Media Update: Positive data from two Phase 3 Dupixent® (dupilumab) trials in prurigo nodularis published in Nature Medicine
Published By Sanofi [English], Mon, May 8, 2023 6:30 AM
Positive data from two Phase 3 Dupixent® (dupilumab) trials in prurigo nodularis published in Nature Medicine
Paris and Tarrytown, N.Y. May 8, 2023. Positive results from two Phase 3 Dupixent® (dupilumab) trials in adults with uncontrolled prurigo nodularis have been published in Nature Medicine. These first published Phase 3 results in this disease show Dupixent significantly reduced itch (the primary endpoint) and skin lesions compared to placebo. Dupixent also significantly improved health-related quality of life while reducing measures of skin pain and symptoms of anxiety/depression. Results from the trials were the basis for the U.S. Food and Drug Administration (FDA) approval of Dupixent in September 2022 and the European Medicines Agency
Professor of Dermatology, Miller School of Medicine, University of Miami, Director of the Miami Itch Center and principal investigator of the trial
“The publication of these Phase 3 results in Nature Medicine provide a detailed look at the significant clinical benefit of targeting key and central drivers of type 2 inflammation with dupilumab for adults with prurigo nodularis. The extreme itch makes this disease have one of the highest impacts on a patient’s quality of life among all inflammatory skin diseases, and these data show that dupilumab can improve symptoms and health-related aspects of their lives that I see my patients struggle with every day.”
Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and has one of the highest impacts on a patient’s quality of life among all inflammatory skin diseases dues to the extreme itch it causes. Those with prurigo nodularis experience intense, persistent itch with thick skin lesions (called nodules) that can cover most of the body. The disease is often painful, with burning, stinging and tingling of the skin and can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. There are about 75,000 and 70,000 adults in the U.S. and Europe, respectively, who are living with prurigo nodularis and are most in need of novel treatment options.
Safety results through 24 weeks were generally consistent with the known safety profile of Dupixent in its approved dermatology indication. Adverse events that were more commonly observed with Dupixent (≥5%) in either trial included nasopharyngitis and herpes viral infections.
About the Dupixent Prurigo Nodularis Trials
The PRIME and PRIME2 Phase 3 double-blind, placebo-controlled trials evaluated the efficacy and safety of Dupixent in 311 adults with uncontrolled prurigo nodularis. In PRIME and PRIME2, the primary endpoint evaluated the proportion of patients with clinically meaningful improvement in itch from baseline (measured by a ≥4-point reduction in Worst-Itch Numeric Rating Scale [WI-NRS]) at 24 and 12 weeks, respectively.
Additional endpoints included the proportion of patients with clear or almost clear skin of nodules at 24 weeks (measured by a score of 0 or 1 on the Investigator's Global Assessment PN-Stage [IGA PN-S]), improvement from baseline in health-related quality of life (measured by the Dermatology Life Quality Index [DLQI]), improvement from baseline in skin pain (measured by a Numerical Rating Scale), and improvement from baseline in symptoms of anxiety and depression (measured by the Hospital Anxiety and Depression Scale [HADS]).
Dupixent 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 key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE) and prurigo nodularis.
Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 600,000 patients are being treated with Dupixent globally.
Dupilumab Development Program
Dupilumab is being jointly developed by Sanofi and Regeneron 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, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation and bullous pemphigoid. 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.
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Sally Bain | + 1 617 834 6026 | [email protected]
Eva Schaefer-Jansen | + 33 7 86 80 56 39 | [email protected]
Arnaud Delépine | + 33 6 73 69 36 93 | [email protected]
Corentine Driancourt | + 33 6 40 56 92 21 | [email protected]
Felix Lauscher | + 1 908 612 7239 | [email protected]
Tarik Elgoutni| + 1 617 710 3587 | tarik.e [email protected]
Nathalie Pham | + 33 7 85 93 30 17 | [email protected]
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.