Dupilumab significantly improves itch and hives in patients with chronic spontaneous urticaria (CUPID study C)

Abstract

Background

Chronic spontaneous urticaria (CSU) can be difficult to manage with many patients experiencing inadequate disease control despite treatment with H1-antihistamines.

Methods

LIBERTY-CSU CUPID Study C (NCT04180488), a randomized, placebo-controlled, double-blind 24-week phase III trial compared dupilumab with placebo treatment in omalizumab-naive patients with symptomatic CSU despite standard-of-care H1-antihistamines treatment (up to 4-fold approved dose) (n = 151, age ≥ 6 years). Patients were randomized to receive add-on dupilumab 300 mg (adults and adolescents ≥ 60 kg) or 200 mg (adolescents < 60 kg, children ≥ 30 kg) (n = 74) or matching placebo (n = 77) subcutaneously every 2 weeks. Efficacy endpoints included Itch Severity Score over 7 days (ISS7, range: 0-21) and Urticaria Activity Score over 7 days (UAS7, range: 0-42). Safety and tolerability were assessed.

Results

Dupilumab significantly improved ISS7 and UAS7 vs placebo at week 24 (least squares mean change in ISS7 from baseline: −8.6 dupilumab vs −6.1 placebo; difference: −2.5, P = .02; least squares mean change in UAS7: −15.9 dupilumab vs −11.2 placebo; difference: –4.7, P = .02). A higher proportion of patients receiving dupilumab achieved well-controlled disease status (UAS ≤ 6: 41% dupilumab vs 23% placebo, odds ratio = 2.7, P = .005) or complete response (UAS = 0: 30% dupilumab vs 18% placebo, odds ratio = 2.7, P = .02) at week 24 compared with placebo. Overall rates of participants with treatment-emergent adverse events were the same for both groups (53%). Safety was generally consistent with the known safety profile of dupilumab.

Conclusion

Dupilumab significantly reduced itch and urticaria in patients with CSU who were uncontrolled with H1-antihistamine therapy. This research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc and was compliant with GPPG.