Pfizer said that a phase 3 clinical trial of XELJANZ (tofacitinib) in adults with active ankylosing spondylitis (AS) has met its primary endpoint.
The late-stage study’s primary endpoint is assessment in SpondyloArthritis International Society (ASAS) 20 response, compared to placebo at week 16. This was after the percentage of patients achieving an ASAS20 response was found to be significantly greater with tofacitinib, at 56.4%, compared to placebo, at 29.4%.
It also met the key secondary endpoint of ASAS40 response.
The ankylosing spondylitis study is a multicenter, randomized, double-blind, placebo-controlled study that featured 270 adults with active ankylosing spondylitis. The study assessed the efficacy and safety of tofacitinib 5 mg administered daily twice compared to placebo.
Michael Corbo – Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development said: “Ankylosing spondylitis is a debilitating condition, and its often progressive nature affects patients for most of their adult lives, limiting physical function and perceived health-related quality of life.
“We are proud to share these positive results from our Phase 3 investigational study for tofacitinib in adults with ankylosing spondylitis, and we believe they demonstrate Pfizer’s commitment to addressing unmet needs for those living with inflammatory conditions.”
Pfizer’s application for the ankylosing spondylitis indication was accepted by the FDA with the prescription drug user fee act (PDUFA) goal date set for the second quarter of 2021.