Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria

Background: Chronic spontaneous urticaria (CSU) is inadequately controlled in many patients and greatly affects quality of life. Remibrutinib, a highly selective, oral, novel covalent Bruton tyrosine kinase inhibitor, might be effective in CSU. Objective: This first-in-patient trial aimed to evaluat...

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Autores: Maurer, Marcus, Berger, William, Giménez Arnau, Anna Maria, Hayama, Koremasa, Jain, Vipul, Reich, Adam, Haemmerle, Sibylle, Lheritier, Karine, Walsh, Pauline, Xia, Summer, Storim, Julian
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Universitat Pompeu Fabra
Repositorio:Repositorio Digital de la UPF
OAI Identifier:oai:repositori.upf.edu:10230/55511
Acceso en línea:http://hdl.handle.net/10230/55511
http://dx.doi.org/10.1016/j.jaci.2022.08.027
Access Level:acceso abierto
Palabra clave:Bruton tyrosine kinase inhibitor
Chronic spontaneous urticaria
Remibrutinib (LOU064)
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spelling Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticariaMaurer, MarcusBerger, WilliamGiménez Arnau, Anna MariaHayama, KoremasaJain, VipulReich, AdamHaemmerle, SibylleLheritier, KarineWalsh, PaulineXia, SummerStorim, JulianBruton tyrosine kinase inhibitorChronic spontaneous urticariaRemibrutinib (LOU064)Background: Chronic spontaneous urticaria (CSU) is inadequately controlled in many patients and greatly affects quality of life. Remibrutinib, a highly selective, oral, novel covalent Bruton tyrosine kinase inhibitor, might be effective in CSU. Objective: This first-in-patient trial aimed to evaluate the efficacy and safety of remibrutinib in CSU treatment and characterize the dose-response. Methods: This randomized, double-blind, placebo-controlled, phase 2b dose-finding trial evaluated remibrutinib (12 weeks) in patients inadequately controlled with second-generation H1-antihistamines, with at least moderately active CSU, with or without prior anti-IgE treatment (NCT03926611). Patients received remibrutinib 10 mg once daily, 35 mg once daily, 100 mg once daily, 10 mg twice daily, 25 mg twice daily, 100 mg twice daily, or placebo (1:1:1:1:1:1:1 ratio). The main end points were weekly Urticaria Activity Score change from baseline at week 4 and safety. Results: Overall, 311 patients were randomized. Reduced symptom score was observed for all remibrutinib doses from week 1 until week 12, with weekly Urticaria Activity Score change from baseline at week 4: -19.1 (10 mg once daily), -19.1 (35 mg once daily), -14.7 (100 mg once daily), -16.0 (10 mg twice daily), -20.0 (25 mg twice daily), -18.1 (100 mg twice daily), and -5.4 for placebo (nominal P < .0001 for all doses vs placebo). Most adverse events were mild or moderate, with no dose-dependent pattern. Conclusion: Remibrutinib was highly effective in the treatment of CSU over the entire dose range, with a rapid onset of action and a favorable safety profile.Elsevier202320232022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/55511http://dx.doi.org/10.1016/j.jaci.2022.08.027reponame:Repositorio Digital de la UPFinstname:Universitat Pompeu FabraInglésJ Allergy Clin Immunol. 2022 Dec;150(6):1498-1506.e2© 2022 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 license (http://creativecommons.org/licenses/by/4.0/).http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repositori.upf.edu:10230/555112026-06-12T07:21:37Z
dc.title.none.fl_str_mv Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria
title Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria
spellingShingle Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria
Maurer, Marcus
Bruton tyrosine kinase inhibitor
Chronic spontaneous urticaria
Remibrutinib (LOU064)
title_short Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria
title_full Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria
title_fullStr Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria
title_full_unstemmed Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria
title_sort Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria
dc.creator.none.fl_str_mv Maurer, Marcus
Berger, William
Giménez Arnau, Anna Maria
Hayama, Koremasa
Jain, Vipul
Reich, Adam
Haemmerle, Sibylle
Lheritier, Karine
Walsh, Pauline
Xia, Summer
Storim, Julian
author Maurer, Marcus
author_facet Maurer, Marcus
Berger, William
Giménez Arnau, Anna Maria
Hayama, Koremasa
Jain, Vipul
Reich, Adam
Haemmerle, Sibylle
Lheritier, Karine
Walsh, Pauline
Xia, Summer
Storim, Julian
author_role author
author2 Berger, William
Giménez Arnau, Anna Maria
Hayama, Koremasa
Jain, Vipul
Reich, Adam
Haemmerle, Sibylle
Lheritier, Karine
Walsh, Pauline
Xia, Summer
Storim, Julian
author2_role author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Bruton tyrosine kinase inhibitor
Chronic spontaneous urticaria
Remibrutinib (LOU064)
topic Bruton tyrosine kinase inhibitor
Chronic spontaneous urticaria
Remibrutinib (LOU064)
description Background: Chronic spontaneous urticaria (CSU) is inadequately controlled in many patients and greatly affects quality of life. Remibrutinib, a highly selective, oral, novel covalent Bruton tyrosine kinase inhibitor, might be effective in CSU. Objective: This first-in-patient trial aimed to evaluate the efficacy and safety of remibrutinib in CSU treatment and characterize the dose-response. Methods: This randomized, double-blind, placebo-controlled, phase 2b dose-finding trial evaluated remibrutinib (12 weeks) in patients inadequately controlled with second-generation H1-antihistamines, with at least moderately active CSU, with or without prior anti-IgE treatment (NCT03926611). Patients received remibrutinib 10 mg once daily, 35 mg once daily, 100 mg once daily, 10 mg twice daily, 25 mg twice daily, 100 mg twice daily, or placebo (1:1:1:1:1:1:1 ratio). The main end points were weekly Urticaria Activity Score change from baseline at week 4 and safety. Results: Overall, 311 patients were randomized. Reduced symptom score was observed for all remibrutinib doses from week 1 until week 12, with weekly Urticaria Activity Score change from baseline at week 4: -19.1 (10 mg once daily), -19.1 (35 mg once daily), -14.7 (100 mg once daily), -16.0 (10 mg twice daily), -20.0 (25 mg twice daily), -18.1 (100 mg twice daily), and -5.4 for placebo (nominal P < .0001 for all doses vs placebo). Most adverse events were mild or moderate, with no dose-dependent pattern. Conclusion: Remibrutinib was highly effective in the treatment of CSU over the entire dose range, with a rapid onset of action and a favorable safety profile.
publishDate 2022
dc.date.none.fl_str_mv 2022
2023
2023
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/10230/55511
http://dx.doi.org/10.1016/j.jaci.2022.08.027
url http://hdl.handle.net/10230/55511
http://dx.doi.org/10.1016/j.jaci.2022.08.027
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv J Allergy Clin Immunol. 2022 Dec;150(6):1498-1506.e2
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by/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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