Effectiveness of ustekinumab dose escalation in Crohn's disease patients with insufficient response to standard-dose subcutaneous maintenance therapy

U. Kopylov*, J. Hanzel, C. Liefferinckx, D. De Marco, N. Imperatore, N. Plevris, I. Baston-Rey, R.J. Harris, M. Truyens, V. Domislovic, S. Vavricka, V. Biemans, S. Myers, S. Sebastian, S. Ben-Horin, Y.G. Lama, C. Gilletta, B.G.S. Ariella, Z. Zelinkova, R. WeishofD. Storan, E. Zittan, K. Farkas, T. Molnar, D. Franchimont, A. Cremer, W. Afif, F. Castiglione, C. Lees, M. Barreiro-de Acosta, T. Lobaton, G. Doherty, Z. Krznaric, M. Pierik, F. Hoentjen, D. Drobne

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Background Ustekinumab is effective in Crohn's disease. However, a substantial proportion of patients will not respond or lose response to ustekinumab. The current evidence to support the effectiveness of dose-optimisation for ustekinumab nonresponse is limited.Aim To assess the effectiveness of dose escalation of ustekinumab.Methods This was a multicentre retrospective cohort study. We included active Crohn's disease patients who received a standard-dose intravenous induction and at least one subcutaneous ustekinumab 90 mg dose. All enrolled patients received dose escalation by either shortening the interval between the doses to every 4 or 6 weeks, intravenous reinduction or a combination of strategies. The primary outcome of the study was clinical response at week 16 after dose escalation.Results A total of 142 patients (22 centres/14 countries) were included. The patients were dose-escalated after a median treatment duration of 30 weeks. At week 16 from escalation, 73/142 (51.4%) responded to treatment, including 55/142 (38.7%) in clinical remission. Corticosteroid-free remission was achieved in 6/34 (17.6%) patients on corticosteroids at the time of escalation; 118/142 (83%) continued treatment beyond week 16. Follow-up data beyond week 16 were available for 74/118 (62.7%) patients. On the last follow-up, 51/98 (52%) patients with available data responded to treatment, including 41/98 (42%) in clinical remission.Conclusions Intensification of ustekinumab maintenance dosage was effective in over 50% of the patients. This strategy should be considered in patients who are nonresponsive to every 8 weeks ustekinumab maintenance dosing.
Original languageEnglish
Pages (from-to)135-142
Number of pages8
JournalAlimentary Pharmacology & Therapeutics
Issue number1
Publication statusPublished - 1 Jul 2020


  • experience
  • induction


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