Original Article
Question: How reliable are various biomarkers for fibrosis in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) staging?
Design/Method: Data for this study were collected from the LITMUS meta cohort of the prospective European NAFLD Registry. The LITMUS collected clinical data from individuals with suspected NAFLD between 2010 and 2017. Comorbidities like dyslipidemia, hypertension, and diabetes were recorded. Liver biopsy samples were assessed for NAFLD activity and fibrosis. 17 biomarkers were assessed for detecting fibrosis or NASH (non-alcoholic steatohepatitis), with clinically significant fibrosis and advanced fibrosis as target conditions
Setting: European
Patients/Study community: Patients with NAFLD
Results: None of the single markers or multimarker scores achieved the predefined acceptable area under the receiver operating characteristic curve (AUC) for replacing biopsy in detecting people with both NASH and clinically significant fibrosis. Nevertheless, several biomarkers could be applied in a prescreening strategy in clinical trial recruitment
Commentary: The study evaluates non-invasive markers for NASH and fibrosis detection in NAFLD. Single biomarkers don’t meet the criteria, but multimarker scores like SomaSignal and ADAPT can identify advanced fibrosis. The fact that no biomarkers are approved by FDA or EMA underscores the need for continued research and validation in the field of NAFLD. The LITMUS consortium is advancing understanding of NAFLD and NASH by collecting data and analyzing blood-based and imaging biomarkers in the Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS) study cohort, aiming to improve clinical care and outcomes for NAFLD patients
Citation: Vali Y, Lee J, Boursier J, Petta S, Wonders K. Biomarkers for staging fibrosis and non-alcoholic steatohepatitis in non-alcoholic fatty liver disease (the LITMUS project): a comparative diagnostic accuracy study. Lancet Gastroenterology and Hepatology. 2023; 8: 714–25
DOI: 10.1016/S2468-1253(23)00017-1
https://www.thelancet.com/journals/langas/article/PIIS2468-1253(23)00017-1/fulltext
Topics: Non-Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
