Upadacitinib in real clinical practice: new horizons in the treatment of axial spondyloarthritis

Abstract

Introduction. Axial spondyloarthritis (axSpA) is an inflammatory disorder affecting the axial skeleton, accompanied by pain, restricted mobility, and other symptoms. The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a metric expressing disease activity, assessing inflammation and symptoms. In clinical trials, Upadacitinib has demonstrated reduced axSpA activity, but real-world evidence remains limited. Objective. The objective of this study is to evaluate the therapeutic effectiveness of Upadacitinib in axSpA by analysing its impact on symptoms, activity, and inflammatory markers in real clinical practice. Additional goals include comparing outcomes between biologic-naive and biologic-experienced patients, as well as assessing the influence of radiographic stage on Upadacitinib's therapeutic response. Methods. Sixty-four patients with axSpA were enrolled in Upadacitinib treatment. Among them, 42 were evaluated after 6 months and 13 after 12 months of therapy. ASDAS was assessed at various time points and analyzed based on prior experience with biologic drugs and radiographic stage of sacroiliitis. Results. A notable reduction in mean ASDAS values was observed after 6 months of Upadacitinib treatment (3.5 vs. 1.9, p < 0.001), with this reduction being sustained after 12 months (1.6 vs. 1.9, p > 0.05). A substantial proportion of patients (80.9%) achieved ASDAS values below 2.1 after 6 months, and this achievement was maintained after 12 months (84.6%, p > 0.05). No significant differences were found between biologic-naive and biologic-experienced patient subgroups (84.2% vs. 78.3%, p > 0.05). Similar trends were observed in the analysis of other parameters such as BASDAI, fatigue, pain, CRP, haemoglobin, and ESR. Upadacitinib increased the number of patients with low disease activity regardless of radiographic stage after 6 and 12 months (23.7 vs. 83.3% and 5.7 vs. 85.3%, p < 0.001). Conclusion. Upadacitinib proves to be effective in axSpA treatment. Regardless of demographic, clinical, and radiographic disease characteristics, as well as "biologic-naive/biofailure" status, Upadacitinib leads to ASDAS improvement after 6 and 12 months of treatment. This medication represents an effective tool in real-world clinical practice for controlling axSpA activity.