Dupilumab Significantly Increases Itch- and Hive-Free Days in Chronic Spontaneous Urticaria

New phase 3 data from the LIBERTY-CSU CUPID Study C demonstrate that dupilumab significantly increases the number of itch-free and hive-free days in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine therapy.

In this 24-week, randomized, placebo-controlled phase 3 trial, 151 patients with antihistamine-refractory CSU were randomized to dupilumab (n=74) or placebo (n=77). Patients were required to have moderate-to-severe disease at baseline (Urticaria Activity Score [UAS]7 ≥16, Itch Severity Score [ISS]7 ≥8) despite ongoing antihistamine therapy. The primary analysis assessed cumulative itch-free (ISS=0), hive-free (Hive Severity Score=0), and combined itch- and hive-free (UAS=0) days over 24 weeks. 

Dupilumab significantly improved symptom-free days across all measures. Patients receiving dupilumab achieved greater cumulative days without symptoms compared with placebo: 55.3 vs 35.3 itch-free days, 57.6 vs 37.3 hive-free days, and 52.5 vs 33.0 combined itch- and hive-free days (all nominal P<0.03). 

These differences translate to more than 19 additional symptom-free days over the study period, representing a clinically meaningful improvement in disease burden.

“In patients with antihistamine-refractory CSU, dupilumab significantly increased the number of itch- and hive-free days more than 19 days over 24 weeks, highlighting greater symptom-free days beyond traditional disease activity scores,” the authors concluded. “Safety was generally consistent with the known dupilumab safety profile.”

These findings reinforce dupilumab’s role as an effective option for patients with difficult-to-treat CSU, particularly in improving meaningful patient-centered outcomes such as symptom-free days.

Reference

Yosipovitch G, Ensina LF, Lima HC, et al. Dupilumab improves itch- and hive-free days in patients with chronic spontaneous urticaria. Presented at: American Academy of Dermatology Annual Meeting; March 27–31, 2026; Denver, Colorado.