Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks
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- dc.contributor.author Jain, Vipul
- dc.contributor.author Giménez Arnau, Anna Maria
- dc.contributor.author Hayama, Koremasa
- dc.contributor.author Reich, Adam
- dc.contributor.author Carr, Warner
- dc.contributor.author Tillinghast, Jeffrey
- dc.contributor.author Dahale, Swapnil
- dc.contributor.author Lheritier, Karine
- dc.contributor.author Walsh, Pauline
- dc.contributor.author Zharkov, Artem
- dc.contributor.author Hugot, Sophie
- dc.contributor.author Haemmerle, Sibylle
- dc.date.accessioned 2024-05-21T06:24:19Z
- dc.date.available 2024-05-21T06:24:19Z
- dc.date.issued 2024
- dc.description.abstract Background: Remibrutinib (LOU064), an oral, highly selective Bruton tyrosine kinase inhibitor, offers fast disease control in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with second-generation H1 antihistamines. It is currently in phase 3 development for CSU. Objective: We sought to evaluate long-term safety and efficacy of remibrutinib in patients with CSU inadequately controlled with H1 antihistamines. Methods: In this phase 2b extension study, patients who completed the core study and had a weekly Urticaria Activity Score (UAS7) ≥16 at the beginning of the extension study received remibrutinib 100 mg twice daily for 52 weeks. The primary objective was to assess long-term safety and tolerability. Key efficacy end points included change from baseline in UAS7 and proportion of patients with complete response to treatment (UAS7 = 0) and well-controlled disease (UAS7 ≤6) at week 4 and over 52 weeks. Results: Overall, 84.3% (194/230) of patients entered the treatment period and received ≥1 doses of remibrutinib. The overall safety profile of remibrutinib was comparable between the extension and core studies. Most treatment-emergent adverse events were mild to moderate and considered unrelated to remibrutinib by investigators. The 3 most common treatment-emergent adverse events by system organ class were infections (30.9%), skin and subcutaneous tissue (26.8%), and gastrointestinal disorders (16.5%). At week 4 and 52, mean ± SD change from baseline in UAS7 was -17.6 ± 13.40 and -21.8 ± 10.70; UAS7 = 0 (as observed) was achieved in 28.2% and 55.8% and UAS7 ≤6 (as observed) was achieved in 52.7% and 68.0% of patients, respectively. Conclusions: Remibrutinib demonstrated a consistent favorable safety profile with fast and sustained efficacy for up to 52 weeks in patients with CSU.
- dc.format.mimetype application/pdf
- dc.identifier.citation Jain V, Giménez-Arnau A, Hayama K, Reich A, Carr W, Tillinghast J, et al. Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. J Allergy Clin Immunol. 2024 Feb;153(2):479-86.e4. DOI: 10.1016/j.jaci.2023.10.007
- dc.identifier.doi http://dx.doi.org/10.1016/j.jaci.2023.10.007
- dc.identifier.issn 0091-6749
- dc.identifier.uri http://hdl.handle.net/10230/60196
- dc.language.iso eng
- dc.publisher Elsevier
- dc.relation.ispartof J Allergy Clin Immunol. 2024 Feb;153(2):479-86.e4
- dc.rights © 2023 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-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
- dc.subject.keyword Bruton tyrosine kinase inhibitor
- dc.subject.keyword FcεRI
- dc.subject.keyword IgE
- dc.subject.keyword Chronic spontaneous urticaria
- dc.subject.keyword Efficacy
- dc.subject.keyword Long-term safety
- dc.subject.keyword Remibrutinib (LOU064)
- dc.subject.keyword Urticaria
- dc.title Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/publishedVersion