Abstract Background 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 at the end of 12-week induction therapy and 52-week maintenance therapy. Results 151 patients met inclusion criteria, endoscopic response and remission were achieved in 56.25% (27/48) and 43.75% (21/48), while mucosal healing occurred in 29.17% (14/48) by week 12. 56.91% (70/123) achieved clinical response and 40.65% (50/123) achieved clinical remission. Among the 72 patients completed 52-week maintenance therapy, 62.96% (17/27), 55.56% (15/27), 29.63% (8/27) of them achieved endoscopic response, endoscopic remission and mucosal healing, respectively. Clinical response and clinical remission were observed in 66.67% (42/63) and 53.97% (34/63) patients. Adverse events were recorded in 34.44% of patients, with lymphopenia and transaminase elevation being the most frequent. The baseline CDAI, 12-week CDAI, and 52-week CDAI scores of patients treated with 30mg upadacitinib in maintenance therapy were all higher than those of the 15mg group, but the clinical remission rate at week 52 of the 15mg group was higher than that of the 30mg group. 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. Conflict of interest: Ms. Fu, Xiaoyu: No conflict of interest Zhu, Liangru: No conflict of interest
Fu et al. (2026) studied this question.