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Efficacy and Safety of Cosibelimab for Advanced Cutaneous Squamous Cell Carcinoma: An Expert Consensus Panel

Bartley, Brooke; Rosenberg, Angela; DeBusk, Lauren; Farberg, Aaron S; Dinehart, Scott M; Trotter, Shannon C; Ackerman, Lindsay; Groisser, Daniel; Schlesinger, Todd; Rosso, James Q Del; Lebwohl, Mark; Rigel, Darrell
BACKGROUND:Cutaneous squamous cell carcinoma (cSCC) represents a significant clinical challenge in patients with locally advanced (laCSCC) or metastatic (mCSCC) disease who are not candidates for surgery or radiation. In addition to PD-1 inhibitors, pembrolizumab and cemiplimab, cosibelimab, a PD-L1 inhibitor, has been recently approved by the US Food and Drug Administration (FDA) for laCSCC and mCSCC. Given its recent approval, practical guidance is needed to support clinician decision-making regarding cosibelimab's efficacy and safety. METHODS:A comprehensive literature review of PubMed and Google Scholar was completed for studies related to cosibelimab efficacy and safety in la and mCSCC. An expert panel of nine dermatologists with significant expertise in the treatment of cSCC gathered to review the articles and create consensus statements on the role of cosibelimab in managing laCSCC and mCSCC. A modified Delphi process was used to approve each statement, and the strength of recommendation was assigned using the Strength of Recommendation Taxonomy (SORT) criteria. RESULTS:The literature search produced over 200 articles that met the criteria, and a screening of the studies for relevance resulted in 13 articles. The panel developed six consensus statements, with five unanimously adopted with a strength of "A". CONCLUSION/CONCLUSIONS:Available data suggests that cosibelimab is an effective treatment for patients with laCSCC and mCSCC who are not candidates for surgery or radiation. Cosibelimab demonstrates a unique and favorable safety profile with no reported grade 4 or 5 immune-related adverse events after more than 2 years of follow-up.
PMID: 42081637
ISSN: 1545-9616
CID: 6070910

Sport-related skin conditions: Traumatic and inflammatory dermatoses

Burshtein, Joshua; Donohue, Stephen; Rigel, Darrell S
BACKGROUND/UNASSIGNED:Athletes are at risk of developing dermatologic conditions, particularly traumatic and inflammatory dermatoses, owing to the physical and environmental stresses associated with sports participation. As sports participation continues to increase worldwide, recognition of these conditions has become increasingly important for dermatologists and sports medicine professionals. OBJECTIVE/UNASSIGNED:To review the epidemiology, clinical presentations, prevention strategies, and treatment approaches for common traumatic and inflammatory dermatoses encountered in athletes. METHODS/UNASSIGNED:A comprehensive literature search was completed using a combination of keywords: "sports," "traumatic," "inflammatory," "skin," and "dermatoses." The authors reviewed all studies and included those that addressed the topic of the review. RESULTS/UNASSIGNED:Traumatic dermatoses represented the most frequently reported conditions. Inflammatory dermatoses primarily included contact dermatitis and lichen simplex chronicus. Many conditions demonstrate sport-specific patterns related to repetitive friction, pressure, direct trauma, moisture, or exposure to athletic equipment. Preventive measures include proper equipment fit, reduction of friction and moisture, and use of protective barriers, while treatment strategies ranged from wound care and topical therapies to procedural interventions. CONCLUSION/UNASSIGNED:Sports participation is associated with a broad spectrum of traumatic and inflammatory skin disorders that may affect athlete comfort, performance, and participation.
PMID: 42522517
ISSN: 1087-2108
CID: 6070434

The role of aryl hydrocarbon receptor agonists in the management of inflammatory skin diseases: An expert consensus panel

DeBusk, Lauren; Bartley, Brooke; Armstrong, April W; Bunick, Christopher G; Del Rosso, James; Desai, Seemal R; Eichenfield, Lawrence F; Elewski, Boni E; Golant, Alexandra K; Issa, Naiem; Stein Gold, Linda; Swanson, Lisa; Bohman, M Hunter; Rosenberg, Angela; Rigel, Darrell; Lebwohl, Mark
BACKGROUND/UNASSIGNED:Inflammatory skin diseases, including psoriasis and atopic dermatitis, require long-term management strategies that balance efficacy with safety. The 2025 American Academy of Dermatology guidelines encourage the judicious application of topical corticosteroids when their use is deemed necessary and for short durations of therapy. Recent availability of newer nonsteroidal topical therapies that are effective and safe, including for prolonged durations and on sensitive skin sites, has prompted a need for evidence-based guidance for clinicians in real-world practice. Tapinarof, a first-in-class, nonsteroidal aryl hydrocarbon receptor (AhR) agonist, was approved by the US Food and Drug Administration for the treatment of plaque psoriasis in adults and atopic dermatitis in patients aged 2 years and older in 2022 and 2025, respectively; however, its optimal place in therapy remains to be established. OBJECTIVE/UNASSIGNED:To develop expert consensus statements on the role of AhR agonists in the management of inflammatory skin diseases. METHODS/UNASSIGNED:A literature search produced 31 articles meeting inclusion criteria that were independently reviewed by an 11-member expert panel that convened on January 19, 2026. A modified Delphi process was used to develop 9 consensus statements. CONSENSUS RECOMMENDATIONS/ KEY FINDINGS/UNASSIGNED:AhR agonists represent a distinct therapeutic class with a unique multimodal mechanism involving immune modulation across Th1/Th2/Th17/Th22 pathways, skin barrier normalization, and antioxidant activity; tapinarof demonstrates a favorable safety profile with no restrictions on anatomic site, body surface area, or duration of use; tapinarof may be used concomitantly with systemic therapies; tapinarof is appropriate as both initial and long-term therapy for psoriasis in adults and atopic dermatitis in patients aged 2 years and older; and nonsteroidal topical therapies are preferred for chronic inflammatory skin diseases, particularly on the face and intertriginous areas. CONCLUSION/UNASSIGNED:AhR agonist therapy offers a clinically meaningful, advanced nonsteroidal option that addresses key limitations of traditional topical therapies in inflammatory skin disease management.
PMID: 42522513
ISSN: 1087-2108
CID: 6070433

Lichen planus autoimmune comorbidities: A retrospective case control study

Rosenberg, Angela L; Wu, Alexander; DeBusk, Lauren; Mehta, Apoorva; Bartley, Brooke; McAleer, Leah; Dominguez, Ryan; Rigel, Darrell; Mauskar, Melissa; Merola, Joseph F; Nezafati, Kaveh
PURPOSE/OBJECTIVE:To assess whether patients with lichen planus (LP) show increased prevalence and odds of autoimmune and viral comorbidities compared with matched controls using real-world data. METHODS:We analyzed TriNetX Linked Network electronic health records and claims data from 2016 to 2024 (more than 112 million patients). LP was defined by at least 2 International Classification of Diseases, Tenth Revision, Clinical Modification codes (excluding drug-induced variants) and matched 1:1 to controls on age, sex, and race. We calculated odds ratios (ORs), 95% confidence intervals, prevalence, and absolute risk differences (ARDs). RESULTS:The matched cohort included 43 458 LP and control patients (mean age, 53.8 years; 64.4% female). LP was associated with higher prevalence of autoimmune conditions, including psoriasis (6.59% versus 2.54%; ARD, 4.05%; OR, 2.71), lupus erythematosus (2.87% versus 1.13%; ARD, 1.74%; OR, 2.58), and autoimmune thyroiditis (3.09% versus 1.61%; ARD, 1.48%; OR, 1.95). Associations were also seen for Sjögren syndrome, alopecia areata, localized scleroderma, and vitiligo. Hepatitis C virus was more common in LP (2.95% versus 2.03%; ARD, 0.92%) but with a lower OR (1.47). CONCLUSION/CONCLUSIONS:LP was associated with substantially higher odds and prevalence of several autoimmune comorbidities, exceeding those for viral infections such as hepatitis C. These findings inform LP pathogenesis and comorbidity patterns but do not support changes to clinical management.
PMID: 42246344
ISSN: 1087-2108
CID: 6044652

Advances in the noninvasive diagnosis of melanoma-40 years beyond the ABCDs

Burshtein, Joshua; Witkowski, Alexander; Zakria, Danny; Shah, Milaan; Rosenberg, Angela; DeBusk, Lauren; Ludzik, Joanna; Pellacani, Giovanni; Rigel, Darrell
The early detection of cutaneous melanoma is critical to survival outcomes. Because less than one half of melanomas in the United States are diagnosed by dermatologists, the ABCD (asymmetry, border irregularity, color variation, diameter >6 mm) acronym, created 40 years ago with the later addition of "E" for evolution (ABCDE), was developed for nondermatologist health care professionals and the public to simplify and enhance the diagnosis of early melanoma. It continues to be the global, naked-eye, nondevice-assisted standard for initial triage of pigmented lesions. This clinical review discusses the changing clinical diagnostic landscape and examines the currently available first-line and second-line detection modalities for melanoma. It also provides updates to the first-line triage approach and discusses the challenges of regulatory agency oversight for the safe and effective use of current and emerging skin cancer detection technologies. It is critical that health care professionals globally have knowledge of these technologies to enhance their diagnosis of melanoma.
PMCID:12856975
PMID: 41614452
ISSN: 1542-4863
CID: 6003762

Response to Reynolds, et al "Commentary on "Impact of climate and UV variables on melanoma incidence across United States counties" [Letter]

Adler, Robert; Burshtein, Joshua G; Marson, Justin W; Rigel, Darrell S
PMID: 41620026
ISSN: 1097-6787
CID: 6003922

The Passing of Alfred W. Kopf, MD

Rigel, Darrell S
PMID: 41525976
ISSN: 1097-6787
CID: 5986042

Real-World Treatment Patterns of Patients with Basal Cell Carcinoma Using Sonidegib and Vismodegib: Discontinuation Rates and Clinical Conditions During Treatment

Lebwohl, Mark G; Rigel, Darrell S; Eroglu, Zeynep; Barghout, Victoria E; Gupta, Deepshekhar; Zanardo, Enrico; Huynh, Lynn; Yenikomshian, Mihran A; Squittieri, Nicholas; Ferro, Thomas J; Patel, Kunal
INTRODUCTION/BACKGROUND:Sonidegib and vismodegib are Hedgehog pathway inhibitors (HHIs) approved for the treatment of locally advanced basal cell carcinoma (laBCC), as well as metastatic basal cell carcinoma (mBCC) for vismodegib. Few studies have compared real-world treatment patterns associated with HHI treatment. The objective of this study was to investigate the real-world treatment patterns and conditions of patients receiving HHIs for BCC. METHODS:In this longitudinal study, claims from the Komodo Health Claims Database (between 2016 and 2023) were used to identify patients. Baseline characteristics and comorbidities of patients were assessed. Time to treatment discontinuation (TTD), odds of discontinuation, and clinical conditions experienced during treatment were analyzed. RESULTS:Patients who received sonidegib remained on treatment longer than those on vismodegib (log-rank test; P = 0.041) and were 23% less likely (P = 0.036) and 32% less likely (P = 0.013) to discontinue treatment at 6 and 9 months, respectively. Sonidegib-treated patients were less likely to experience gastrointestinal-related conditions (33% less likely; P = 0.045), taste- and smell-related conditions (71% less likely; P = 0.048), and muscle spasms (52% less likely; P = 0.009) during treatment compared with patients who received vismodegib. CONCLUSION/CONCLUSIONS:In the real-world setting, sonidegib-treated patients remained on treatment longer than vismodegib-treated patients and were less likely to experience pharmacologically relevant clinical conditions.
PMID: 41419705
ISSN: 2193-8210
CID: 5979852

31-Gene expression profiling for cutaneous melanoma: an expert consensus panel

Burshtein, Joshua; Cockerell, Clay; Cotter, David; Farberg, Aaron; Ferris, Laura; Kaufmann, Mark; Leachman, Sancy; Rizzo, Jason; Schlesinger, Todd; Shah, Milaan; DeBusk, Lauren; Rosenberg, Angela; Bartley, Brooke; Lebwohl, Mark; Rigel, Darrell
Purpose To review published literature on the clinical efficacy, use, and accuracy of the 31-gene expression profiling (31-GEP) test for prognostic information in invasive melanoma. Methods A comprehensive literature search used keywords "31-gene expression profiling," "melanoma," "prognosis," "clinical efficacy," and "clinical utility." A panel of 10 dermatologists with expertise in melanoma management reviewed the articles and created consensus statements. A modified Delphi process approved each statement, requiring supermajority approval through multiple rounds of real-time voting, with strength of recommendation assigned. Results The search produced 150 articles; 26 met inclusion criteria. The panel unanimously voted to adopt 9 consensus statements and recommendations regarding 31-GEP testing: 8 with strength "A" and 1 with strength "C." Conclusion The panel agreed there is strong support for using 31-GEP testing to provide prognostic information for invasive melanoma. The test provides prognostic information when thickness and other traditional factors are unknown, improves prognosis assessment when added to American Joint Committee on Cancer 8th edition staging system, and is associated with improved melanoma-specific mortality and overall survival. The panel concluded that the robust existing literature strongly supports its use as a best practice for appropriate patients with melanoma.
PMID: 41725468
ISSN: 1087-2108
CID: 6009582

Impact of Climate and UV Variables on Melanoma Incidence Across United States Counties

Adler, Robert; Burshtein, Joshua G; Marson, Justin W; Rigel, Darrell S
PMID: 40716575
ISSN: 1097-6787
CID: 5902922