Introduction
Liver fibrosis stands out as the main prognostic risk factor in MASLD. The enhanced liver fibrosis (ELF) score is a composite of direct fibrosis biomarkers that reflect extracellular matrix turnover. While the ELF test exhibits high diagnostic accuracy for advanced liver fibrosis in MASLD patients, its role as a prognostic biomarker remains uncertain.
Aims & Methods
Our aim is to compare the prognostic effectiveness of ELF, liver stiffness measurement (LSM), FIB4, and liver histology in patients with MASLD.
We retrospectively enrolled patients with MASLD who underwent liver biopsy between 2013 and 2023. The ELF score was automatically using a serum sample collected at baseline. FIB4 computation, LSM with Fibroscan and liver biopsy were performed at baseline. Liver fibrosis stage was assessed according to the NASH CRN Scoring System. The primary outcome was a composite endpoint including all-cause mortality, hepatocellular carcinoma, liver transplantation or complications related to cirrhosis (ascites, variceal bleeding, hepatic encephalopathy, MELD≥15). Subjects were stratified based on existing literature cut-offs for ELF (<9.8, 9.8-11.2, >11.2), LSM (<10, 10-15, >15 kPa), FIB-4 (<1.3, 1.3-2.67, >2.67), and histology (F≤2, F3, F4) to assess the risk of occurrence of the primary outcome.
Results
We included data of 289 patients (30.4% female, median age 50y [IQR 39-58]). Over a median follow-up time of 41 months (IQR 21-68), the composite endpoint occurred in 34 (11.8%) patients. The frequency of the primary outcome exhibited a stepwise increase with ELF scores <9.8 (0.5%), 9.8 to 11.2 (14.5%) and >11.2 (69.7%). Survival curves for comparisons between groups revealed significant differences for all index tests based on pre-defined histological and non-invasive test stratification (Log Rank test p <0.05). At multivariate Cox regression analysis, ELF and liver histology were significant predictors of the primary outcome after adjusting for gender, diabetes, age and BMI. (ELF > 11.2 vs < 9.8 HR 132.7 [95%CI 15.6-1127.4 p<0.01], 9.8-11.2 vs <9.8 HR 22.5 [95%CI 2.8-184.3 p=0.04]) (F4 vs F≤2 HR 92.0 [95%CI 20.1-421.9 p<0.01], F3 vs F≤2 HR 10.2 [95%CI 2.3-45.5 p=0.05]). Furthermore, the intermediate and high risk group defined by LSM had a significantly higher risk of developing the composite outcome compared to the low-risk group (LSM 10-15kPa vs <10kPa HR 5.51 [95%CI 1.25 – 24.18 p=0.02], LSM >15kPa vs <15 kPa HR 22.89 [95%CI 6.17 – 84.94 p<0.01]). Intermediate risk group according to FIB4 displayed no significant higher risk of composite outcome compared to low-risk group (HR 2.87 [95%CI 0.53 – 15.55 p=0.22]).
Conclusion
The ELF test demonstrated comparable performance to histologically evaluated fibrosis in forecasting clinical outcomes. It should be regarded as a viable alternative to liver biopsy for conducting prognostic assessments in patients with MASLD.
