Upadacitinib for treatment of Nonradiographic Axial Spondyloarthritis

Abbvie to present upadacitinib’s results from its SELECT-AXIS 2 (Study 2) in patients with Nonradiographic Axial Spondyloarthritis (nr-axSpA)

Janus kinase (JAK) inhibitors have been identified as a potential treatment option for Ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). Upadacitinib, a JAK inhibitor, has shown efficacy and safety in treating AS, but no JAK inhibitor studies in nonradiographic axSpA (nr-axSpA) have been done so far.

SELECT-AXIS 2 trial highlights the efficacy and safety data of upadacitinib (RINVOQ) in patients with nr-axSpA and patients with AS with an inadequate response to biologic disease-modifying antirheumatic drugs (bDMARDs).

SELECT-AXIS 2 (Study 2) is a Phase III trial to study the efficacy and safety of upadacitinib in patients with active nr-axSpA. According to the interim results, upadacitinib met the primary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 40 response and most ranked secondary endpoints at Week 14. Significantly more upadacitinib-treated patients achieved ASAS40 response (45%) at Week 14 than placebo (23%).

In January this year, the company submitted applications seeking approvals for upadacitinib (RINVOQ, 15 mg once daily) to the US FDA and the EMA for the treatment of adults with active nr-axSpA with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). These applications are supported by the Phase III SELECT-AXIS 2 (Study 2) clinical trial, and its complete results will be presented at the EULAR 2022 conference.

Conclusion

Looking at the existing spondyloarthritis treatment regimen, the disease activity of ~30% of patients with SpA cannot be controlled with currently approved drugs.

JAK inhibitors are the latest class of synthetic (nonbiologic) disease-modifying antirheumatic medicines (DMARDs) that are effective in clinical studies for the treatment of psoriatic arthritis and AS. Moreover, its oral route of administration makes it a more convenient treatment option than other therapies, which may result in increased compliance.

Even though upadacitinib is associated with some serious infections and major adverse cardiovascular events (MACE), clinical trials have shown its effectiveness in treating the signs and symptoms of the disease. Abbvie has already showcased its leadership in rheumatology research with its leading candidate Rinvoq (upadacitinib). The drug is already approved for other indications such as rheumatoid arthritis and psoriatic arthritis.

In April this year, it also gained success in the axial spondyloarthritis (axSpA) disease space with its approval for treating active AS based on the Phase III SELECT-AXIS 2 trial. The company is looking forward to bagging approval for its leading drug for the treatment of nr-axSpA and expanding its presence in the axial spondyloarthritis therapeutic landscape.

For more detailed analysis, visit: Axial Spondyloarthritis market