Abstract Background Real-world comparative evidence on the effectiveness and safety of ustekinumab and vedolizumab in biologic-experienced patients with moderate-to-severe inflammatory bowel disease (IBD) remains limited. Methods This multicenter retrospective study included adult patients with moderate-to-severe inflammatory bowel disease (IBD) who had prior exposure to biologic therapy and were subsequently treated with vedolizumab or ustekinumab. Clinical, demographic, radiologic, and endoscopic data were obtained from electronic medical records or standardized follow-up forms. The primary endpoints were clinical response and clinical remission at weeks 14, 52, and 102, assessed using the partial Mayo score for ulcerative colitis (UC) and the Harvey–Bradshaw Index (HBI) for Crohn’s disease (CD). Secondary endpoints included serological remission, endoscopic response, adverse events, and treatment persistence. Results A total of 384 patients were included (vedolizumab: n = 150; ustekinumab: n = 234). Baseline demographic characteristics, BMI categories, smoking and alcohol use, and laboratory values were similar between the groups. UC was more frequent in the vedolizumab cohort (60% vs 33.8%), whereas CD predominated in the ustekinumab group (64.5%) (p 0.001). Extraintestinal manifestations (26.7% vs 42.3%, p = 0.002) and prior IBD-related surgery (20% vs 32.9%, p = 0.006) were significantly higher in the ustekinumab cohort. Prior biologic exposure also differed significantly, with ustekinumab patients more likely to have received ≥3 biologics (15.4% vs 4.0%, p = 0.001). Clinical outcomes were largely comparable between vedolizumab and ustekinumab in both UC and CD. In UC, week-14 response and remission rates were similar (74.4% vs 83.5%; 47.8% vs 43.0%). Remission rates at week-52 (63.6% vs 62.3%) and week-104 (47.8% vs 53.8%) also showed no significant difference. Serological and endoscopic responses were comparable. Treatment discontinuation was more common with vedolizumab (38.9% vs 22.8%, p = 0.03), while adverse events were rare. In CD, week-14 response and remission rates were similar (76.3% vs 85.4%; 42.4% vs 48.3%). At week-52, ustekinumab achieved higher remission (69.6% vs 55.2%, p = 0.039). Week-104 remission rates were again comparable (48.1% vs 60.0%). Serological and endoscopic responses showed no significant differences, and although treatment discontinuation was numerically higher with vedolizumab (35.6% vs 25.8%), this was not statistically significant. Conclusion Ustekinumab and vedolizumab showed comparable real-world effectiveness and safety, with ustekinumab demonstrating higher week-52 remission in Crohn’s disease. Conflict of interest: Dr. Cankurtaran, Rasim Eren: none Karpuzcu, Hulusi Can: none Kandemir, Halit: none İnce, Mustafa: none Ergul, Mucahit: none Kilic, Guner: none Ozgul, Seckin: none Arabaci, Sanli: none Karataş, Ali: none Kahramanoglu Aksoy, Evrim: none Tayfur Yurekli, Oyku: none Özderin Özin, Yasemin: none Karakan, Tarkan: none
Cankurtaran et al. (Thu,) studied this question.