DOP77 Ustekinumab is associated with better effectiveness outcomes when compared with vedolizumab in Crohn’s disease patients with prior anti-TNF failure: comparative effectiveness study from the ICC Registry

V. Biemans drs1, J. van der Woude2, G. Dijkstra3, A. van der Meulen- de Jong4, M. Löwenberg5, N. de Boer6, B. Oldenburg7, N. Srivastava8, J. Jansen9, A. Bodelier10, R. West11, A. de Vries2, J. Haans12, D. de Jong13, F. Hoentjen13, M. Pierik12, on behalf of the Dutch Initiative on Crohn and Colitis (ICC)

1Radboud University Nijmegen Medical Centre, Maastricht University Medical Centre, Department of Gastroenterology, Nijmegen, The Netherlands, Department of Gastroenterology and Hepatology, 2Erasmus Medical Centre, Rotterdam, The Netherlands, 3Department of Gastroenterology and Hepatology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands, 4Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands, 5Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, Academic Medical Centre, Amsterdam, The Netherlands, 6Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, Vrije Universiteit, Amsterdam Gastroenterology and Metabolism Research Institute, Amsterdam, The Netherlands, 7Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands, 8Department of Gastroenterology and Hepatology, Haaglanden Medical Centre, the Hague, The Netherlands, 9Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands, 10Department of Gastroenterology and Hepatology, Amphia Hospital, Breda, The Netherlands, 11Department of Gastroenterology and Hepatology, Franciscus Gasthuis and Vlietland, Rotterdam, The Netherlands, 12Department of Gastroenterology and Hepatology, Maastricht University Medical Centre, Maastricht, The Netherlands, 13Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands


Both vedolizumab and ustekinumab can be considered for the treatment of Crohn’s disease (CD) when anti-TNF treatment fails. However, head-to-head trials are currently not available or planned in the near future. The aim of this study was to compare vedolizumab and ustekinumab in CD patients using a quasi-experimental study design in a prospective registry specifically developed for comparative studies.


CD patients who failed anti-TNF treatment and started vedolizumab or ustekinumab in standard care as second-line biological and naïve to the latter two therapies, were identified in the observational prospective ICC Registry. Corticosteroid-free clinical remission (Harvey Bradshaw Index ≤4), biochemical remission (C-reactive protein ≤5 mg/l and faecal calprotectin ≤250 µg/g), combined corticosteroid-free clinical and biochemical remission, and safety outcomes were compared after 52 weeks of treatment. To adjust for confounding and selection bias, we used multiple logistic regression (correcting for current smoker, disease duration, complicated disease (stricturing or penetrating behaviour), prior CD-related surgery, number of prior anti-TNF treatments, HBI at baseline and biochemical disease at baseline) and propensity score matching (variables include the same variables as logistic regression analysis with addition of disease location and behaviour, corticosteroid and immunosuppressant use at baseline).


In total, 128 vedolizumab- and 85 ustekinumab-treated patients fulfilled the inclusion criteria. By using propensity score matching, 69 vedolizumab-treated patients were matched with 69 ustekinumab-treated patients. After adjusting for confounders, ustekinumab-treated patients were more likely to achieve corticosteroid-free clinical remission (OR: 2.56, 95% CI: 1.35–4.87, p = 0.004), biochemical remission (OR: 2.22, 95% CI: 1.04–4.74, p = 0.040), and combined corticosteroid-free clinical and biochemical remission (OR: 2.58, 95% CI: 1.15–5.78, p = 0.022), while safety outcomes (infections: OR: 1.26, 95% CI: 0.63–2.54, p = 0.517; adverse events: OR: 1.33, 95% CI: 0.62–2.81, p = 0.464; hospitalisations: OR: 0.67, 95% CI: 0.32–1.39, p = 0.282) were comparable between the two groups. The propensity score matched cohort showed comparable results.


In this prospective, comparative analysis ustekinumab was associated with higher effectiveness outcomes of ustekinumab when compared with vedolizumab. Safety outcomes were comparable after 52 weeks of treatment in CD patients who have failed anti-TNF treatment.