Accuracy of non‐invasive scoring systems for diagnosing non‐alcoholic steatohepatitis‐related fibrosis: Multicenter validation study

Aim Hepatic fibrosis is the most important factor for estimating the prognosis of patients with non‐alcoholic fatty liver disease (NAFLD). A novel non‐invasive scoring system, the FM‐fibro index, showed high accuracy in a pilot study. The purpose of this study was to validate the efficacy of the FM‐fibro index in a multicenter cohort. Methods Among 18 institutions, we analyzed 400 Japanese patients with biopsy‐proven NAFLD. We evaluated the accuracies of the FM‐fibro index, CA‐fibro index, and European Liver Fibrosis (ELF) panel by area under the receiver operator characteristics curves (AUROC). The FM‐fibro index includes three formulas for type IV collagen 7S, hyaluronic acid, and vascular cell adhesion molecule‐1. Results Among 400 patients, 205 were women, and the median age was 56 years. The histological distribution of Matteoni types 1, 2, 3, and 4 was 11, 40, 15, and 334, and the distribution of hepatic fibrosis stages 0 to 4 was 67, 183, 55, 63, and 32, respectively. The AUROCs of the FM‐fibro index, CA‐fibro index, and ELF panel for non‐alcoholic steatohepatitis (NASH)‐related fibrosis were 0.7178/0.7095/0.7065, 0.7093, and 0.7245, respectively. The sensitivity and specificity of the FM‐fibro index for predicting NASH‐related fibrosis was 0.5359/0.5210/0.4641 and 0.8333/0.8182/0.8788, respectively. The accuracy of the FM‐fibro index was not significantly different from that of the CA‐fibro index or the ELF panel. Conclusions The FM‐fibro index can predict NASH‐related fibrosis with sufficient accuracy compared with previous scoring systems. Further analyses that verify the accuracy of the FM‐fibro index to distinguish significant or advanced fibrosis in patients with NAFLD are awaited. (UMIN‐CTR: UMIN000018158).