Ligelizumab improves angioedema, disease severity and quality-of-life in patients with chronic spontaneous urticaria
Mostra el registre complet Registre parcial de l'ítem
- dc.contributor.author Metz, Martin
- dc.contributor.author Bernstein, Jonathan A.
- dc.contributor.author Giménez Arnau, Anna Maria
- dc.contributor.author Hide, Michihiro
- dc.contributor.author Maurer, Marcus
- dc.contributor.author Sitz, Karl
- dc.contributor.author Soong, Weily
- dc.contributor.author Sussman, Gordon
- dc.contributor.author Hua, Eva
- dc.contributor.author Barve, Avantika
- dc.contributor.author Barbier, Nathalie
- dc.contributor.author Balp, Maria Magdalena
- dc.contributor.author Severin, Thomas
- dc.date.accessioned 2023-05-16T06:15:51Z
- dc.date.available 2023-05-16T06:15:51Z
- dc.date.issued 2022
- dc.description.abstract 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 improve health related quality of life in patients with moderate-to-severe CSU. Clinicaltrailsgov nct number: NCT02477332; NCT02649218.
- dc.format.mimetype application/pdf
- dc.identifier.citation Metz M, Bernstein JA, Giménez-Arnau AM, Hide M, Maurer M, Sitz K, Soong W, Sussman G, Hua E, Barve A, Barbier N, Balp MM, Severin T. Ligelizumab improves angioedema, disease severity and quality-of-life in patients with chronic spontaneous urticaria. World Allergy Organ J. 2022 Nov 15;15(11):100716. DOI: 10.1016/j.waojou.2022.100716
- dc.identifier.doi http://dx.doi.org/10.1016/j.waojou.2022.100716
- dc.identifier.issn 1939-4551
- dc.identifier.uri http://hdl.handle.net/10230/56822
- dc.language.iso eng
- dc.publisher Elsevier
- dc.relation.ispartof World Allergy Organ J. 2022 Nov 15;15(11):100716
- dc.rights © 2022 The Authors. Published by Elsevier Inc. on behalf of World Allergy Organization. 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 Angioedema
- dc.subject.keyword Chronic spontaneous urticaria
- dc.subject.keyword Dermatology life quality index
- dc.subject.keyword IgE
- dc.subject.keyword Ligelizumab
- dc.title Ligelizumab improves angioedema, disease severity and quality-of-life in patients with chronic spontaneous urticaria
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/publishedVersion