P0824Real-World Effectiveness of Ustekinumab in Postoperative Crohn’s Disease Management: Evidence from a Chinese Multicenter Cohort

Abstract Background Postoperative recurrence (POR) remains one of the most challenging aspects of Crohn’s disease (CD) management, with endoscopic recurrence rates exceeding 70% within the first year after surgery without adequate prophylaxis. While ustekinumab has revolutionised treatment for moderate-to-severe CD, its real-world performance in the postoperative setting, particularly in Asian populations, remains largely unexplored. This multicentre study aimed to bridge this critical knowledge gap by evaluating ustekinumab’s effectiveness in both preventing and treating POR in a Chinese cohort. Methods We conducted a comprehensive retrospective analysis of 71 postoperative CD patients with multiple high-risk features receiving ustekinumab across four major tertiary referral centres in China. Our cohort represented real-world clinical practice, stratified into first-line (biologic-naïve, n = 45) and second-line (prior biologic failure, n = 26) treatment groups. The primary endpoint was endoscopic improvement, defined as a clinically meaningful ≥1-point reduction in Rutgeerts score at 24 weeks, providing an objective measure of ustekinumab’s mucosal healing capabilities. Results The results demonstrated compelling evidence for ustekinumab’s effectiveness in postoperative management. Remarkably, 81.7% of patients achieved endoscopic improvement, with over one-third (36.6%) attaining complete endoscopic remission (Rutgeerts i0), representing a profound level of mucosal healing. Clinically, 91.5% of patients reached remission, supported by a dramatic reduction in HBI scores from 5.5±2.8 to 2.1±1.7 (p 0.001). Multivariate analysis revealed that first-line ustekinumab therapy (OR = 1.727, p = 0.034) and shorter disease duration (OR = 0.979 per year, p = 0.001) were powerful independent predictors of treatment success. Importantly, patients with complex disease behaviours (stricturing and penetrating phenotypes) showed particularly favourable responses. The safety profile was exemplary, with only 9.9% experiencing mild to moderate adverse events, supporting long-term treatment feasibility. Conclusion Ustekinumab demonstrates multidimensional effectiveness for postoperative CD management, combining potent endoscopic efficacy with excellent clinical outcomes and favourable safety. These real-world findings from a Chinese multicentre cohort provide compelling evidence for ustekinumab’s role as a cornerstone therapy in the postoperative setting, offering new hope for optimising treatment strategies and improving long-term outcomes for Asian patients with CD. References: 1. Bai X, Zhang H, Ruan G, Lv H, Li Y, Li J, et al. Long-term Disease Behavior and Surgical Intervention Analysis in Hospitalized Patients With Crohn’s Disease in China: A Retrospective Cohort Study. Inflamm Bowel Dis. 2022;28(Suppl 2):S35-35S41. https://doi.org/10.1093/ibd/izab295. 2. Sandborn WJ, Rebuck R, Wang Y, Zou B, Adedokun OJ, Gasink C, et al. Five-Year Efficacy and Safety of Ustekinumab Treatment in Crohn’s Disease: The IM-UNITI Trial. Clin Gastroenterol Hepatol. 2022;20(3):578-90.e4. https://doi.org/10.1016/j.cgh.2021.02.025. 3. Yao L, Lin X, Tang J, Gao H, Gao X, Cao Q, et al. Effectiveness, treatment pattern, and safety of ustekinumab in treating bio-naïve patients with Crohn’s disease in the real-world clinical setting in China. Chin Med J (Engl). 2025. https://doi.org/10.1097/CM9.0000000000003694. Conflict of interest: Dr. Xianzong, Ma: No conflict of interest Jia, Yan: No conflict of interest Zhao, Xinmei: No conflict of interest Tian, Feng: No conflict of interest Xingzhao, Han: No conflict of interest Xuchun, Zhou: No conflict of interest Ling, Lei: No conflict of interest Linyan, Zhou: No conflict of interest Wenyu, Zhang: No conflict of interest