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Upadacitinib Achieves Promising Results for Axial Spondyloarthritis Treatment

Upadacitinib met the primary endpoint of ASAS40 in patients with active non-radiographic axial spondyloarthritis and treatment-refractory active ankylosing spondylitis with inadequate response to biologic disease-modifying antirheumatic drugs.

Today, AbbVie announced the results from 2 studies evaluating upadacitinib in adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and patients with treatment-refractory active ankylosing spondylitis (AS) with inadequate response (IR) to biologic disease-modifying antirheumatic drugs (bDMARDs). The results from the SELECT-AXIS 2 (NCT04169373) program revealed that both studies met the primary endpoint of Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) at week 14 when compared with placebo. Data was presented at the European Alliance of Associations for Rheumatology (EULAR) 2022 conference.

"The new data observed from SELECT-AXIS 2 reinforce the potential of upadacitinib for patients across the spectrum of axial spondyloarthritis disease," Neil Gallagher, MD, PhD, vice president, development, chief medical officer, AbbVie, stated. "At AbbVie, the needs of patients drive us to continue to innovate new ways to change the treatment landscape. We are encouraged by these positive data, which we hope will lead to the availability of a new treatment option for patients with nr-axSpA."

Results from the SELECT-AXIS 2 nr-axSpA study showed that a significant percentage of patients receiving upadacitinib achieved ASAS40 at week 14 when compared with placebo (45% vs 23%; P<0.0001). Secondary endpoints, including change from baseline in patient-reported total back pain, Ankylosing Spondylitis Disease Activity Score (ASDAS) Low Disease Activity, Bath Ankylosing Spondylitis Functional Index (BASFI), MRI Spondyloarthritis Research Consortium of Canada (SPARCC) score for sacroiliac joints, and Ankylosing Spondylitis Quality of Life (ASQoL), also showed significant improvements within the upadacitinib cohort.

In the SELECT-AXIS 2 AS bDMARD-IR study, similar significant improvements were seen in ASAS40 at week 14 for patients receiving upadacitinib when compared with placebo (45% vs 18%, P<0.0001). All multiplicity-controlled secondary endpoints were achieved in the upadacitinib group, including BASFI, ASDAS low disease activity, MRI SPARCC score for spine, ASQoL, and patient-reported total back pain.

No safety risks were identified with either study and the percentage of adverse events were similar among patients receiving either upadacitinib or placebo (48% vs 46%, respectively). Serious adverse events were noted in 4 patients in the upadacitinib cohort and 2 patients receiving placebo. No malignancy, venous thromboembolic events (VTE), major adverse cardiovascular events (MACE), or deaths were reported within the upadacitinib cohort.

THE SELECT-AXIS 2 PROGRAM

SELECT-AXIS 2 included 2 studies evaluating both bDMARD-IR AS and nr-axSpA. In the bDMARD-IR AS trail, 420 patients with a clinical diagnosis of AS who had both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and total back pain score of ≥4 and had an inadequate response to bDMARD therapy were included in the randomized, double-blind, placebo-controlled, phase 3 trial.

The SELECT-AXIS 2 nr-axSpA study analyzed the efficacy and safety of the drug compared with placebo in 314 patients with a clinical diagnosis of nr-axSpA. Eligible patients had active inflammation and/or high sensitivity C-reactive protein (hs-CRP) >upper limit of normal (2.87 mg/L) at screening, with a BASDAI and total back pain score of ≥4.

“These data suggest the potential of upadacitinib to help counter inflammation, relieve pain, and improve function, helping patients living with nr-axSpA take control of their disease,” Filip Van den Bosch, MD, professor in the Department of Rheumatology at the University Hospital of Ghent University, stated.