Regeneron and Sanofi announced positive results from the Phase 3 LIBERTY-CUPID Study C, evaluating Dupixent (dupilumab) for chronic spontaneous urticaria (CSU) in patients inadequately controlled by antihistamines. The data, presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting, demonstrated significant reductions in itch and hive activity, with a notable proportion of patients achieving well-controlled disease status.
Key Findings from the LIBERTY-CUPID Study C
The study enrolled 151 adults and children with CSU who were biologic-naïve and still symptomatic despite antihistamine treatment. Participants were randomized to receive Dupixent or placebo in addition to standard-of-care antihistamines. At 24 weeks, Dupixent showed significant improvements compared to placebo:
- Itch severity score reduction from baseline: 8.64 points vs. 6.10 points (p=0.02)
- Urticaria activity score reduction from baseline: 15.86 points vs. 11.21 points (p=0.02)
- Well-controlled disease status (urticaria activity score ≤6): 41% vs. 23% (p=0.005)
- Complete response (urticaria activity score=0): 30% vs. 18% (p=0.02)
According to Thomas B. Casale, M.D., Professor at the University of South Florida, "These data confirm results seen in the previous Study A and reinforce the potential of Dupixent to significantly alleviate symptoms for patients, helping them to better control this challenging disease."
Safety Profile
The safety results were consistent with the known safety profile of Dupixent in its approved dermatological indications. Overall rates of treatment emergent adverse events (AEs) were 53% for both Dupixent and placebo. Common AEs with Dupixent included injection site reactions (12% vs. 4%), accidental overdose (7% vs. 3%), and COVID-19 infection (8% vs. 5%).
Regulatory Status and Future Plans
Dupixent is already approved for CSU in Japan and the United Arab Emirates (UAE), and is under regulatory review in the European Union. Regeneron and Sanofi plan to resubmit for U.S. regulatory approval by the end of the year. If approved, Dupixent would be the first new targeted treatment for CSU in the U.S. in over a decade.
About Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria (CSU) is a chronic inflammatory skin disease characterized by sudden hives and persistent itching. It affects over 300,000 people in the U.S. whose symptoms are inadequately controlled by antihistamines. The disease is driven by type 2 inflammation. Current treatments primarily involve H1 antihistamines, but many patients require alternative options to manage their debilitating symptoms.
