Andrew F. Alexis, MD, MPH, co-chair of the Skin of Color Update 2025, opened the meeting this morning in New York City with an overview of recent FDA approvals relevant to patients with skin of color, including new therapies for atopic dermatitis (AD), hidradenitis suppurativa (HS), and more.

He highlighted 9 treatments: 4 topical medications and 5 biologic agents. Of these, most were previously approved for other indications.

FDA approvals since the last Skin of Color Update expand topical and biologic options for various dermatological conditions, benefiting patients with skin of color. | Image Credit: Tada Images - stock.adobe.com

Expanding Topical Treatment Options

Tapinarof Cream, 1% Approved for AD in Patients 2 Years and Older

Alexis first highlighted tapinarof cream, 1% (Vtama; Organon), which gained approval last December for patients aged 2 and older with AD.1 It was supported by the phase 3 ADORING 1 (NCT05014568) and 2 (NCT05032859) studies, a pharmacokinetics trial in children, and interim results from the ongoing ADORING 3 (NCT05142774) trial.

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 roflumilast 0.3% foam (Zoryve; Arcutis Biotherapeutics) for patients aged 12 and older with plaque psoriasis.2 The May 2025 approval was supported by positive results from the phase 3 ARRECTOR trial (NCT05028582) and the phase 2 Trial 204.

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

Approved July 2025, Alexis noted that delgocitinib (Anzupgo; LEO Pharma) became the first steroid-free Janus kinase inhibitor specifically for moderate-to-severe chronic hand eczema in adults.3 This was based on DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101), a pair of phase three 16-week analyses where 960 patients were evaluated for their response to the twice-daily application of either 20 mg/g delgocitinib or cream vehicle.

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 ruxolitinib cream, 1.5% (Opzelura; Incyte) for moderate AD in non-immunocompromised patients aged 2 and older.4 This approval was based on data from the phase 3 TRuE-AD3 (NCT04921969) clinical study.

“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 lebrikizumab (Ebglyss; Eli Lilly), an IL-13 inhibitor approved last September for patients aged 12 and older with moderate to severe AD not yet controlled with topical therapies.5

It is supported by positive data from the ADvocate 1 (NCT04146363), ADvocate 2 (NCT04178967), and ADhere (NCT04250337) studies. On average, 38% achieved clear skin at 16 weeks vs 12% with placebo. Of patients who did so, 77% maintained clear skin for a year with monthly doses, and 48% did so even after switching to a placebo.

Alexis highlighted a study he authored that was published earlier this year, which used the PDCA-DERM scale, a novel end point, to measure changes in pigmentation from baseline to the end of lebrikizumab treatment in patients with AD.6

“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 nemolizumab (Nemluvio; Galderma), approved last December for the treatment of moderate to severe AD in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCIs) when the disease is not controlled by topical prescription therapies among patients aged 12 and older.7 This approval made it the first FDA-approved monoclonal antibody that exclusively targets IL-31 receptor alpha.

The phase 3 ARCADIA clinical trial program (NCT03989349) demonstrated statistically significant improvements in skin clearance with nemolizumab in combination with TCS, with or without TCI. Additionally, nemolizumab achieved a 75% reduction in EASI after 16 weeks of treatment vs placebo with TCS, with or without TCI.

FDA Approves Bimekizumab in Hidradenitis Suppurativa

In addition, Alexis spotlighted the approval of bimekizumab (Bimzelc; UCB Pharma) last November for adult patients with moderate to severe HS.8 The phase 3 BE HEARD I (NCT04242446) and II (NCT04242498) trials showed treatment responses noted at week 16 endured through week 48.

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 chronic spontaneous urticaria (CSU) whose hives and itching remain uncontrolled by antihistamines; this marks the first approval in over a decade for this condition.9

It was supported by 2 phase 3 studies, study A and LIBERTY-CUPID (study C; NCT04180488). In both studies, patients aged 6 years and older with CSU and prior antihistamine therapy showed significant reductions in itch and urticaria severity at week 24.

The final approval discussed was dupilumab for bullous pemphigoid, based on results from the LIBERTY-BP ADEPT (NCT04206553) phase 2 and 3 study.10 Results showed that dupilumab achieved sustained disease remission in 20% of patients at 36 weeks vs 4% of those receiving placebo (P = .0114).

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 guidelines strongly recommend tapinarof cream, roflumilast 0.15% cream, lebrikizumab, and nemolizumab for adult patients.11

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

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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