FDA approves Xeljanz for active ankylosing spondylitis
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The FDA has approved Xeljanz for the treatment of adults with active ankylosing spondylitis who have had an inadequate response, or intolerance to, TNF inhibitors, according to a Pfizer press release.
The announcement marks the fifth indication for the drug, making it the first and only oral JAK inhibitor approved in the United States for five diseases, according to Pfizer. Xeljanz (tofacitinib) had previously been approved for adults with moderately-to-severely active rheumatoid arthritis, active psoriatic arthritis, moderately-to-severely active ulcerative colitis, as well as in children aged 2 years and older with active polyarticular course juvenile idiopathic arthritis who had previously failed on TNF inhibitors.
“We are proud to offer Xeljanz, a treatment option for ankylosing spondylitis that does not require an injection or an infusion, to treat this debilitating and chronic immuno-inflammatory disease,” Mike Gladstone, global president of inflammation and immunology at Pfizer, said in the release. “This regulatory approval affirms the clinical value and versatility of Xeljanz, the first and only Janus kinase (JAK) inhibitor approved for five indications in the United States for the treatment of patients with certain immuno-inflammatory conditions.”
The FDA based its approval on data from a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that examined the efficacy and safety of tofacitinib 5 mg twice daily, compared with placebo. Patients included 269 adults with active AS. In that study, 56.4% of patients who received tofacitinib achieved an Assessment in Spondyloarthritis international Society 20 (ASAS20) response at week 16, compared with 29.4% in the placebo group (P < .0001), thus meeting its primary endpoint.
In addition, 40.6% of patients treated with tofacitinib achieved the ASAS40 response, compared with 12.5% in the placebo group — a key secondary endpoint. The drug’s safety profile in AS was consistent with results seen in patients with RA and PsA patients treated with tofacitinib.
“Ankylosing spondylitis, a type of arthritis that causes inflammation in certain parts of the spine, affects more than 350,000 people in the U.S.,” Steven Taylor, executive vice president of mission and strategic initiatives at the Arthritis Foundation, said in the Pfizer release. “This disease often occurs in early adulthood and causes pain, swelling and possibly restricted mobility. With this approval, physicians and patients now have an additional oral treatment option that can help address this chronic and often progressive disease.”
The FDA updated the prescribing information for tofacitinib earlier this month to include a new boxed warning for major adverse cardiovascular events, and updated previous boxed warnings regarding mortality, malignancies and thrombosis. Additionally, indications for adults with moderately-to-severely active RA or active PsA, and children aged 2 years or older with active polyarticular course JIA were adjusted to require inadequate response or intolerance to one or more TNF inhibitors.
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