Phenotyping disease progression in Metabolic Dysfunction-Associated Steatohepatitis (MASH): Insights from medical claims data and clinical trial representation

Author(s): Magda Berberova*, Petar Nikolov, Deepa Kumar, Liuqiang Lu

Background and aims: This study evaluated the U.S. MASH population using medical records to characterize disease features, identify fast-progressing phenotypes, and compare them with late-phase clinical trial cohorts.

Methods: A retrospective cohort analysis of anonymized U.S. medical and prescription records (Oct 2018–Sep 2020) identified newly diagnosed MASH patients, defined by no prior MASH or cirrhosis records within two years. Progression was assessed by cirrhosis-related conditions recorded within three years post-diagnosis, classifying patients as fast progressors or others. Descriptive statistics, significance testing (p<0.05), and progression analyses were performed. Population characteristics were compared with late-phase clinical trial cohorts.

Results: Among 38,823 newly diagnosed MASH cases, 5,993 (15%) met the fast progressors definition. Over half were female, with significantly higher female representation and older age in fast progressors (61.3 ± 13.1 vs. 53.7 ± 14.2). Comorbidities were more frequent in this group: Type 2 diabetes (40% vs. 28%), dyslipidemia (40% vs. 37%), anemia (16% vs. 9%), coronary artery disease (12% vs. 7%), and heart failure (5% vs. 1%). Clinical trial cohorts showed similar gender and age profiles, higher metabolic comorbidities, and lower cardiovascular comorbidities. Obesity, age, and female gender were identified as independent risk factors for progression.

Conclusion: Approximately 15% of MASH patients exhibit rapid progression with distinct clinical features, aligning well with clinical trial representation and comparability.

PDF