November 06, 2020: Pfizer announced positive results from a Phase 3 investigational study evaluating the safety and efficacy of tofacitinib in adults with active ankylosing spondylitis (AS). Tofacitinib is not currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of 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 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).
The AS study is a Phase 3, 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.1b
“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,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.
“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.”
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.