Dupilumab Effective in Adults, Adolescents with Skin of Color Living with Atopic Dermatitis

Dupilumab (Dupixent) use in adults and adolescents with moderate-to-severe atopic dermatitis and skin of color leads to significant improvements in signs and symptoms from baseline across different skin tones, new findings suggest.1

These late-breaking, phase 4 data were released by Regeneron Pharmaceuticals, Inc., and Sanofi, and they were presented at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference in Nashville.1,2 The data were the conclusion of the DISCOVER trial (NCT05590585), an analysis in which investigators evaluated dupilumab’s use among both adults and adolescents with moderate-to-severe atopic dermatitis who also did not identify as White.

“Atopic dermatitis, a chronic disease with underlying type 2 inflammation, has a high prevalence and quality of life impact on patients with skin of color,” Andrew Alexis, MD, MPH, professor of Clinical Dermatology at Weill Cornell Medicine, said in a statement.2 “Unique clinical features like darker patches of hyperpigmentation versus redness typically seen on lighter skin may lead to less accurate diagnoses and underestimation of disease severity.”

These are the first results for dupilumab in a large population of individuals with darker skin tones and atopic dermatitis. The disease is is a chronic skin condition with underlying type 2 inflammation, characterized by persistent skin lesions as well as itch, dryness, and other impacts.

Those who identify as having skin of color are known to be moee likely to have hardened skin lesions and to report severe levels of pruritus, dryness in their skin, dyspigmentation, and increased severity of their disease than patients with lighter skin tones. The redness often resulting from atopic dermatitis also appears differently on darker skin than it does on lighter skin, leading to potential misdiagnoses.

To assess such individuals the phase 4, open-label, single-arm, 24-week DISCOVER study aimed to assess the efficacy and the safety of dupilumab utilization among those who have skin of color as well as moderate-to-severe atopic dermatitis.1 Skin of color was defined by having Fitzpatrick skin types IV-VI.

Over this 24-week treatment period, all of those involved as trial participants were given dupilumab as monotherapy on an every-2-week basis, and this was based on their weight after a loading dose. The investigators’ main endpoint that they looked into was the proportion of subjects attaining at least 75% Eczema Area and Severity Index (EASI-75) score improvement at the 24-week mark.

In terms of secondary endpoints, they evaluated the proportion of participants attaining an improvement of ≥4 points on the Peak-Pruritus Numerical Rating Scale (PP-NRS) at the same point in time. Further endpoints highlighted by the investigative team included shifts in skin dryness on the patient-reported Xerosis NRS and on the clinician-reported Post-Inflammatory Hyperpigmentation Severity Scale.

The results indicated that signs and symptoms of atopic dermatitis saw improvements from baseline across various skin tones.1,2 Specifically, it was noted that 76% had achieved a ≥75% improvement in overall severity as measured by EASI-75. The team further noted achievement by 53% of clinically meaningful pruritus improvements based on PP-NRS scores.

Such itch improvements were observed by some of those involved in the DISCOVER analysis by as early as 2 weeks. A 53% reduction from baseline in post-inflammatory hyperpigmentation, was also observed, dropping from 5.1 points (moderate/marked) to 2.4 points (mild). Additionally, the investigators noted that 18% reported being very or extremely bothered by their dry skin compared to 78% at the point of baseline.

In assessing dupilumab’s safety in the DISCOVER study, findings were shown to have been generally consistent with the treatment’s existing safety profile in its approved dermatological indications. When they looked at adverse event (AE) rates, 42% of subjects reported AEs, with the most common (≥2%) being headache among 3%, upper respiratory tract infection among 2%, and eczema, conjunctivitis, and allergic conjunctivitis all being noted by 2% each.

“The results from the DISCOVER trial showed that [dupilumab] patients with atopic dermatitis and darker skin not only experienced reduced disease severity and itch but also saw improvements in areas of particular concern including dyspigmentation and dry skin,” Alexis said in his statement.2 “These data deepen the clinical understanding of atopic dermatitis within this underserved population, including use of newly validated scales.”

References

1. Markowitz O, Mayo T, Callender V, et al. Dupilumab monotherapy in patients with skin of color and moderate-to-severe atopic dermatitis: results from a phase 4, open-label study. Presented at the Revolutionizing Atopic Dermatitis (RAD) 2025 Annual Meeting June 6 – 7, 2025. Nashville, TN.

2. Dupixent® (dupilumab) Data at Revolutionizing Atopic Dermatitis (RAD) Conference Reinforce Use in Atopic Dermatitis Patients with Skin of Color. Regeneron Pharmaceuticals, Inc. June 7, 2025. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-data-revolutionizing-atopic-dermatitis-rad.