Upadacitinib Phase 3 Clinical Trials Meet Primary and Most Ranked Secondary Endpoints

Today, AbbVie announced that they achieved positive results from both studies of the Phase 3 SELECT-AXIS clinical trials.

The first of the 2 studies, a clinical trial evaluating the efficacy and safety of upadacitinib (RINVOQ; 15 mg, once daily) in patients with active ankylosing spondylitis (AS) who had an inadequate response to biologic disease-modifying antirheumatic drug (bDMARD) therapy, met its primary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 40 response as well as all ranked secondary endpoints at week 14.

At week 14, significantly more patients treated with upadacitinib achieved ASAS40 response compared with placebo (45% compared with 18%, respectively; P<0.0001).

In study 2 of the Phase 3 SELECT-AXIS clinical trial in adults with active non-radiographic axial spondyloarthritis (nr-axSpA), the results showed that upadacitinib (RINVOQ; 15 mg, once daily) met the primary endpoint of ASAS40 response and the majority of ranked secondary endpoints at week 14.

Compared with placebo, a significantly higher amount of upadacitinib-treated patients achieved ASAS40 response at week 14 (23% compared with 45%, respectively; P<0.0001).

The First Study: SELECT-AXIS 1

This study focused on adult patients with ankylosing spondylitis who had an inadequate response to bDMARDs as well as nonsteroidal anti-inflammatory drugs (NSAIDs). The results of Phase 2/3 SELECT-AXIS 1 were used to support the European Commission approval of upadacitinib for the treatment of active ankylosing spondylitis in January 2021.

No new risks were identified and safety data were found to be consistent with SELECT-AXIS 1, previous Phase 3 studies in other indications and the known safety profile of upadacitinib.

Treatment with upadacitinib showed statistically significant reductions in the symptoms of ankylosing spondylitis including inflammation and back pain. It also improved physical function and disease activity at week 14.

Patients who were treated with upadacitinib achieved a Low Disease Activity on the Ankylosing Spondylitis Disease Activity Score (ASDAS) compared to those treated with placebo (44% compared with 10%).

The Second Study: SELECT-AXIS 2

This was the first trial to examine the efficacy and safety of upadacitinib in adult patients with non-radiographic axial spondyloarthritis.

No new risks were identified, safety data were found to be consistent with SELECT-AXIS 1, previous Phase 3 studies in other indications as well as the known safety profile of upadacitinib. Of the secondary endpoints, 12 of 14 were met.

Patients with non-radial axial spondyloarthritis that were treated with upadacitinib showed reductions in symptoms including inflammation and back pain and improved physical function and disease activity at week 14.

When looking at the Ankylosing Spondylitis Disease Activity Score, significantly more patients treated with upadacitinib achieved Low Disease Activity compared with placebo (42% compared with 18%).

About Upadacitinib (RINVOQ)

Upadacitinib is a selective and reversible JAK inhibitor, an oral therapy approved in the EU for the treatment of active ankylosing spondylitis. It is also being studied as a treatment for multiple immune-mediated diseases. It was discovered and developed by AbbVie.

“People living with active non-radiographic spondyloarthritis suffer from chronic inflammatory back pain and limited physical function that can be very debilitating,” said Michael Severino, M.D. vice chairman and president, AbbVie, in a statement. “These patients need treatments that help them improve their physical function and quality of life. We are encouraged by the potential of upadacitinib in helping to provide relief of these signs and symptoms through meaningful disease control.”