Evaluation of the Safety Profile of Baricitinib in Patients with Rheumatoid Arthritis: Meta-analysis of Clinical Trials
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | https://doi.org/10.25756/rpf.v13i1.266 |
Resumo: | Introduction: Baricitinib, a selective inhibitor of janus kinase (JAK) - JAK1 and JAK2, is one of the most recent approved therapeutic alternatives for patients with rheumatoid arthritis (RA). This study is aimed at conducting a meta-analysis to assess the safety profile of baricitinib, at the doses of 2 mg and 4 mg, when compared with placebo.Methods: A literature review was conducted in the PubMed and Clinicaltrails.gov databases. Software RevMan, version 5.3, was used to estimate the relative risk (RR) and 95% confidence intervals (CIs), using the Mantel-Haenszel random effects model.Results: The meta-analysis included 6 randomized clinical trials evaluating baricitinib in adult patients with RA. Baricitinib 2 mg did not increase the risk of total adverse events (RR: 1.01, 95% CI: 0.92-1.11, p = 0.80), serious adverse events (RR: 0.69, 95% CI: 0.38-1.25, p = 0.22), severe infections (RR: 0.97, 95% CI: 0.28-3.37, p = 0.96) nor herpes zoster (RR: 2.32, 95% CI: 0.27-19.93, p = 0.44). Baricitinib 4 mg did not increase the risk of serious adverse events (RR: 1.11, 95% CI: 0.77-1.60, p = 0.58) nor serious infections (RR: 1.00, 95% CI: 0.51-1.96, p = 1.00). However, it was identified an increased risk of total adverse events (RR: 1.14, 95% CI: 1.04-1.24, p = 0.005) and herpes zoster (RR: 3.81, 95% CI: 1.35-10.71, p = 0.01) in patients treated with baricitinib 4 mg when compared to placebo.Conclusion: The results of this meta-analysis identified increased risks of total adverse events and herpes zoster associated with baricitinib 4 mg, when compared with placebo. No new risks have been identified. |
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Evaluation of the Safety Profile of Baricitinib in Patients with Rheumatoid Arthritis: Meta-analysis of Clinical TrialsAvaliação do Perfil de Segurança do Baricitinib em Doentes com Artrite Reumatoide: Meta-análise de Ensaios ClínicosIntroduction: Baricitinib, a selective inhibitor of janus kinase (JAK) - JAK1 and JAK2, is one of the most recent approved therapeutic alternatives for patients with rheumatoid arthritis (RA). This study is aimed at conducting a meta-analysis to assess the safety profile of baricitinib, at the doses of 2 mg and 4 mg, when compared with placebo.Methods: A literature review was conducted in the PubMed and Clinicaltrails.gov databases. Software RevMan, version 5.3, was used to estimate the relative risk (RR) and 95% confidence intervals (CIs), using the Mantel-Haenszel random effects model.Results: The meta-analysis included 6 randomized clinical trials evaluating baricitinib in adult patients with RA. Baricitinib 2 mg did not increase the risk of total adverse events (RR: 1.01, 95% CI: 0.92-1.11, p = 0.80), serious adverse events (RR: 0.69, 95% CI: 0.38-1.25, p = 0.22), severe infections (RR: 0.97, 95% CI: 0.28-3.37, p = 0.96) nor herpes zoster (RR: 2.32, 95% CI: 0.27-19.93, p = 0.44). Baricitinib 4 mg did not increase the risk of serious adverse events (RR: 1.11, 95% CI: 0.77-1.60, p = 0.58) nor serious infections (RR: 1.00, 95% CI: 0.51-1.96, p = 1.00). However, it was identified an increased risk of total adverse events (RR: 1.14, 95% CI: 1.04-1.24, p = 0.005) and herpes zoster (RR: 3.81, 95% CI: 1.35-10.71, p = 0.01) in patients treated with baricitinib 4 mg when compared to placebo.Conclusion: The results of this meta-analysis identified increased risks of total adverse events and herpes zoster associated with baricitinib 4 mg, when compared with placebo. No new risks have been identified.Introdução: O baricitinib, uma das mais recentes alternativas terapêuticas para doentes com artrite reumatoide (AR), é um inibidor seletivo da janus quinase (JAK) – JAK1 e JAK2. Este estudo teve como objetivo realizar uma meta-análise de forma a avaliar o perfil de segurança do baricitinib nas doses de 2 e 4 mg, tendo por base a comparação com o placebo.Métodos: Recorreu-se às bases de dados PubMed e Clinicaltrails.gov para efetuar a pesquisa bibliográfica. Foi utilizado o programa RevMan versão 5.3 para calcular o risco relativo (RR) e intervalos de confiança de 95% (ICs) para todos os resultados ao longo da meta-análise, usando o modelo dos efeitos aleatórios Mantel-Haenszel.Resultados: Foram selecionados seis ensaios clínicos aleatorizados que avaliaram a segurança do baricitinib em doentes adultos com AR. O baricitinib 2 mg demonstrou não aumentar os eventos adversos totais (RR: 1,01; 95% IC: 0,92-1,11; p=0,80), os eventos adversos graves (RR: 0,69; 95% IC: 0,38-1,25; p=0,22), as infeções graves (RR: 0,97; 95% IC: 0,28-3,37; p=0,96) nem de herpes zoster (RR: 2,32; 95% IC: 0,27-19,93; p=0,44). O baricitinib 4 mg também não aumentou o risco de eventos adversos graves (RR: 1,11; 95% IC: 0,77-1,60; p=0,58), de infeções graves (RR: 1,00; 95% IC: 0,51-1,96; p=1,00) ou de eventos cardiovasculares graves (RR: 1,16; 95% IC 0,24-5,48; p=0,85). No entanto, existiu uma tendência de aumento dos eventos adversos totais (RR: 1,14; 95% IC: 1,04-1,24; p=0,005) e de herpes zoster (RR: 3,81; 95% IC: 1,35-10,71; p=0,01) comparativamente ao placebo.Conclusão: Os resultados desta meta-análise de ensaios clínicos demonstraram a dose mais elevada de baricitinib, 4 mg aumenta o risco de reações adversas totais e de herpes zoster face a placebo. Não foram identificados riscos acrescidos de novas reações adversas.Formifarma2021-07-23info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttps://doi.org/10.25756/rpf.v13i1.266https://doi.org/10.25756/rpf.v13i1.266Revista Portuguesa de Farmacoterapia / Portuguese Journal of Pharmacotherapy; Vol 13 No 1 (2021): Janeiro/Fevereiro/Março; 19-29Revista Portuguesa de Farmacoterapia; v. 13 n. 1 (2021): Janeiro/Fevereiro/Março; 19-292183-73411647-354Xreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPporhttp://revista.farmacoterapia.pt/index.php/rpf/article/view/312http://revista.farmacoterapia.pt/index.php/rpf/article/view/312/289Direitos de Autor (c) 2021 Revista Portuguesa de Farmacoterapiahttp://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessAbrunheiro, Nuno AlexandreAlves, CarlosBatel Marques, Francisco2023-09-01T04:35:06Zoai:ojs.farmacoterapia.pt:article/312Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T15:11:42.220151Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Evaluation of the Safety Profile of Baricitinib in Patients with Rheumatoid Arthritis: Meta-analysis of Clinical Trials Avaliação do Perfil de Segurança do Baricitinib em Doentes com Artrite Reumatoide: Meta-análise de Ensaios Clínicos |
title |
Evaluation of the Safety Profile of Baricitinib in Patients with Rheumatoid Arthritis: Meta-analysis of Clinical Trials |
spellingShingle |
Evaluation of the Safety Profile of Baricitinib in Patients with Rheumatoid Arthritis: Meta-analysis of Clinical Trials Abrunheiro, Nuno Alexandre |
title_short |
Evaluation of the Safety Profile of Baricitinib in Patients with Rheumatoid Arthritis: Meta-analysis of Clinical Trials |
title_full |
Evaluation of the Safety Profile of Baricitinib in Patients with Rheumatoid Arthritis: Meta-analysis of Clinical Trials |
title_fullStr |
Evaluation of the Safety Profile of Baricitinib in Patients with Rheumatoid Arthritis: Meta-analysis of Clinical Trials |
title_full_unstemmed |
Evaluation of the Safety Profile of Baricitinib in Patients with Rheumatoid Arthritis: Meta-analysis of Clinical Trials |
title_sort |
Evaluation of the Safety Profile of Baricitinib in Patients with Rheumatoid Arthritis: Meta-analysis of Clinical Trials |
author |
Abrunheiro, Nuno Alexandre |
author_facet |
Abrunheiro, Nuno Alexandre Alves, Carlos Batel Marques, Francisco |
author_role |
author |
author2 |
Alves, Carlos Batel Marques, Francisco |
author2_role |
author author |
dc.contributor.author.fl_str_mv |
Abrunheiro, Nuno Alexandre Alves, Carlos Batel Marques, Francisco |
description |
Introduction: Baricitinib, a selective inhibitor of janus kinase (JAK) - JAK1 and JAK2, is one of the most recent approved therapeutic alternatives for patients with rheumatoid arthritis (RA). This study is aimed at conducting a meta-analysis to assess the safety profile of baricitinib, at the doses of 2 mg and 4 mg, when compared with placebo.Methods: A literature review was conducted in the PubMed and Clinicaltrails.gov databases. Software RevMan, version 5.3, was used to estimate the relative risk (RR) and 95% confidence intervals (CIs), using the Mantel-Haenszel random effects model.Results: The meta-analysis included 6 randomized clinical trials evaluating baricitinib in adult patients with RA. Baricitinib 2 mg did not increase the risk of total adverse events (RR: 1.01, 95% CI: 0.92-1.11, p = 0.80), serious adverse events (RR: 0.69, 95% CI: 0.38-1.25, p = 0.22), severe infections (RR: 0.97, 95% CI: 0.28-3.37, p = 0.96) nor herpes zoster (RR: 2.32, 95% CI: 0.27-19.93, p = 0.44). Baricitinib 4 mg did not increase the risk of serious adverse events (RR: 1.11, 95% CI: 0.77-1.60, p = 0.58) nor serious infections (RR: 1.00, 95% CI: 0.51-1.96, p = 1.00). However, it was identified an increased risk of total adverse events (RR: 1.14, 95% CI: 1.04-1.24, p = 0.005) and herpes zoster (RR: 3.81, 95% CI: 1.35-10.71, p = 0.01) in patients treated with baricitinib 4 mg when compared to placebo.Conclusion: The results of this meta-analysis identified increased risks of total adverse events and herpes zoster associated with baricitinib 4 mg, when compared with placebo. No new risks have been identified. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-07-23 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://doi.org/10.25756/rpf.v13i1.266 https://doi.org/10.25756/rpf.v13i1.266 |
url |
https://doi.org/10.25756/rpf.v13i1.266 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
http://revista.farmacoterapia.pt/index.php/rpf/article/view/312 http://revista.farmacoterapia.pt/index.php/rpf/article/view/312/289 |
dc.rights.driver.fl_str_mv |
Direitos de Autor (c) 2021 Revista Portuguesa de Farmacoterapia http://creativecommons.org/licenses/by-nc-nd/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Direitos de Autor (c) 2021 Revista Portuguesa de Farmacoterapia http://creativecommons.org/licenses/by-nc-nd/4.0 |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Formifarma |
publisher.none.fl_str_mv |
Formifarma |
dc.source.none.fl_str_mv |
Revista Portuguesa de Farmacoterapia / Portuguese Journal of Pharmacotherapy; Vol 13 No 1 (2021): Janeiro/Fevereiro/Março; 19-29 Revista Portuguesa de Farmacoterapia; v. 13 n. 1 (2021): Janeiro/Fevereiro/Março; 19-29 2183-7341 1647-354X reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository.name.fl_str_mv |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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1799129987102539776 |