Dupilumab Approved for Uncontrolled Chronic Spontaneous Urticaria: Daily Dose

Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On April 18, 2025, we reported on the US FDA approval of dupilumab (Dupixent) as an add-on maintenance treatment for adults and adolescents aged ≥12 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with H₁ antihistamines.

The approval

The FDA's decision was based on data from the LIBERTY-CUPID phase 3 clinical trial program, which included 3 randomized, double-blind, placebo-controlled studies. Study A (n=136) and Study C (n=148) assessed dupilumab in biologic-naïve patients aged ≥12 years with CSU uncontrolled by antihistamines. Dupilumab significantly reduced itch severity at 24 weeks compared with placebo and also improved urticaria activity scores. Patients receiving dupilumab were more likely to achieve well-controlled disease (UAS7 ≤6) or complete response (UAS7=0) than those receiving placebo.

Study B (n=108) included patients aged ≥12 years who were symptomatic despite antihistamines and were inadequate responders or intolerant to anti–immunoglobulin E (IgE) therapy. This study did not meet the primary endpoint of itch severity reduction in the US but contributed additional safety data.

In all 3 trials, dupilumab was administered every 2 weeks following a loading dose. Adolescent dosing varied by weight. Safety findings were consistent with the known profile of dupilumab, with injection site reactions being the most commonly reported adverse event (≥2%) occurring more frequently than with placebo.

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