FDA approves Xeljanz/Xeljanz XR for ankylosing spondylitis.
The approval of Xeljanz for AS is based on data from a Phase III, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of tofacitinib 5 mg twice daily versus placebo in 269 adult patients living with active AS. The study met its primary endpoint showing that at week 16, the percentage of patients achieving an Assessment in SpondyloArthritis international Society (ASAS)20 response was significantly greater with tofacitinib (56.4%, n= 75) versus placebo (29.4%, n=40).
In addition, the percentage of patients achieving an ASAS40 response was significantly greater with tofacitinib (40.6%, n=54) versus placebo (12.5%, n=17) (p<0.0001), a key secondary endpoint of the study. asas20 40 are used for defining improvement or response to treatment. the safety profile observed in patients with as treated with xeljanz was consistent with the safety profile observed in rheumatoid arthritis (ra) and psoriatic arthritis (psa) patients.
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