Time to Disease Progression and All-Cause Mortality in Adult MASH Patients in Real-World US Cohort.

Challenge

Drug developers and payers needed real-world data on disease progression timelines and mortality risk across MASH severity strata—without cirrhosis, with compensated cirrhosis, and with decompensated cirrhosis—to model the value of intervention and design adequately powered outcome trials.

Solution

The TARGET-NASH cohort was used to conduct time-to-event analyses of MASH progression to compensated cirrhosis, first decompensation event, and all-cause mortality across the three disease subgroups, generating cumulative incidence estimates and hazard ratios for each transition.

Impact

Providing real-world progression rate and mortality benchmarks across MASH severity strata enables sponsors to build evidence-based natural history assumptions into economic models, power outcome trials appropriately, and demonstrate the value of disease-modifying therapy to payers and regulators.