Identification of novel molecular drivers, prognostic and diagnostic biomarkers for Inflammatory Bowel Disease (IBD): protocol for the Nottingham/AstraZeneca prospective IBD observational cohort study
Serna-Valverde, Ana Lilia Rodriguez-Suarez, Eva Marks, Daniel J B Gehrmann, Ulf Neisen, Jessica Clarke, Sarah Chew, Thean Soon Cummings, Fraser De Silva, Shanika Gordon, John Nicholas
Serna-Valverde, Ana Lilia
Rodriguez-Suarez, Eva
Marks, Daniel J B
Gehrmann, Ulf
Neisen, Jessica
Clarke, Sarah
Chew, Thean Soon
Cummings, Fraser
De Silva, Shanika
Gordon, John Nicholas
Affiliation
University of Nottingham School of Medicine; AstraZeneca UK Limited; Sheffield Teaching Hospitals NHS Foundation Trust; The Dudley Group NHS Foundation Trust et al
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Publication date
2025-11-23
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Abstract
INTRODUCTION: Crohn's disease (CD) and ulcerative colitis (UC) are chronic, inflammatory bowel diseases (IBDs) of unknown origin, affecting the gastrointestinal tract and often causing extraintestinal symptoms. Conventional treatments (eg, glucocorticosteroids, immunomodulators) and targeted advanced treatments, including anti-TNFα, antibodies to p40 subunit of IL-12/23, antibodies to p19 subunit of IL-23, anti-α4β7 integrin, Janus kinase inhibitors (JAKis) and sphingosine-1-phosphate receptor (S1PR) modulators, do not achieve sustained responses for all patients, leaving significant unmet therapeutic needs.
METHODS AND ANALYSIS: This prospective, multi-centre observational study will follow a cohort of 240 patients across multiple study centres within NHS trusts in the UK who are initiating or switching biologics, specifically anti-TNFα and anti-α4β7 integrin for UC, and anti-TNFα, antibodies to p40 subunit of IL-12/2 and JAKi for CD. Through comprehensive profiling of immunological, transcriptional, microbiome, genetic and proteomic markers at baseline, week 12, and week 52, this study aims to uncover non-invasive biomarkers that predict response to these drug classes, ultimately advancing personalised medicine in IBD.
ETHICS AND DISSEMINATION: Ethical approval for the Nottingham/AstraZeneca study was granted by the West of Scotland Research Ethics Committee. Recruitment began in December 2022 and is currently ongoing at 10 NHS Trust sites across the UK. Study findings will be disseminated by publication in peer-reviewed journals and presentations at relevant national and international conferences.
Citation
Serna-Valverde AL, Rodriguez-Suarez E, Marks DJB, Gehrmann U, Neisen J, Clarke S, Chew TS, Cummings F, De Silva S, Gordon JN, Knight P, Limdi J, Patel K, Crooks B, Sebastian S, Polytarchou C, Hannan NRF, Moran GW. Identification of novel molecular drivers, prognostic and diagnostic biomarkers for Inflammatory Bowel Disease (IBD): protocol for the Nottingham/AstraZeneca prospective IBD observational cohort study. BMJ Open. 2025 Nov 23;15(11):e105790. doi: 10.1136/bmjopen-2025-105790
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Article