Pfizer's tofacitinib shows treatment benefit in ankylosing spondylitis study

• Pfizer (NYSE:PFE) has announced today positive results from a Phase 3 study evaluating efficacy and safety of tofacitinib in adults with active ankylosing spondylitis (AS), is a rare type of arthritis affecting the spine. Data will be presented on Monday, at the American College of Rheumatology/ Association of Rheumatology Professionals Annual Meeting.
• The 270-subject study met its primary and key secondary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 20 and 40 response, respectively, compared to placebo. ASAS is a scale used to define improvement or response to treatment.
• At week 16, 56.4% of patients in tofacitinib arm achieved an ASAS20 response, versus 29.4% in placebo. Also, 40.6% patients achieved the ASAS40 response, with tofacitinib versus placebo (12.5%).
• The most common adverse events were upper respiratory tract infection, nasopharyngitis, diarrhea, alanine aminotransferase  increased, arthralgia and headache.
• The FDA has accepted Pfizer’s marketing application for tofacitinib in AS indication, with agency date in Q2 2021.
• https://seekingalpha.com/news/3633076-pfizers-tofacitinib-shows-treatment-benefit-in-ankylosing-spondylitis-study