Avaliação do Perfil de Segurança do Baricitinib em Doentes com Artrite Reumatoide: Meta-análise de Ensaios Clínicos

Abstract

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.