Efficacy and safety of tofacitinib in ankylosing spondylitis patients: a systematic review and meta-analysis.

BACKGROUND: Tofacitinib, an oral Janus Kinase (JAK) inhibitor, exhibits promising therapeutic potential for Ankylosing Spondylitis (AS). This meta-analysis aimed to assess its efficacy and safety in AS patients. METHODS: PubMed, Embase, Web of Science and Cochrane Library, were systematically searched for relevant studies until May 21, 2025. Literature screening was conducted using EndNote 21. Risk of bias for encompassed Randomized Controlled Trials (RCTs) was examined via the Cochrane Risk of Bias tool (RoB2.0). The quality of cohort studies was rated using the Newcastle-Ottawa Scale (NOS). Meta-analysis was performed via Stata 18.0. RESULTS: Five studies were encompassed: three RCTs and two cohort studies. Regarding primary efficacy outcomes, tofacitinib significantly increased response rates for ASAS20 (Relative Risk [RR = 1.96]; 95% Confidence Intervals [95% CI: 1.74‒2.21]), ASAS40 (RR = 1.88; 95% CI: 1.48‒2.40) and ASAS-PR (RR = 2.55; 95% CI: 1.82‒3.58). Regarding Disease Activity (DA), tofacitinib demonstrated significant benefits in achieving BASDAI50 (RR = 1.90; 95% CI: 1.64‒2.20) and ASDAS. Physical Function (PF) and Quality of Life (QoL) outcomes were also notably ameliorated in the intervention group. Subgroup analysis indicated that 5 mg dosage and 16-week treatment duration exhibited the most favorable efficacy trends across most outcomes. Overall rates of Adverse Events (AEs) and Serious Adverse Events (SAEs) were similar between tofacitinib and placebo groups. However, the risk of Upper Respiratory Tract Infection (URTI) was significantly higher in the tofacitinib group (RR = 2.15; 95% CI: 1.27‒3.63). CONCLUSION: Tofacitinib is an effective and generally well-tolerated active AS therapy, significantly ameliorating DA, PF, and QoL, although it may elevate the risk of URTI.