The safety and efficacy of Baricitinib for systemic lupus erythematosus: a systematic review and meta-analysis of randomized controlled trials

Abstract

Background and objective: Baricitinib is a JAK1 and JAK2 inhibitor approved for treating active rheumatoid arthritis and atopic dermatitis. Therefore, the authors aim to evaluate the safety and efficacy of once-daily oral Baricitinib 2 mg or 4 mg versus placebo in active SLE patients receiving standard care. Methods: The authors synthesized randomized controlled studies (RCTs) from MEDLINE, Scopus, EMBASE, PubMed, and Cochrane Library until 20 March 2023. The study protocol was registered in PROSPERO. Results: Three RCTs with 1849 participants were included. The Baricitinib group had a significant SRI-4 response [RR: 1.11 with 95% CI (1.03, 1.21), P=0.008] and greater than or equal to 4-point SLEDAI-2K domain improvement [RR: 1.13 with 95% CI (1.02, 1.25), P=0.02] compared to the placebo group; however, there was no statistically significant difference between the two groups, regarding the secondary endpoints. For safety outcomes, Baricitinib was significantly associated with a higher incidence of Any serious adverse event [RR: 1.48 with 95% CI (1.07, 2.05), P=0.02]. Conclusion: Baricitinib is associated with significant outcomes of SRI-4 response, greater than or equal to 4-point improvement SLEDAI-2K score, and Joint Indices. Regarding safety, there was no difference in the outcomes other than the serious adverse events.