Ustekinumab Therapy in Inflammatory Bowel Disease: Outcomes from Routine Clinical Practice

Abstract

Background: Ustekinumab has emerged as an effective therapeutic option for patients with Crohn’s disease, including those with prior exposure to other biologic agents. However, data from routine clinical practice remain essential to better characterize its effectiveness and safety in heterogeneous patient populations. Methods: We conducted a retrospective observational study including patients with Crohn’s disease treated with ustekinumab. Patients previously exposed to another biologic agent within three months before ustekinumab initiation were excluded to limit potential confounding. Clinical, biological, and treatment-related data were collected at baseline and during follow-up. Clinical response, remission rates, and safety outcomes were assessed according to predefined criteria. Results: Thirty-five patients with inflammatory bowel disease were included, including 26 with Crohn’s disease (74.3%) and 9 with ulcerative colitis (25.7%); mean age at inclusion was 44.2 years, with a male predominance (62.9%). Ustekinumab was mainly initiated after anti-TNF failure or intolerance (94.3%). After 6–24 months of follow-up, 71.4% of patients achieved a marked clinical response, while 20.0% required dose interval shortening to every 6 weeks, and 8.6% discontinued treatment due to lack of efficacy. A significant biological response was observed, with a >50% reduction in CRP and fecal calprotectin in the majority of patients by week 13. Endoscopic improvement was documented in most patients, and no treatment-related adverse events were reported. Conclusion: In this cohort, ustekinumab demonstrated sustained effectiveness and a favorable safety profile in patients with Crohn’s disease, including those with prior biologic exposure. These findings support its use as a valuable therapeutic option in routine clinical practice and are consistent with previously published observational and clinical trial data.