Abstract Background Upadacitinib, a selective Janus kinase 1 (JAK1) inhibitor, has demonstrated efficacy in clinical trials for Ulcerative Colitis (UC) but real-world evidence remains limited. This study aims to characterize treatment patterns of upadacitinib in UC patients in China, evaluating therapeutic efficacy and safety through endoscopic and clinical outcomes during both 8-week induction and 52-week maintenance therapy phases. Methods This single-center, retrospective, real-world study was conducted at Union Hospital, Wuhan, China. The study enrolled adult patients with active UC who initiated upadacitinib treatment between February 2023 and June 2025. Data collection included baseline characteristics, endoscopic findings, and clinical assessments obtained at the end of the 8-week induction and 52-week maintenance therapy phases. Efficacy was evaluated using the following endpoints: clinical remission and clinical response defined by Adapted Mayo score, endoscopic improvement, endoscopic remission and mucosal healing defined by the endoscopic subscore. Results A total of 43 patients completed the upadacitinib induction therapy. The cohort was predominantly male (69.77%), with an average age of 46.95 ± 15.33 years. At baseline, 86.05% presented with moderate-to-severe disease activity, 97.67% had prior exposure to biologic agents. Following induction therapy, 33.33% (4/12) achieved clinical remission and 58.33% (7/12) attained clinical response. Endoscopic outcomes demonstrated 16.67% (2/12) achieving endoscopic remission and 66.67% (8/12) showing endoscopic improvement. A significant reduction from baseline in the Adapted Mayo score was observed. Of the 20 patients who completed the 52-week maintenance therapy, evaluable outcomes revealed a clinical remission rate of 55.56% (5/9), clinical response rate of 66.67% (6/9), endoscopic remission rate of 22.22% (2/9), and endoscopic improvement rate of 77.78% (7/9). Mucosal healing was documented in 22.22% (2/9) of these patients. Biomarkers of inflammatory burden, including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and fecal calprotectin (FC), demonstrated significant reductions from baseline levels throughout the treatment. The most frequently reported adverse event was hyperlipidemia (20.93%, 9/43) with no serious adverse events were reported during the study period. Conclusion This real-world study demonstrated that upadacitinib provided rapid onset and potent anti-inflammatory efficacy in active UC, effectively improving clinical symptoms and endoscopic appearances while promoting mucosal healing. With a well-tolerated safety profile, it represented a viable sequential treatment option for patients with prior biologic failure. Conflict of interest: Ms. Fu, Xiaoyu: No conflict of interest Zhu, Liangru: No conflict of interest
Fu et al. (Thu,) studied this question.