Upadacitinib Highlights: EULAR 2022

Efficacy and safety of upadacitinib in patients with active non-radiographic axial spondyloarthritis: a double-blind, randomized, placebo-controlled Phase III trial (Abstract # OP0016)

At Week 14 of the Phase III SELECT-AXIS 2 clinical study, Abbvie's upadacitinib outperformed placebo in terms of signs and symptoms, pain, function, disease activity, and MRI-detected spine inflammation.

Upadacitinib significantly increased the number of nr-axSpA patients who met the primary endpoint (45%) of ASAS40 at Week 14 compared to placebo, according to the findings (23%). In terms of secondary endpoints, upadacitinib treated patients had better outcomes based on Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Functional Index (BASFI), MRI Spondyloarthritis Research Consortium of Canada (SPARCC) score for sacroiliac joints, and Ankylosing Spondylitis Quality of Life (ASQoL), and low disease activity. During 14 weeks of treatment with the JAK inhibitor, 48% and 46% of people in the upadacitinib and placebo groups, respectively, experienced adverse events, with no fatalities or serious adverse cardiovascular events.

KOL insights

“This is the first study showing that the JAK inhibitor upadacitinib might be a therapeutic option in patients with active non-radiographic spondyloarthritis and the data suggest upadacitinib, an oral therapy, has the potential to help counter inflammation, relieve pain and improve function, helping patients living with nr-axSpA take control of their disease” – Expert Opinion

Conclusion

According to the current spondyloarthritis therapy regimen, the disease activity of ~30% of individuals with SpA cannot be controlled with currently approved medicines.

JAK inhibitors are the latest class of synthetic (nonbiologic) disease-modifying antirheumatic medicines (DMARDs) that are effective in clinical studies for the treatment of axSpA, and its oral route of administration makes it a more convenient treatment option than other therapies, which may result in increased compliance. The drug is already approved for indications such as rheumatoid arthritis and psoriatic arthritis.

Moreover, Abbvie has already showcased its leadership in the axSpA space with its leading candidate Rinvoq (upadacitinib), getting approved for treating active ankylosing spondylitis. Upadacitinib 15 mg once daily demonstrated significant improvements in the signs and symptoms of nr-axSpA versus placebo after 14 weeks of treatment, and this study shows for the first time the potential use of upadacitinib as a treatment option in patients with nr-axSpA.