Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials

Marcus Maurer, Thomas B. Casale, Sarbjit S. Saini, Moshe Ben-Shoshan, Ana M. Giménez-Arnau, Jonathan A. Bernstein, Akiko Yagami, Aleksandra Stjepanovic, Allen Radin, Heribert W. Staudinger, Naimish Patel, Nikhil Amin, Bolanle Akinlade, Chunpeng Fan, Deborah Bauer, George D. Yancopoulos, Kiran Patel, Leda P. Mannent, Elizabeth Laws

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4 Citations (Scopus)

Abstract

Background: Chronic spontaneous urticaria (CSU) is a chronic inflammatory disease characterized by recurrent pruritic wheals (hives) and/or angioedema. Patients with CSU could remain symptomatic despite standard-of-care H1 antihistamines (H1-AH) or anti-IgE (omalizumab) treatment. Dupilumab blocks IL-4/IL-13 signaling and is approved for multiple type 2/atopic indications. Objective: We conducted two phase 3, randomized, placebo-controlled, double-blind trials comparing dupilumab with placebo in patients with symptomatic CSU despite H1-AH. Methods: In LIBERTY-CSU CUPID Study A, patients were omalizumab-naive (n = 138, aged ≥6 years). In Study B, patients were omalizumab-intolerant/incomplete responders (n = 108, aged ≥12 years). The primary end point was either change from baseline over 7 days in the Urticaria Activity Score (UAS7) or Itch Severity Score (ISS7) at week 24, with the other as a key secondary end point, depending on regional regulatory requirements. Studies were pooled for safety assessment. Results: In Study A, UAS7 and ISS7 improved with dupilumab versus placebo (difference −8.5 [95% CI, −13.2 to −3.9; P = .0003] and −4.2 [95% CI, −6.6 to −1.8; P = .0005]). In Study B, tested at α = 0.043 after interim analysis, UAS7 improved (difference −5.8 [95% CI, −11.4 to −0.3; P = .0390]), with a numerical trend in ISS7 (difference −2.9 [95% CI, −5.7 to −0.07; nominal P = .0449, not significant]). Pooled safety data were consistent between dupilumab and placebo and with the known dupilumab safety profile. Conclusions: Dupilumab reduced urticaria activity by reducing itch and hives severity in omalizumab-naive patients with CSU uncontrolled with H1-AH. Although the primary end point for Study B was not met, dupilumab effects were small in patients who were omalizumab-intolerant/incomplete responders.

Original languageEnglish
JournalJournal of Allergy and Clinical Immunology
DOIs
Publication statusAccepted/In press - 2024

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology

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