Trial results for a Phase 3 study evaluating upadacitinib (Rinvoq) for the treatment of active non-radiographic axial spondyloarthritis were published on 2022-01-01. The study, known as SELECT-AXIS 2, was a randomized, double-blind, placebo-controlled trial.
Background
Upadacitinib, also known by its brand name Rinvoq, is a Janus kinase (JAK) inhibitor. It is used in the treatment of various inflammatory conditions. This particular study focused on its efficacy and safety in adults with active non-radiographic axial spondyloarthritis, a chronic inflammatory disease primarily affecting the spine and sacroiliac joints, often causing back pain and stiffness. Non-radiographic axial spondyloarthritis is characterized by symptoms similar to ankylosing spondylitis but without clear radiographic evidence of structural damage to the sacroiliac joints.
Trial design
The SELECT-AXIS 2 study was a Phase 3, randomized, double-blind, placebo-controlled trial. Its primary objective was to evaluate upadacitinib for the treatment of active non-radiographic axial spondyloarthritis. The trial design involved comparing upadacitinib against a placebo arm to assess its therapeutic effects and safety profile in the target patient population.
What this means
The publication of Phase 3 trial results for upadacitinib in active non-radiographic axial spondyloarthritis is a significant development for clinicians and patients. Pivotal trial data from a randomized, double-blind, placebo-controlled study provides robust evidence that can inform treatment guidelines and potentially support regulatory submissions for new indications. For patients living with non-radiographic axial spondyloarthritis, these findings may offer a new therapeutic option to manage their chronic inflammatory condition, which can significantly impact quality of life.
Source
The information regarding these trial results was obtained from PubMed, a database of biomedical literature. The publication, titled "Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial," was published on 2022-01-01 and is accessible via pubmed.ncbi.nlm.nih.gov.