Ankylosing spondylitis (AS) is a chronic inflammatory disease with symptoms usually appearing before the age of 30 and rarely after the age of 45. Its main symptoms include chronic pain and stiffness in the back and hips, and can negatively impact health-related quality of life. Over time, some patients may develop fusion of the vertebrae in the spine. Research shows that more than 350,000 people in the United States have ankylosing spondylitis.
On December 14, 2021, Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for XELJANZ®/XELJANZ®
Tofacitinib is a JAK inhibitor that reduces cytokine signaling, cytokine-induced gene expression and cell activation by inhibiting the JAK pathway, thereby reducing a variety of chronic inflammatory reactions.
"We are pleased to offer patients with ankylosing spondylitis a treatment option (XELJANZ) that does not require injections or infusions to treat this debilitating chronic immune-inflammatory disease," said Mike Gladstone, Global President of Inflammation and Immunology at Pfizer. "XELJANZ is the first and only Janus kinase (JAK) inhibitor (with five indications) approved in the U.S. for the treatment of certain patients with immune inflammation, and this approval validates the clinical value and versatility of XELJANZ."
The approval is based on data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of tofacitinib (dose: 5 mg twice daily) compared with placebo in 269 adults with active AS. The study met its primary endpoint, with a significantly higher percentage of patients achieving the International Spondyloarthritis Society (ASAS) 20 response assessment at week 16 in the tofacitinib group (56.4%, n=75) than in the placebo group (29.4%, n=40). Additionally, on the key secondary endpoint, a significantly higher percentage of the tofacitinib group (40.6%, n=54) achieved an ASAS 40 response compared with the placebo group (12.5%, n=17). ASAS20/40 is used to define improvement or response to treatment. The safety profile of XELJANZ in patients with ankylosing spondylitis is consistent with that in patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA).
Reference materials: FDA instructions were updated on February 21, 2025. FDA instructions website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213082
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