High Concordance Between Nonalcoholic Fatty Liver Disease and Metabolic Dysfunction-Associated Steatotic Liver Disease in the TARGET-NASH Real-World Cohort
Authors: Andrea R. MospanHeather L. Morris
View publication →Challenge
The 2023 global nomenclature shift from NAFLD/NASH to MASLD/MASH created immediate uncertainty for sponsors and investigators about whether patients enrolled under prior criteria could be re-classified, potentially invalidating years of longitudinal follow-up data.
Solution
The TARGET-NASH cohort was interrogated to assess the degree of overlap between NAFLD and MASLD case definitions across a large, multi-site US population, providing the first real-world concordance estimate at population scale.
Impact
Demonstrating very high concordance between NAFLD and MASLD classifications validates the continued use of the TARGET-NASH longitudinal dataset under the new nomenclature, directly protecting the investment in existing RWE infrastructure and supporting uninterrupted evidence generation for drug development.
Use Cases / Links
Nomenclature transition risk assessment for longitudinal RWE cohorts, Regulatory-grade evidence for MASLD/NAFLD dataset continuity, Cohort harmonization support for sponsors with pre-2023 trial or registry data