Regeneron and Sanofi Announce Positive Dupixent Trial Results in Atopic Dermatitis Patients with Skin of Color
TARRYTOWN, N.Y. and PARIS – June 7, 2025 –
In a move that could reshape treatment for a significant patient population, Regeneron Pharmaceuticals and Sanofi today presented compelling Phase 4 trial data showcasing the efficacy of Dupixent (dupilumab) in treating moderate-to-severe atopic dermatitis in adults and adolescents with skin of color. These landmark findings, unveiled at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, mark the first large-scale clinical trial results for Dupixent in this often-underserved demographic.
The news is particularly impactful, as atopic dermatitis disproportionately affects communities of color. These patients often experience unique disease manifestations, which can lead to misdiagnosis or an underestimation of the illness’s severity.
“Atopic dermatitis, driven by underlying type 2 inflammation, severely impacts the quality of life for patients with skin of color,” explains Dr. Andrew Alexis, Professor of Clinical Dermatology at Weill Cornell Medicine. “This trial highlights the potential of Dupixent to alleviate not only the severity of the disease and the itch, but also to address critical concerns like dyspigmentation and dry skin. This data helps us deepen the clinical understanding of atopic dermatitis within this underserved population”
The DISCOVER trial enrolled 120 patients with atopic dermatitis and skin of color. The patient pool included 82% Black, 11% Asian, 2% American Indian/Alaska Native, and 5% Arab, Central American, or other individuals. Results, measured at 24 weeks, paint a promising picture:
* 76% of patients achieved a significant improvement (≥75%) in overall disease severity (EASI-75), the study’s primary endpoint. Early improvements were noted as soon as two weeks.
* 53% of patients experienced a clinically meaningful reduction in itch (≥4-point reduction on the PP-NRS). Rapid symptom relief was achieved within two weeks for some patients.
* A 53% reduction in post-inflammatory hyperpigmentation was observed from baseline
* The study also revealed an 18% of patients reporting they were very or extremely bothered by dry skin, compared to 78% at baseline.
The DISCOVER trial’s safety profile aligned with the well-established safety of Dupixent for its approved dermatological indications. The overall adverse events rate was 42%, with the most frequent events being headaches, upper respiratory tract infections, eczema, conjunctivitis, and allergic conjunctivitis.
**Understanding Atopic Dermatitis in Skin of Color**
Atopic dermatitis is a chronic, type 2 inflammation-driven skin disease that causes intense itching, leading to lesions that often cover large areas of the body. The effects can include skin dryness, cracking, pain, crusting, and oozing. In individuals with skin of color, the presentation of these lesions can vary. Frequently, they display a hardened skin and intensified skin dryness, itch, and dyspigmentation. These presentations can lead to underestimation of severity.
**About the DISCOVER Clinical Trial**
The DISCOVER trial was a Phase 4, single-arm study that assessed Dupixent’s effectiveness and safety in adults and adolescents (12 years and older) with moderate-to-severe atopic dermatitis with skin of color, as defined by a Fitzpatrick skin type of IV-VI. Patients received Dupixent monotherapy every two weeks for 24 weeks following a loading dose. The primary endpoint was the percentage of patients who achieved at least a 75% improvement on the Eczema Area and Severity Index (EASI-75) at 24 weeks. Secondary endpoints included itch improvement and changes in skin pigmentation.
**About Dupixent**
Dupixent, developed through Regeneron’s VelocImmune technology, is a fully human monoclonal antibody that targets the IL-4 and IL-13 pathways, without immunosuppressant properties. It has received regulatory approval in over 60 countries for various indications, including certain cases of atopic dermatitis, asthma, and other conditions. Over one million patients globally have been treated with Dupixent.
**About Regeneron**
Regeneron is a leading biotechnology company focused on the development of life-transforming medicines. The company’s VelociSuite technology allows for the creation of fully human monoclonal antibodies. Regeneron scientists have used the VelociSuite technology to make multiple FDA-approved fully human antibodies. This includes Dupixent, and others. The company’s focus is on tackling diseases, including eye diseases, allergic and inflammatory diseases, cancer, and more.
The company maintains a robust pipeline and an ongoing commitment to scientific advancement, with the goal of bringing novel therapies to patients in need.
**About Sanofi**
Sanofi is an R&D-driven, AI-powered biopharma company focused on improving lives. Sanofi prioritizes a deep understanding of the immune system to create medicines and vaccines. Their focus is on medicines and vaccines to treat and protect global populations.
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