Efficacy and Safety of Tofacitinib in the Management of Ankylosing Spondylitis: A Comprehensive Systematic Review

TL;DR

This review evaluates how well tofacitinib, a JAK inhibitor, works and is safe for treating ankylosing spondylitis, finding it effective with manageable side effects.

Contribution

The study provides a systematic review of tofacitinib's efficacy and safety in ankylosing spondylitis, highlighting its potential as a treatment option.

Findings

Tofacitinib 5 mg twice daily improved clinical outcomes in ankylosing spondylitis with ASAS response rates of about 80%.

MRI studies showed significant reductions in sacroiliac joint and spinal inflammation with tofacitinib treatment.

The drug had a rapid onset of action and was well-tolerated, with common side effects being mild infections.

Abstract

Ankylosing spondylitis (AS) is a chronic, immune-mediated inflammatory arthritis that can severely impair the quality of life. Although biologic therapies have significantly advanced disease management, a substantial number of patients continue to experience suboptimal treatment outcomes. This systematic review evaluated the efficacy and safety of tofacitinib, an oral Janus kinase (JAK) inhibitor, in the management of AS. We conducted a comprehensive search across multiple databases for studies published between 2015 and 2025, ultimately including 11 relevant studies (two randomized controlled trials (RCTs) and nine post-hoc or observational analyses). Evidence consistently demonstrated that tofacitinib 5 mg twice daily significantly improved clinical outcomes compared to placebo, with Assessment of Spondyloarthritis International Society (ASAS) response rates of approximately 80% in controlled trials. Tofacitinib demonstrated a rapid onset of action, with improvements in pain occurring within one month and benefits across multiple domains, including fatigue, morning stiffness, and quality of life. Magnetic resonance imaging (MRI) studies confirmed significant reductions in sacroiliac joint and spinal inflammation. The safety profile was consistent with that observed in other indications, with nasopharyngitis and upper respiratory infections being the most common adverse events. Limited cases of herpes zoster were reported, with no documented tuberculosis, malignancies, or thromboembolic events within the study periods. The review supports tofacitinib as an effective option for AS management, with efficacy maintained across various patient subgroups. However, longer-term studies and head-to-head comparisons with biologics are needed to establish its optimal position in treatment algorithms for AS.

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