An application for a new indication for upadacitinib in the treatment of adults with active ankylosing spondylitis has been submitted for review to the Food and Drug Administration (FDA).
The application is supported by data from the multicenter, double-blind, placebo-controlled phase 2/3 SELECT-AXIS 1 study that evaluated the efficacy and safety of upadacitinib in 187 patients with active ankylosing spondylitis. Patients were randomized 1:1 to receive either upadacitinib 15mg once daily (n=93) or placebo (n=94) for 14 weeks.
Results from the study showed a greater proportion of patients treated with upadacitinib achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 response (primary end point) at week 14 compared with placebo (52% vs 26%, respectively; P <.001).
The safety profile of upadacitinib was found to be consistent with that seen in previous studies of the drug; no new safety risks were observed. The most common treatment-emergent adverse event was increased creatinine phosphokinase (9% for upadacitinib vs 2% for placebo).
Upadacitinib, which is marketed under the brand name Rinvoq by AbbVie, is a selective and reversible Janus kinase (JAK) inhibitor. It is already approved for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate.
The treatment is also being investigated for psoriatic arthritis, Crohn disease, ulcerative colitis, atopic dermatitis, and giant cell arteritis.
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- AbbVie submits regulatory application to FDA for Rinvoq™ (upadacitinib) for the treatment of adults with active ankylosing spondylitis. https://www.prnewswire.com/news-releases/abbvie-submits-regulatory-application-to-fda-for-rinvoq-upadacitinib-for-the-treatment-of-adults-with-active-ankylosing-spondylitis-301117875.html. Accessed August 25, 2020.
- van der Heijde D, Song IH, Pangan AL, et al. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial [published online November 12, 2019. The Lancet. doi: 10.1016/S0140-6736(19)32534-6.