Safety profile of baricitinib in patients with systemic lupus erythematosus: an integrated analysis.

ABSTRACT:

Objectives

To assess the safety of the oral Janus kinase inhibitor baricitinib in adult patients with systemic lupus erythematosus (SLE) receiving stable background therapy. Topics of special interest included infections and cardiovascular and thromboembolic events.

Methods

This analysis included integrated safety data from three randomised, placebo-controlled studies (one phase 2 and two phase 3) and one long-term extension study. Data are reported in three data sets: placebo-controlled, extended exposure and all-baricitinib. Outcomes include treatment-emergent adverse events (AEs), AEs of special interest and abnormal laboratory changes. Proportions of patients with events and incidence rates (IRs) were calculated.

Results

A total of 1655 patients received baricitin

SUBMITTER: Morand E 

PROVIDER: S-EPMC10445377 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature