Fibromax and Inflamatory Markers Cannot Replace Liver Biopsy in the Evaluation of Non-Alcoholic Fatty Liver Disease

BACKGROUND: To evaluate the performance of a non-invasive test (FibromaxTM, Ferring Pharmaceutical, Saint-Prex, Switzerland) and inflamatory markers (IL-1 beta, IL-6, IL-8, TNF-alpha, MCP-1) in the diagnosis and staging of patients with non-alcoholic fatty liver disease. METHODS: Patients older than 18 years with steatosis were prospectively evaluated at a tertiary hospital in southern Brazil. Liver biopsy, FibromaxTM test and inflamatory markers (IL-1 beta, IL-6, IL-8, TNF-alpha, MCP-1) were performed. Measures of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were used, considering liver biopsy as the gold standard. RESULTS: Seventy-three FibromaxTM tests were analyzed. SteatoTest presented a sensitivity of 95.5% and PPV of 97.0% for the diagnosis of steatosis. NashTest obtained a sensitivity of 83.3%, specificity of 37.5%, PPV of 90.9% and NPV of 23.1% for the diagnosis of non-alcoholic steatohepatitis (NASH). FibroTest presented a sensitivity of 38.9%, specificity of 92.7%, PPV of 63.6% and NPV of 82.3% to evaluate advanced fibrosis. In the evaluation of patients with grade 2 and 3 steatosis, ROC analyses showed an area under the curve (AUROC) for SteatoTest of 0.68 (P=0.015). NashTest AUROC was 0.59 (P=0.417) for the evaluation of NASH. FibroTest AUROC was 0.79 (P<0.001) for advanced fibrosis. Kappa coefficient values for SteatoTest, NashTest and FibroTest were not statistically significant. Thirty-seven patients performed also analysis of the inflamatory markers, showing that patients with inflammatory activity grade 2-3 on liver biopsy had significantly higher levels of IL6 (P=0.016) and lower TNF-alpha (P=0.034), but there was no other difference when analysed fibrosis or steatosis. CONCLUSIONS: The FibromaxTM test and the inflamatory markers (IL-1 beta, IL-6, IL-8, TNF-alpha, MCP-1) did not present a satisfactory performance to be considered a good alternative to replace liver biopsy in the evaluation of non-alcoholic fatty liver disease.