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Abstract Details
A composite biomarker using multiparametric magnetic resonance imaging and blood analytes accurately identifies patients with non-alcoholic steatohepatitis and significant fibrosis
Andrea Dennis1, Sofia Mouchti2, Matt Kelly2, Jonathan A Fallowfield3, Gideon Hirschfield4, Michael Pavlides5, Rajarshi Banerjee2
Author information
1Perspectum, Gemini One, 5520 John Smith Drive, Oxford, OX4 2LL, UK. andrea.dennis@perspectum.com.
2Perspectum, Gemini One, 5520 John Smith Drive, Oxford, OX4 2LL, UK.
3Centre for Inflammation Research, University of Edinburgh, Edinburgh, UK.
4Toronto Centre for Liver Disease, University Health Network, Toronto, Canada.
5Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
Abstract
Non-alcoholic steatohepatitis (NASH) is major health burden lacking effective pharmacological therapies. Clinical trials enrol patients with histologically-defined NAFLD (non-alcoholic fatty liver disease) activity score (NAS) ≥ 4 and Kleiner-Brunt fibrosis stage (F) ≥ 2; however, screen failure rates are often high following biopsy. This study evaluated a non-invasive MRI biomarker, iron-corrected T1 mapping (cT1), as a diagnostic pre-screening biomarker for NASH. In a retrospective analysis of 86 biopsy confirmed NAFLD patients we explored the potential of blood and imaging biomarkers, both in isolation and in combination, to discriminate those who have NAS ≥ 4 and F ≥ 2 from those without. Stepwise logistic regression was performed to select the optimal combination of biomarkers, diagnostic accuracy was determined using area under the receiver operator curve and model validated confirmed with and fivefold cross-validation. Results showed that levels of cT1, AST, GGT and fasting glucose were all good predictors of NAS ≥ 4 and F ≥ 2, and the model identified the combination of cT1-AST-fasting glucose (cTAG) as far superior to any individual biomarker (AUC 0.90 [0.84-0.97]). This highlights the potential utility of the composite cTAG score for screening patients prior to biopsy to identify those suitable for NASH clinical trial enrolment.