OBJECTIVES: Motivated by the growing number of pharmacological treatments for Crohn’s disease (CD), the BISCUITS study is the first to use real world data from a cohort of the 40,000 CD patient records held on the UK IBD Registry (IBDR) to explore drug sequencing following treatment failure with tumour necrosis factor inhibitors (TNFi). Using locally feasible IT solutions integrated into routine workflows, we developed an agile research framework to generate high quality, validated data for BISCUITS as an exemplar for research delivery at pace and scale with academic and industry partners.

METHODS: This is a retrospective cohort analysis of CD patients stratified by primary non-response (PNR) and loss of response (LoR) to initial TNFi treatment. Study initialisation was accelerated by the IBDR information governance framework and ethical approval for the registry as a research database. A rapid feasibility study conducted in 2022 quantified a potential study cohort of 2,678 CD patients on a TNFi who switched to a second biologic after August 2015 (when alternative biologics to TNFis were approved for CD). Primary outcomes are time to treatment failure after within-class (WCS) or out-of-class switch (OCS) using Kaplan-Meier analysis and adjusted Cox proportional hazards methods in a cohort of approximately 400 patients. Secondary outcomes include corticosteroid-free drug survival and IBD-related surgery.

RESULTS: Pilot data from one site has verified technical feasibility. Interim analysis of the first 59 patients (unadjusted for confounding) shows differences in rates of drug persistence at one year of 89% and 48%, and steroid- and surgery-free drug survival of 66% and 38%, between the OCS and WCS groups respectively.

CONCLUSIONS: This study demonstrates the potential of the IBDR infrastructure (i.e. submission of standardised data under generic permissions, e-Consent, and use of legacy data for site identification) as a robust study platform, facilitating delivery of efficient multicentre research.