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Lookup NU author(s): Professor Quentin AnsteeORCiD
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).
© The Author(s) 2024.Metabolic dysfunction-associated steatohepatitis (MASH) is a major cause of liver-related morbidity and mortality, yet treatment options are limited. Manual scoring of liver biopsies, currently the gold standard for clinical trial enrollment and endpoint assessment, suffers from high reader variability. This study represents the most comprehensive multisite analytical and clinical validation of an artificial intelligence (AI)-based pathology system, AI-based measurement of metabolic dysfunction-associated steatohepatitis (AIM-MASH), to assist pathologists in MASH trial histology scoring. AIM-MASH demonstrated high repeatability and reproducibility compared to manual scoring. AIM-MASH-assisted reads by expert MASH pathologists were superior to unassisted reads in accurately assessing inflammation, ballooning, MAS ≥ 4 with ≥1 in each score category and MASH resolution, while maintaining non-inferiority in steatosis and fibrosis assessment. These findings suggest that AIM-MASH could mitigate reader variability, providing a more reliable assessment of therapeutics in MASH clinical trials.
Author(s): Pulaski H, Harrison SA, Mehta SS, Sanyal AJ, Vitali MC, Manigat LC, Hou H, Madasu Christudoss SP, Hoffman SM, Stanford-Moore A, Egger R, Glickman J, Resnick M, Patel N, Taylor CE, Myers RP, Chung C, Patterson SD, Sejling A-S, Minnich A, Baxi V, Subramaniam GM, Anstee QM, Loomba R, Ratziu V, Montalto MC, Anderson NP, Beck AH, Wack KE
Publication type: Article
Publication status: Published
Journal: Nature Medicine
Year: 2024
Volume: 31
Pages: 315-322
Online publication date: 04/11/2024
Acceptance date: 16/09/2024
Date deposited: 19/11/2024
ISSN (print): 1078-8956
ISSN (electronic): 1546-170X
Publisher: Nature Research
URL: https://doi.org/10.1038/s41591-024-03301-2
DOI: 10.1038/s41591-024-03301-2
Data Access Statement: The histopathology data collected for this study are maintained by PathAI to preserve patient confidentiality and the proprietary image analysis. Access to histopathology features will be granted to academic investigators without relevant conflicts of interest for noncommercial use who agree to not distribute the data. Access requests can be made to A.H.B. (andy.beck@pathai.com). Any additional information required to reanalyze the data reported in this paper relating directly to the clinical datasets (REGENERATE, FALCON 1, FALCON 2 and semaglutide datasets) will be considered at the discretion of the source institute for the clinical trial in question. Requests will be considered from academic investigators without relevant conflicts of interest for noncommercial use who agree to not distribute the data. Data requests should be sent to A.H.B. (andy.beck@pathai.com). PathAI will respond to these requests within 1 month of receipt.
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