Medical Information

In this Phase 3 trial, Dupixent added to standard-of-care antihistamines nearly doubled reduction in itch and urticaria activity scores compared to standard-of-care alone at 24 weeks in biologic-naïve patients uncontrolled on antihistamines

Data reinforce the potential of targeting IL-4 and IL-13, key drivers of type 2 inflammation, in this complex chronic disease.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced detailed positive results for Dupixent® (dupilumab) in patients with chronic spontaneous urticaria (CSU) who are biologic-naïve (i.e., not previously treated with omalizumab). The pivotal trial showed adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives at 24 weeks compared to antihistamines alone in this investigational setting. These results will be presented today in a late-breaking session at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.

"Despite standard-of-care antihistamines, many patients with chronic spontaneous urticaria continue to struggle with extreme itch, burning and pain associated with hives and swelling under the skin, which can significantly disrupt their daily lives," said Marcus Maurer, M.D., Professor of Dermatological Allergology, Clinic for Dermatology, Venerology and Allergology at the Charité University of Medicine in Berlin, Germany. "These encouraging results showed that, in those unable to achieve disease control on antihistamines alone, patients who added dupilumab experienced improved signs and symptoms and better control of their disease."

Topline results from the randomized, double-blind, placebo-controlled pivotal trial, which met primary and all key secondary endpoints at week 24, were announced in July 2021. Data presented at the 2022 AAAAI Annual Meeting showed that patients who added Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone (placebo) with continuous improvement out to 24 weeks. These patients experienced a:

63% reduction in itch severity with Dupixent versus 35% with placebo, as measured by a 0-21 point itch severity scale (10.24 point reduction with Dupixent versus 6.01 point reduction with placebo, p<0.001), the primary endpoint in the U.S. (secondary endpoint in the EU).

65% reduction in urticaria activity (itch and hive) severity with Dupixent versus 37% with placebo, as measured by a 0-42 point urticaria activity scale (20.53 point reduction with Dupixent versus 12.00 point reduction with placebo, p<0.001), the primary endpoint in EU (secondary endpoint in the U.S.).

The trial demonstrated safety results similar to the known safety profile of Dupixent in its approved dermatology indications. For the 24-week treatment period, overall rates of adverse events were generally similar between the Dupixent and placebo groups (50% Dupixent, 59% placebo). The most common adverse event was injection site reactions (11% Dupixent, 13% placebo).

The potential use of Dupixent in CSU is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

About Chronic Spontaneous Urticaria (CSU)

CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin. Despite standard-of-care treatment, people with CSU often experience symptoms including a persistent itch or burning sensation, which can be debilitating and significantly impact quality of life. Swelling often occurs on the face, hands and feet, but can also affect the throat and upper airways. CSU is typically treated with antihistamines, but the disease remains uncontrolled for up to 50% of patients who have limited available treatment options. More than 300,000 people in the U.S. have moderate-to-severe CSU that does not respond adequately to antihistamines alone.

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. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).

Dupixent is currently approved in the U.S., Europe, Japan and other countries around the world for use in specific patients with moderate-to-severe atopic dermatitis, as well as certain patients with asthma or CRSwNP in different age populations. Dupixent is also approved in one or more of these indications in more than 60 countries around the world and more than 350,000 patients have been treated globally.

https://www.prnewswire.com/news-releases/late-breaking-phase-3-data-at-2022-aaaai-annual-meeting-show-dupixent-dupilumab-significantly-reduced-itch-and-hives-in-patients-with-chronic-spontaneous-urticaria-301490843.html