Prospective validation of the EASL-EASD algorithm for risk stratification in patients with metabolic dysfunction-associated steatotic liver disease and type 2 diabetes

Abstract

Background and aim: Individuals with type2 diabetes are at increased risk of severe metabolic dysfunction-associated steatotic liver disease(MASLD). The European Association for the Study of Diabetes(EASD) recently proposed a two-step algorithm for risk stratification and referral, developed in collaboration with the European Association for the Study of the Liver(EASL), but its real-world performance remains unassessed.

Methods: In prospective study, adult patients with type2 diabetes attending our Diabetology clinic were consecutively assessed using FIB-4 index. Those with FIB-4≥1.3 underwent further evaluation in collaboration with Hepatology, including transient elastography(TE), abdominal ultrasound, ELF score, exclusion of other liver diseases, and liver biopsy when indicated. Patients with known liver disease or type 1 diabetes were excluded. At-risk individuals were defined as those with TE≥8kPa or FIB-4>2.67. Advanced liver disease was defined as fibrosis stage ≥F3 on biopsy, TE>12kPa, or ultrasound evidence of cirrhosis. A contemporary population-based cohort of over 12000 individuals served as a reference for MASLD severity.

Results: Between Q4 2024 and Q1 2025, 1108 patients were screened; 984 remained eligible. Of these, 736(74.8%) had FIB-4<1.3 and 248(25.2%;95% CI:22.5-27.9) had elevated FIB-4(1.3-2.67 in 182;>2.67 in 66). Among the latter, 53(21.4%;95% CI: 16.7-26.9) had previously undiagnosed advanced MASLD, with prevalence exceeding that in the reference population. An additional 15patients(6%) had other significant liver diseases: autoimmune hepatitis, primary biliary cholangitis, viral hepatitis...Overall, the algorithm identified advanced liver disease of any aetiology in 27.4%.

Conclusions: About one in five patients with FIB-4≥1.3 had advanced MASLD. The EASL-EASD algorithm supports early detection and referral.