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Xeljanz receives marketing authorisation from the European Commission for the treatment of active ankylosing spondylitis.

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Last updated:22nd Nov 2021
Published:22nd Nov 2021
Pfizer Inc. announced that the European Commission has approved Xeljanz (tofacitinib) 5 mg twice daily for the treatment of adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

Xeljanz is the first and only oral Janus kinase (JAK) inhibitor approved for five indications in the European Union (EU), including in adults with moderate to severe active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), adults with moderately to severely active ulcerative colitis (UC), and patients 2 years of age or older with active polyarticular juvenile idiopathic arthritis (pcJIA) and juvenile psoriatic arthritis (PsA).

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%) 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. in general, the types of adverse drug reactions in patients with ankylosing spondylitis were consistent with the known safety profile of xeljanz.></0.0001),></0.0001).>

Condition: Ankylosing Spondylitis
Type: drug

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