• Vince B C Biemans, Andrea E van der Meulen-de Jong, Christine J van der Woude, Mark Löwenberg, Gerard Dijkstra, Bas Oldenburg, Nanne K H de Boer, Sander van der Marel, BodelierAlexander G LAGLDepartment of Gastroenterology and Hepatology, Amphia Hospital, Breda, The Netherlands., Jeroen M Jansen, HaansJeoffrey J LJJLDepartment of Gastroenterology and Hepatology, Maastricht University Medical Centre, Maastricht, The Netherlands., Rosaline Theeuwen, Dirk de Jong, Marie J Pierik, and Frank Hoentjen.
• Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands.
• J Crohns Colitis. 2020 Jan 1; 14 (1): 33-45.

Background And AimsUstekinumab is approved for the treatment of Crohn's disease [CD]. Systematically registered prospective real-world data are scarce. We therefore aimed to study the effectiveness, safety and usage of ustekinumab for CD in everyday practice.MethodsWe prospectively enrolled CD patients initiating ustekinumab in regular care between December 2016 and January 2019. Clinical (Harvey Bradshaw Index [HBI]), biochemical (C-reactive protein [CRP] and faecal calprotectin [FCP]), extra-intestinal manifestations and, peri-anal fistula activity, ustekinumab dosage, concomitant medication use, and adverse events were documented at weeks 0, 12, 24, and 52. The primary outcome was corticosteroid-free clinical remission.ResultsIn total, 221 CD patients were included (98.6% anti-tumour necrosis factor [TNF] and 46.6% vedolizumab exposed) with a median follow-up of 52.0 weeks [interquartile range 49.3-58.4]. Corticosteroid-free clinical remission rates at weeks 24 and 52 were 38.2% and 37.1%, respectively. An initial dosing schedule of 8 weeks, compared to 12 weeks, correlated with a lower discontinuation rate [20.0% vs 42.6%, p = 0.01], but comparable corticosteroid-free clinical remission at week 52 (46.3% [q8w] vs 34.6% [q12w], p = 0.20). There was no clinical benefit of combination therapy after 52 weeks when compared to ustekinumab monotherapy [combi 40.6% vs mono 36.0%, p = 0.64]. At baseline, 28 patients had active peri-anal fistula, of whom 35.7% showed complete clinical resolution after 24 weeks. During follow-up we encountered six severe infections [3.5 per 100 patient-years], with all patients being on concomitant immunosuppressant therapies. Ustekinumab treatment discontinuation was observed in 75 [33.9%] patients mainly due to lack of response.ConclusionUstekinumab is a relatively safe and effective treatment option for CD patients with prior failure of anti-TNF and anti-integrin therapies.Copyright © 2019 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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