FDA Approves Upadacitinib for Active Ankylosing Spondylitis

The U.S. Food and Drug Administration (FDA) has approved upadacitinib at a dose of 15 mg once daily for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to 1 or more tumor necrosis factor (TNF) blockers.

Efficacy and safety data from the phase 3 SELECT-AXIS 2 clinical trial evaluated upadacitinib among patients who had an inadequate response or intolerance to 1 or 2 biologic disease-modifying antirheumatic drugs (bDMARDs). Patients who were naïve to bDMARDs and had an inadequate response or intolerance to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) participated in the phase 2/3 SELECT-AXIS 1 clinical trial of upadacitnib in this subgroup.

In the SELECT-AXIS 2 trial 51.0% of patients treated with upadacitinib 15 mg achieved the primary endpoint of Assessment in Ankylosing Spondylitis (ASAS) 40 response at week 14, compared to 26.0% of the placebo group. Clinical responses were observed as early as week 4 in SELECT-AXIS 2 for ASAS 40. In SELECT-AXIS 1, 44.5% of patients receiving upadacitinib achieved ASAS 40 at week 14 compared to 18.2% who received placebo.

Overall, the safety profile observed in patients with active AS treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis and psoriatic arthritis.

--Rebecca Mashaw

RINVOQ® (upadacitinib) approved by U.S. FDA as an oral treatment for adults with active ankylosing spondylitis. News release. AbbVie; April 29, 2022. Accessed May 2, 2022. https://news.abbvie.com/news/press-releases/rinvoq-upadacitinib-approved-by-us-fda-as-an-oral-treatment-for-adults-with-active-ankylosing-spondylitis.htm