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

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

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

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dc.contributor.author Maurer, Marcus
dc.contributor.author Casale, Thomas B.
dc.contributor.author Saini, Sarbjit S.
dc.contributor.author Ben-Shoshan, Moshe
dc.contributor.author Giménez Arnau, Anna Maria
dc.contributor.author Bernstein, Jonathan A.
dc.contributor.author Yagami, Akiko
dc.contributor.author Stjepanovic, Aleksandra
dc.contributor.author Radin, Allen
dc.contributor.author Staudinger, Heribert W.
dc.contributor.author Patel, Naimish
dc.contributor.author Amin, Nikhil
dc.contributor.author Akinlade, Bolanle
dc.contributor.author Fan, Chunpeng
dc.contributor.author Bauer, Deborah
dc.contributor.author Yancopoulos, George D.
dc.contributor.author Patel, Kiran
dc.contributor.author Mannent, Leda P.
dc.contributor.author Laws, Elizabeth
dc.date.accessioned 2024-10-23T06:09:18Z
dc.date.available 2024-10-23T06:09:18Z
dc.date.issued 2024
dc.description.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.
dc.format.mimetype application/pdf
dc.identifier.citation Maurer M, Casale TB, Saini SS, Ben-Shoshan M, Giménez-Arnau AM, Bernstein JA, et al. Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials. J Allergy Clin Immunol. 2024 Jul;154(1):184-94. DOI: 10.1016/j.jaci.2024.01.028
dc.identifier.doi http://dx.doi.org/10.1016/j.jaci.2024.01.028
dc.identifier.issn 0091-6749
dc.identifier.uri http://hdl.handle.net/10230/68315
dc.language.iso eng
dc.publisher Elsevier
dc.relation.ispartof J Allergy Clin Immunol. 2024 Jul;154(1):184-94
dc.rights © 2024 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.rights.uri http://creativecommons.org/licenses/by/4.0/
dc.subject.keyword Chronic spontaneous urticaria
dc.subject.keyword H(1) antihistamines
dc.subject.keyword Dupilumab
dc.subject.keyword Intolerant/incomplete responders
dc.subject.keyword Omalizumab
dc.subject.keyword Uncontrolled
dc.subject.keyword Urticaria activity
dc.title Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials
dc.type info:eu-repo/semantics/article
dc.type.version info:eu-repo/semantics/publishedVersion

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