Enhanced Liver Fibrosis Test, FIB ‐4 and FibroScan : Real‐World Prognostic Accuracy for MASLD in a Biopsy‐Controlled Cohort

BACKGROUND AND AIMS: Liver fibrosis is a major determinant of liver-related events (LREs) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Effective stratification based on fibrosis severity is essential for accurate prognosis. The Enhanced Liver Fibrosis (ELF) test, a non-invasive test measuring direct fibrosis markers, offers a potential alternative to traditional methods like FIB-4, liver stiffness measurement (LSM) and liver biopsy. This study aims to evaluate the prognostic value of the ELF test in comparison with these established methods. METHODS: We retrospectively analysed 289 MASLD patients (30.4% female, median age 49 years [IQR 39-58], 28% with type 2 diabetes) from the PROMETEO cohort (NCT04371042). We excluded patients with prior or current evidence of decompensated cirrhosis. At baseline, patients underwent liver biopsy, FIB-4, ELF and LSM assessments. The primary outcome was development of Liver Related Events (LRE), a composite of liver-related death, hepatocellular carcinoma, liver transplantation, ascites, encephalopathy or variceal bleeding. RESULTS: Over a median follow-up of 64 months [IQR 39-81], 41 patients (14.2%) experienced LREs. Event rates increased markedly across ELF categories (1% for ELF < 9.8, 27.8% for ELF ≥ 9.8 to < 11.3 and 72.7% for ELF ≥ 11.3). ELF demonstrated discriminative performance comparable to histological fibrosis stage and LSM, with the highest overall AUC among evaluated tests. In adjusted Cox models, higher ELF categories remained strongly associated with LRE risk, although confidence intervals were wide due to the limited number of events. CONCLUSIONS: In this biopsy-proven MASLD cohort, ELF provided prognostic stratification for liver-related events comparable to liver histology and LSM. Given the limited number of outcome events, these findings support the non-inferiority of ELF rather than definitive superiority. Larger prospective studies are needed to confirm these results and refine risk prediction strategies.