Biologics Sequencing in Clinical Units (BISCUITS): UK IBD Registry Agile Research

Author(s)

Bartalucci G1, Taylor F2, Gleave C3, Dobson L2, Bodger K4, Dodd S4, Bloom S2, Passey A5, Nissinen R6, Wirth D7, Duva A8, Lee J9, Cummings JRF2
1Southampton General Hospital, West Wellow, HAM, UK, 2The IBD Registry, London, Greater London, UK, 3The IBD Registry, Bournemouth, UK, 4University of Liverpool, Liverpool, Merseyside, UK, 5Janssen-Cilag UK, High Wycombe, Buckinghamshire, UK, 6Janssen-Cilag Oy, Espoo, Uusimaa, Finland, 7Janssen-Cilag GmbH, Neuss, North Rhine-Westphalia, Germany, 8Janssen-Cilag Farmacêutica LTDA, São Paulo, São Paulo, Brazil, 9Janssen-Cilag A/S, Birkerod, Rudersdal, Denmark

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.

Conference/Value in Health Info

2023-11, ISPOR Europe 2023, Copenhagen, Denmark

Value in Health, Volume 26, Issue 11, S2 (December 2023)

Code

SA19

Topic

Study Approaches

Topic Subcategory

Electronic Medical & Health Records, Registries

Disease

Biologics & Biosimilars, Gastrointestinal Disorders

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