Clinical outcomes, predictors of prognosis and health economics consequences in IBD patients after discontinuation of the first biological therapy

Uday Shivaji, Alina Bazarova, Tamsin Critchlow, Samuel CL Smith, Olga Nardone, Melanie Love, Joanne Davis, Subrata Ghosh, Marietta Iacucci

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Background:In real-world clinical practice, biologics in inflammatory bowel diseases (IBD) may be discontinued for a variety of reasons, including discontinuation initiated by gastroenterologists. The aims of the study are to report outcomes after discontinuation and predictors of prognosis after a minimum follow-up of 24 months; outcomes of gastroenterologist-initiated discontinuation with resulting direct cost implications on the health system were also studied.
Methods:IBD patients who discontinued their first-use biologics between January 2013 and December 2016 were identified at our tertiary centre. Reasons for discontinuation and pre-defined adverse outcomes (AO) were recorded. Data were analysed using univariable and multivariable logistic regressions within a machine learning technique to predict AO. Gastroenterologist-initiated discontinuations were analysed separately, and Kaplan–Meier survival analysis performed; direct costs of AO due to discontinuation were assessed.
Results:A total of 147 patients discontinued biologics (M = 74; median age 39 years; Crohn’s Disease = 110) with median follow-up of 40 months (range 24–60 months). In the total cohort, there were fewer AO among gastroenterologist-initiated discontinuations compared with patient-initiated; 54% (of the total group) had AO within 6 months. Among 59 gastroenterologist-initiated discontinuations, 23 (40%) had IBD-related AO within 6 months and 53 (90%) patients had AO by end of follow-up. Some 44 (75%) patients needed to restart biologics during follow-up, and direct costs due to AO and restart of biologics were high.
Conclusions:The proportion of patients who have AO following discontinuation of biologics is high; clinicians need to carefully consider predictors of poor prognosis and high relapse rates when discussing discontinuation. The direct costs of managing AO probably offset theoretical economic gains, especially in the era where cost of biologics is reducing. Biologics should probably be continued without interruptions in most patients who have achieved remission for the duration these remain effective and safe.
Original languageEnglish
Pages (from-to)1-16
JournalTherapeutic Advances in Gastroenterology
Early online date27 Dec 2020
Publication statusPublished - 1 Jan 2021

Bibliographical note

Funding Information:
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This paper presents independent research funded by the NIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.


  • Crohn’s disease
  • IBD
  • biologics discontinuation
  • biologics withdrawal
  • direct costs
  • health economics
  • predictors of prognosis
  • ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology


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