Supplementary Material for: Disease progression for histologic diagnosis of metabolic dysfunction-associated steatotic liver disease in the real-world - a nationwide U.S. study

Introduction:
We compared clinical characteristics and outcomes in real-world metabolic dysfunction-associated steatotic liver disease (MASLD) patients with or without liver biopsy using a nationwide cohort in United States (US) to fill in gaps in selection of biopsy patients.

Methods:
We conducted a retrospective cohort study of adult MASLD patients using Marketscan® Databases (1/2007-12/2021). Patients were categorized into those with or without liver biopsy during follow-up.

Results:
We analyzed 540,326 MASLD patients: 23,732 with and 516,594 without biopsy. Only 4% of MASLD patients received liver biopsy and biopsy rate decreased in the last 5 years (9.4% to 3.6%). After 1:5 propensity score matching on baseline characteristics including age, sex, and comorbidities, a total of 23,731 patients with biopsy and 118,396 matched patients without biopsy were analyzed. The incidence per 1,000 person-years for hepatocellular carcinoma (HCC) were 0.22 vs. 2.18, cirrhosis 29.75 vs. 90.44 and hepatic decompensation 15.84 vs. 28.25 compared patients with and without biopsy. In multivariable analysis, patients with biopsy had more than 9 times higher risk of developing HCC, 3 times higher risk of cirrhosis, and 78% higher risk of hepatic decompensation. In subgroup analysis, the association remained consistent when stratified by age (<50 and ≥50), sex, and diabetes mellitus. Predictors of having biopsy included age, metabolic disease, and living in North central or Northeast of US.

Conclusion:

These data can inform clinical patient management that biopsy patients likely represent a selected group at higher risk for disease progression, especially in clinical trials for MASLD therapies.