FDA Approves Tofacitinib for Ankylosing Spondylitis

The US Food and Drug Administration has approved the Janus kinase (JAK) inhibitor tofacitinib as a treatment option for ankylosing spondylitis (AS), offering an oral therapy option to patients with AS.

This approval is based on the results from a phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of tofacitinib 5 mg twice daily versus placebo among 269 adult patients with active AS. At week 16 of the study, “the percentage of patients achieving an Assessment in SpodyloArthritis International Society (ASAS)20 response was significantly greater with tofacitinib (56.4%, n=75) versus placebo (29.4%, n=40) (p<0.0001).” A significantly greater percentage of patients treated with tofacitinib achieved an ASAS40 response (40.6%, n=54) than with placebo (12.5%, n=17) (p<0.0001). The safety profile of this treatment in patients with AS was consistent with the safety profile observed in rheumatoid arthritis (RA) and psoriatic arthritic (PsA).

Tofacitinib has been approved for adult patients with moderately to severely active RA who have inadequate response or intolerance to 1 or more TNF blockers; active PsA; moderately to severely active ulcerative colitis; and children aged 2 years and older with active polyarticular course juvenile idiopathic arthritis.

—Allison Casey

Reference:
U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Ankylosing Spondylitis. News release. Pfizer Inc ; December 14, 2021.