生物学的製剤使用歴のある強直性脊椎炎患者におけるトファシチニブの有効性と安全性: 事後解析
ACR Open Rheumatol. 2023;5(12)632–643 doi 10.1002/acr2.11601
In this post hoc analysis by Deoodhar, et al., the authors found that tofacitinib demonstrated greater efficacy than placebo in bDMARD-naïve and TNFi-IR AS patients. They also found that safety event rates for tofacitinib therapy were numerically higher in the TNFi-IR subgroup than the bDMARD-naïve subgroup.
The analysis was carried out on the results of a Phase 3 trial. AS patients were randomised 1:1 to tofacitinib or placebo for 16 weeks, then the placebo group was switched to tofacitinib and both treatment arms were monitored up to Week 48. Patients were stratified by prior dMARD use and clinical efficacy, patient-reported outcomes, and safety events were assessed.