Effectiveness, Durability, and Safety of Ustekinumab in Inflammatory Bowel Disease: Results from the Taiwan Multicenter Real-world Ustekinumab Study (T-RUST Study)

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BACKGROUND: Real-world data on ustekinumab (UST) in Asian inflammatory bowel disease (IBD) populations remain limited. The T-RUST (Taiwan Multicenter Real-world Ustekinumab Study) study evaluated the effectiveness, durability, and safety of UST in patients with Crohn's disease (CD) and ulcerative colitis (UC). METHODS: This retrospective multicenter study utilized data from the Taiwan Association for the Study of Intestinal Diseases IBD Registry between September 2019 and April 2025. Patients with CD or UC treated with UST were evaluated for clinical response and remission at weeks 4, 8, and 52. Subgroup analyses examined drug persistence according to biologic treatment history (biologic naive vs biologic experienced), prior advanced therapies, and difficult-to-treat IBD status. Fistula closure, endoscopic, radiologic, and histological remission, as well as safety outcomes, were assessed. RESULTS: A total of 379 patients were included, comprising 301 (79.4%) with CD and 78 (20.6%) with UC. Among patients with available week 52 data, clinical response was achieved in 183 (90.1%) of 203 CD patients and 40 (97.6%) of 41 UC patients. Corresponding clinical remission was achieved in 172 (84.7%) of 203 and 37 (90.2%) of 41 patients, respectively. Fistula closure was achieved in 17 (45.9%) of 37 patients with active fistulizing CD, including 10 (45.5%) of 22 patients with perianal fistulas. One-year UST persistence exceeded 80% in both cohorts, with persistence observed in 273 (91.0%) of 300 CD patients and 67 (85.9%) of 78 UC patients. UST was generally well tolerated, with no new safety signals identified. CONCLUSIONS: UST demonstrated sustained effectiveness, meaningful fistula healing, and a favorable safety profile in this real-world IBD cohort. These findings support its role as a durable and well-tolerated therapeutic option in Asian clinical practice.

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