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Lookup NU author(s): Professor Alastair BurtORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© The Author(s) 2024.Clinical trials in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis) require histologic scoring for assessment of inclusion criteria and endpoints. However, variability in interpretation has impacted clinical trial outcomes. We developed an artificial intelligence-based measurement (AIM) tool for scoring MASH histology (AIM-MASH). AIM-MASH predictions for MASH Clinical Research Network necroinflammation grades and fibrosis stages were reproducible (κ = 1) and aligned with expert pathologist consensus scores (κ = 0.62–0.74). The AIM-MASH versus consensus agreements were comparable to average pathologists for MASH Clinical Research Network scores (82% versus 81%) and fibrosis (97% versus 96%). Continuous scores produced by AIM-MASH for key histological features of MASH correlated with mean pathologist scores and noninvasive biomarkers and strongly predicted progression-free survival in patients with stage 3 (P < 0.0001) and stage 4 (P = 0.03) fibrosis. In a retrospective analysis of the ATLAS trial (NCT03449446), responders receiving study treatment showed a greater continuous change in fibrosis compared with placebo (P = 0.02). Overall, these results suggest that AIM-MASH may assist pathologists in histologic review of MASH clinical trials, reducing inter-rater variability on trial outcomes and offering a more sensitive and reproducible measure of patient responses.
Author(s): Iyer JS, Juyal D, Le Q, Shanis Z, Pokkalla H, Pouryahya M, Pedawi A, Stanford-Moore SA, Biddle-Snead C, Carrasco-Zevallos O, Lin M, Egger R, Hoffman S, Elliott H, Leidal K, Myers RP, Chung C, Billin AN, Watkins TR, Patterson SD, Resnick M, Wack K, Glickman J, Burt AD, Loomba R, Sanyal AJ, Glass B, Montalto MC, Taylor-Weiner A, Wapinski I, Beck AH
Publication type: Article
Publication status: Published
Journal: Nature Medicine
Year: 2024
Pages: epub ahead of print
Online publication date: 07/08/2024
Acceptance date: 03/07/2024
Date deposited: 19/08/2024
ISSN (print): 1078-8956
ISSN (electronic): 1546-170X
Publisher: Nature Research
URL: https://doi.org/10.1038/s41591-024-03172-7
DOI: 10.1038/s41591-024-03172-7
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 not to distribute the data. Access requests can be made to Andrew Beck (andy.beck@pathai.com). Any additional information required to reanalyze the data reported in this paper relating directly to the clinical datasets (STELLAR-3, STELLAR-4, GS-US-321-0105, GS-US 321-0106, GS-US-384-1497, ENHANCE, HBV, PSC, EMMINENCE and ATLAS 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 not to distribute the data. The rest of the data access statement is available in the published paper
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