Atopic dermatitis is a chronic disease that disproportionately impacts communities of color
Dupixent achieved 75% or greater improvement in overall disease severity, the primary endpoint, in more than three-quarters of treated patients
Patients experienced substantial reductions in hyperpigmentation, dry skin and itch from baseline
Results support commitment to enhance clinical understanding of chronic diseases in communities of color
TARRYTOWN, N.Y. and PARIS, June 07, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented results from the DISCOVER Phase 4, single-arm, open-label trial assessing Dupixent® (dupilumab) in adults and adolescents with moderate-to-severe atopic dermatitis with skin of color. These are the first clinical trial results for Dupixent in a large population of patients with darker skin tones. The results, along with the Dupixent Phase 3 trials, demonstrated patients taking Dupixent experienced improvements in signs and symptoms of atopic dermatitis from baseline across many skin tones. The data were shared in an oral presentation at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference.
“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. 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,” said Andrew Alexis, M.D., M.P.H., Professor of Clinical Dermatology at Weill Cornell Medicine. “The results from the DISCOVER trial 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. These data deepen the clinical understanding of atopic dermatitis within this underserved population, including use of newly validated scales.”
In the trial, 120 patients with atopic dermatitis and skin of color (82% Black, 11% Asian, 2% American Indian/Alaska Native, 5% Arab, Central American or other) were treated with Dupixent every two weeks using a weight-based dosing regimen. At 24 weeks:
- 76% achieved a ≥75% improvement in overall disease severity (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 trial were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. The overall rate of adverse events (AEs; n=124) in the DISCOVER trial was 42%, with the most common (≥2%) AEs being headache (3%), upper respiratory tract infection (2%), eczema (2%), conjunctivitis (3%) and allergic conjunctivitis (2%).
About Atopic Dermatitis in Skin of ColorAtopic dermatitis is a chronic skin disease with underlying type 2 inflammation that causes intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, crusting and oozing. In patients with skin of color, the type and location of the lesions can vary, and they are more likely to have hardened skin lesions and severe skin dryness, itch, dyspigmentation and greater disease severity than those with lighter skin. Additionally, redness that is observed on lighter skin typically appears as darkened, grey or violet on darker skin tones. Because the disease presents differently in people with skin of color, it can be misdiagnosed or the severity underestimated, which can contribute to higher levels of healthcare resource utilization.
About the DISCOVER Clinical TrialThe DISCOVER Phase 4 open-label, single-arm trial evaluated the efficacy and safety of Dupixent in adults and adolescents aged 12 years and older with moderate-to-severe atopic dermatitis and skin of color, as defined by Fitzpatrick skin types IV-VI (those with high melanin; light brown to black). During the 24-week treatment period, all patients in the trial received Dupixent monotherapy every two weeks based on weight after a loading dose: patients weighing ≥30 to