
Experts Highlight New Dermatological Treatments, Importance of Clinical Trial Diversity
Experts at the Skin of Color Update today in New York City highlighted recent FDA-approved dermatological treatments and emphasized the importance of clinical trial diversity.
Experts discussed recent FDA approvals for dermatology treatments and the importance of clinical trial diversity when evaluating potential treatments at the Skin of Color Update in New York City on September 13.
Advances in Topical Therapies
Andrew F. Alexis, MD, MPH, FAAD, Skin of Color Update co-chair, professor of clinical dermatology, and vice-chair for diversity and inclusion at Weill Cornell Medicine, began his presentation by discussing recent topical therapy FDA approvals.
He first highlighted roflumilast and tapinarof, which were each first approved for patients with psoriasis. Roflumilast is a phosphodiesterase 4 (PDE4) inhibitor, resulting in increased intracellular cyclic adenosine monophosphate (cAMP); it prevents the degradation of cAMP, leading to downregulation of inflammatory cytokines.
The FDA first
On July 29, 2022, Alexis noted that the FDA
This approval was based on data from the phase 3 DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389)
Alexis explained that roflumilast has since been approved to treat patients of other disease states, including seborrheic dermatitis. The FDA
He next highlighted the latest roflumilast
Alexis concluded by discussing potential future indications of tapinarof and roflumilast. He first highlighted the potential approval of tapinarof cream 1% for AD treatment since Dermavant Sciences
Advances in Biologic Therapies
Alexis then focused on recent biologic therapy approvals, beginning with that of
The approval was supported by the phase 3 BE READY (NCT03410992), BE VIVID (NCT03370133), and BE SURE (NCT03412747) trials. By week 16, a 320 mg dose of bimekizumab administered every 4 weeks was associated with more than 80% of treated patients achieving clear or almost clear skin per Psoriasis Area Severity Index scores of 90% and above (PASI 90) and IGA scores of 0 or 1.
Next, Alexis highlighted the
Lastly, Alexis discussed the FDA
These found that 56% and 49% of patients treated in Olympia 1 and 2, respectively, achieved at least a 4-point itch intensity reduction on the peak-pruritus numerical rating scale at week 16 compared with 16% in both placebo groups.
“Our armamentarium has strengthened greatly, and we’ve been offered so much more for our patients of all skin types, especially our patients with skin of color, who have historically had so many unmet needs in terms of treatment options,” Alexis concluded.
Keeping Diversity in the Forefront
With the development of new therapies, Valerie M. Harvey, MD, MPH, founder and director of the Hampton Roads Center for Dermatology, reminded audience members during her presentation to ensure their clinical trial populations include patients of diverse backgrounds. To help with this, she explained that the FDA is
Under the DAP, companies performing large phase 3 trials must provide the FDA with their plans for enrolling patients considered representative of those who would take the respective product. They are encouraged to include their enrollment goals, rationale, and their plan for meeting these goals.
Although it may be difficult at times to define “adequate” clinical trial diversity in terms of race/ethnicity, Harvey suggested that companies look at the prevalence of the disease across populations to ensure they account for all groups affected.
“When we’re designing these studies, when we’re asking these research questions, it’s really important to engage the community from the outset to really get a sense of what their priorities are, what their concerns are, so that we can build that into the study design,” she said. “I think that is so important to get meaningful diversity and so that we can really translate what we learn from these clinical trials into practice.”
References
- 1. Elder AJ, Patel P, Daveluy S. Tapinarof. PubMed. Accessed September 13, 2024.
https://www.ncbi.nlm.nih.gov/books/NBK594244/ - Stocum L. Tapinarof cream 1% is FDA approved. Dermatology Times. May 24, 2022. Accessed September 13, 2024.
https://www.dermatologytimes.com/view/tapinarof-cream-1-is-fda-approved - Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for plaque psoriasis. New England Journal of Medicine. 2021;385(24):2219-2229. doi:10.1056/nejmoa2103629
- FDA approves Arcutis' Zorvye (Roflumilast) cream 0.3% for the treatment of plaque psoriasis in individuals age 12 and older. Arcutis Biotherapeutics. July 29, 2022. Accessed September 13, 2024.
https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-3-for-the-treatment-of-plaque-psoriasis-in-individuals-age-12-and-older/ - Lebwohl MG, Kircik LH, Moore AY, et al. Effect of roflumilast cream vs vehicle cream on chronic plaque psoriasis: the DERMIS-1 and DERMIS-2 randomized clinical trials. JAMA. 2022;328(11):1073-1084. doi:10.1001/jama.2022.15632
- Smith T. FDA announces approval of roflumilast foam for seborrheic dermatitis. December 15, 2023. Accessed September 13, 2024.
https://www.hcplive.com/view/fda-announces-approval-of-roflumilast-foam-for-seborrheic-dermatitis - Blauvelt A, Draelos ZD, Stein Gold L, et al. Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: a randomized, double-blinded, vehicle-controlled, phase 3 trial. J Am Acad Dermatol. 2024;90(5):986-993. doi:10.1016/j.jaad.2023.12.065
- McCormick B. FDA approves roflumilast for patients 6 years and older with atopic dermatitis. July 9, 2024. Accessed September 13, 2024.
https://www.ajmc.com/view/fda-approves-roflumilast-for-patients-6-years-and-older-with-atopic-dermatitis - Dermavant announces FDA acceptance of Supplemental New Drug Application (sNDA) for VTAMA (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. April 29, 2024. Accessed September 13, 2024.
https://dermavant.com/dermavant-announces-fda-acceptance-of-supplemental-new-drug-application-snda-for-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-old/ - Kunzmann K. FDA approves bimekizumb for adults with plaque psoriasis. October 18, 2023. Accessed September 13, 2024.
https://www.hcplive.com/view/fda-approves-bimekizumab-adults-plaque-psoriasis - Joszt L. Secukinumab gains FDA approval to treat hidradenitis suppurativa. October 31, 2023. Accessed September 13, 2024.
https://www.ajmc.com/view/secukinumab-gains-fda-approval-to-treat-hidradenitis-suppurativa - McCormick B. FDA approves nemolizumab for adult patients with prurigo nodularis. August 13, 2024. Accessed September 13, 2024.
https://www.ajmc.com/view/fda-approves-nemolizumab-for-adult-patients-with-prurigo-nodularis - What we're reading: Plan B use plunges; lower drug costs; clinical trial diversity guidance. June 27, 2024. Accessed September 13, 2024.
https://www.ajmc.com/view/what-we-re-reading-plan-b-use-plunges-lower-drug-costs-clinical-trial-diversity-guidance
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