Ustekinuma b for Crohn's Disease: Two-Year Results of the Initiative on Crohn and Colitis (ICC) Registry, a Nationwide Prospective Observational Cohort Study

T. Straatmijer*, V.B.C. Biemans, F. Hoentjen, N.K.H. de Boer, A.G.L. Bodelier, G. Dijkstra, W.A. van Dop, J.J.L. Haans, J.M. Jansen, P.W.J. Maljaars, S. van der Marel, B. Oldenburg, C.Y. Ponsioen, M.C. Visschedijk, A.C. de Vries, R.L. West, C.J. van der Woude, M. Pierik, M. Duijvestein, A.E. van der Meulen-de Jong

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Aims: Ustekinumab is a monoclonal antibody that selectively targets p40, a shared subunit of the cytokines interleukin [IL]-12 and IL-23. It is registered for the treatment of inflammatory bowel diseases. We assessed the 2-year effectiveness and safety of ustekinumab in a real world, prospective cohort of patients with Crohn's disease [CD].Methods: Patients who started ustekinumab were prospectively enrolled in the nationwide Initiative on Crohn and Colitis [ICC] Registry. At weeks 0, 12, 24, 52 and 104, clinical remission Harvey Bradshaw Index <= 4 points], biochemical remission (faecal calprotectin <= 200 mu g/g and/or C-reactive protein <= 5 mg/L], perianal fistula remission, extra-intestinal manifestations, ustekinumab dosage and safety outcomes were determined. The primary outcome was corticosteroid-free clinical remission at week 104.Results; In total, 252 CD patients with at least 2 years of follow-up were included. Of all included patients, the proportion of patients in corticosteroid-free clinical remission was 32.3% [81/251], 41.4% [104/251], 39% [97/249] and 34.0% [84/247] at weeks 12, 24, 52 and 104, respectively. In patients with combined clinical and biochemical disease activity at baseline [n = 122], the corticosteroid-free clinical remission rates were 23.8% [29/122], 35.2% [43/122], 40.0% [48/120] and 32.8% [39/119] at weeks 12, 24, 52 and 104, respectively. The probability of remaining on ustekinumab treatment after 52 and 104 weeks in all patients was 64.3% and 54.8%, respectively. The main reason for discontinuing treatment after 52 weeks was loss of response [66.7%]. No new safety issues were observed.Conclusion: After 104 weeks of ustekinumab treatment, one-third of CD patients were in corticosteroid-free clinical remission.
Original languageEnglish
Pages (from-to)1920-1930
Number of pages11
JournalJournal of Crohn's & Colitis
Issue number11
Publication statusPublished - 1 Nov 2021


  • Ustekinumab
  • Crohn's disease
  • real-world
  • ICC Registry

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