Tofacitinib for the treatment of ankylosing spondylitis was
A Study was conducted to assess the efficacy/safety of tofacitinib in adult patients with active ankylosing spondylitis (AS).

This phase III, randomised, double-blind, placebo-controlled study enrolled patients aged more than 18 years diagnosed with active AS, meeting the modified New York criteria, with centrally read radiographs, and an inadequate response or intolerance to more than 2 NSAIDs.

Patients were randomised 1:1 to receive tofacitinib 5mg two times per day or placebo for 16 weeks. After week 16, all patients received open-label tofacitinib until week 48. The primary and key secondary endpoints were Assessment of SpondyloArthritis international Society more than 20% improvement (ASAS20) and more than 40% improvement (ASAS40) responses, respectively, at week 16. Safety was assessed throughout.

--269 patients were randomised and treated: tofacitinib, n=133; placebo, n=136.

--At week 16, the ASAS20 response rate was significantly greater with tofacitinib (56.4%) versus placebo (29.4%), and the ASAS40 response rate was significantly greater with tofacitinib (40.6%) versus placebo (12.5%).

--Up to week 16, with tofacitinib and placebo, respectively, 73 of 133 and 70 of 136 patients had adverse events; 2 of 133 and 1 of 136 had serious adverse events.

--Up to week 48, with tofacitinib, 3 of 133 patients had adjudicated hepatic events, 3 of 133 had non-serious herpes zoster, and 1 of 133 had a serious infection; with placebo tofacitinib, 2 patients had non-serious herpes zoster.

--There were no deaths, malignancies, major adverse cardiovascular events, thromboembolic events or opportunistic infections.

Conclusively, In adults with active AS, tofacitinib demonstrated significantly greater efficacy versus placebo. No new potential safety risks were identified.