The phase 3 research being presented at the EULAR 2022 conference evaluated the efficacy and safety of upadacitinib in patients with active non-radiographic axial spondyloarthritis.
This article was originally published on Rheumatology Network.
Filip Van den Bosch, MD, discussed his European Alliance of Associations for Rheumatology (EULAR) 2022 conference presentation, “Efficacy and Safety of Upadacitinib in Patients With Active Non-Radiographic Axial Spondyloarthritis: a Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial” in an interview with Rheumatology Network.
Van den Bosch is Head-of-Clinic and Associate Professor of Rheumatology in the Department of Rheumatology at the University Hospital of Ghent University.
The SELECT-AXIS 2 program was conducted to assess the efficacy and safety of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA).
The primary endpoint for the SELECT-AXIS 2 program was the Assessment in Spondylo-Arthritis international Society (ASAS) 40 response at week 14.
“The ASAS score can be used by physicians to measure whether a patient’s condition has improved and ASAS disease areas assessed include back pain, patient global assessment of disease activity, functional limitation, and morning stiffness,” Van den Bosch explained.
Secondary endpoints evaluated at week 14 were improvements from baseline in disease activity, pain, function, inflammation, spinal mobility, enthesitis, and health-related quality of life.
Results from the SELECT-AXIS 2 nr-axSpA study found upadacitinib demonstrated significantly greater improvements in signs and symptoms, pain, function, disease activity, and MRI-detected spine inflammation with upadacitinib compared to placebo at week 14. Significantly more nr-axSpA patients achieved the primary endpoint of ASAS40 at week 14 with upadacitinib versus placebo (45 percent versus 23 percent; P<0.0001).
Rheumatology Network: What is the clinical significance of these results?
Filip Van den Bosch, MD: The data obtained from the SELECT-AXIS 2 program reinforce the potential of upadacitinib to be a meaningful treatment option for patients across the spectrum of axSpA. These 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.
RN: Does your team plan on doing any further research on this drug regarding nr-axSpA/AS?
VDB: We’re continuing to conduct research across the spectrum of axSpA to reinforce the potential of upadacitinib to be a meaningful treatment option for patients. The SELECT-AXIS 2 studies are ongoing and currently have data through two years in patients with axSpA.
RN: Is there anything else you’d like our audience to know?
VDB: There is an unmet need in axSpA with gaps in diagnosis and disease management. AxSpA can be difficult to test for, often resulting in delays in diagnosis, leading to a nine-year average period between symptom onset and AS diagnosis. Early, effective, and comprehensive disease management of axSpA is key to reducing the risk of functional disability and to improving health outcomes.