Dupilumab (Dupixent, Sanofi & Regeneron) achieved 75% or greater improvement in overall atopic dermatitis (AD) disease severity in more than three-quarters of patients with darker skin tones, according to a Phase 4 study presented at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference in Nashville, TN.

Moreover, study participants experienced substantial reductions in hyperpigmentation, dry skin, and itch from baseline, the study showed.

First Results in Darker Skin Tones

These are the first clinical study results for dupilumab in a large population of patients with darker skin tones. The results, along with the Dupixent Phase 3 studies, demonstrated patients taking Dupixent experienced improvements in signs and symptoms of atopic dermatitis from baseline across many skin tones.

“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,” says Andrew Alexis, MD, MPH, Professor of Clinical Dermatology at Weill Cornell Medicine in New York City, in a news release. “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.”

The results showed that “Dupixent 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,” he says. “These data deepen the clinical understanding of atopic dermatitis within this underserved population, including use of newly validated scales.”

Study Highlights

For the study, 120 patients with AD and skin of color (82% Black, 11% Asian, 2% American Indian/Alaska Native, 5% Arab, Central American, or other) were treated with dupilumab every two weeks using a weight-based dosing regimen. At 24 weeks:

• 76% achieved a ≥75% improvement in overall disease severity (Eczema Area and Severity Index [EASI-75]), the primary endpoint. Improvements were seen by some patients as early as two weeks.
• 53% achieved clinically meaningful improvement in itch (≥4-point reduction on the peak-pruritus numerical rating scale [PP-NRS]). Improvements were seen by some patients as early as two weeks.
• Patients experienced a 53% reduction from baseline in post-inflammatory hyperpigmentation, dropping from 5.1 points (moderate/marked) to 2.4 points (mild).
• 18% were very or extremely bothered by dry skin vs. 78% at baseline, based on patient reporting.

The safety results in the DISCOVER study were generally consistent with the known safety profile of dupilumab in its approved dermatological indications. The overall rate of adverse events (AEs; n=124) in the DISCOVER study was 42%, with the most common (≥2%) AEs being headache (3%), upper respiratory tract infection (2%), eczema (2%), conjunctivitis (3%), and allergic conjunctivitis (2%).