
Recent FDA Approvals Expand Dermatology Options for Patients With Skin of Color
Key Takeaways
- Recent FDA approvals include new therapies for AD, HS, and plaque psoriasis, impacting patients with skin of color.
- Tapinarof cream, roflumilast foam, and delgocitinib are notable topical treatments approved for various dermatological conditions.
FDA approvals since the last Skin of Color Update expand topical and biologic options for various dermatological conditions, benefiting patients with skin of color.
Andrew F. Alexis, MD, MPH, co-chair of the
He highlighted 9 treatments: 4 topical medications and 5 biologic agents. Of these, most were previously approved for other indications.
Expanding Topical Treatment Options
Tapinarof Cream, 1% Approved for AD in Patients 2 Years and Older
Alexis first highlighted
In ADORING 1 and 2, respectively, 45.4% and 46.4% of patients achieved clear or almost clear skin by week 8, compared with 18% on vehicle (P < .0001). Similarly, in ADORING 3, 378 of 728 participants achieved complete disease clearance, with a mean first treatment-free interval of about 80 consecutive days.
“These trials did enroll sizable proportions of patients with skin of color, enough to be able to conduct some subpopulation analyses and look at the effect, safety, and efficacy across different racial and ethnic subgroups,” Alexis said. “We see consistent efficacy with respect to reduction in eczema severity across Asian, Black or African American, White, or other racial and ethnic populations.”
FDA Approves Roflumilast Topical Foam 0.3% for Plaque Psoriasis
Next, Alexis acknowledged the approval of
The ARRECTOR study met its co-primary end points of Scalp-Investigator Global Assessment (S-IGA) and Body-Investigator Global Assessment (B-IGA) success. At week 8, 66.4% achieved S-IGA success compared with 27.8% on vehicle (P < .0001), and 45.5% achieved Body-IGA success vs 20.1% on vehicle (P < .0001).
Similarly, the phase 2 trial met its primary end points, with 56.7% achieving S-IGA success at week 8 vs 11.0% of those on vehicle. Additionally, 39.0% achieved B-IGA success compared with 7.4% on vehicle (P < .0001).
FDA Approves Delgocitinib for Moderate to Severe Hand Eczema
Both studies had the primary efficacy end point of IGA for chronic hand eczema at week 16, defined as a score of clear (0) or almost clear (1) and at least a 2-point improvement from baseline. In DELTA 1, overall patient response rates were 20% for delgocitinib vs 10% cream vehicle (P = .006). Similarly, in DELTA 2, the overall response rate was 29% among the delgocitinib group vs 7% in the vehicle group (P < .0001).
FDA Approves Ruxolitinib Cream for Patients as Young as 2 Years With AD
Alexis concluded his discussion on newly approved topical treatments by spotlighting last month’s approval of
“This study, which was just published this month and looked at the efficacy and safety of ruxolitinib cream in this younger-aged cohort with atopic dermatitis, demonstrated safety, efficacy, and high tolerability,” Alexis said. “Interestingly, this study also included a high proportion of patients of color.”
As described, significantly more patients treated with ruxolitinib achieved IGA-treatment success vs those on the placebo. Those using ruxolitinib cream also demonstrated a 75% improvement in the Eczema Area and Severity Index (EASI) at the end of the 8-week vehicle-controlled period.
More Biologic Agents Added to the Toolkit
FDA Approves Lebrikizumab for Moderate to Severe Atopic Dermatitis
Alexis transitioned into biologic agents by first highlighting
It is supported by positive data from the ADvocate 1 (
Alexis highlighted a study he authored that was
“What we found was that most patients, almost two-thirds of patients, with baseline hyperpigmentation showed improvement at week 24 of treatment with lebrikizumab,” Alexis said.
Nemolizumab Granted FDA Approval for Moderate-to-Severe Atopic Dermatitis
Alexis also discussed
The phase 3 ARCADIA clinical trial program (
FDA Approves Bimekizumab in Hidradenitis Suppurativa
In addition, Alexis spotlighted the approval of
Patients in the treatment groups saw greater improvement than those who received placebo, with 48% vs 29% in BE HEARD I, for a 123% greater chance of improved disease control (OR, 2.23; 95% CI, 1.16-4.31; P = .0060), and 52% vs 32% in BE HEARD II, for a 129% greater chance (OR, 2.29; 95% CI, 1.22-4.29; P = .0032).
FDA Greenlights Dupilumab for Chronic Spontaneous Urticaria, Bullous Pemphigoid
Lastly, Alexis recognized 2 new indications for dupilumab (Dupixent; Sanofi/Regeneron), one being for patients aged 12 and older with
It was supported by 2 phase 3 studies, study A and LIBERTY-CUPID (study C;
The final approval discussed was dupilumab for
Dupilumab’s efficacy included the absence of disease relapse after patients completed oral corticosteroid taper (59% vs 16%; nominal P = .0023), the absence of a need for rescue therapy during treatment (42% vs 12%; nominal P = .0004), and the achievement of complete remission and discontinuation of oral corticosteroids by week 16 (38% vs 27%; not significant).
“After so many decades of not having any approved therapies, and depending on systemic steroids and systemic immunosuppressants, we now have a biologic that we’re very familiar with, dupilumab, recently approved just in June for the treatment of bullous pemphigoid,” Alexis said.
Impact on Practice and Key Takeaways
Although recent, many of these treatments are already influencing practice. approved within the past year, many are already making an impact. As highlighted by Alexis, focused updated AD treatment
Considering advancements made in AD and beyond, Alexis concluded by reflecting on the dermatological innovations this past year.
“It's been an extraordinary year with more and more developments for treating our medical dermatological conditions, many of which affect our patients with skin of color uniquely,” he said.
References
- Andrus E, Bosslett M. FDA approves tapinarof cream, 1% for atopic dermatitis in patients 2 years and older. Dermatology Times. December 16, 2024. Accessed October 3, 2025.
https://www.dermatologytimes.com/view/fda-approves-tapinarof-cream-1-for-atopic-dermatitis-in-patients-2-years-and-older - Steinzor P. FDA approves roflumilast topical foam 0.3% for plaque psoriasis. The American Journal of Managed Care® (AJMC). May 22, 2025. Accessed October 3, 2025.
https://www.ajmc.com/view/fda-approves-roflumilast-topical-foam-0-3-for-plaque-psoriasis - Shaw ML. FDA approves delgocitinib for moderate to severe hand eczema. AJMC. July 24, 2025. Accessed October 3, 2025.
https://www.ajmc.com/view/fda-approves-delgocitinib-for-moderate-to-severe-hand-eczema - McCrear S. FDA approves ruxolitinib cream for patients as young as 2 years with atopic dermatitis. September 19, 2025. Accessed October 3, 2025.
https://www.ajmc.com/view/fda-approves-ruxolitinib-cream-for-patients-as-young-as-2-years-with-atopic-dermatitis - Andrus E, Hebebrand M. FDA approves lebrikizumab-lbkz for moderate to severe atopic dermatitis. September 13, 2024. Accessed October 3, 2025.
https://www.dermatologytimes.com/view/fda-approves-lebrikizumab-lbkz-for-moderate-to-severe-atopic-dermatitis - Alexis A, Moiin A, Waibel J, et al. Efficacy and safety of lebrikizumab in adult and adolescent patients with skin of color and moderate-to-severe atopic dermatitis: results from the phase IIIb, open-label ADmirable study. Am J Clin Dermatol. 2025;26(5):803-817. doi:10.1007/s40257-025-00970-8
- Ferruggia K. Nemolizumab granted FDA approval for moderate-to-severe atopic dermatitis. Pharmacy Times. December 16, 2024. Accessed October 3, 2025.
https://www.pharmacytimes.com/view/nemolizumab-granted-fda-approval-for-moderate-to-severe-atopic-dermatitis - Shaw ML. FDA approves bimekizumab in hidradenitis suppurativa. AJMC. November 20, 2024. Accessed October 3, 2025.
https://www.ajmc.com/view/fda-approves-bimekizumab-in-hidradenitis-suppurativa - Santoro C. FDA greenlights dupilumab for chronic spontaneous urticaria, marking first approval in a decade. AJMC. April 18, 2025. Accessed October 3, 2025.
https://www.ajmc.com/view/fda-greenlights-dupilumab-for-chronic-spontaneous-urticaria-marking-first-approval-in-a-decade - Santoro C. FDA expands dupilumab approval as first new biologic for bullous pemphigoid. AJMC. June 20, 2025. Accessed October 3, 2025.
https://www.ajmc.com/view/fda-expands-dupilumab-approval-as-first-new-biologic-for-bullous-pemphigoid - Davis DMR, Frazer-Green L, Alikhan A, et al. Focused update: guidelines of care for the management of atopic dermatitis in adults. J Am Acad Dermatol. 2025;93(3):745.e1-745.e7. doi:10.1016/j.jaad.2025.05.1386
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