TOPLINE:

Dupilumab, approved in 2025 by the US FDA to treat chronic spontaneous urticaria (CSU), significantly reduced symptoms in patients with antihistamine (AH)-resistant CSU in a randomized, double-blind phase 3 trial.

METHODOLOGY:

• Researchers conducted two randomized, placebo-controlled, double-blind, 24-week phase 3 trials (LIBERTY-CSU CUPID-A and CUPID-C) in 10 countries across Asia, Europe, and North and South America.
• A total of 289 anti-immunoglobulin E-naive patients aged 6-80 years with CSU uncontrolled with an H1-antagonist were evaluated, including 151 participants in CUPID-C.
• Participants received either dupilumab (600-mg loading dose followed by 300 mg every 2 weeks for adults and adolescents ≥ 60 kg) or placebo while continuing their background H1-AH treatment.
• Primary endpoints included change in Itch Severity Score over 7 days (ISS7) or Urticaria Activity Score over 7 days (UAS7) at week 24.

TAKEAWAY:

• In the CUPID-C trial, dupilumab demonstrated significant improvements in ISS7 (least squares mean difference [LSMD], -2.54; P = .02) and UAS7 (LSMD, -4.65; P = .02) vs placebo at week 24.
• More dupilumab recipients achieved well-controlled disease (UAS7 ≤ 6: 40.5% vs 23.4%; odds ratio [OR], 3.14; P = .005) and complete response (UAS7 = 0: 29.7% vs 18.2%; P = .02).
• A pooled analysis of the CUPID-A and CUPID-C trials (n = 289) showed well-controlled CSU activity in 43.1% vs 23.4% of patients treated with dupilumab vs placebo (OR, 2.99; P < .001).
• A total of 53.5% vs 55.9% of patients receiving dupilumab vs placebo had treatment-emergent adverse events, with no new safety signals.

IN PRACTICE:

“Dupilumab demonstrated significant and clinically meaningful efficacy in omalizumab-naive patients with CSU who remained symptomatic despite H1-AH treatment in CUPID-C,” which is consistent with the findings from the CUPID-A study, the authors of the study wrote. The combined data from CUPID-A and CUPID-C, they added, “collectively reinforce the clinical benefits and safety profile of dupilumab for H1-AH-refractory and omalizumab-naive patients with CSU.”

SOURCE:

The study was led by Thomas B. Casale, MD, University of South Florida, Tampa, Florida, and was published online on February 18 in JAMA Dermatology.

LIMITATIONS:

The study follow‑up was limited to 24 weeks, pediatric representation was small, and racial or ethnic diversity was limited.

DISCLOSURES:

The study was sponsored by Sanofi and Regeneron Pharmaceuticals. Casale reported receiving grants from the University of South Florida and personal fees from Genentech, Jasper, Novartis, Regeneron Pharmaceuticals Inc., and Sanofi. Several authors reported receiving consulting fees, honoraria, grants, and personal fees from many drug companies, including Sanofi and Regeneron Pharmaceuticals, and having patents pending for treatment of CSU. Four authors reported having equity in Sanofi and Regeneron Pharmaceuticals, with one author being employed by Sanofi during the study period.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.