Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks

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 fo...

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Autores: Jain, Vipul, Giménez Arnau, Anna Maria, Hayama, Koremasa, Reich, Adam, Carr, Warner, Tillinghast, Jeffrey, Dahale, Swapnil, Lheritier, Karine, Walsh, Pauline, Zharkov, Artem, Hugot, Sophie, Haemmerle, Sibylle
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Recursos:Universitat Pompeu Fabra
Repositorio:Repositorio Digital de la UPF
OAI Identifier:oai:repositori.upf.edu:10230/60196
Acesso em linha:http://hdl.handle.net/10230/60196
http://dx.doi.org/10.1016/j.jaci.2023.10.007
Access Level:acceso abierto
Palavra-chave:Bruton tyrosine kinase inhibitor
FcεRI
IgE
Chronic spontaneous urticaria
Efficacy
Long-term safety
Remibrutinib (LOU064)
Urticaria
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spelling Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeksJain, VipulGiménez Arnau, Anna MariaHayama, KoremasaReich, AdamCarr, WarnerTillinghast, JeffreyDahale, SwapnilLheritier, KarineWalsh, PaulineZharkov, ArtemHugot, SophieHaemmerle, SibylleBruton tyrosine kinase inhibitorFcεRIIgEChronic spontaneous urticariaEfficacyLong-term safetyRemibrutinib (LOU064)UrticariaBackground: 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.Elsevier202420242024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/60196http://dx.doi.org/10.1016/j.jaci.2023.10.007reponame:Repositorio Digital de la UPFinstname:Universitat Pompeu FabraInglésJ Allergy Clin Immunol. 2024 Feb;153(2):479-86.e4© 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/).http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:repositori.upf.edu:10230/601962026-06-12T07:21:37Z
dc.title.none.fl_str_mv Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks
title Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks
spellingShingle Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks
Jain, Vipul
Bruton tyrosine kinase inhibitor
FcεRI
IgE
Chronic spontaneous urticaria
Efficacy
Long-term safety
Remibrutinib (LOU064)
Urticaria
title_short Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks
title_full Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks
title_fullStr Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks
title_full_unstemmed Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks
title_sort Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks
dc.creator.none.fl_str_mv Jain, Vipul
Giménez Arnau, Anna Maria
Hayama, Koremasa
Reich, Adam
Carr, Warner
Tillinghast, Jeffrey
Dahale, Swapnil
Lheritier, Karine
Walsh, Pauline
Zharkov, Artem
Hugot, Sophie
Haemmerle, Sibylle
author Jain, Vipul
author_facet Jain, Vipul
Giménez Arnau, Anna Maria
Hayama, Koremasa
Reich, Adam
Carr, Warner
Tillinghast, Jeffrey
Dahale, Swapnil
Lheritier, Karine
Walsh, Pauline
Zharkov, Artem
Hugot, Sophie
Haemmerle, Sibylle
author_role author
author2 Giménez Arnau, Anna Maria
Hayama, Koremasa
Reich, Adam
Carr, Warner
Tillinghast, Jeffrey
Dahale, Swapnil
Lheritier, Karine
Walsh, Pauline
Zharkov, Artem
Hugot, Sophie
Haemmerle, Sibylle
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Bruton tyrosine kinase inhibitor
FcεRI
IgE
Chronic spontaneous urticaria
Efficacy
Long-term safety
Remibrutinib (LOU064)
Urticaria
topic Bruton tyrosine kinase inhibitor
FcεRI
IgE
Chronic spontaneous urticaria
Efficacy
Long-term safety
Remibrutinib (LOU064)
Urticaria
description 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.
publishDate 2024
dc.date.none.fl_str_mv 2024
2024
2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/60196
http://dx.doi.org/10.1016/j.jaci.2023.10.007
url http://hdl.handle.net/10230/60196
http://dx.doi.org/10.1016/j.jaci.2023.10.007
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv J Allergy Clin Immunol. 2024 Feb;153(2):479-86.e4
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Repositorio Digital de la UPF
instname:Universitat Pompeu Fabra
instname_str Universitat Pompeu Fabra
reponame_str Repositorio Digital de la UPF
collection Repositorio Digital de la UPF
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812429

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