Efficacy and Safety of Upadacitinib for Axial Spondyloarthritis: A Systematic Review and Meta-Analysis.

Introduction: Upadacitinib, a selective JAK1 inhibitor, has demonstrated promising results in the treatment of axial Spondyloarthritis (AxSpA). AxSpA management remains challenging since there is a gap in knowledge regarding the potential effect of upadacitinib in axSpA patients. Exploring novel therapeutic options is crucial. Therefore, we performed this systematic review and meta-analysis to summarize and synthesize results collected from available randomized-- controlled trials (RCTs) about the efficacy and safety of upadacitinib for patients with axSpA.

Methods: A systematic literature search of Medline via PubMed, Web of Science, Scopus, EBSCO, and Cochrane Central was conducted in October 2023. Relevant RCTs were selected, and their data were extracted and analyzed using the RevMan 5.4 software. The main outcomes were assessment in Spondylarthritis International Society (ASAS) 20, ASAS40, SPARCC MRI sacroiliac joint, and Bath Ankylosing Spondylitis disease activity index (BASDAI) 50.

Results: Three RCTs with a total of 920 participants were included in this study. Upadacitinib showed significant improvement in the ASAS40 response, ASAS20 response, BASDAI50 response, and SPARCC MRI Sacroiliac Joint change from baseline compared to placebo at 14-week duration (RR 2.19, 95% CI (1.79 to 2.68), P < 0.00001), (RR 1.62, 95% CI [1.42 to 1.84), P < 0.00001), (RR 2.16, 95% CI (1.75 to 2.67), P < 0.00001), and (MD -3.32 points, 95% CI (-3.96 to -2.68), P < 0.00001) respectively. However, this efficacy decreased after the 52-week duration in terms of ASAS40 RR 2.19 vs. 1.02, ASAS20 RR 1.62 vs. 0.98, BASDAI 50 RR 2.16 vs. 1.05, and ASAS Partial Remission RR 3.82 vs. 1.07.

Conclusion: Upadacitinib 15 mg showed satisfactory and promising efficacy in the treatment of AxSpA, with no difference in safety profile compared to the placebo.