ASSESSING THE FEASIBILITY OF A GERMAN ELECTRONIC HEPATOLOGY NETWORK DATABASE AS A REAL-WORLD DATA SOURCE FOR STEATOTIC LIVER DISEASE RESEARCH
Author(s)
Karolin Weber, PhD1, Milica Matijevic, PhD1, Tobias Heidler, Staatsexamen Pharmazie1, Mohammed Dagher, MPH2, Dennis Häckl, Jun.-Prof. Dr.3, Michael Schultze, Dr. med. vet.2, Marc Pignot, PhD2, Ingolf Schiefke, Prof. Dr. med.4.
1WIG2 GmbH – Scientific Institute for Health Economics and Health System Research, Leipzig, Germany, 2ZEG Berlin, Berlin, Germany, 3Leipzig University, Leipzig, Germany, 4GREENBAY research GmbH, Leipzig, Germany.
1WIG2 GmbH – Scientific Institute for Health Economics and Health System Research, Leipzig, Germany, 2ZEG Berlin, Berlin, Germany, 3Leipzig University, Leipzig, Germany, 4GREENBAY research GmbH, Leipzig, Germany.
OBJECTIVES: Steatotic liver diseases (SLDs) affect ~20-30% of adults in Germany, mainly as Metabolic Dysfunction-Associated SLD (MASLD), potentially progressing to Metabolic Dysfunction-Associated Steatohepatitis (MASH). Despite their high prevalence, SLDs remain underdiagnosed within the statutory health insurance system, highlighting the need for additional Real-World Data (RWD) sources for comprehensive SLDs’ research. To address this, we evaluated an electronic health record (EHR) from a national network of over 50 general practitioners and specialists.
METHODS: MASLD and MASH patients from EHR were characterized by demographics, comorbidities, and liver-related events (e.g., ascites, varices) in 2019-2025. Key SLD biomarkers, including alpha-1 antitrypsin (A1AT) and fibrosis-4 index (FIB-4), were longitudinally monitored, with FIB-4 enabling stratification of advanced fibrosis risk. Patients underwent liver stiffness measurement by transient elastography (TE) allowing fibrosis stages grading (F0-F4).
RESULTS: Of the EHR patients, 525 had MASH and 1,867 had MASLD, with median age of 59 and 56 years, and even sex distribution (49.5% female). Seventeen out of the eighteen observed liver-related events occurred in MASH patients (3.2% vs. <0.1%). TE coverage was 99.9%, revealing nearly all MASLD patients (99.6%) fell within F0-F1 group, whereas 5.7% of MASH patients had F4 stage. Advanced fibrosis risk was over twofold in MASH (21.1% vs. 9.6%). While A1AT deficiency was comparable between groups (4.4% and 4.0%), the MASH group showed higher rates of elevated bilirubin, gamma-GT and alanine aminotransferase (18.7%, 74.6%, and 68.5% vs. 10.8%, 53.9%, and 51.1%). Thrombocytopenia (platelet count <150x109/L) occurred more than twice in MASH compared to MASLD (21.1% vs. 8.6%), with the greater difference for platelet count <100x109/L (5.9% vs. 1.7%).
CONCLUSIONS: The combination of clinical and laboratory data, namely the high TE coverage and repeated biomarkers’ records makes this EHR database a valuable RWD source for hepatic fibrosis assessment, particularly in patients with MASH and MASLD.
METHODS: MASLD and MASH patients from EHR were characterized by demographics, comorbidities, and liver-related events (e.g., ascites, varices) in 2019-2025. Key SLD biomarkers, including alpha-1 antitrypsin (A1AT) and fibrosis-4 index (FIB-4), were longitudinally monitored, with FIB-4 enabling stratification of advanced fibrosis risk. Patients underwent liver stiffness measurement by transient elastography (TE) allowing fibrosis stages grading (F0-F4).
RESULTS: Of the EHR patients, 525 had MASH and 1,867 had MASLD, with median age of 59 and 56 years, and even sex distribution (49.5% female). Seventeen out of the eighteen observed liver-related events occurred in MASH patients (3.2% vs. <0.1%). TE coverage was 99.9%, revealing nearly all MASLD patients (99.6%) fell within F0-F1 group, whereas 5.7% of MASH patients had F4 stage. Advanced fibrosis risk was over twofold in MASH (21.1% vs. 9.6%). While A1AT deficiency was comparable between groups (4.4% and 4.0%), the MASH group showed higher rates of elevated bilirubin, gamma-GT and alanine aminotransferase (18.7%, 74.6%, and 68.5% vs. 10.8%, 53.9%, and 51.1%). Thrombocytopenia (platelet count <150x109/L) occurred more than twice in MASH compared to MASLD (21.1% vs. 8.6%), with the greater difference for platelet count <100x109/L (5.9% vs. 1.7%).
CONCLUSIONS: The combination of clinical and laboratory data, namely the high TE coverage and repeated biomarkers’ records makes this EHR database a valuable RWD source for hepatic fibrosis assessment, particularly in patients with MASH and MASLD.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
RWD160
Topic
Real World Data & Information Systems, Study Approaches
Topic Subcategory
Health & Insurance Records Systems
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity), Gastrointestinal Disorders