Experts convened at the Skin of Color Update 2024 in New York City to discuss recent advances in dermatological treatments and the critical need for greater diversity in clinical research. The meeting underscored the importance of inclusive practices in clinical trials and highlighted new therapeutic options for various dermatological conditions.
Topical Therapies: Roflumilast and Tapinarof
Andrew F. Alexis, MD, MPH, FAAD, discussed recent FDA approvals for topical therapies, including roflumilast and tapinarof. Roflumilast cream 0.15% (Zoryve; Arcutis) received approval for treating atopic dermatitis in adults and children as young as 6 years old. This once-daily, steroid-free cream has demonstrated rapid disease clearance and significant itch reduction, making it suitable for long-term use. Clinical trials, INTEGUMENT-1 and INTEGUMENT-2, showed that 31.1% of patients in the roflumilast group achieved Validated Investigator Global Assessment-AD (vIGA-AD) success at week 4 compared with 14.1% of the vehicle group.
Tapinarof cream 1% (Vtama; Dermavant) has also shown promise in improving itch in phase 3 trials for moderate to severe atopic dermatitis. It has demonstrated significant efficacy and is well-tolerated in adults and children as young as 2 years old, as seen in the ADORING 1 and 2 trials. The FDA accepted Dermavant's sNDA for tapinarof cream 1% for AD treatment in adult and pediatric patients 2 years and older, with a PDUFA action date set for the fourth quarter of 2024.
Biologic Therapies: Bimekizumab, Secukinumab, and Nemolizumab
Alexis also highlighted recent approvals in biologic therapies. Bimekizumab (Bimzelx; UCB), a dual inhibitor of interleukin 17A (IL-17A) and 17F (IL-17F), was approved for treating moderate to severe plaque psoriasis in adults. Phase 3 trials (BE READY, BE VIVID, and BE SURE) supported this approval, showing that a 320 mg dose of bimekizumab every 4 weeks led to clear or almost clear skin in over 80% of patients by week 16.
Secukinumab (Cosentyx; Novartis) gained approval for adult patients with moderate to severe hidradenitis suppurativa (HS). The treatment involves 300 mg administered via subcutaneous injection every 4 weeks. Phase 3 trials (SUNSHINE and SUNSET) demonstrated rapid relief from HS symptoms as early as week 2.
Nemolizumab (Nemluvio; Galderma) was approved as a pre-filled pen for subcutaneous injection to treat adult patients with prurigo nodularis every 4 weeks. Phase 3 trials (Olympia 1 and 2) showed that 56% and 49% of patients treated in Olympia 1 and 2, respectively, achieved at least a 4-point reduction in itch intensity on the peak-pruritus numerical rating scale at week 16, compared to 16% in both placebo groups.
The Imperative of Diversity in Clinical Trials
Valerie M. Harvey, MD, MPH, emphasized the critical need for diversity in clinical trials. She noted that the lack of progress in increasing racial and ethnic minority participation over the past three decades has exacerbated health disparities. Harvey highlighted the FDA's development of a Diversity Action Plan (DAP) to ensure pharmaceutical companies enroll more women and people of color in clinical trials.
Under the DAP, companies conducting large phase 3 trials must provide the FDA with plans to enroll patients representative of those who would use the product. This includes enrollment goals, rationale, and strategies for meeting these goals. Harvey suggested companies examine disease prevalence across populations to ensure all affected groups are accounted for in clinical trials.
"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," Harvey stated. "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."
