This site is intended for healthcare professionals
News

FDA approves Xeljanz/Xeljanz XR for ankylosing spondylitis.

Read time: 1 mins
Published:15th Dec 2021
Pfizer announced that the FDA has approved the supplemental New Drug Application (sNDA) for Xeljanz / Xeljanz XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

The approval of Xeljanz for AS is based on data from a Phase III, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of tofacitinib 5 mg twice daily versus placebo in 269 adult patients living with active AS. The study met its primary endpoint showing that at week 16, the percentage of patients achieving an Assessment in SpondyloArthritis international Society (ASAS)20 response was significantly greater with tofacitinib (56.4%, n= 75) versus placebo (29.4%, n=40).

In addition, the percentage of patients achieving an ASAS40 response was significantly greater with tofacitinib (40.6%, n=54) versus placebo (12.5%, n=17) (p<0.0001), a key secondary endpoint of the study. asas20 40 are used for defining improvement or response to treatment. the safety profile observed in patients with as treated with xeljanz was consistent with the safety profile observed in rheumatoid arthritis (ra) and psoriatic arthritis (psa) patients.

Condition: Ankylosing Spondylitis
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.