Sustained Treatment Success With Ustekinumab in Symptomatic Stricturing Crohn's Disease: A Retrospective Single‐Arm Observational Cohort Study

ABSTRACT Despite being a common complication of Crohn's disease (CD), evidence regarding the use of ustekinumab (UST) for treating symptomatic strictures in China remains limited. This study evaluated the effectiveness of UST in this population and identified the predictors of successful therapy. This cohort study enrolled adults with CD initiating UST therapy for symptomatic strictures confirmed by endoscopy or imaging. The primary outcome at Week 52 was continued UST therapy without prohibited adjunctive treatments. A clinical prediction model was developed, and its performance was evaluated for identifying baseline factors associated with treatment success. Of the 73 patients screened between June 2022 and April 2024, 54 were included. At Week 52, 44 (81.5%) achieved treatment success, with most demonstrating improvements in obstructive symptom score, CD Activity Index (CDAI), endoscopic and computed tomography enterography (CTE) findings, and biochemical parameters. Nonsmoking status and C‐reactive protein (CRP) levels predicted treatment success, with the model demonstrating 86.4% discriminative ability. No severe adverse events were reported, except for one case of leukemia (2%) and two cases of serious infections (4%). The study highlighted that UST effectively alleviated intestinal strictures in CD, with most patients achieving symptom remission, improved stricture morphology, and reduced inflammation.