Effect of pegbelfermin on NASH and fibrosis-related biomarkers and correlation with histological response in the FALCON 1 trial.
JHEP Reports（2023）
摘要
FALCON 1 was a study of pegbelfermin . placebo in patients with non-alcoholic steatohepatitis (NASH) without cirrhosis; in this study, patients who responded to pegbelfermin treatment were identified through examination of liver fibrosis in tissue samples collected through biopsy. In the current analysis, non-invasive blood- and imaging-based measures of fibrosis, liver fat, and liver injury were used to determine pegbelfermin treatment response to see how they compared with the biopsy-based results. We found that many of the non-invasive tests, particularly those that measured liver fat, identified patients who responded to pegbelfermin treatment, consistent with the liver biopsy findings. These results suggest that there may be additional value in using data from non-invasive tests, along with liver biopsy, to evaluate how well patients with NASH respond to treatment.
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关键词
ALT, alanine aminotransferase,APRI, AST-to-platelet ratio index,AST, aspartate aminotransferase,CK-18 M30, caspase-cleaved cytokeratin 18,ELF, enhanced liver fibrosis,FGF21, fibroblast growth factor 21,FIB-4, fibrosis-4 index,MRE, magnetic resonance elastography,MRI-PDFF, MRI-proton density fat fraction,NAFLD, non-alcoholic fatty liver disease,NAS, NAFLD activity score,NASH, non-alcoholic steatohepatitis,P3NP, procollagen-3 N-terminal propeptide,PC3X, crosslinked ADAMTS-2-released N-terminal type III collagen propeptide,PGBF, pegbelfermin,PRO-C3, monomeric ADAMTS-2-released N-terminal type III collagen propeptide,SomaSignal,T2D, type 2 diabetes,TG, triglycerides,TIMP-1, tissue inhibitor of metalloproteinases type 1,fibroblast growth factor 21,liver fibrosis,non-alcoholic steatohepatitis,precirrhotic NASH,steatosis
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