Background and aims: Upadacitinib, a selective Janus kinase 1 (JAK1) inhibitor, has demonstrated efficacy in clinical trials for Crohn's disease (CD) but real-world evidence remains limited. This study aimed to evaluate the effectiveness and safety of upadacitinib as induction therapy in a Chinese cohort with active CD.
Methods: We conducted a retrospective, single-center cohort study of CD patients who received upadacitinib at Union Hospital (Wuhan, China) between June 2023 and February 2025. Clinical and endoscopic outcomes and safety events were systematically assessed. Multivariate analyses were performed to identify predictors of therapeutic response.
Results: 94 patients met inclusion criteria, endoscopic response and remission were achieved in 50.00% and 38.89%, while mucosal healing occurred in 27.78% by week 12. 53.25% achieved clinical response and 42.86% achieved clinical remission. Biomarker normalization was observed in 62.71% (CRP), 70.91% (ESR), and 29.63% (fecal calprotectin). Adverse events were recorded in 34.0% of patients, with lymphopenia being the most frequent. Lower baseline CDAI and SES-CD scores were associated with higher remission rates.
Conclusion: This real-world study demonstrates that upadacitinib is effective and generally well tolerated in biologic-experienced Chinese patients with active CD. Our findings support the clinical utility of JAK1 inhibition in a real-world setting.
Keywords: Crohn’ s disease; Endoscopic remission; JAK1 inhibitor; Real-world evidence; Upadacitinib.
© 2025. The Author(s).