Phase III study of Xeljanz meets endpoints in ankylosing spondylitis.- Pfizer

Pfizer announced positive results from a Phase III investigational study evaluating the safety and efficacy of Xeljanz (tofacitinib) in adults with active ankylosing spondylitis (AS). The study met its primary and key secondary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 20 and 40 response, respectively, compared to placebo at week 16. The AS study is a Phase III, multicenter, randomized, double-blind, placebo-controlled study that included 270 adult patients with active AS. The study evaluated the efficacy and safety of tofacitinib 5 mg twice daily versus placebo. The study met its primary endpoint showing that at week 16, the percentage of patients achieving an ASAS20 response was significantly greater with tofacitinib (56.4%) versus placebo (29.4%) (p<0.0001). in addition, the percentage of asas40 response was significantly greater with tofacitinib (40.6%) versus placebo (12.5%) (p><0.0001), a key secondary endpoint of the study. asas20 40 are used for defining improvement or response to treatment. the most common adverse events in this study, occurring in greater than five percent of any treatment group, were upper respiratory tract infection, nasopharyngitis, diarrhea, alanine aminotransferase (alt) increased, arthralgia and headache. tofacitinib is not currently approved by the fda for the treatment of as. the data will be presented for the first time during a late-breaking virtual oral presentation on monday, november 9 at 12:45 p.m. et during acr convergence, the american college of rheumatology (acr) association of rheumatology professionals (arp) annual meeting (november 5-9).a3921120is a phase iii, multicenter, double-blind, placebo-controlled, efficacy and safety study. the study enrolled patients aged 18 years or older with a diagnosis of as, who met modified new york criteria, and had an inadequate response or intolerance to two or more nonsteroidal anti-inflammatory drug (nsaid) therapy. a total of 270 patients were randomized to receive twice daily tofacitinib 5 mg or matching placebo for 16 weeks, 269 were treated. eligible subjects completing the 16-week double-blind treatment period of the study were assigned to receive open-label tofacitinib 5 mg twice daily for an additional 32 weeks. subjects then entered a 4-week follow-up period in the study.the fda has accepted pfizer’s application for the as indication and the prescription drug user fee act (pdufa) goal date is in q2 2021.>