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AbbVie: RINVOQ Meets Primary Endpoints In Phase 3 Studies - Quick Facts

AbbVie (ABBV) reported positive top-line results from the first of two studies of the phase 3 SELECT-AXIS 2 clinical trial evaluating RINVOQ in patients with active ankylosing spondylitis who had an inadequate response to biologic DMARD therapy. RINVOQ met its primary endpoint of ASAS 40 response and all ranked secondary endpoints at week 14. Safety data were consistent with SELECT-AXIS 1, previous phase 3 studies in other indications, and the known safety profile of RINVOQ, with no new risks identified.

Separately, AbbVie reported positive top-line results from study 2 of the phase 3 SELECT-AXIS 2 clinical trial in adults with active non-radiographic axial spondyloarthritis, showing RINVOQ met the primary endpoint of Assessment in ASAS 40 response and the majority of ranked secondary endpoints at week 14. Safety data were consistent with SELECT-AXIS 1, previous phase 3 studies in other indications, and the known safety profile of upadacitinib, with no new risks identified.

RINVOQ 15 mg is approved by the FDA for adults with moderately to severely active rheumatoid arthritis. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.

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