Dupixent® (dupilumab) Data at Revolutionizing Atopic Dermatitis (RAD) Conference Reinforce Use in Atopic Dermatitis Patients with Skin of Color

Associated Press

08-06-2025

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:
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 Color
Atopic 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 Trial
The 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 <60 kg received 200 mg and patients weighing ≥60 kg received 300 mg.
The primary endpoint assessed the proportion of patients who achieved at least 75% improvement on the Eczema Area and Severity Index (EASI-75) at 24 weeks. Secondary endpoints included the proportion of patients who achieved ≥4-point improvement on the Peak-Pruritus Numerical Rating Scale (PP-NRS) at 24 weeks. Additional endpoints included pigmentary changes on the clinician-reported Post-Inflammatory Hyperpigmentation Severity Scale (PHSS; scale: 0-8) and skin dryness on the newly developed patient-reported Xerosis NRS (X-AD; scale: 0-10) at 24 weeks.
About Dupixent
Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.
Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, chronic spontaneous urticaria (CSU) and chronic obstructive pulmonary disease (COPD) in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.1
About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite ® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024.
Dupilumab Development Program
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin, bullous pemphigoid, and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine.
DUPIXENT is not used to treat any other forms of hives (urticaria).
IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, or chronic spontaneous urticaria, and also have asthma. Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine, without talking to your healthcare provider. This may cause other symptoms that were controlled by those medicines to come back.
DUPIXENT can cause serious side effects, including:
The most common side effects include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed by your healthcare provider. It's an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it's recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.
Please see accompanying full Prescribing Information including Patient Information.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
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1 Data on File