Ligelizumab improves sleep interference and disease burden in patients with chronic spontaneous urticaria

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• dc.contributor.author Giménez Arnau, Anna Maria
• dc.contributor.author Maurer, Marcus
• dc.contributor.author Bernstein, Jonathan A.
• dc.contributor.author Staubach, Petra
• dc.contributor.author Barbier, Nathalie
• dc.contributor.author Hua, Eva
• dc.contributor.author Severin, Thomas
• dc.contributor.author Joubert, Yolandi
• dc.contributor.author Janocha, Reinhold
• dc.contributor.author Balp, Maria Magdalena
• dc.date.accessioned 2022-08-30T09:32:39Z
• dc.date.available 2022-08-30T09:32:39Z
• dc.date.issued 2022
• dc.description.abstract Background: Chronic spontaneous urticaria (CSU) negatively impacts patients' sleep, thereby reducing health-related quality of life (HRQoL). Half of patients with inadequately controlled CSU report sleep interference often or every night, which can lead to depression, anxiety, social, and work-related problems. Methods: This randomized, double-blind, placebo-controlled Phase 2b core study (NCT02477332) included adult patients ≥18 years with moderate to severe CSU inadequately controlled with H1 -antihistamines. The current analysis includes patients randomized to receive ligelizumab 72 or 240 mg, omalizumab 300 mg or placebo every 4 weeks (q4w) for five injections over 20 weeks with treatment-free follow-up for 24 weeks. Patients could enter the open-label extension study (NCT02649218) from Week 32 onwards if their weekly urticaria activity score was ≥12, which included an open-label treatment (52 weeks of ligelizumab 240 mg q4w) and a 48-week post-treatment follow-up. Weekly Sleep Interference Scores (SIS7, range 0 [no interference]-21 [substantial interference]), Weekly Activity Interference Score (AIS7), Dermatology Life Quality Index (DLQI) scores, and Overall Work Impairment were assessed. Results: Mean baseline SIS7 scores were balanced between the treatment arms for ligelizumab 72 mg (n = 84) and 240 mg (n = 85), omalizumab 300 mg (n = 85), and placebo (n = 43). By Week 12, patients experienced large improvements in sleep interference, with least square mean (standard error) changes from baseline (CFB) in SIS7 of -7.84 (0.58), -7.55 (0.61), -6.98 (0.60), and -5.85 (0.81), respectively. By Week 12, CFB in AIS7 were -8.25 (0.57), -8.25 (0.59), -7.30 (0.60), and -5.62 (0.79), DLQI scores were -9.79 (0.77), -9.93 (0.81), -8.35 (0.79), and -6.99 (1.11), and Overall Work Impairment scores were -28.96 (3.73), -30.76 (3.71), -25.74 (3.91), and -20.13 (5.10) for ligelizumab 72 and 240 mg, omalizumab 300 mg and placebo, respectively. Improvements in each patient-reported outcome were sustained with ligelizumab 240 mg treatment during the extension study. Conclusions: Ligelizumab showed effective and sustained responses in managing sleep interference in patients with CSU, and numerically higher responses than with omalizumab and placebo. Treating the symptoms of CSU with ligelizumab improved disease burden, HRQoL, and markedly improved sleep quality.
• dc.format.mimetype application/pdf
• dc.identifier.citation Giménez-Arnau A, Maurer M, Bernstein J, Staubach P, Barbier N, Hua E, Severin T, Joubert Y, Janocha R, Balp MM. Ligelizumab improves sleep interference and disease burden in patients with chronic spontaneous urticaria. Clin Transl Allergy. 2022 Feb;12(2):e12121. DOI: 10.1002/clt2.12121
• dc.identifier.doi http://dx.doi.org/10.1002/clt2.12121
• dc.identifier.issn 2045-7022
• dc.identifier.uri http://hdl.handle.net/10230/53942
• dc.language.iso eng
• dc.publisher Wiley
• dc.relation.ispartof Clin Transl Allergy. 2022 Feb;12(2):e12121
• dc.rights © 2022 The Authors. Clinical and Translational Allergy published by John Wiley & Sons Ltd on behalf of European Academy of Allergy and Clinical Immunology. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Lebensqualität
• dc.subject.keyword Schlafstörung
• dc.subject.keyword Chronische spontane Urtikaria
• dc.subject.keyword Daily functioning
• dc.subject.keyword Quality of life
• dc.subject.keyword Sleep interference
• dc.subject.keyword Tägliches Funktionieren
• dc.title Ligelizumab improves sleep interference and disease burden in patients with chronic spontaneous urticaria
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion