Ustekinumab for Crohn's Disease: Results of the ICC Registry, a Nationwide Prospective Observational Cohort Study

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, Alexander G.L. Bodelier, Jeroen M. Jansen, Jeoffrey J.L. Haans, Rosaline Theeuwen, Dirk De Jong, Marie J. Pierik, Frank Hoentjen*, on behalf of the Dutch Initiative on Crohn and Colitis (ICC)

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background and Aims: Ustekinumab 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. Methods: We 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. Results: In 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. Conclusion: Ustekinumab is a relatively safe and effective treatment option for CD patients with prior failure of anti-TNF and anti-integrin therapies.

Original languageEnglish
Pages (from-to)33-45
Number of pages13
JournalJournal of Crohn's and Colitis
Volume14
Issue number1
DOIs
Publication statusPublished - 1 Jan 2020

Cite this

Biemans, V. B. C., Van Der Meulen-De Jong, A. E., Van Der Woude, C. J., Löwenberg, M., Dijkstra, G., Oldenburg, B., ... on behalf of the Dutch Initiative on Crohn and Colitis (ICC) (2020). Ustekinumab for Crohn's Disease: Results of the ICC Registry, a Nationwide Prospective Observational Cohort Study. Journal of Crohn's and Colitis, 14(1), 33-45. https://doi.org/10.1093/ecco-jcc/jjz119