Analytical and Clinical Validation of AIM-NASH: A Digital Pathology Tool for Artificial Intelligence-based Measurement of Nonalcoholic Steatohepatitis Histology
Year: 2024
Type: preprint
Abstract: 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 multi-site analytical and clinical validation of an AI-based pathology system, Artificial Intelligence-based Measurement of Nonalcoholic Steatohepatitis (AIM-NASH), to assist pathologists in MASH trial histology scoring. AIM-NASH demonstrated high repeatability and reproducibility compared to manual scoring. AIM-NASH-assisted reads by expert MASH pathologists were superior to unassisted reads in accurately assessing inflammation, ballooning, NAS >= 4 with >=1 in each score category, and MASH resolution, while maintaining non-inferiority in steatosis and fibrosis assessment. These findings suggest AIM-NASH could mitigate reader variability, providing a more reliable assessment of therapeutics in MASH clinical trials.
Source: medRxiv
Authors: Hanna Pulaski, Stephen A. Harrison, Shraddha S. Mehta, Arun J Sanyal, Marlena C. Vitali, Laryssa C. Manigat, Hypatia Hou, Susan P. Madasu Christudoss, Sara M. Hoffman, Adam Stanford-Moore, Robert Egger, Jonathan Glickman, Murray Resnick, Neel Patel, Cristin E. Taylor, Robert P. Myers, Chuhan Chung, Scott D. Patterson, Anne-Sophie Sejling, Anne Minnich, Vipul Baxi, G. Mani Subramaniam, Quentin M. Anstee, Rohit Loomba, Vlad Ratziu, Michael C Montalto, Andrew H Beck, Katy Wack
Institutions: PathAI (United States), Pinnacle Clinical Research, AbbVie (United States), Virginia Commonwealth University, Invicro (United Kingdom), Invicro (United States), Harvard University, Massachusetts General Hospital, Brown University, Rhode Island Hospital, Gilead Sciences (United States), Novo Nordisk (Denmark), Bristol-Myers Squibb (United States), Newcastle University, University of California San Diego, Inserm, Sorbonne Université, Centre de Recherche des Cordeliers, Fondation pour l’innovation en Cadiométabolisme et Nutrition, Amgen (United States)
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, GlaxoSmithKline, Gilead Sciences, Regeneron Pharmaceuticals, European Federation of Pharmaceutical Industries and Associations, Arrowhead Pharmaceuticals, NGM Biopharmaceuticals, Newcastle University, Novo Nordisk, Genentech
OpenAlex ID: W4399190134