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Results of the SELECT-AXIS 2 study supported the efficacy and safety profile of upadacitinib in patients with active ankylosing spondylitis who had an inadequate response to biologic DMARD therapy.
In an interview with HCPLive Rheumatology, Xenofon Baraliakos, MD, PhD, professor of Internal Medicine and Rheumatology, Ruhr-University Bochum, discussed the results of the SELECT-AXIS 2 study, which evaluated the safety and efficacy of upadacitinib in patients with active ankylosing spondylitis (AS) who had an inadequate response to biologic disease-modifying antirheumatic drug (bDMARD) therapy. These findings were presented at the European Congress of Rheumatology (EULAR) 2023.1
In the Phase 3 pivotal SELECT-AXIS 1 and 2 trials, upadacitinib demonstrated efficacy and safety in patients with radiographic axial spondyloarthritis, including those who had an inadequate response or intolerance to biologic DMARD antirheumatic therapies. The goal of the ongoing long-term extension trial was to assess those results at 1-year.
The study included patients who received continuous upadacitinib and those who were switched to upadacitinib after a 14-week placebo-controlled period. Baraliakos and his team evaluated efficacy and safety in both groups, which enrolled over 400 patients.
Results supported the efficacy and safety profile of upadacitinib in this patient population.
Why did your team decide to focus on upadacitinib treatment for patients with ankylosing spondylitis in particular?
Axial spondyloarthritis is a spectrum of disease that includes radiographic and non-radiographic axial spondyloarthritis. While radiographic axial spondyloarthritis may be detectable on MRIs—unlike non-radiographic axial spondyloarthritis, there is still a major unmet need in the time it typically takes someone from onset of symptoms to diagnosis, and in the availability of effective treatment options.
Radiographic axial spondyloarthritis, a disease that causes bones in the spine to fuse over time, comes with many complications like spine stiffness and inflexibility, restricted lung capacity, eye and bowel inflammation, and compression fractures. One of the biggest challenges facing patients living with radiographic axial spondyloarthritis is decreased mobility and increased risk of depression and anxiety, which makes it difficult to do daily activities like finding or keeping a job, participating in hobbies, and socializing with friends and family.
There is still a lot of work that needs to be done in this field to develop effective treatments that not only help manage symptoms, but also slow disease progression and onset of severe complications that hinder quality of life for patients.
Why did your team choose to solely include patients with an inadequate response or intolerance to biologic disease-modifying antirheumatic drugs?
There is no cure for radiographic axial spondyloarthritis, but our goal is to find an effective treatment early on to slow disease progression and help prevent irreversible damage. DMARDs are a common treatment used for immune-mediated diseases, including radiographic axial spondyloarthritis, but still many patients do not have an adequate treatment response to these medicines. Therefore, it’s important to continue to research and find additional treatment options for these patients who are having an inadequate response or not tolerating first line DMARD therapy.
Were there any strengths or limitations of the study that you’d like to highlight?
The study has shown very clearly that treatment with upadacitinib is efficacious, and the results can be seen already some days after treatment initiation. Patients were included after having had radiographic axial spondyloarthritis diagnosed by a rheumatologist and supported by the Assessment of Spondyloarthritis International Society (ASAS) classification criteria. The only limitation I see is the non-inclusion of non-radiographic patients to assess the effect of upadacitinib in the entire axial spondyloarthritis population. However, other studies have been performed independently for that purpose.
Given this is a phase 3 study, does your team plan on doing any further research on this drug for treating this patient population/other autoimmune diseases?
Certainly, there are also other scientific and clinically relevant questions for further research in this field. Especially subgroups of patients with different clinical characteristics would be interesting to explore in subsequent analyses.
Is there anything else you’d like our audience to know?
As treatments advance, we aren’t only managing symptoms anymore, we have the opportunity to actually slow disease progression and halt the onset of irreversible damage to the spine. This is an exciting time in the field of research, and studies like the SELECT-AXIS 2 program are helping to move the needle for patients living with radiographic axial spondyloarthritis and raise the standard of care – something that wasn’t always thought of as a possibility for this chronic immune-mediated disease.