CHMP Approves Upadacitinib for Treating Active Psoriatic Arthritis and Ankylosing Spondylitis

In both the Phase 3 SELECT-PsA 1 and SELECT-PsA 2 clinical trials, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis who had an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs) or biologic DMARDs, respectively.

RINVOQ also met the primary endpoint of Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 14 versus placebo in SELECT-AXIS 1, a Phase 2/3 study in patients who were naïve to biologic DMARDs and had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs).

Safety results from SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1 have been previously reported and were consistent with those observed in rheumatoid arthritis, with no new significant safety risks identified.

The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union. The Marketing Authorization would be valid in all member states of the European Union, as well as Iceland, Liechtenstein and Norway.