Comparison of histological and non-invasive assessment of significant fibrosis in a multicenter cohort of MASLD patients

Background: Current guidelines recommend FIB-4 and transient elastography (TE) for non-invasive risk stratification in metabolic dysfunction-associated steatotic liver disease (MASLD). These tests have been established to predict the presence or absence of advanced fibrosis, but their accuracy in assessing histologically significant fibrosis (≥F2) is unclear.

Methods: In a multicenter cohort of 361 biopsy-proven MASLD patients, we evaluated the suitability of FIB-4 in identifying MASLD with significant fibrosis. Additionally, we compared the accuracy of FIB-4 with TE in a sub-cohort of 195 patients and assessed the diagnostic performance of their sequential use.

Results: We demonstrate that their accuracy in identifying MASLD patients with histologically significant fibrosis (≥F2) remains suboptimal resulting in a remarkable proportion of overdiagnoses and a non-negligible underestimation of MASLD with significant fibrosis.

Conclusion: Risk stratification using these tests leads to a misclassification of a considerable number of MASLD patients who would be inappropriately treated with novel MASLD drugs approved for F2/F3 fibrosis.

Publication History

Article published online:
20 January 2025