medwireNews: The US FDA has approved upadacitinib for the treatment of adult patients with active psoriatic arthritis (PsA) and an inadequate response or intolerance to at least one tumor necrosis factor (TNF) inhibitor.
This approval is based on data from the SELECT-PsA-1 and SELECT-PsA-2 trials, which demonstrated significant benefits of the oral Janus kinase (JAK)1-selective inhibitor versus placebo in PsA patients with and without prior biologic exposure. Upadacitinib is approved at a dose of 15 mg/day for the treatment of PsA, and is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants such as azathioprine or cyclosporine.
Upadacitinib was initially FDA approved in 2019 for the treatment of rheumatoid arthritis (RA) following an inadequate response to methotrexate, but its use in RA is now also restricted to those with an inadequate response or intolerance to TNF inhibitors. This label change was made in light of data from the ORAL Surveillance study showing a potentially increased risk for major adverse cardiovascular events (MACE) and malignancy with another JAK inhibitor, tofacitinib, compared with TNF inhibitors in patients at high cardiovascular risk.
The label for upadacitinib carries a boxed warning for serious infection, mortality, MACE, malignancy, and thrombosis risk.
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