Regeneron and Sanofi have announced positive results from the Phase 3 LIBERTY-CUPID Study C, evaluating Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in biologic-naive patients whose condition is uncontrolled despite antihistamine therapy. The data, presented at the American College of Allergy, Asthma & Immunology 2024 Annual Scientific Meeting, demonstrated significant improvements in itch and urticaria activity scores, with a greater proportion of patients achieving well-controlled disease status compared to placebo.
The LIBERTY-CUPID Study C enrolled 151 adults and children who were randomized to receive either Dupixent or placebo in addition to standard-of-care histamine-1 antihistamines. At 24 weeks, Dupixent demonstrated statistically significant improvements compared to placebo in several key endpoints:
- Itch severity score
- Urticaria activity score
- Well-controlled disease status
- Complete response
The safety results from the study were consistent with the known safety profile of Dupixent in its approved dermatological indications. Overall rates of treatment-emergent adverse events were similar between the Dupixent and placebo groups (53% in each group). Adverse events more commonly observed with Dupixent compared to placebo included injection site reactions, accidental overdose, and COVID-19 infection.
Dupixent is currently approved for CSU in Japan and the United Arab Emirates. Regulatory review is underway in the European Union based on earlier trial readouts. Outside of Japan and the UAE, the safety and efficacy of Dupixent for CSU has not been fully evaluated by any regulatory authority.
