Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis

Deodhar et al. conducted a pooled analysis of Phase 2 and 3 RCT data to assess the safety of tofacitinib in AS. The results showed that tofacitinib 5 mg BID had a tolerable safety profile over 48 weeks, consistent with its use in other inflammatory conditions such as RA and PsA.

The study pooled data from 16- and 48-week cohorts of AS patients treated with tofacitinib, evaluating adverse events, cardiovascular risk, and infections. This analysis demonstrated the absence of new safety signals and aligned with findings in other clinical programmes and real-world studies.