ABSTRACT Background Clinical trials have demonstrated the long‐term efficacy of ustekinumab in the treatment of ulcerative colitis (UC). However, real‐world data on its long‐term effectiveness beyond 1 year of follow‐up remain limited. Methods This multicenter cohort study evaluated the effectiveness of ustekinumab in adults with UC treated in routine clinical practice for up to 4 years. Data were obtained from two prospective Dutch registries: IBDREAM and the ICC registry. The primary outcome was corticosteroid‐free remission at year 3, with remission defined as a hierarchical, composite endpoint based on endoscopic, biochemical, and clinical parameters. Subgroup analysis was performed in patients with difficult‐to‐treat IBD, defined as prior failure of ≥ 2 advanced therapies with different mechanisms of action. Secondary outcomes included dose escalation and safety. Results A total of 198 patients were included; median age was 49 years, 48% were women, median disease duration was 8 years, and 42.4% had difficult‐to‐treat IBD. At years 2, 3, and 4, 35.8% (49/137), 34.3% (34/99), and 26.6% (17/64) of patients were in corticosteroid‐free remission. Among patients in corticosteroid‐free remission at week 12 ( n = 83), 50.0% remained in remission at year 3. Corticosteroid‐free remission rates at year 3 in patients with difficult‐to‐treat IBD and other patients were 19.2% and 51.1%, respectively. One‐hundred‐seven adverse events were recorded in 64 patients, including six serious adverse events. Conclusion These real‐world data confirm the effectiveness of ustekinumab in inducing and maintaining remission for up to 4 years in UC. The medication was particularly effective in patients with limited prior exposure to advanced therapies. Results support the established safety profile of ustekinumab.
Totté et al. (Fri,) studied this question.