Study results show treatment with tofacitinib imrpveos symptoms in patients with ankylosing spondylitis.
An international team found that tofacitinib (TOFA) helped patients with ankylosing spondylitis (AS). Reporting at the 2015 American College of Rheumatology Annual Meeting in San Francisco, CA, Desiree van der Heijde, of Leiden University Medical Center, Leiden, NL, and colleagues there and in other nations said they had conducted a 16-week multicenter randomized double-blind, placebo controlled study of patients with AS.
The Phase 2 study was meant to investigate the safety, efficacy, and dose-response of tofacitinib (Xeljanz/Pfizer.) The study group included 196 patients who completed the study.
Patients who were given TOFA 10 mg BID had a high response rate, they reported. They also gave some patients a dose of 5 mg BID.
"Observed ASAS20 response rates were significantly greater with TOFA 5mg BID vs. placebo, compared with 2 or 10 mg BID," the authors reported.
The 2 mg dose was too low, showing no greater efficacy than placebo.
"TOFA 5 and 10 mg BID demonstrated greater clinical and imaging efficacy vs. placebo in reducing the signs and symptoms of AS in adults with active AS," they concluded. Safety was "similar to that reported for TOFA studies in other indications.
The research will be presented at meeting on Nov. 10.