Concordance of MASLD and NAFLD nomenclature in youth participating in the TARGET-NASH real-world cohort

The transition from NAFLD to MASLD nomenclature introduced uncertainty about whether pediatric cohorts enrolled under prior criteria would retain diagnostic continuity, limiting the utility of existing longitudinal data for drug development programs targeting pediatric fatty liver disease.

The TARGET-NASH real-world cohort, which enrolled pediatric patients under NAFLD criteria, was used to prospectively assess concordance between MASLD and NAFLD classifications, providing empirical evidence that prior data assets retain validity under the new nomenclature.

By confirming high concordance between NAFLD and MASLD in youth, this study preserves the value of the TARGET-NASH pediatric dataset for sponsors developing therapies across the MASLD spectrum, reducing the need for costly re-enrollment or new baseline data collection.

Pediatric MASLD cohort continuity and nomenclature transition analysis, Real-world natural history data bridging NAFLD and MASLD eras, Support for regulatory submissions referencing pre-2023 pediatric cohort data