BISCUIT - the Biologic dISContinUatIon sTudy

Project start date and end date: 2021 - 2024


Biologic drugs are increasingly used to treat pediatric patients with inflammatory bowel disease (IBD). However, despite availability of new medications and monitoring techniques, drug discontinuation remains common, leading to loss of treatment options. The reasons for this are varied, and may include developing anti-drug antibodies, adverse drug reactions, insurance problems, among other reasons. This problem can be serious for some patients, who may run out of treatment options before they reach adulthood. There is little evidence to predict risk of biologic drug discontinuation. We propose to evaluate the predictors of and reasons for biologic drug discontinuation among pediatric patients with Crohn’s disease (CD).


  • Aim 1. Determine the frequency of biologic drug discontinuation, including associations with patient and practice characteristics, as well as drug dosing and monitoring among children with CD.
  • Aim 2. Determine the associations between biologic drug discontinuation and adverse events, evaluation performed prior to drug discontinuation, and barriers to care.
  • Aim 3. Determine practice patterns including evaluations that are associated with lower risk of biologic drug discontinuation.

Research Topics & Methods:

This is a retrospective cohort study of pediatric patients with CD in the ImproveCareNow Network who have been on any biologic drug at any time during the study period. We will perform per-patient longitudinal analyses, characterizing the time from diagnosis to starting each biologic drug, duration of use of that drug, and changes in dosing. From the available data, we will attempt to determine if subgroups of patients can be identified who are at greater risk of biologic drug discontinuation. We will supplement registry data with information abstracted from the medical record from patients from a subgroup of sites in the ImproveCareNow Network.


It is important to develop strategies for preventing loss of therapeutic options in order to continue to improve long-term outcomes for young people with IBD. We anticipate that armed with information, we will be enabled to develop:

  1. Evidence-based predictors of biologic drug discontinuation;
  2. Educational materials aimed at reducing unnecessary drug discontinuation;
  3. Guidelines for improving evaluation prior to drug discontinuation; and
  4. Published evidence to inform policy aimed at improving insurance coverage of appropriate dosing and monitoring.


The project is funded by the Gary and Rachel Glick Charitable Fund.        


Sabina Ali, MD, UCSF
Jess Kaplan, MD, Mass General for Children Benioff Children’s Hospital
Jon Moses, MD, Rainbow Babies and Children’s Hospital
Brad Pasternak, MD, Phoenix Children’s
Chip Samson, MD, Washington University of Medicine St. Louis
David Suskind, MD, Seattle Children’s

Project Manager:

Lauren Manning

For more information, please contact:
Clinical Professor, Department of Pediatrics, Division of Pediatric Gastroenterology
Interim Director, Susan B. Meister Child Health Evaluation and Research Center
1500 E. Medical Center Drive
MPB D5200, Box SPC5718
Ann Arbor, MI 48109-5718