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

J Crohns Colitis. 2021 Apr 28;jjab081. doi: 10.1093/ecco-jcc/jjab081. Online ahead of print.

Tessa Straatmijer 1Vince B C Biemans 1Frank Hoentjen 2Nanne K H de Boer 3Alexander G L Bodelier 4Gerard Dijkstra 5Willemijn A van Dop 2Jeoffrey J L Haans 6Jeroen M Jansen 7P W Jeroen Maljaars 8Sander van der Marel 9Bas Oldenburg 10Cyriel Y Ponsioen 11Marijn C Visschedijk 7Annemarie C de Vries 12Rachel L West 13C Janneke van der Woude 12Marieke Pierik 6Marjolijn Duijvestein 11Andrea E van der Meulen-de Jong 8


Author information

  • 1Initiative on Crohn and Colitis, Amsterdam / Leiden, the Netherlands.
  • 2Department of Gastroenterology, Radboud University Medical Centre, Nijmegen, The Netherlands.
  • 3Amsterdam University Medical Centre, Vrije Universiteit Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam , The Netherlands.
  • 4Amphia Hospital, Breda, The Netherlands.
  • 5University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
  • 6Maastricht University Medical Centre, Maastricht, The Netherlands.
  • 7Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
  • 8Leiden University Medical Centre, Department of Gastroenterology and Hepatology, Leiden, The Netherlands.
  • 9Haaglanden Medisch Centre, The Hague, The Netherlands.
  • 10University Medical Centre Utrecht, Utrecht, The Netherlands.
  • 11Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism (AGEM) Research Institute, Amsterdam, the Netherlands.
  • 12Erasmus Medical Centre, Rotterdam, The Netherlands.
  • 13Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.


Objective: 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 two-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 week 0, 12, 24, 52 and 104, clinical remission (HBI ≤ 4 points), biochemical remission (fecal calprotectin (FC) ≤200 μg/g and/or CRP ≤5 mg/L), peri-anal 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 patient with at least two 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 week 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 week 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.

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