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 study demonstrated significant reductions in itch and hive activity, with a notable proportion of patients achieving well-controlled disease status.
The late-breaking data, presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2024 Annual Scientific Meeting, highlighted Dupixent's potential to address a significant unmet need in CSU management. More than 300,000 people in the U.S. suffer from CSU that is not adequately controlled by antihistamines.
Key Findings from the LIBERTY-CUPID Study C
The study enrolled 151 adults and children who were randomized to receive Dupixent (n=74) or placebo (n=77) in addition to standard-of-care antihistamines. At 24 weeks, Dupixent demonstrated statistically significant improvements compared to placebo across several key endpoints:
- Itch Severity: Dupixent showed an 8.64-point reduction in itch severity score from baseline compared to a 6.10-point reduction with placebo (p=0.02).
- Urticaria Activity: The urticaria activity score (itch and hives) decreased by 15.86 points in the Dupixent group versus 11.21 points in the placebo group (p=0.02).
- Disease Control: 41% of Dupixent-treated patients achieved well-controlled disease status (urticaria activity score ≤6) compared to 23% of placebo-treated patients (p=0.005).
- Complete Response: 30% of patients on Dupixent achieved complete response (urticaria activity score=0) compared to 18% on placebo (p=0.02).
Safety Profile
The safety results were consistent with the known safety profile of Dupixent in its approved dermatological indications. Treatment emergent adverse events (AEs) occurred at similar rates in both the Dupixent and placebo groups (53%). AEs more commonly observed with Dupixent included injection site reactions (12% vs. 4% with placebo), accidental overdose (7% vs. 3%), and COVID-19 infection (8% vs. 5%).
Expert Commentary
"Chronic spontaneous urticaria is an inflammatory skin condition that affects patients with unpredictable episodes of intense itching and hives, often severely impacting their daily lives," said Thomas B. Casale, M.D., Professor, Internal Medicine, Morsani College of Medicine at the University of South Florida, USA. "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."
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 based on these confirmatory data. If approved, Dupixent would be the first new targeted treatment for CSU in the U.S. in more than 10 years.
About Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria (CSU) is a chronic inflammatory skin disease driven in part by type 2 inflammation, characterized by sudden and debilitating hives and persistent itch. While H1 antihistamines are commonly used, many patients remain symptomatic, highlighting the need for alternative treatment options.
