Ligelizumab improves angioedema, disease severity and quality-of-life in patients with chronic spontaneous urticaria

Martin Metz, MD; Jonathan A. Bernstein, MD; Ana M. Giménez-Arnau, MD, PhD; Michihiro Hide, MD, PhD; Marcus Maurer, MD; Karl Sitz, MD; Weily Soong, MD; Gordon Sussman, MD; Eva Hua, MSc; Avantika Barve, PhD; Nathalie Barbier, MSc; Maria-Magdalena Balp, MD; Thomas Severin, MD

World Allergy Organization Journal (Nov 2022)

Ligelizumab improves angioedema, disease severity and quality-of-life in patients with chronic spontaneous urticaria

Martin Metz, MD,
Jonathan A. Bernstein, MD,
Ana M. Giménez-Arnau, MD, PhD,
Michihiro Hide, MD, PhD,
Marcus Maurer, MD,
Karl Sitz, MD,
Weily Soong, MD,
Gordon Sussman, MD,
Eva Hua, MSc,
Avantika Barve, PhD,
Nathalie Barbier, MSc,
Maria-Magdalena Balp, MD,
Thomas Severin, MD

Affiliations

Martin Metz, MD: Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany; Corresponding author. Institute of Allergology, Charité - Universitätsmedizin Berlin, Germany.
Jonathan A. Bernstein, MD: University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, OH, United States
Ana M. Giménez-Arnau, MD, PhD: Dermatology Department, Hospital Del Mar-Parc de Salut Mar, IMIM Universitat Autònoma and Universitat Pompeu Fabra, Barcelona, Spain
Michihiro Hide, MD, PhD: Department of Dermatology, Hiroshima University, Hiroshima, Japan; Department of Dermatology, Hiroshima City Hospital, Hiroshima, Japan
Marcus Maurer, MD: Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany
Karl Sitz, MD: Little Rock Allergy and Asthma Clinic, Little Rock, AR, United States
Weily Soong, MD: AllerVie Health-Alabama Allergy and Asthma Center, Clinical Research Center of Alabama, Birmingham, AL, USA
Gordon Sussman, MD: Division of Allergy and Clinical Immunology, University of Toronto, Canada
Eva Hua, MSc: Shanghai Novartis Trading Ltd., Shanghai, China
Avantika Barve, PhD: Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States
Nathalie Barbier, MSc: Novartis Pharma AG, Basel, Switzerland
Maria-Magdalena Balp, MD: Novartis Pharma AG, Basel, Switzerland
Thomas Severin, MD: Novartis Pharma AG, Basel, Switzerland

Journal volume & issue: Vol. 15, no. 11
p. 100716

Abstract

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Background: Disease burden is particularly high in Chronic Spontaneous Urticaria (CSU) patients with angioedema, and patients whose signs and symptoms are inadequately controlled by H1-antihistamines need new treatment options. Here we report an exploratory analysis, from the ligelizumab Phase 2b study, investigating angioedema occurrence in patients with CSU and describe the changes in angioedema following treatment with ligelizumab, omalizumab, or placebo. Methods: Data from the ligelizumab Phase 2b core (ligelizumab 72 mg, 240 mg, omalizumab 300 mg and placebo) and extension study (ligelizumab 240 mg) were used. Changes in Weekly Angioedema Activity Score (AAS7), the Dermatology Life Quality Index (DLQI), and Weekly Urticaria Activity Score (UAS7) among each time point were analyzed for each treatment arm. Results: From a total of 297 patients analyzed, 165 (55.6%) reported angioedema occurrence at baseline, with mean AAS7 ranging 30.6—42.2 across treatment arms. At Week 12 of the core study 87.5%, 84.6%, 75.0%, and 61.0% of patients were angioedema free for ligelizumab 72 mg, 240 mg, omalizumab 300 mg, and placebo arms, respectively. In CSU patients with angioedema at baseline, the largest change from baseline in AAS7 score was observed with ligelizumab 72 mg (−31.9) at week 16 in the core study. Patients with angioedema had a higher mean DLQI at baseline (14.9—16.1) vs. patients without angioedema (10.6—12.0). In patients with angioedema, low AAS7 was significantly associated with complete response on UAS7 (UAS7 = 0) and complete normalization of DLQI (DLQI 0—1). Conclusion: In the Phase 2b study, ligelizumab effectively reduced angioedema and urticaria symptoms, and improved health related quality of life in patients with moderate-to-severe CSU. Clinicaltrails.gov NCT number: NCT02477332; NCT02649218.

Published in World Allergy Organization Journal

ISSN: 1939-4551 (Online)
Publisher: Elsevier
Country of publisher: Netherlands
LCC subjects: Medicine: Internal medicine: Specialties of internal medicine: Immunologic diseases. Allergy
Website: https://www.journals.elsevier.com/world-allergy-organization-journal/

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