Evidence Hub

Infection Risk Profiles of 4mg Baricitinib in Patient with Rheumatoid Arthritis: A Meta-Analysis of Randomized Clinical Trials

Mohd Haidir Mohd Yusof, Marcel Jinih

Journal of Clinical Rheumatology and Immunology, 2025

3,032 participants

Abstract

Background:

There is an increasing suggestion that 4mg baricitinib may elevate the risk of infections in patients with rheumatoid arthritis (RA). To better understand this potential infection risk, we conducted a meta-analysis using data from randomized clinical trials (RCTs) to evaluate the overall risk of infections in these patients.

Methods:

We conducted a comprehensive systematic search in EMBASE, MEDLINE, and CENTRAL from their inception until 31st December 2024 to identify relevant RCTs reporting the occurrence of infections in patients with RA who were treated with monotherapy baricitinib (4mg once daily orally) regardless of the background RA therapy used in these patients. The primary outcomes were the incidence of total infections, serious infections, non-serious infections, and opportunistic infections (including herpes zoster and tuberculosis). The secondary outcomes were the incidence of various sites of infections, including the upper respiratory tract, lower respiratory tract, gastrointestinal tract and others. In anticipation of study heterogeneity, the effect estimate was pooled with a random-effects model, to obtain the risk ratios (RR) and 95% confidence intervals (CI), using Mantel-Haenszel statistical method.

Results:

Eight RCTs were included, involving a total of 3,032 RA patients. Compared to the control group (placebo and other active treatments), patients treated with 4mg baricitinib exhibited a significant increase in the risk of total infections…

How strong is the evidence?

Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 3,032 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

Read the paper

Related studies

Go deeper in Evidence Hub

Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.

Open this study Sign up free