Non-alcoholic Steatohepatitis Disease Progression in Participants from the United States TARGET-NASH Real World Longitudinal Observational Study.

Challenge

Real-world natural history data on NASH disease progression rates—from non-cirrhotic NASH through compensated and decompensated cirrhosis—were needed to support economic modeling, trial powering, and health technology assessment for NASH drug development programs.

Solution

The TARGET-NASH longitudinal cohort was analyzed to describe MASH disease progression incidence, mortality rates, and time-to-event estimates across severity subgroups, providing prospective real-world natural history data from a large, multi-site US population.

Impact

Providing prospective disease progression benchmarks from a large US cohort directly supports health economic models used in payer negotiations, informs sample size calculations for outcome trials, and establishes the natural history context required for regulatory submissions.