Positive topline results were announced from the phase 3 SELECT-AXIS 2 study evaluating upadacitinib in adults with active ankylosing spondylitis (AS) and in adults with active non-radiographic axial spondyloarthritis (nr-axSpA).

The randomized, double-blind, placebo-controlled SELECT-AXIS 2 trial (ClinicalTrials.gov Identifier: NCT04169373) included 2 standalone studies evaluating the efficacy and safety of upadacitinib in 421 adults with active AS who had an inadequate response to biologic disease-modifying antirheumatic drugs (Study 1) and in 313 adults with active nr-axSpA (Study 2). In both studies, patients were randomly assigned 1:1 to receive either upadacitinib 15mg once daily or placebo.

Results from Study 1 demonstrated that among patients with active AS, upadacitinib met the primary endpoint with a greater proportion of patients achieving Assessment in SpondyloArthritis International Society 40 response at week 14 compared with placebo (45% vs 18%, respectively; P <.0001). Moreover, upadacitinib met all ranked secondary endpoints achieving the following results at week 14 compared with placebo, respectively (all P <.0001):


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  • Ankylosing Spondylitis Disease Activity Score Low Disease Activity: 44% vs 10%;
  • Mean change from baseline in Magnetic Resonance Imaging Spondyloarthritis Research Consortium of Canada Score for spine: -3.95 vs -0.04;
  • Mean change from baseline in Patient’s Assessment of Total Back Pain: -3.00 vs -1.47;
  • Mean change from baseline in Bath Ankylosing Spondylitis Functional Index: -2.26 vs -1.09.

Results from Study 2 showed that among patients with active nr-axSpA, upadacitinib met the primary endpoint with a greater proportion of patients achieving Assessment in SpondyloArthritis International Society 40 response at week 14 compared with placebo (45% vs 23%, respectively; P <.0001). Moreover, upadacitinib met most ranked secondary endpoints achieving the following results at week 14 compared with placebo, respectively:

  • Ankylosing Spondylitis Disease Activity Score Low Disease Activity: 42% vs 18% (P <.0001);
  • Mean change from baseline in Magnetic Resonance Imaging Spondyloarthritis Research Consortium of Canada Score for SI-joints: -2.49 vs 0.57 (P <.0001);
  • Mean change from baseline in Patient’s Assessment of Total Back Pain: -2.91 vs -2.00 (P =.0004);
  • Mean change from baseline in Bath Ankylosing Spondylitis Functional Index: -2.61 vs -1.47 (P <.0001).

No new safety risks were identified in the studies. The most common adverse events were COVID-19, headache, nasopharyngitis and nausea. There were no adjudicated major adverse cardiovascular events, venous thromboembolic events or deaths reported in either treatment arm through week 14.

Full study results will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.

Upadacitinib, a Janus kinase inhibitor, is currently marketed under the trade name Rinvoq and is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate. 

References

  1. AbbVie’s upadacitinib (Rinvoq®) met primary and most ranked secondary endpoints in phase 3 study for non-radiographic axial spondyloarthritis. News release. AbbVie. Accessed October 7, 2021. https://www.prnewswire.com/news-releases/abbvies-upadacitinib-rinvoq-met-primary-and-most-ranked-secondary-endpoints-in-phase-3-study-for-non-radiographic-axial-spondyloarthritis-301395109.html
  2. AbbVie’s Rinvoq® (upadacitinib) met primary and all ranked secondary endpoints in phase 3 study in ankylosing spondylitis. News release. AbbVie. Accessed October 7, 2021. https://www.prnewswire.com/news-releases/abbvies-rinvoq-upadacitinib-met-primary-and-all-ranked-secondary-endpoints-in-phase-3-study-in-ankylosing-spondylitis-301395108.html.

This article originally appeared on MPR