Press Release: Dupixent late-breaking positive phase 3 data in chronic spontaneous urticaria to be presented at ACAA

Dupixent late-breaking positive phase 3 data in chronic spontaneous urticaria to be presented at ACAAI

Dupixent significantly reduced itch and hive activity from baseline; 41% of patients achieved well-controlled disease status

Confirmatory data to support US regulatory resubmission by year-end; if approved, Dupixent would be the first new targeted treatment for people living with chronic spontaneous urticaria in more than 10 years

More than 300,000 people in the US suffer from chronic spontaneous urticaria that is inadequately controlled by antihistamines

Paris and Tarrytown, NY, October 24, 2024. Positive data from the phase 3 LIBERTY-CUPID Study C evaluating the investigational use of Dupixent (dupilumab) in biologic-naive patients with uncontrolled chronic spontaneous urticaria (CSU) who receive background therapy with antihistamines will be presented in a late-breaking oral presentation at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 Annual Scientific Meeting in Boston, Massachusetts. Results showed treatment with Dupixent significantly reduced itch and urticaria activity (itch and hive) scores from baseline, and a higher proportion of patients achieved well-controlled disease status, compared to placebo.

Thomas B. Casale, M.D.

Professor, Internal Medicine, Morsani College of Medicine at the University of South Florida, USA

“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. 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.”

Study C enrolled 151 children and adults who were randomized to receive Dupixent (n=74) or placebo (n=77) added to standard-of-care histamine-1 (H1) antihistamines. At 24 weeks, Dupixent demonstrated significant improvements compared to placebo on:
Itch severity score (8.64- vs. 6.10-point reduction from baseline; p=0.02) Urticaria (itch and hive) activity score (15.86- vs. 11.21-point reduction from baseline; 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)

The safety results in Study C were generally 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. AEs more commonly observed with Dupixent (≥5%) compared to placebo included injection site reactions (12% vs. 4%), accidental overdose (7% vs. 3%) and COVID-19 infection (8% vs. 5%).

Dupixent has been approved for CSU in Japan, the United Arab Emirates (UAE) and is also under regulatory review 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.