TARRYTOWN, N.Y. and PARIS, July 29, 2021 /PRNewswire/ --
Fifth disease in which Dupixent has demonstrated positive pivotal results
Phase 3 trial met primary and all key secondary endpoints at 24 weeks, showing Dupixent nearly doubled reduction in itch and urticaria activity scores
CSU results further demonstrate the potential of targeting IL-4 and IL-13 via IL-4Ra blockade to improve diseases with components of type 2 inflammation
Approximately 300,000 people in the U.S. have moderate-to-severe CSU that does not respond adequately to antihistamines alone
Data continue to support well-established safety profile of Dupixent
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU) met its primary and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naïve patients, compared to antihistamines alone in Study A, the first of two trials of the LIBERTY-CUPID clinical program.
"This is the first Phase 3 trial to show that by targeting IL-4 and IL-13, Dupixent can address the debilitating symptoms of chronic spontaneous urticaria like persistent itch and hives when standard-of-care antihistamines cannot sufficiently control the disease," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "These data add to the increasing body of evidence that Dupixent can reduce the disease burden of a diverse range of dermatologic, respiratory and gastrointestinal diseases. By early 2022, we look forward to reporting results from a second trial in patients who were unable to control their chronic spontaneous urticaria with another biologic medicine, as well as other trial results in additional dermatologic diseases."
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, and 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. CSU is the fifth disease for which Dupixent has positive Phase 3 data including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis (EoE, investigational).
"The chronic nature of CSU, coupled with intense itch, causes both a physical and emotional burden on people who have not found an effective treatment," said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi. "This is the fifth inflammatory disease in which Dupixent has demonstrated a significant improvement in symptoms and disease manifestations in Phase 3 pivotal studies. The success of this trial underscores the agility of our clinical operations team considering the pandemic conditions and underscores our ability to deliver on an aggressive timeline for addressing a significant unmet need for this patient population."
In the trial (n=138), adding 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. 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