Tofacitinib given restricted FDA approval for ankylosing spondylitis
medwireNews: The Janus kinase (JAK) inhibitor tofacitinib may be used for the treatment of active ankylosing spondylitis (AS) in adults with an inadequate response or intolerance to tumor necrosis factor (TNF) inhibitors, says the US FDA.
Previously approved in the USA for four indications – rheumatoid arthritis (RA), psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and ulcerative colitis – tofacitinib is now approved for AS at a dose of 5 mg twice daily or 11 mg once daily taken orally.
On the basis of findings from the ORAL Surveillance study, the FDA has restricted the use of tofacitinib to patients with an inadequate response to at least one TNF inhibitor for all indications. Additionally, the label carries boxed warnings for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
The approval of tofacitinib for AS is based on a phase 3 trial showing favorable efficacy and safety profiles of the 5 mg twice daily dose in patients with an inadequate response to two or more nonsteroidal anti-inflammatory drugs.
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