Efficacy and Safety of Janus Kinase Inhibitors in Systemic Lupus Erythematosus: A Systematic Review and Meta-analysis of Randomized Controlled Trials

OBJECTIVE: To assess the efficacy and safety of Janus kinase inhibitors (JAKi) in patients with active systemic lupus erythematosus (SLE). METHODS: We conducted a systematic review of randomized, double-blind, placebo-controlled phase 2 and 3 trials involving JAKi in adults with active SLE. Five trials (n=1802) were included, evaluating baricitinib 4 mg (n=3), deucravacitinib 3 mg twice daily (n=1), and upadacitinib 30 mg (n=1). The primary outcome was the SLE Responder Index-4 (SRI-4) response at weeks 24 to 52. Secondary outcomes included the BICLA response, Lupus Low Disease Activity State (LLDAS), and safety endpoints such as serious adverse events, serious infections, herpes zoster, and venous thromboembolism. Pooled odds ratios (ORs) were calculated using random-effects Mantel-Haenszel models. RESULTS: JAKi significantly improved the SRI-4 response compared with placebo (54.4% vs. 43.8%; OR: 1.78, 95% CI: 1.41-2.25; p