FDA

Dupixent OK’d for chronic spontaneous urticaria

April 22, 2025

FDA approved Dupixent (dupilumab) for the treatment of adults and adolescents ≥12 years of age with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.

CSU is the seventh disease with underlying type 2 inflammation in which Dupixent is approved. Others include asthma, atopic dermatitis, COPD, eosinophilic esophagitis, chronic rhinosinusitis, and prurigo nodularis.

Efficacy

The LIBERTY-CUPID Phase 3 program (NCT04180488) evaluating Dupixent for CSU consisted of Study A (N = 136), Study B (N = 108), and Study C (N = 148). These trials were randomized, double-blind, placebo-controlled clinical trials that evaluated the efficacy and safety of Dupixent as an add-on therapy to standard-of-care antihistamines compared to antihistamines alone. Studies A and C were replicate trials that assessed patients ≥6 years of age who remained symptomatic despite the use of antihistamines. Study B was conducted in patients ≥12 years of age who were symptomatic despite use of antihistamines and were inadequate responders or intolerant to anti-IgE therapy. During the 24-week treatment period in all three trials, patients received an initial loading dose followed by 300 mg Dupixent q2wks, except for pediatric patients weighing <60 kg who received 200 mg q2wks.

The primary endpoint assessed in all 3 studies was the change from baseline in itch at 24 weeks (measured by the weekly itch severity score [ISS7], 0-21 scale). Key secondary endpoints (also assessed at 24 weeks) included change from baseline in itch and hives (weekly urticaria activity score [UAS7], 0-42 scale). Additional secondary endpoints assessed at 24 weeks evaluated the proportion of patients achieving well-controlled disease status (UAS7 ≤6) and the proportion of patients with complete response (UAS7 = 0).

Studies A and C met their primary and key secondary endpoints with Dupixent demonstrating reductions in itch severity and urticaria activity (a composite of pruritus and hives) compared with placebo at 24 weeks. Dupixent also increased the likelihood of well-controlled disease or complete response compared with placebo at 24 weeks.

Study B, however, didn’t meet the primary endpoint in the U.S. of reduction in ISS7 compared with placebo at 24 weeks.

Safety

In pooled data from the three CSU trials, the most common adverse event (≥2%) more frequently observed in patients on Dupixent vs. placebo was injection site reactions.

Sources:

Dupixent® (dupilumab) approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria (CSU). [News release]. 2025.

Dupixent (dupilumab) [package insert]. Regeneron. https://www.regeneron.com/downloads/dupixent_fpi.pdf Revised April 2025. Accessed April 21, 2025.