Non-alcoholic Steatohepatitis Disease Progression in Participants from the United States TARGET-NASH Real World Longitudinal Observational Study
Authors: Derek GazisAndrea R. MospanHeather L. MorrisMichael W. Fried, MD, FAASLD
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.
Use Cases / Links
NASH/MASH natural history benchmarking for economic modeling and trial design, Disease progression and mortality rate quantification for drug development planning, Real-world comparator arm data for MASH outcome trials