The objective of the study was to report efficacy and safety of Upadacitinib ( Rinvoq ) through 1 year in patients with ankylosing spondylitis ( AS ).
In the SELECT-AXIS 1 study, adults with active ankylosing spondylitis 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% or more of patients achieved these endpoints based on non-responder imputation ( NRI ) and 81% or more based on as-observed ( AO ) analyses.
Furthermore, 34% or more ( NRI ) and 39% or more ( 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.
In conclusion, Upadacitinib 15 mg QD ( once a day ) has shown 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. ( Xagena )
Deodhar A et al, Arthritis Rheumatol 2021; Online ahead of print