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Safety and efficacy of upadacitinib in patients with active ankylosing spondylitis and an inadequate response to nonsteroidal antiinflammatory drug therapy: One‐year results of a double‐blind, placebo‐controlled study and open‐label extension

Arthritis & Rheumatology Nov 18, 2021

Deodhar A, van der Heijde D, Sieper J, et al. - Analyzing upadacitinib’s efficacy and safety for ankylosing spondylitis (AS), a sustained and consistent efficacy of upadacitinib 15 mg once daily was evident over 1 year. Similar efficacy was observed between patients who switched from placebo to upadacitinib at week 14 vs those who received continuous upadacitinib.

  • Upadacitinib 15 mg once daily or placebo was given to adults with active AS and an inadequate response to nonsteroidal anti-inflammatory drugs, in the SELECT-AXIS 1 study.

  • At week 14, those on placebo were switched to upadacitinib, and 178 patients on study drug entered the open-label extension; interim data up to week 64 are presented herein.

  • In the continuous upadacitinib or placebo-to-upadacitinib group, similar proportions of patients achieved Assessment of SpondyloArthritis international Society 40% response or Ankylosing Spondylitis Disease Activity Score exhibiting low disease activity at week 64.

  • Consistent improvement or sustained maintenance through the study was observed in mean changes from baseline (week 0) to week 64 in pain, function, and inflammation.

  • Serious infections, major adverse cardiovascular events, venous thromboembolic events, gastrointestinal perforation, or deaths did not occur.

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