Dupilumab in patients with cold urticaria: Results from a phase 3 trial.

Background: Cold urticaria (ColdU) is a chronic inducible urticaria characterized by the appearance of itchy wheals and/or angioedema following contact with cold. Although dupilumab treatment showed significant improvements in chronic spontaneous urticaria, there are currently no approved therapies for ColdU. Objective: Our aim was to evaluate the efficacy and safety of dupilumab in adult and adolescent patients with ColdU who remain symptomatic despite the use of antihistamines. Methods: LIBERTY-CINDU CUrIADS (ClinicalTrial.gov identifier NCT04681729) was a phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter trial in which patients aged 12 years or older who had ColdU received dupilumab, 300 mg, or placebo every 2 weeks. The efficacy and safety of dupilumab were assessed after a 24-week treatment period. The primary end point was the proportion of patients with a negative ice cube provocation test result at week 24. The key secondary end points were change from baseline in Peak Pruritus Numeric Rating Scale score at the provocation site, and health-related quality of life, as measured by Dermatology Life Quality Index. Results: In total, 82 adult patients were enrolled in the study. There were no statistically significant differences between the dupilumab and placebo recipients in terms of primary or secondary end points. The proportion of adult patients with ColdU with treatment-emergent adverse events was lower with dupilumab than with placebo (53.5% vs 69.2%). Conclusion: Dupilumab treatment did not lead to statistically significant improvements in signs and symptoms of ColdU as compared with placebo over the 24-week treatment period.