Shots:

• The approval is based on the P-III study to evaluate the efficacy & safety of tofacitinib (5mg, bid) vs PBO in 269 adult patients with active AS who have had an inadequate response or intolerance to one or more TNF blockers
• The study met its 1EPs i.e., @16wks., the proportion of patients treated with tofacitinib achieved an assessment in ASAS 20 response (56.4% vs 29.4%) while patients achieved an ASAS40 response (40.6% vs 12.5%). The safety profile was consistent with the safety profile observed in RA & PsA
• Xeljanz is the 1st oral JAK inhibitor approved in the US in 5 indications i.e., AS, RA, active PsA, UC & pcJIA. The therapy has been studied in 50+ clinical trials globally

Ref: Pfizer | Image: Pfizer