing PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome,” they said in their discussion.

The study findings were limited by several factors including the small sample size and short follow-up period, and by the inclusion of only patients with severe disease; and prospective, placebo-controlled studies are needed to confirm the results, the researchers noted.

However, the results suggest that bimekizumab could be a treatment approach for PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome, and warrant a prospective, randomized, placebo-controlled, randomized clinical trial to confirm the findings, they concluded.

Dr. Passeron disclosed fees from AbbVie, ACM Pharma, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Calypso, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte, Janssen, LEO Pharma, Eli Lilly, Novartis, Roivant Sciences, Sun Pharmaceuticals, and VYNE Therapeutics outside the current study; he is a cofounder of Yukin Therapeutics. Three authors disclosed receiving personal fees from UCB, manufacturer of bimekizumab, outside of the submitted work, another author disclosed receiving personal fees from UCB during the conduct of the study, and another reported receiving grants from UCB and several other companies, outside the submitted work.

The study findings were also presented at a meeting, Les Journées Dermatologiques de Paris 2023, on December 6, in Paris.

Treatment with bimekizumab significantly improved symptoms in adults with palmoplantar pustulosis (PPP) and palmoplantar plaque psoriasis with pustules, in a case series of 21 individuals.

PPP is a type of pustular psoriasis that remains a treatment challenge, and available treatments for palmoplantar plaque psoriasis with pustules also “remain unsatisfactory,” according to Thierry Passeron, MD, PhD, of the dermatology service at Centre Hospitalier Universitaire de Nice (France), and colleagues. Bimekizumab, an anti-interleukin (IL)-17A and anti-IL-17F antibody therapy, has been used for psoriasis and psoriatic arthritis (PsA), but its effectiveness for PPP has not been studied, they said. In the United States, bimekizumab (Bimzelx), administered subcutaneously, was recently approved for treating moderate to severe plaque psoriasis in adults; in the European Union, it is approved for treating psoriasis, in addition to psoriatic arthritis, axial spondyloarthritis and ankylosing spondylitis.

In the case series published in JAMA Dermatology, Dr. Passeron and coinvestigators identified 11 adults with PPP and 10 with palmoplantar plaque psoriasis with pustules who were treated at one of seven tertiary dermatology centers in France from September 2022 through June 2023. PPP also has been associated with bone and joint inflammation in SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) syndrome.

All patients received bimekizumab for at least 3 months. The patients — 19 women and 2 men — ranged in age from 24 to 68 years (mean age, 46 years). The primary outcome was complete clearance, defined as an Investigator Global Assessment (IGA) score of 0.

A total of 17 patients achieved an IGA score of zero in 1-4 months. Over 3-6 months, three patients achieved an IGA score of 1 (almost clear), and one patient achieved an IGA score of 2 (mild).

Three patients with PPP also had acrodermatitis continua of Hallopeau; in these patients, nail involvement improved by 50%-70% after 4-6 months of bimekizumab use. Two patients with SAPHO experienced complete clearance of skin lesions associated with improvement in joint pain.

Four patients developed oral and genital candidiasis during treatment, but all were treated successfully with antifungals. None of the patients discontinued bimekizumab because of adverse events. “All patients are still receiving treatment, and their psoriatic lesions remain controlled,” the authors wrote.

“The rapid and consistent improvement observed in the present case series supports the effectiveness of bimekizumab therapy in managing PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome,” they said in their discussion.

The study findings were limited by several factors including the small sample size and short follow-up period, and by the inclusion of only patients with severe disease; and prospective, placebo-controlled studies are needed to confirm the results, the researchers noted.

However, the results suggest that bimekizumab could be a treatment approach for PPP, palmoplantar plaque psoriasis with pustules, and SAPHO syndrome, and warrant a prospective, randomized, placebo-controlled, randomized clinical trial to confirm the findings, they concluded.

Dr. Passeron disclosed fees from AbbVie, ACM Pharma, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Calypso, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte, Janssen, LEO Pharma, Eli Lilly, Novartis, Roivant Sciences, Sun Pharmaceuticals, and VYNE Therapeutics outside the current study; he is a cofounder of Yukin Therapeutics. Three authors disclosed receiving personal fees from UCB, manufacturer of bimekizumab, outside of the submitted work, another author disclosed receiving personal fees from UCB during the conduct of the study, and another reported receiving grants from UCB and several other companies, outside the submitted work.

The study findings were also presented at a meeting, Les Journées Dermatologiques de Paris 2023, on December 6, in Paris.

Tape stripping, which allows sampling of the epidermis to the midgranular layer, is a valid, minimally invasive way to identify cutaneous biomarkers in patients with hidradenitis suppurative (HS), results from a novel study showed.

“Tape strips can provide important clues to when and which drugs to use in HS in patients with both early and late disease, which can change clinical practice,” corresponding study author Emma Guttman-Yassky, MD, PhD, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said in an interview. “It is noninvasive and nonscarring,” she added.

Tape stripping has been validated in atopic dermatitis, psoriasis, and other dermatologic conditions in recent years. For the current study, which was published online in the Journal of the American Academy of Dermatology, and is believed to be the first of its kind, Dr. Guttman-Yassky and colleagues performed RNA sequencing from large D-Squame tape strips collected from lesional and nonlesional skin of 22 patients with HS and from 21 age- and sex-matched healthy controls. They correlated the expression of skin biomarkers between tape strips and a previously published gene-signature of HS biopsies. The mean age of patients with HS was 43 years, while the mean age of healthy controls was 35. The average International Hidradenitis Suppurativa Severity Score System (IHS4) score of the HS cohort was 36.

Consistent with published studies, the researchers found that tape strips identified an overall higher inflammatory burden in HS. Specifically, they observed an upregulation of known cytokines within the following pathways: Th1 (such as IFNG, CXCL9/10/11, and CCR5); Th17 (such as interleukin [IL]-17A/F, IL12B, IL23A, CAMP, and CCL20); Th2 (such as IL4R, IL13/IL31/IL10, CCR4, CCL7/CCL13/CCL24, TNFSF4/OX40L, and TNFRSF4/OX40); and Th22 (such as IL22 and IL32).

The researchers also found that the expression of Th17 and tumor necrosis factor (TNF)–alpha pathways were highly correlated between tape strips and biopsies and that HS clinical severity was significantly associated with expression of biomarkers, such as TNF-alpha, IL17A/F, OX40, JAK1-3, and IL4R in HS lesional and/or nonlesional skin.

“It was quite unexpected that we are able to identify, using a minimally invasive approach that samples only the upper layers of the epidermis, products and processes that are considered to be deeper-situated, such as IL-17, and other immune markers,” Dr. Guttman-Yassky said in the interview. “We were also surprised to see how well the tape-stripped–derived skin molecular profile correlated with that of biopsies, as well as how well it correlated with the clinical disease severity of HS.”

Also surprising, she added, was that the biomarkers in nonlesional tape-stripped skin, such as IL-17 and TNF alpha, “show high correlations with disease severity and provide clues to early disease.”

If using tape strips in HS is validated in larger cohort studies, the potential cost implications of using this approach in practice remain unclear, Dr. Guttman-Yassky said. “It is currently not cheap, but we are hoping that one day, we can provide a means to diagnose the disease and treat it early, and appropriately, utilizing this approach,” she commented. “We are excited about the applicability of this study to the early treatment and longitudinal follow up of HS with drugs that are targeting specific immune molecules and pathways,” she said, adding that it will also be useful for helping determine which drug should be used for which patient.

She and her co-authors acknowledged certain limitations of the study, including its small sample size and the fact that tape stripping is limited to the epidermis.

Asked to comment on the study, Jennifer L. Hsiao, MD, a dermatologist who directs the HS clinic at the University of Southern California, Los Angeles, said the findings “have important potential implications for our ability to one day personalize treatments for a patient with early HS in a minimally invasive way.”

As the study authors point out, she added, “tape strips only allow sampling of the epidermis, which is limiting in a disease like HS where much of the disruption is in the dermis with deep nodules and dermal tunnels. However, our overall goal should be to catch patients in the early stages of their disease before the occurrence of irreversible tissue damage such as dermal tunnels. Thus, the ongoing campaign for early diagnosis and early intervention by various stakeholders in the field of HS can help mitigate the impact of this inherent limitation of tape strips. It will be exciting to see larger studies that investigate tape strip results in relation to clinical phenotypes, disease progression, and therapeutic responses.”

The study was funded by an International Dermatology Outcome Measures Hidradenitis Suppurativa Grant. Dr. Guttman-Yassky disclosed that she has been a consultant to, an adviser for, and has received research grants from many pharmaceutical companies. Of the remaining authors, 2 also had multiple disclosures and 11 had no disclosures. Dr. Hsiao disclosed that she is a member of the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

Tape stripping, which allows sampling of the epidermis to the midgranular layer, is a valid, minimally invasive way to identify cutaneous biomarkers in patients with hidradenitis suppurative (HS), results from a novel study showed.

“Tape strips can provide important clues to when and which drugs to use in HS in patients with both early and late disease, which can change clinical practice,” corresponding study author Emma Guttman-Yassky, MD, PhD, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said in an interview. “It is noninvasive and nonscarring,” she added.

Tape stripping has been validated in atopic dermatitis, psoriasis, and other dermatologic conditions in recent years. For the current study, which was published online in the Journal of the American Academy of Dermatology, and is believed to be the first of its kind, Dr. Guttman-Yassky and colleagues performed RNA sequencing from large D-Squame tape strips collected from lesional and nonlesional skin of 22 patients with HS and from 21 age- and sex-matched healthy controls. They correlated the expression of skin biomarkers between tape strips and a previously published gene-signature of HS biopsies. The mean age of patients with HS was 43 years, while the mean age of healthy controls was 35. The average International Hidradenitis Suppurativa Severity Score System (IHS4) score of the HS cohort was 36.

Consistent with published studies, the researchers found that tape strips identified an overall higher inflammatory burden in HS. Specifically, they observed an upregulation of known cytokines within the following pathways: Th1 (such as IFNG, CXCL9/10/11, and CCR5); Th17 (such as interleukin [IL]-17A/F, IL12B, IL23A, CAMP, and CCL20); Th2 (such as IL4R, IL13/IL31/IL10, CCR4, CCL7/CCL13/CCL24, TNFSF4/OX40L, and TNFRSF4/OX40); and Th22 (such as IL22 and IL32).

The researchers also found that the expression of Th17 and tumor necrosis factor (TNF)–alpha pathways were highly correlated between tape strips and biopsies and that HS clinical severity was significantly associated with expression of biomarkers, such as TNF-alpha, IL17A/F, OX40, JAK1-3, and IL4R in HS lesional and/or nonlesional skin.

“It was quite unexpected that we are able to identify, using a minimally invasive approach that samples only the upper layers of the epidermis, products and processes that are considered to be deeper-situated, such as IL-17, and other immune markers,” Dr. Guttman-Yassky said in the interview. “We were also surprised to see how well the tape-stripped–derived skin molecular profile correlated with that of biopsies, as well as how well it correlated with the clinical disease severity of HS.”

Also surprising, she added, was that the biomarkers in nonlesional tape-stripped skin, such as IL-17 and TNF alpha, “show high correlations with disease severity and provide clues to early disease.”

If using tape strips in HS is validated in larger cohort studies, the potential cost implications of using this approach in practice remain unclear, Dr. Guttman-Yassky said. “It is currently not cheap, but we are hoping that one day, we can provide a means to diagnose the disease and treat it early, and appropriately, utilizing this approach,” she commented. “We are excited about the applicability of this study to the early treatment and longitudinal follow up of HS with drugs that are targeting specific immune molecules and pathways,” she said, adding that it will also be useful for helping determine which drug should be used for which patient.

She and her co-authors acknowledged certain limitations of the study, including its small sample size and the fact that tape stripping is limited to the epidermis.

Asked to comment on the study, Jennifer L. Hsiao, MD, a dermatologist who directs the HS clinic at the University of Southern California, Los Angeles, said the findings “have important potential implications for our ability to one day personalize treatments for a patient with early HS in a minimally invasive way.”

As the study authors point out, she added, “tape strips only allow sampling of the epidermis, which is limiting in a disease like HS where much of the disruption is in the dermis with deep nodules and dermal tunnels. However, our overall goal should be to catch patients in the early stages of their disease before the occurrence of irreversible tissue damage such as dermal tunnels. Thus, the ongoing campaign for early diagnosis and early intervention by various stakeholders in the field of HS can help mitigate the impact of this inherent limitation of tape strips. It will be exciting to see larger studies that investigate tape strip results in relation to clinical phenotypes, disease progression, and therapeutic responses.”

The study was funded by an International Dermatology Outcome Measures Hidradenitis Suppurativa Grant. Dr. Guttman-Yassky disclosed that she has been a consultant to, an adviser for, and has received research grants from many pharmaceutical companies. Of the remaining authors, 2 also had multiple disclosures and 11 had no disclosures. Dr. Hsiao disclosed that she is a member of the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

Tape stripping, which allows sampling of the epidermis to the midgranular layer, is a valid, minimally invasive way to identify cutaneous biomarkers in patients with hidradenitis suppurative (HS), results from a novel study showed.

“Tape strips can provide important clues to when and which drugs to use in HS in patients with both early and late disease, which can change clinical practice,” corresponding study author Emma Guttman-Yassky, MD, PhD, professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York City, said in an interview. “It is noninvasive and nonscarring,” she added.

Tape stripping has been validated in atopic dermatitis, psoriasis, and other dermatologic conditions in recent years. For the current study, which was published online in the Journal of the American Academy of Dermatology, and is believed to be the first of its kind, Dr. Guttman-Yassky and colleagues performed RNA sequencing from large D-Squame tape strips collected from lesional and nonlesional skin of 22 patients with HS and from 21 age- and sex-matched healthy controls. They correlated the expression of skin biomarkers between tape strips and a previously published gene-signature of HS biopsies. The mean age of patients with HS was 43 years, while the mean age of healthy controls was 35. The average International Hidradenitis Suppurativa Severity Score System (IHS4) score of the HS cohort was 36.

Consistent with published studies, the researchers found that tape strips identified an overall higher inflammatory burden in HS. Specifically, they observed an upregulation of known cytokines within the following pathways: Th1 (such as IFNG, CXCL9/10/11, and CCR5); Th17 (such as interleukin [IL]-17A/F, IL12B, IL23A, CAMP, and CCL20); Th2 (such as IL4R, IL13/IL31/IL10, CCR4, CCL7/CCL13/CCL24, TNFSF4/OX40L, and TNFRSF4/OX40); and Th22 (such as IL22 and IL32).

The researchers also found that the expression of Th17 and tumor necrosis factor (TNF)–alpha pathways were highly correlated between tape strips and biopsies and that HS clinical severity was significantly associated with expression of biomarkers, such as TNF-alpha, IL17A/F, OX40, JAK1-3, and IL4R in HS lesional and/or nonlesional skin.

“It was quite unexpected that we are able to identify, using a minimally invasive approach that samples only the upper layers of the epidermis, products and processes that are considered to be deeper-situated, such as IL-17, and other immune markers,” Dr. Guttman-Yassky said in the interview. “We were also surprised to see how well the tape-stripped–derived skin molecular profile correlated with that of biopsies, as well as how well it correlated with the clinical disease severity of HS.”

Also surprising, she added, was that the biomarkers in nonlesional tape-stripped skin, such as IL-17 and TNF alpha, “show high correlations with disease severity and provide clues to early disease.”

If using tape strips in HS is validated in larger cohort studies, the potential cost implications of using this approach in practice remain unclear, Dr. Guttman-Yassky said. “It is currently not cheap, but we are hoping that one day, we can provide a means to diagnose the disease and treat it early, and appropriately, utilizing this approach,” she commented. “We are excited about the applicability of this study to the early treatment and longitudinal follow up of HS with drugs that are targeting specific immune molecules and pathways,” she said, adding that it will also be useful for helping determine which drug should be used for which patient.

She and her co-authors acknowledged certain limitations of the study, including its small sample size and the fact that tape stripping is limited to the epidermis.

Asked to comment on the study, Jennifer L. Hsiao, MD, a dermatologist who directs the HS clinic at the University of Southern California, Los Angeles, said the findings “have important potential implications for our ability to one day personalize treatments for a patient with early HS in a minimally invasive way.”

As the study authors point out, she added, “tape strips only allow sampling of the epidermis, which is limiting in a disease like HS where much of the disruption is in the dermis with deep nodules and dermal tunnels. However, our overall goal should be to catch patients in the early stages of their disease before the occurrence of irreversible tissue damage such as dermal tunnels. Thus, the ongoing campaign for early diagnosis and early intervention by various stakeholders in the field of HS can help mitigate the impact of this inherent limitation of tape strips. It will be exciting to see larger studies that investigate tape strip results in relation to clinical phenotypes, disease progression, and therapeutic responses.”

The study was funded by an International Dermatology Outcome Measures Hidradenitis Suppurativa Grant. Dr. Guttman-Yassky disclosed that she has been a consultant to, an adviser for, and has received research grants from many pharmaceutical companies. Of the remaining authors, 2 also had multiple disclosures and 11 had no disclosures. Dr. Hsiao disclosed that she is a member of the board of directors for the Hidradenitis Suppurativa Foundation. She has also served as a consultant for AbbVie, Aclaris, Boehringer Ingelheim, Incyte, Novartis, and UCB; as a speaker for AbbVie; and as an investigator for Amgen, Boehringer Ingelheim, and Incyte.

Combined therapy with rituximab and omalizumab appears to be well tolerated, and improves outcomes and accelerates time to remission in patients with refractory bullous pemphigoid who do not respond to rituximab alone, results of a case series suggest.

Bullous pemphigoid (BP) is a rare, chronic, inflammatory, blistering disease that mainly occurs in people in their 50s through their 70s. BP has high morbidity and mortality, especially in people with comorbidities common to the elderly, yet no Food and Drug Administration–approved therapies for BP exist, Stephanie T. Le, MD, a dermatologist in the department of dermatology of the University of California, Davis, told this publication.

May Iosotaluno

All participants received 1000 mg intravenous rituximab on days 0 and 15. In addition to rituximab, seven patients received subcutaneous high-dose omalizumab (300 mg every 2 weeks); and three patients received low-dose omalizumab (300 mg every 4 weeks or 150 mg every 2 weeks).

After a mean of 2.1 months, all patients in the high-dose omalizumab-plus-rituximab group had achieved complete remission. By contrast, all patients in the low-dose omalizumab-plus-rituximab group improved after a mean of 13 months, and none achieved complete remission.

At 3 months, all study participants were rated as being very much improved. All four patients in the high-dose omalizumab group who tapered omalizumab dosage or frequency had flare-ups within 1-3 months that resolved when they restarted the medication. Among patients who achieved complete remission, 4 of 7 required rituximab redosing between 6 and 16 months later. Rituximab alone did not achieve remission: Three patients needed to add high-dose omalizumab. All reported adverse effects were mild.

Alternatives to Corticosteroids Are Needed

For BP, “with no FDA-approved therapies available, corticosteroids remain first line for acute flares. However, prolonged corticosteroid use is associated with multiple adverse effects, including increased susceptibility to infection, osteoporosis, and diabetes mellitus,” Dr. Le pointed out. “Patients with BP who are treated with high-dose corticosteroids have significantly increased mortality and have very poor 1-year survival.

“Rituximab and omalizumab dual therapy offers another potential treatment option for severe or treatment-refractory BP,” she added. “We are hopeful that other physicians will adopt this therapy.”

The authors acknowledged limitations of the study, including its retrospective design, small sample size, lack of standardized intervals between rituximab and omalizumab, and variation in concurrent therapies, and they recommended further related research.

No conflicts of interest were reported. No funding details were provided.

Combined therapy with rituximab and omalizumab appears to be well tolerated, and improves outcomes and accelerates time to remission in patients with refractory bullous pemphigoid who do not respond to rituximab alone, results of a case series suggest.

Bullous pemphigoid (BP) is a rare, chronic, inflammatory, blistering disease that mainly occurs in people in their 50s through their 70s. BP has high morbidity and mortality, especially in people with comorbidities common to the elderly, yet no Food and Drug Administration–approved therapies for BP exist, Stephanie T. Le, MD, a dermatologist in the department of dermatology of the University of California, Davis, told this publication.

May Iosotaluno

All participants received 1000 mg intravenous rituximab on days 0 and 15. In addition to rituximab, seven patients received subcutaneous high-dose omalizumab (300 mg every 2 weeks); and three patients received low-dose omalizumab (300 mg every 4 weeks or 150 mg every 2 weeks).

After a mean of 2.1 months, all patients in the high-dose omalizumab-plus-rituximab group had achieved complete remission. By contrast, all patients in the low-dose omalizumab-plus-rituximab group improved after a mean of 13 months, and none achieved complete remission.

At 3 months, all study participants were rated as being very much improved. All four patients in the high-dose omalizumab group who tapered omalizumab dosage or frequency had flare-ups within 1-3 months that resolved when they restarted the medication. Among patients who achieved complete remission, 4 of 7 required rituximab redosing between 6 and 16 months later. Rituximab alone did not achieve remission: Three patients needed to add high-dose omalizumab. All reported adverse effects were mild.

Alternatives to Corticosteroids Are Needed

For BP, “with no FDA-approved therapies available, corticosteroids remain first line for acute flares. However, prolonged corticosteroid use is associated with multiple adverse effects, including increased susceptibility to infection, osteoporosis, and diabetes mellitus,” Dr. Le pointed out. “Patients with BP who are treated with high-dose corticosteroids have significantly increased mortality and have very poor 1-year survival.

“Rituximab and omalizumab dual therapy offers another potential treatment option for severe or treatment-refractory BP,” she added. “We are hopeful that other physicians will adopt this therapy.”

The authors acknowledged limitations of the study, including its retrospective design, small sample size, lack of standardized intervals between rituximab and omalizumab, and variation in concurrent therapies, and they recommended further related research.

No conflicts of interest were reported. No funding details were provided.

Combined therapy with rituximab and omalizumab appears to be well tolerated, and improves outcomes and accelerates time to remission in patients with refractory bullous pemphigoid who do not respond to rituximab alone, results of a case series suggest.

Bullous pemphigoid (BP) is a rare, chronic, inflammatory, blistering disease that mainly occurs in people in their 50s through their 70s. BP has high morbidity and mortality, especially in people with comorbidities common to the elderly, yet no Food and Drug Administration–approved therapies for BP exist, Stephanie T. Le, MD, a dermatologist in the department of dermatology of the University of California, Davis, told this publication.

May Iosotaluno

All participants received 1000 mg intravenous rituximab on days 0 and 15. In addition to rituximab, seven patients received subcutaneous high-dose omalizumab (300 mg every 2 weeks); and three patients received low-dose omalizumab (300 mg every 4 weeks or 150 mg every 2 weeks).

After a mean of 2.1 months, all patients in the high-dose omalizumab-plus-rituximab group had achieved complete remission. By contrast, all patients in the low-dose omalizumab-plus-rituximab group improved after a mean of 13 months, and none achieved complete remission.

At 3 months, all study participants were rated as being very much improved. All four patients in the high-dose omalizumab group who tapered omalizumab dosage or frequency had flare-ups within 1-3 months that resolved when they restarted the medication. Among patients who achieved complete remission, 4 of 7 required rituximab redosing between 6 and 16 months later. Rituximab alone did not achieve remission: Three patients needed to add high-dose omalizumab. All reported adverse effects were mild.

Alternatives to Corticosteroids Are Needed

For BP, “with no FDA-approved therapies available, corticosteroids remain first line for acute flares. However, prolonged corticosteroid use is associated with multiple adverse effects, including increased susceptibility to infection, osteoporosis, and diabetes mellitus,” Dr. Le pointed out. “Patients with BP who are treated with high-dose corticosteroids have significantly increased mortality and have very poor 1-year survival.

“Rituximab and omalizumab dual therapy offers another potential treatment option for severe or treatment-refractory BP,” she added. “We are hopeful that other physicians will adopt this therapy.”

The authors acknowledged limitations of the study, including its retrospective design, small sample size, lack of standardized intervals between rituximab and omalizumab, and variation in concurrent therapies, and they recommended further related research.

No conflicts of interest were reported. No funding details were provided.

Follicular occlusion, mast cell disease, and eczema were common presentations among patients with hypermobile Ehlers-Danlos syndrome (hEDS), in a study of nearly 500 individuals.

The genetic cause of hEDS, a common inherited connective tissue disorder, remains unknown, wrote Alan Snyder, MD, of the department of dermatology and dermatologic surgery at Medical University of South Carolina, Charleston, and colleagues.

Previous research suggests that changes in dermal mechanics predispose these patients to a range of skin conditions including mast cell activation disorder (MCAD) spectrum and chronic spontaneous urticaria, abnormal scars or wound healing, piezogenic papules, dyshidrosis, skin laxity or softness, easy bruising, local anesthesia resistance, keratosis pilaris, striae, and hidradenitis suppurativa, the researchers wrote.

However, data on these and other dermatologic manifestations of hEDS are limited, they said.

The diagnosis of hEDS will continue to be made more frequently and carefully, as the condition becomes more recognized and understood in the medical community, especially with anticipated capabilities of genetic testing, Dr. Snyder said in an interview.

“Being able to be aware of disease-specific comorbidities, such as those discovered in this study, allows providers to better stratify phenotypes and improve patient disease co-management,” he said.

In the study, published in the Journal of the American Academy of Dermatology, the researchers reviewed data on 1,364 patients with ICD-10 or ICD-9 codes for hEDS or EDS unspecified who were seen at a single institution between June 2005 and May 2022. Most of the patients were White (95.4%) and female (86.7%); the average age was 29.2 years.

Of the 1,364 patients included in the chart review, 497 (36.4%) had documented skin manifestations. Of these, 118 (24.2%) had disorders of follicular occlusion (12 had hidradenitis suppurativa, 32 had folliculitis, and 74 had acne); 112 (23%) had eczema or atopic dermatitis, 98 (19.7%) had mast cell disorder, 32 (6.4%) had psoriasis, and 32 (6.4%) had wound healing issues (16 had hypertrophic keloids/scarring, 5 had abscesses, 3 had abnormal bruising, and 8 had other would healing issues).

The study also included results of a multiple-choice patient survey from 1,354 individuals. In the survey, approximately two-thirds of patients reported abnormal scarring, abnormal wound healing, and cutaneous laxity (61.7%, 69.0%, and 71.0%, respectively).

The findings were limited by several factors including the retrospective study design, lack of testing to confirm hEDS diagnosis, and the potential interdisciplinary selection bias for diagnoses, the authors noted.

However, the results support previous studies showing increased rates of occlusive conditions in hEDS and higher rates of acne, folliculitis, and psoriasis, and highlight the need for clinician education to manage patients and promote better outcomes, the researchers concluded.

Data Enhance Clinical Awareness

“Given the increasingly understood relation between TH2-directed and mast-cell mediated diseases and hEDS, it was not necessarily a surprise to find the increased prevalence of atopy and mast cell disease, but rather an interesting confirmation, within the limitations that exist with retrospective chart review,” Dr. Snyder told this news organization. “While it may make some intuitive sense that certain cohorts with higher risk of HS may have a higher risk of acne, this had not been reported in the literature to date,” he noted. “Given the high levels of patient reported issues with scarring and wound healing, I was surprised that so few analogous diagnoses were physician-reported in the medical records.”

In clinical practice, “health care professionals and patients need to be aware hEDS is associated with high rates of eczematous, mast-cell mediated and follicular occlusive cutaneous disorders,” Dr. Snyder said in an interview. “There seems to be a discrepancy between patients and physician awareness of scarring or wound healing issues in this patient population,” he added.

Looking ahead, “we need to better research and characterize the various hEDS phenotypes to understand who is at highest risk for various TH2-mediated or follicular occlusive disorders,” said Dr. Snyder. “Moreover, a greater understanding is needed of the wound healing inadequacies that predispose these patients to poor outcomes during dermatologic surgery,” he said.

The study was supported by the Ehlers-Danlos Society and the Milton and Tamar Maltz Family Foundation. The researchers had no financial conflicts to disclose.

Follicular occlusion, mast cell disease, and eczema were common presentations among patients with hypermobile Ehlers-Danlos syndrome (hEDS), in a study of nearly 500 individuals.

The genetic cause of hEDS, a common inherited connective tissue disorder, remains unknown, wrote Alan Snyder, MD, of the department of dermatology and dermatologic surgery at Medical University of South Carolina, Charleston, and colleagues.

Previous research suggests that changes in dermal mechanics predispose these patients to a range of skin conditions including mast cell activation disorder (MCAD) spectrum and chronic spontaneous urticaria, abnormal scars or wound healing, piezogenic papules, dyshidrosis, skin laxity or softness, easy bruising, local anesthesia resistance, keratosis pilaris, striae, and hidradenitis suppurativa, the researchers wrote.

However, data on these and other dermatologic manifestations of hEDS are limited, they said.

The diagnosis of hEDS will continue to be made more frequently and carefully, as the condition becomes more recognized and understood in the medical community, especially with anticipated capabilities of genetic testing, Dr. Snyder said in an interview.

“Being able to be aware of disease-specific comorbidities, such as those discovered in this study, allows providers to better stratify phenotypes and improve patient disease co-management,” he said.

In the study, published in the Journal of the American Academy of Dermatology, the researchers reviewed data on 1,364 patients with ICD-10 or ICD-9 codes for hEDS or EDS unspecified who were seen at a single institution between June 2005 and May 2022. Most of the patients were White (95.4%) and female (86.7%); the average age was 29.2 years.

Of the 1,364 patients included in the chart review, 497 (36.4%) had documented skin manifestations. Of these, 118 (24.2%) had disorders of follicular occlusion (12 had hidradenitis suppurativa, 32 had folliculitis, and 74 had acne); 112 (23%) had eczema or atopic dermatitis, 98 (19.7%) had mast cell disorder, 32 (6.4%) had psoriasis, and 32 (6.4%) had wound healing issues (16 had hypertrophic keloids/scarring, 5 had abscesses, 3 had abnormal bruising, and 8 had other would healing issues).

The study also included results of a multiple-choice patient survey from 1,354 individuals. In the survey, approximately two-thirds of patients reported abnormal scarring, abnormal wound healing, and cutaneous laxity (61.7%, 69.0%, and 71.0%, respectively).

The findings were limited by several factors including the retrospective study design, lack of testing to confirm hEDS diagnosis, and the potential interdisciplinary selection bias for diagnoses, the authors noted.

However, the results support previous studies showing increased rates of occlusive conditions in hEDS and higher rates of acne, folliculitis, and psoriasis, and highlight the need for clinician education to manage patients and promote better outcomes, the researchers concluded.

Data Enhance Clinical Awareness

“Given the increasingly understood relation between TH2-directed and mast-cell mediated diseases and hEDS, it was not necessarily a surprise to find the increased prevalence of atopy and mast cell disease, but rather an interesting confirmation, within the limitations that exist with retrospective chart review,” Dr. Snyder told this news organization. “While it may make some intuitive sense that certain cohorts with higher risk of HS may have a higher risk of acne, this had not been reported in the literature to date,” he noted. “Given the high levels of patient reported issues with scarring and wound healing, I was surprised that so few analogous diagnoses were physician-reported in the medical records.”

In clinical practice, “health care professionals and patients need to be aware hEDS is associated with high rates of eczematous, mast-cell mediated and follicular occlusive cutaneous disorders,” Dr. Snyder said in an interview. “There seems to be a discrepancy between patients and physician awareness of scarring or wound healing issues in this patient population,” he added.

Looking ahead, “we need to better research and characterize the various hEDS phenotypes to understand who is at highest risk for various TH2-mediated or follicular occlusive disorders,” said Dr. Snyder. “Moreover, a greater understanding is needed of the wound healing inadequacies that predispose these patients to poor outcomes during dermatologic surgery,” he said.

The study was supported by the Ehlers-Danlos Society and the Milton and Tamar Maltz Family Foundation. The researchers had no financial conflicts to disclose.

Follicular occlusion, mast cell disease, and eczema were common presentations among patients with hypermobile Ehlers-Danlos syndrome (hEDS), in a study of nearly 500 individuals.

The genetic cause of hEDS, a common inherited connective tissue disorder, remains unknown, wrote Alan Snyder, MD, of the department of dermatology and dermatologic surgery at Medical University of South Carolina, Charleston, and colleagues.

Previous research suggests that changes in dermal mechanics predispose these patients to a range of skin conditions including mast cell activation disorder (MCAD) spectrum and chronic spontaneous urticaria, abnormal scars or wound healing, piezogenic papules, dyshidrosis, skin laxity or softness, easy bruising, local anesthesia resistance, keratosis pilaris, striae, and hidradenitis suppurativa, the researchers wrote.

However, data on these and other dermatologic manifestations of hEDS are limited, they said.

The diagnosis of hEDS will continue to be made more frequently and carefully, as the condition becomes more recognized and understood in the medical community, especially with anticipated capabilities of genetic testing, Dr. Snyder said in an interview.

“Being able to be aware of disease-specific comorbidities, such as those discovered in this study, allows providers to better stratify phenotypes and improve patient disease co-management,” he said.

In the study, published in the Journal of the American Academy of Dermatology, the researchers reviewed data on 1,364 patients with ICD-10 or ICD-9 codes for hEDS or EDS unspecified who were seen at a single institution between June 2005 and May 2022. Most of the patients were White (95.4%) and female (86.7%); the average age was 29.2 years.

Of the 1,364 patients included in the chart review, 497 (36.4%) had documented skin manifestations. Of these, 118 (24.2%) had disorders of follicular occlusion (12 had hidradenitis suppurativa, 32 had folliculitis, and 74 had acne); 112 (23%) had eczema or atopic dermatitis, 98 (19.7%) had mast cell disorder, 32 (6.4%) had psoriasis, and 32 (6.4%) had wound healing issues (16 had hypertrophic keloids/scarring, 5 had abscesses, 3 had abnormal bruising, and 8 had other would healing issues).

The study also included results of a multiple-choice patient survey from 1,354 individuals. In the survey, approximately two-thirds of patients reported abnormal scarring, abnormal wound healing, and cutaneous laxity (61.7%, 69.0%, and 71.0%, respectively).

The findings were limited by several factors including the retrospective study design, lack of testing to confirm hEDS diagnosis, and the potential interdisciplinary selection bias for diagnoses, the authors noted.

However, the results support previous studies showing increased rates of occlusive conditions in hEDS and higher rates of acne, folliculitis, and psoriasis, and highlight the need for clinician education to manage patients and promote better outcomes, the researchers concluded.

Data Enhance Clinical Awareness

“Given the increasingly understood relation between TH2-directed and mast-cell mediated diseases and hEDS, it was not necessarily a surprise to find the increased prevalence of atopy and mast cell disease, but rather an interesting confirmation, within the limitations that exist with retrospective chart review,” Dr. Snyder told this news organization. “While it may make some intuitive sense that certain cohorts with higher risk of HS may have a higher risk of acne, this had not been reported in the literature to date,” he noted. “Given the high levels of patient reported issues with scarring and wound healing, I was surprised that so few analogous diagnoses were physician-reported in the medical records.”

In clinical practice, “health care professionals and patients need to be aware hEDS is associated with high rates of eczematous, mast-cell mediated and follicular occlusive cutaneous disorders,” Dr. Snyder said in an interview. “There seems to be a discrepancy between patients and physician awareness of scarring or wound healing issues in this patient population,” he added.

Looking ahead, “we need to better research and characterize the various hEDS phenotypes to understand who is at highest risk for various TH2-mediated or follicular occlusive disorders,” said Dr. Snyder. “Moreover, a greater understanding is needed of the wound healing inadequacies that predispose these patients to poor outcomes during dermatologic surgery,” he said.

The study was supported by the Ehlers-Danlos Society and the Milton and Tamar Maltz Family Foundation. The researchers had no financial conflicts to disclose.

In a letter dated Nov. 30, 2023, the Food and Drug Administration informed isotretinoin manufacturers that they have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for the acne drug isotretinoin.

The development follows a March 2023 joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee about iPLEDGE REMS requirements, which included feedback from patients and dermatologists and recommendations for changes to the REMS program, aimed at minimizing the burden of the program on patients, pharmacies, and prescribers while continuing to maintain safe use of the highly teratogenic drug for patients.

The five changes include the following:

• Remove the requirement that pregnancy tests must be performed in a specially certified (i.e., Clinical Laboratory Improvement Amendments [CLIA]) laboratory. In the opinion of John S. Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, this change “may make it easier to perform pregnancy tests in a clinic setting without needing to send the patient to a separate lab,” he said in an interview.
• Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. According to Dr. Barbieri, this means that two pregnancy tests prior to starting isotretinoin must be done in a lab or office setting. “However, all the pregnancy tests on therapy can be either in a medical setting or using a home pregnancy test,” he told this news organization. “This option facilitates the use of telemedicine so that patients would not need to come in; they can just share a pregnancy test with their name and date with their dermatologist.”
• Remove the waiting period requirement — also known as the “19-day lockout” — for patients if they do not obtain isotretinoin within the first 7-day prescription window. According to Dr. Barbieri, this change helps to ensure that patients can begin isotretinoin in a timely manner. “Insurance and pharmacy delays that are no fault of the patient can commonly cause missed initial window periods,” he said. “Allowing for immediate repeat of a pregnancy test to start a new window period, rather than requiring the patient to wait 19 more days, can ensure patient safety and pregnancy prevention without negatively impacting access.”
• Revise the pregnancy registry requirement to remove the objective to document the pregnancy and fetal outcomes for each pregnancy.
• Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment. Dr. Barbieri characterized this change as “major” and said that it could eliminate the need for monthly visits for persons of non–childbearing potential. “This could substantially reduce logistical burdens for patients and reduce wait times to see a dermatologist,” he said.

Future changes to iPLEDGE that Dr. Barbieri would like to see include allowing for home pregnancy tests prior to starting therapy — particularly the test after the 30-day window period. “In addition, it would be good to be able to reduce the 30-day waiting period prior to therapy to something shorter,” such as 14 days, which would still “reliably exclude pregnancy, particularly for those on stable long-acting reversible contraception,” he said. There are also opportunities to improve the iPLEDGE website functionality and to ensure that the website is accessible to patients with limited English proficiency, he added.

He also recommended greater transparency by the Isotretinoin Products Manufacturers Group and inclusion of input from diverse stakeholders such as dermatologists, patients, and pharmacists.

Dr. Barbieri reported personal fees from Dexcel Pharma.

In a letter dated Nov. 30, 2023, the Food and Drug Administration informed isotretinoin manufacturers that they have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for the acne drug isotretinoin.

The development follows a March 2023 joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee about iPLEDGE REMS requirements, which included feedback from patients and dermatologists and recommendations for changes to the REMS program, aimed at minimizing the burden of the program on patients, pharmacies, and prescribers while continuing to maintain safe use of the highly teratogenic drug for patients.

The five changes include the following:

• Remove the requirement that pregnancy tests must be performed in a specially certified (i.e., Clinical Laboratory Improvement Amendments [CLIA]) laboratory. In the opinion of John S. Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, this change “may make it easier to perform pregnancy tests in a clinic setting without needing to send the patient to a separate lab,” he said in an interview.
• Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. According to Dr. Barbieri, this means that two pregnancy tests prior to starting isotretinoin must be done in a lab or office setting. “However, all the pregnancy tests on therapy can be either in a medical setting or using a home pregnancy test,” he told this news organization. “This option facilitates the use of telemedicine so that patients would not need to come in; they can just share a pregnancy test with their name and date with their dermatologist.”
• Remove the waiting period requirement — also known as the “19-day lockout” — for patients if they do not obtain isotretinoin within the first 7-day prescription window. According to Dr. Barbieri, this change helps to ensure that patients can begin isotretinoin in a timely manner. “Insurance and pharmacy delays that are no fault of the patient can commonly cause missed initial window periods,” he said. “Allowing for immediate repeat of a pregnancy test to start a new window period, rather than requiring the patient to wait 19 more days, can ensure patient safety and pregnancy prevention without negatively impacting access.”
• Revise the pregnancy registry requirement to remove the objective to document the pregnancy and fetal outcomes for each pregnancy.
• Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment. Dr. Barbieri characterized this change as “major” and said that it could eliminate the need for monthly visits for persons of non–childbearing potential. “This could substantially reduce logistical burdens for patients and reduce wait times to see a dermatologist,” he said.

Future changes to iPLEDGE that Dr. Barbieri would like to see include allowing for home pregnancy tests prior to starting therapy — particularly the test after the 30-day window period. “In addition, it would be good to be able to reduce the 30-day waiting period prior to therapy to something shorter,” such as 14 days, which would still “reliably exclude pregnancy, particularly for those on stable long-acting reversible contraception,” he said. There are also opportunities to improve the iPLEDGE website functionality and to ensure that the website is accessible to patients with limited English proficiency, he added.

He also recommended greater transparency by the Isotretinoin Products Manufacturers Group and inclusion of input from diverse stakeholders such as dermatologists, patients, and pharmacists.

Dr. Barbieri reported personal fees from Dexcel Pharma.

In a letter dated Nov. 30, 2023, the Food and Drug Administration informed isotretinoin manufacturers that they have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for the acne drug isotretinoin.

The development follows a March 2023 joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee about iPLEDGE REMS requirements, which included feedback from patients and dermatologists and recommendations for changes to the REMS program, aimed at minimizing the burden of the program on patients, pharmacies, and prescribers while continuing to maintain safe use of the highly teratogenic drug for patients.

The five changes include the following:

• Remove the requirement that pregnancy tests must be performed in a specially certified (i.e., Clinical Laboratory Improvement Amendments [CLIA]) laboratory. In the opinion of John S. Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, this change “may make it easier to perform pregnancy tests in a clinic setting without needing to send the patient to a separate lab,” he said in an interview.
• Allow prescribers the option of using home pregnancy testing for their patients during and after isotretinoin treatment. Prescribers who rely on the patient to perform a home pregnancy test need to take steps to minimize patients falsifying the results of these tests. According to Dr. Barbieri, this means that two pregnancy tests prior to starting isotretinoin must be done in a lab or office setting. “However, all the pregnancy tests on therapy can be either in a medical setting or using a home pregnancy test,” he told this news organization. “This option facilitates the use of telemedicine so that patients would not need to come in; they can just share a pregnancy test with their name and date with their dermatologist.”
• Remove the waiting period requirement — also known as the “19-day lockout” — for patients if they do not obtain isotretinoin within the first 7-day prescription window. According to Dr. Barbieri, this change helps to ensure that patients can begin isotretinoin in a timely manner. “Insurance and pharmacy delays that are no fault of the patient can commonly cause missed initial window periods,” he said. “Allowing for immediate repeat of a pregnancy test to start a new window period, rather than requiring the patient to wait 19 more days, can ensure patient safety and pregnancy prevention without negatively impacting access.”
• Revise the pregnancy registry requirement to remove the objective to document the pregnancy and fetal outcomes for each pregnancy.
• Revise the requirement for prescribers to document patient counseling in patients who cannot become pregnant from monthly to only at enrollment. Dr. Barbieri characterized this change as “major” and said that it could eliminate the need for monthly visits for persons of non–childbearing potential. “This could substantially reduce logistical burdens for patients and reduce wait times to see a dermatologist,” he said.

Future changes to iPLEDGE that Dr. Barbieri would like to see include allowing for home pregnancy tests prior to starting therapy — particularly the test after the 30-day window period. “In addition, it would be good to be able to reduce the 30-day waiting period prior to therapy to something shorter,” such as 14 days, which would still “reliably exclude pregnancy, particularly for those on stable long-acting reversible contraception,” he said. There are also opportunities to improve the iPLEDGE website functionality and to ensure that the website is accessible to patients with limited English proficiency, he added.

He also recommended greater transparency by the Isotretinoin Products Manufacturers Group and inclusion of input from diverse stakeholders such as dermatologists, patients, and pharmacists.

Dr. Barbieri reported personal fees from Dexcel Pharma.

TOPLINE:

Patients with psoriasis had a 1.77-fold increased risk of having obstructive sleep apnea, in a study comparing patients with psoriasis with controls.

METHODOLOGY:

• Prior studies have established a link between psoriasis and obstructive sleep apnea (OSA), but some have suggested that confounders may drive the association.
• Using a case-control design, researchers analyzed data from 156,707 participants in the National Institutes of Health’s : 5140 with psoriasis and 151,567 controls.
• They used Pearson’s x 2 test to compare the prevalence of OSA among cases and controls, logistic regression to calculate odds ratios (ORs) in multivariable analysis, and two-sided t-tests to evaluate the significance between continuous variables.

TAKEAWAY:

• Compared with controls, patients with psoriasis were older (a mean of 62.4 vs 57.3 years, respectively), more likely to be White (86.1% vs 70.6%), reported higher annual household incomes (59.9% vs 52.6%), and were more likely to smoke (48.2% vs 43.4%).
• The rate of OSA was significantly higher among patients with psoriasis compared with controls (29.3% vs 17.1%; P < .001).
• On unadjusted multivariable logistic regression controlling for age, gender, and race, psoriasis was significantly associated with OSA (OR, 1.77, 95% CI, 1.66 - 1.89; P < .001).
• Psoriasis was also significantly associated with OSA in the adjusted model controlling for age, gender, race, BMI, and smoking status (OR, 1.66, 95% CI, 1.55 - 1.77; P < .001) and in the adjusted model controlling for age, gender, race, BMI, smoking status, type 2 diabetes, congestive heart failure, hypertension, history of myocardial infarction, angina, and peripheral artery disease (OR, 1.45, 95% CI, 1.35 - 1.55; P <.001).

IN PRACTICE:

“This study further substantiates the association between psoriasis and OSA, reinforcing the importance of evaluation for OSA when clinically appropriate given that both psoriasis and OSA contribute to adverse health outcomes,” the authors conclude.

SOURCE:

Corresponding author Jeffrey M. Cohen, MD, of the Department of Dermatology at Yale University, New Haven, Connecticut, led the research. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

Study limitations included the use of electronic health record data, a potential lack of generalizability to the US population, and reliance on survey data for certain variables such as income and smoking status.

DISCLOSURES:

The All of Us Research Program is supported by the National Institutes of Health. Cohen disclosed that he serves on a data safety and monitoring board for Advarra.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with psoriasis had a 1.77-fold increased risk of having obstructive sleep apnea, in a study comparing patients with psoriasis with controls.

METHODOLOGY:

• Prior studies have established a link between psoriasis and obstructive sleep apnea (OSA), but some have suggested that confounders may drive the association.
• Using a case-control design, researchers analyzed data from 156,707 participants in the National Institutes of Health’s : 5140 with psoriasis and 151,567 controls.
• They used Pearson’s x 2 test to compare the prevalence of OSA among cases and controls, logistic regression to calculate odds ratios (ORs) in multivariable analysis, and two-sided t-tests to evaluate the significance between continuous variables.

TAKEAWAY:

• Compared with controls, patients with psoriasis were older (a mean of 62.4 vs 57.3 years, respectively), more likely to be White (86.1% vs 70.6%), reported higher annual household incomes (59.9% vs 52.6%), and were more likely to smoke (48.2% vs 43.4%).
• The rate of OSA was significantly higher among patients with psoriasis compared with controls (29.3% vs 17.1%; P < .001).
• On unadjusted multivariable logistic regression controlling for age, gender, and race, psoriasis was significantly associated with OSA (OR, 1.77, 95% CI, 1.66 - 1.89; P < .001).
• Psoriasis was also significantly associated with OSA in the adjusted model controlling for age, gender, race, BMI, and smoking status (OR, 1.66, 95% CI, 1.55 - 1.77; P < .001) and in the adjusted model controlling for age, gender, race, BMI, smoking status, type 2 diabetes, congestive heart failure, hypertension, history of myocardial infarction, angina, and peripheral artery disease (OR, 1.45, 95% CI, 1.35 - 1.55; P <.001).

IN PRACTICE:

“This study further substantiates the association between psoriasis and OSA, reinforcing the importance of evaluation for OSA when clinically appropriate given that both psoriasis and OSA contribute to adverse health outcomes,” the authors conclude.

SOURCE:

Corresponding author Jeffrey M. Cohen, MD, of the Department of Dermatology at Yale University, New Haven, Connecticut, led the research. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

Study limitations included the use of electronic health record data, a potential lack of generalizability to the US population, and reliance on survey data for certain variables such as income and smoking status.

DISCLOSURES:

The All of Us Research Program is supported by the National Institutes of Health. Cohen disclosed that he serves on a data safety and monitoring board for Advarra.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with psoriasis had a 1.77-fold increased risk of having obstructive sleep apnea, in a study comparing patients with psoriasis with controls.

METHODOLOGY:

• Prior studies have established a link between psoriasis and obstructive sleep apnea (OSA), but some have suggested that confounders may drive the association.
• Using a case-control design, researchers analyzed data from 156,707 participants in the National Institutes of Health’s : 5140 with psoriasis and 151,567 controls.
• They used Pearson’s x 2 test to compare the prevalence of OSA among cases and controls, logistic regression to calculate odds ratios (ORs) in multivariable analysis, and two-sided t-tests to evaluate the significance between continuous variables.

TAKEAWAY:

• Compared with controls, patients with psoriasis were older (a mean of 62.4 vs 57.3 years, respectively), more likely to be White (86.1% vs 70.6%), reported higher annual household incomes (59.9% vs 52.6%), and were more likely to smoke (48.2% vs 43.4%).
• The rate of OSA was significantly higher among patients with psoriasis compared with controls (29.3% vs 17.1%; P < .001).
• On unadjusted multivariable logistic regression controlling for age, gender, and race, psoriasis was significantly associated with OSA (OR, 1.77, 95% CI, 1.66 - 1.89; P < .001).
• Psoriasis was also significantly associated with OSA in the adjusted model controlling for age, gender, race, BMI, and smoking status (OR, 1.66, 95% CI, 1.55 - 1.77; P < .001) and in the adjusted model controlling for age, gender, race, BMI, smoking status, type 2 diabetes, congestive heart failure, hypertension, history of myocardial infarction, angina, and peripheral artery disease (OR, 1.45, 95% CI, 1.35 - 1.55; P <.001).

IN PRACTICE:

“This study further substantiates the association between psoriasis and OSA, reinforcing the importance of evaluation for OSA when clinically appropriate given that both psoriasis and OSA contribute to adverse health outcomes,” the authors conclude.

SOURCE:

Corresponding author Jeffrey M. Cohen, MD, of the Department of Dermatology at Yale University, New Haven, Connecticut, led the research. The study was published online in the Journal of the American Academy of Dermatology.

LIMITATIONS:

Study limitations included the use of electronic health record data, a potential lack of generalizability to the US population, and reliance on survey data for certain variables such as income and smoking status.

DISCLOSURES:

The All of Us Research Program is supported by the National Institutes of Health. Cohen disclosed that he serves on a data safety and monitoring board for Advarra.

A version of this article appeared on Medscape.com.

NEW YORK — New treatments for acne, including the recent FDA approval of a topical gel that combines an antibiotic, a retinoid, and an antimicrobial agent, and reports on the safe use of lasers in people with darker skin types, were presented at the annual Mount Sinai Winter Symposium – Advances in Medical and Surgical Dermatology.

Also highlighted were recommendations regarding antibiotic stewardship and consideration of a treatment’s beneficial effects beyond 12 weeks.

“Patients want clear skin and many don’t care how they get there. I see patients who have been on minocycline [a broad-spectrum antibiotic] for 2 years; this is really not the best way to treat our patients,” said Joshua Zeichner, MD, associate professor of dermatology at the Icahn School of Medicine at Mount Sinai Hospital, New York, who reviewed the current state of acne treatments at the meeting.

Patients often do not care about the risk of developing antibiotic resistance, he noted, citing a survey (funded by Almirall and presented at a previous conference), which found that less than 10% of adult patients or caregivers of patients being treated for acne were moderately or extremely worried about antibiotics compared with more than 65% of the clinicians. But despite their concerns, nearly 60% of clinicians surveyed reported prescribing broad-spectrum antibiotics “most” or “all of the time,” he said.

Dr. Zeichner said that patients’ short-term wishes overriding dermatologists’ own concerns can lead to antibiotic resistance, with a negative impact on patients’ microbiomes. He encouraged prescribers to incorporate sarecycline and other narrow spectrum antibiotics into their practice as part of antibiotic stewardship. These drugs have less of an impact on the gut microbiome than broad spectrum antibiotics, while targeting the patient’s acne.

Dr. Zeichner noted that “acne is more than a 12-week disease,” but manufacturers of acne treatments can only market information based on what is in the product labeling, which usually includes 12-week results. Yet, for many acne treatments, “as you continue treating over time, you’re seeing much better improvements,” he said.

As an example, he referred to data from an unpublished phase 4 Galderma study. Patients aged 17-35 years with acne and scarring who were treated with trifarotene cream demonstrated about a 52% rate of success in acne clearance as measured by the Investigator Global Assessment (IGA) at 24 weeks, up from 31.4% at 12 weeks, highlighting the need to consider long-term data, which is helpful for patients to know, he said.

Dr. Zeichner noted that many patients and their caregivers are enthusiastic about the idea of treatment that does not involve pharmaceuticals and that these options, while not “silver bullets,” are available and advancing.

These include light-based devices. He referred to a 7-week, open label efficacy and safety study of a photo-pneumatic device with broadband light (Strata Skin Sciences). This device uses thermal heat to target and destroy Cutibacterium acnes and reduce sebum production and has a vacuum feature that removes occlusive material from the pilosebaceous unit, which he said “leads directly to a reduction in acne lesions.”

Of note is the fact that the device’ filters out visible wavelength light, which minimizes absorption by melanin in the epidermis that can damage darker skin, making the treatment safe for most skin types. In the study of patients with mild to moderate facial acne, aged 12-40 years, treatment resulted in significant reductions in mean inflammatory and noninflammatory lesion counts, and mean IGA score at day 49 compared with baseline.

Similarly, Dr. Zeichner presented a 2022 study demonstrating the use of higher spectrum lasers (a 1726-nm [nanometer] laser) to shrink sebaceous glands and reduce sebum production to treat acne. In addition, lasers that operate at such a high frequency do not cause hyperpigmentation in individuals with darker skin types, he said.

Dr. Zeichner disclosed that he is an advisor, consultant, or speaker for AbbVie, Allergan, Arcutis, Beiersdorf, Dermavant, Galderma, Kenvue, L’Oreal, Ortho, Pfizer, Regeneron, UCB, and Sun.

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

NEW YORK — New treatments for acne, including the recent FDA approval of a topical gel that combines an antibiotic, a retinoid, and an antimicrobial agent, and reports on the safe use of lasers in people with darker skin types, were presented at the annual Mount Sinai Winter Symposium – Advances in Medical and Surgical Dermatology.

Also highlighted were recommendations regarding antibiotic stewardship and consideration of a treatment’s beneficial effects beyond 12 weeks.

“Patients want clear skin and many don’t care how they get there. I see patients who have been on minocycline [a broad-spectrum antibiotic] for 2 years; this is really not the best way to treat our patients,” said Joshua Zeichner, MD, associate professor of dermatology at the Icahn School of Medicine at Mount Sinai Hospital, New York, who reviewed the current state of acne treatments at the meeting.

Patients often do not care about the risk of developing antibiotic resistance, he noted, citing a survey (funded by Almirall and presented at a previous conference), which found that less than 10% of adult patients or caregivers of patients being treated for acne were moderately or extremely worried about antibiotics compared with more than 65% of the clinicians. But despite their concerns, nearly 60% of clinicians surveyed reported prescribing broad-spectrum antibiotics “most” or “all of the time,” he said.

Dr. Zeichner said that patients’ short-term wishes overriding dermatologists’ own concerns can lead to antibiotic resistance, with a negative impact on patients’ microbiomes. He encouraged prescribers to incorporate sarecycline and other narrow spectrum antibiotics into their practice as part of antibiotic stewardship. These drugs have less of an impact on the gut microbiome than broad spectrum antibiotics, while targeting the patient’s acne.

Dr. Zeichner noted that “acne is more than a 12-week disease,” but manufacturers of acne treatments can only market information based on what is in the product labeling, which usually includes 12-week results. Yet, for many acne treatments, “as you continue treating over time, you’re seeing much better improvements,” he said.

As an example, he referred to data from an unpublished phase 4 Galderma study. Patients aged 17-35 years with acne and scarring who were treated with trifarotene cream demonstrated about a 52% rate of success in acne clearance as measured by the Investigator Global Assessment (IGA) at 24 weeks, up from 31.4% at 12 weeks, highlighting the need to consider long-term data, which is helpful for patients to know, he said.

Dr. Zeichner noted that many patients and their caregivers are enthusiastic about the idea of treatment that does not involve pharmaceuticals and that these options, while not “silver bullets,” are available and advancing.

These include light-based devices. He referred to a 7-week, open label efficacy and safety study of a photo-pneumatic device with broadband light (Strata Skin Sciences). This device uses thermal heat to target and destroy Cutibacterium acnes and reduce sebum production and has a vacuum feature that removes occlusive material from the pilosebaceous unit, which he said “leads directly to a reduction in acne lesions.”

Of note is the fact that the device’ filters out visible wavelength light, which minimizes absorption by melanin in the epidermis that can damage darker skin, making the treatment safe for most skin types. In the study of patients with mild to moderate facial acne, aged 12-40 years, treatment resulted in significant reductions in mean inflammatory and noninflammatory lesion counts, and mean IGA score at day 49 compared with baseline.

Similarly, Dr. Zeichner presented a 2022 study demonstrating the use of higher spectrum lasers (a 1726-nm [nanometer] laser) to shrink sebaceous glands and reduce sebum production to treat acne. In addition, lasers that operate at such a high frequency do not cause hyperpigmentation in individuals with darker skin types, he said.

Dr. Zeichner disclosed that he is an advisor, consultant, or speaker for AbbVie, Allergan, Arcutis, Beiersdorf, Dermavant, Galderma, Kenvue, L’Oreal, Ortho, Pfizer, Regeneron, UCB, and Sun.

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

NEW YORK — New treatments for acne, including the recent FDA approval of a topical gel that combines an antibiotic, a retinoid, and an antimicrobial agent, and reports on the safe use of lasers in people with darker skin types, were presented at the annual Mount Sinai Winter Symposium – Advances in Medical and Surgical Dermatology.

Also highlighted were recommendations regarding antibiotic stewardship and consideration of a treatment’s beneficial effects beyond 12 weeks.

“Patients want clear skin and many don’t care how they get there. I see patients who have been on minocycline [a broad-spectrum antibiotic] for 2 years; this is really not the best way to treat our patients,” said Joshua Zeichner, MD, associate professor of dermatology at the Icahn School of Medicine at Mount Sinai Hospital, New York, who reviewed the current state of acne treatments at the meeting.

Patients often do not care about the risk of developing antibiotic resistance, he noted, citing a survey (funded by Almirall and presented at a previous conference), which found that less than 10% of adult patients or caregivers of patients being treated for acne were moderately or extremely worried about antibiotics compared with more than 65% of the clinicians. But despite their concerns, nearly 60% of clinicians surveyed reported prescribing broad-spectrum antibiotics “most” or “all of the time,” he said.

Dr. Zeichner said that patients’ short-term wishes overriding dermatologists’ own concerns can lead to antibiotic resistance, with a negative impact on patients’ microbiomes. He encouraged prescribers to incorporate sarecycline and other narrow spectrum antibiotics into their practice as part of antibiotic stewardship. These drugs have less of an impact on the gut microbiome than broad spectrum antibiotics, while targeting the patient’s acne.

Dr. Zeichner noted that “acne is more than a 12-week disease,” but manufacturers of acne treatments can only market information based on what is in the product labeling, which usually includes 12-week results. Yet, for many acne treatments, “as you continue treating over time, you’re seeing much better improvements,” he said.

As an example, he referred to data from an unpublished phase 4 Galderma study. Patients aged 17-35 years with acne and scarring who were treated with trifarotene cream demonstrated about a 52% rate of success in acne clearance as measured by the Investigator Global Assessment (IGA) at 24 weeks, up from 31.4% at 12 weeks, highlighting the need to consider long-term data, which is helpful for patients to know, he said.

Dr. Zeichner noted that many patients and their caregivers are enthusiastic about the idea of treatment that does not involve pharmaceuticals and that these options, while not “silver bullets,” are available and advancing.

These include light-based devices. He referred to a 7-week, open label efficacy and safety study of a photo-pneumatic device with broadband light (Strata Skin Sciences). This device uses thermal heat to target and destroy Cutibacterium acnes and reduce sebum production and has a vacuum feature that removes occlusive material from the pilosebaceous unit, which he said “leads directly to a reduction in acne lesions.”

Of note is the fact that the device’ filters out visible wavelength light, which minimizes absorption by melanin in the epidermis that can damage darker skin, making the treatment safe for most skin types. In the study of patients with mild to moderate facial acne, aged 12-40 years, treatment resulted in significant reductions in mean inflammatory and noninflammatory lesion counts, and mean IGA score at day 49 compared with baseline.

Similarly, Dr. Zeichner presented a 2022 study demonstrating the use of higher spectrum lasers (a 1726-nm [nanometer] laser) to shrink sebaceous glands and reduce sebum production to treat acne. In addition, lasers that operate at such a high frequency do not cause hyperpigmentation in individuals with darker skin types, he said.

Dr. Zeichner disclosed that he is an advisor, consultant, or speaker for AbbVie, Allergan, Arcutis, Beiersdorf, Dermavant, Galderma, Kenvue, L’Oreal, Ortho, Pfizer, Regeneron, UCB, and Sun.

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