Health Canada has approved RINVOQ® (upadacitinib, 15 mg), the first oral, once-daily selective and reversible JAK inhibitor for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response to a biologic disease modifying anti-rheumatic drug (DMARD) or when use of those therapies is inadvisable. RINVOQ, developed by AbbVie, may be used as monotherapy or in combination with nonsteroidal anti-inflammatory drugs (NSAIDS).
This approval is supported by data from two pivotal studies with more than 600 patients: SELECT-AXIS 1, a Phase 2/3 study in adult patients with active AS who were naïve to biologic DMARDs and had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDS)1 and SELECT-AXIS 2, a Phase 3 study in adult patients with active AS who were biologic-inadequate responders3. In both studies, a significantly greater proportion of patients treated with RINVOQ 15 mg achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 response compared to placebo at Week 14. Onset of efficacy was seen as early as Week 2 in SELECT-AXIS 1 and Week 4 in SELECT-AXIS 2.