Standardized, repeatable ulcerative colitis histology scoring and endpoint assessment using an automated, foundation model-based tool.

Waleed Tahir¹, John Shamshoian¹, John Tauber¹, Lani K Clinton¹, Michael Griffin¹, Chintan Shah¹, Geetika Singh¹, Darren Fahy¹, Kathleen Sucipto¹, Jacqueline A Brosnan-Cashman¹, Tara A Altepeter², Sabyasachi Bhattacharya³, Wallace Crandall⁴, Chong Duan⁵, Jeremy D Gale⁵, Vandana Gupta⁶, Hélène Haarmann⁷, Noam Harpaz⁸, Andrea Hooper⁹, Julie Horowitz⁹, Andres Hurtado-Lorenzo¹⁰, Bader E Hussaini⁶, Vipul Jairath¹¹, Autumn Jones¹², Ben Kostiuk¹⁰, F Stephen Laroux¹³, Trevor Lissoos⁴, Russell B McBride⁸, Fedaa Najdawi¹⁴, Anil Nayyar², Mark T Osterman¹⁵, Pratik Panchal⁶, Darren Ruane¹⁶, Paresh Thakker⁶, Simon P Travis¹⁷, Laura Wilson¹⁸, Christina Jayson¹

¹PathAI Inc, Boston, MA.

²US Food and Drug Administration, Silver Spring, MD.

³AbbVie Bay Area, South San Francisco, CA.

⁴Eli Lilly and Company, Indianapolis, IN.

⁵Pfizer Research Technology Center, Cambridge, MA.

⁶Takeda Pharmaceuticals America Inc, Cambridge, MA, United States.

⁷Takeda Pharmaceuticals International, Opfikon, ZH, Switzerland.

⁸Icahn School of Medicine at Mount Sinai, New York, NY.

⁹Regeneron Pharmaceuticals Inc, Tarrytown, NY.

¹⁰Crohn's and Colitis Foundation, New York, NY.

¹¹Western University Faculty of Health Sciences, London, ON, Canada.

¹²Foundation for the National Institutes of Health, North Bethesda, MD.

¹³AbbVie Bioresearch Center, Worcester, MA.

¹⁴Vanderbilt University Medical Center, Nashville, TN.

¹⁵Bristol Myers Squibb, Princeton, NJ.

¹⁶Janssen Research & Development, Raritan, NJ.

¹⁷University of Oxford Nuffield Department of Medicine, Oxford, England, United Kingdom.

¹⁸Kenneth Rainin Foundation, Oakland, CA.

PubMed PMC DOI PDF

Abstract

In clinical trials for ulcerative colitis (UC), pathologists assess disease severity through standardized histological indices, including the Geboes Score, Robarts Histopathology Index (RHI), and Nancy Histologic Index (NHI). Despite strong associations with clinical outcomes, histologic scoring suffers from inter- and intra-reader variability, and consensus criteria for histologic remission remai…

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