Background and aims: The use of ustekinumab and vedolizumab as second line therapy in Crohn's disease patients in which tumour necrosis factor alpha inhibitors (TNFi) failed is still debated. The aim of the study was to compare, in a large multicentre observational retrospective cohort, the effectiveness of ustekinumab and vedolizumab as second line therapy as assessed by clinical and objective outcomes including endoscopy and gastrointestinal imaging. Methods: Clinical response, remission and steroid-free remission at week 26 and 52 were evaluated in a retrospective propensity score weighted and matched cohort of patients in which TNFi failed. Objective response and remission were evaluated by one or more techniques among endoscopy, magnetic resonance/computed tomography (MR/CT) enteroclysis and small bowel ultrasound. Results: 470 Crohn's disease patients (239 ustekinumab and 231 vedolizumab) were included in the study. At week 26, clinical outcomes were similar between the two groups. At week 52, clinical remission (ustekinumab 42.5% vs vedolizumab 55.5%, p=0.01) and steroid-free remission (ustekinumab 40.6% vs vedolizumab 51.1%, p=0.038) rates were significantly higher in vedolizumab-treated patients. 302 patients (135 ustekinumab and 167 vedolizumab) had objective evaluation of disease activity at baseline and week 52. At week 52 objective response and remission rates were similar between the groups. Clinical response at week 26 predicted steroid-free remission at week 52 in both ustekinumab- and vedolizumab-treated patients. Safety profiles were similar between the two groups. Conclusions: In CD patients in which TNFi failed, both ustekinumab and vedolizumab showed similar clinical effectiveness after 26 weeks of treatment. At one-year vedolizumab was associated with higher rate of clinical remission as compared to ustekinumab. Thought, no difference was observed between the two groups when objective outcomes were investigated at this time point.
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