Abstract

To report efficacy and safety of upadacitinib through 1 year in patients with ankylosing spondylitis (AS).In the SELECT-AXIS 1 study, adults with active AS and inadequate response to non-steroidal anti-inflammatory drugs were randomized to upadacitinib 15 mg once daily (QD) or placebo. At week 14, patients continued in the open-label extension and received upadacitinib up to week 104; reported here are interim data up to week 64.Of 187 patients, 178 completed week 14 on study drug and entered the open-label extension. Similar proportions of patients in either group (continuous upadacitinib or placebo-to-upadacitinib) achieved Assessment of SpondyloArthritis international Society (ASAS) 40 or Ankylosing Spondylitis Disease Activity Score (ASDAS) low-disease activity at week 64: =70% of patients achieved these endpoints based on non-responder imputation (NRI) and =81% based on as-observed (AO) analyses. Furthermore, =34% (NRI) and =39% (AO) of patients achieved ASDAS inactive disease or ASAS partial remission at week 64. Mean changes from baseline (week 0) to week 64 in pain, function, and inflammation showed consistent improvement or sustained maintenance through the study. Among 182 patients receiving upadacitinib (237.6 PY), 618 adverse events (260.1/100 PY) were reported. No serious infections, major adverse cardiovascular events, venous thromboembolic events, gastrointestinal perforation, or deaths were reported.Upadacitinib 15 mg QD showed sustained and consistent efficacy over 1 year. Patients who switched from placebo to upadacitinib at week 14 showed similar efficacy versus those who received continuous upadacitinib.

View details for DOI 10.1002/art.41911

View details for PubMedID 34196498