Pfizer has initiated a global phase 3 study intended to evaluate the safety and therapeutic activity of tofacitinib among adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to standard treatment with NSAIDs.
Although tofacitinib (Xeljanz) has been approved by the FDA for the treatment of adults with moderate-to-severe rheumatoid arthritis, ulcerative colitis and active psoriatic arthritis, its safety and efficacy has not been established in ankylosing spondylitis (AS).
Pfizer has initiated a global phase 3 study intended to evaluate the safety and therapeutic activity of tofacitinib among adult patients with active AS, the company said.
“There is a significant need for additional treatment options for people living with this debilitating condition,” Michael S. Vincent, MD, PhD, senior vice president and chief scientific officer of the Inflammation and Immunology Research Unit at Pfizer, told Healio Rheumatology. “Given this need, Pfizer has initiated this phase 3 investigational study to evaluate the efficacy and safety of tofacitinib 5 mg twice daily versus placebo in adult patients with active AS.”
Based on the promising results of an earlier 16-week phase 2 clinical trial — in which 80.8% of patients with AS who received tofacitinib 5 mg twice daily achieved an ASAS20 response — the phase 3 trial from Pfizer is expected to enroll approximately 240 patients from 75 clinical sites in Australia, Europe, North America, South Korea and Taiwan.
According to Pfizer, the trial is expected to be completed by August 2020.