Real-world clinical experience with upadacitinib in a cohort of Italian patients with axial spondyloarthritis

Background There is currently scarce data on the real-world effectiveness and safety of upadacitinib in patients with axial spondyloarthritis (axSpA). This study evaluated clinical outcomes and drug retention rate (DRR) at 6, 12, and 24 months in patients initiating upadacitinib for axSpA.Methods This prospective, observational study enrolled consecutive patients with radiographic axSpA (r-axSpA) or non-radiographic axSpA (nr-axSpA) initiating upadacitinib between December 2022 and January 2025 at 16 Italian centres. The primary endpoints were treatment effectiveness-evaluated using clinimetric indices, including the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) - safety and DRR at 6, 12, and 24 months.Results Overall, 203 patients were analysed (48% male; median age at diagnosis 44 years; 22.7% HLA-B27 positive; 71% with nr-axSpA). Sixty-three patients completed the 24-month follow-up. Upadacitinib demonstrated a statistically significant improvement in effectiveness outcomes at 6 months vs. baseline, which was sustained at 12 and 24 months, regardless of previous biologic therapy lines, axSpA subtype, or sex. Furthermore, DRR was 92%, 80%, and 55% at six, 12, and 24 months, respectively. Forty patients discontinued upadacitinib, including 22 for insufficient effectiveness and two for AEs. Twenty-two patients developed infections.Conclusion Upadacitinib demonstrated a favourable effectiveness profile in the evaluable axSpA population with sustained remission and high treatment retention over a two-year follow-up. Within the limitations inherent to this observational study, the tolerability profile of upadacitinib was generally consistent with that reported in randomized controlled trials, and no new safety signals were identified. Overall, these findings support the effectiveness of Janus kinase inhibitors in the treatment of patients with axSpA.