Screening for metabolic dysfunction-associated steatotic liver disease related advanced fibrosis in diabetology: a prospective multi-center study.

figure

posted on 2025-01-31, 15:01 authored by Cyrielle Caussy, Bruno Vergès, Damien Leleu, Fabien Subtil, Amna Abichou-Klich, Valérie Hervieu, Laurent Milot, Bérénice Ségrestin, Alexia Rouland, Dominique Delaunay, Pierre Morcel, Samy Hadjadj, Claire Primot, Jean-Michel Petit, Sybil Charrière, Philippe Moulin, Massimo Levrero, Bertrand Cariou, Emmanuel Disse

Objective: Screening for advanced fibrosis (AF) due to metabolic dysfunction-associated steatotic liver disease (MASLD) is recommended in diabetology. This study aimed to compare the performance of non-invasive tests (NITs) and 2-step algorithms for detecting patients with high-risk AF requiring referral to hepatologists.

Research Design and Methods: A planned interim analysis of a prospective multi-center study including participants with type 2 diabetes and/or obesity and MASLD with comprehensive liver assessment including blood-based NITs, vibration-controlled transient elastography (VCTE) and two-dimensional shear-wave elastography (2D-SWE). AF risk stratification was determined by a composite criterion, including liver biopsy, magnetic resonance elastography, or VCTE ≥12 kPa depending on availability.

Results: Among 654 patients (87% with type 2 diabetes, 56% male, 74% with obesity), 17.6% had intermediate/high risk of AF, and 9.3% had high-risk of AF. The AUROCs [95% confidence interval] of NITs for high-risk AF detection were: FIB-4: 0.78 [0.72-0.84], FibroMeter®: 0.74: [0.66-0.83], Fibrotest®: 0.78 [0.72-0.85], ELF™: 0.82 [0.76-0.87], SWE: 0.84 [0.78-0.89]. Algorithms with FIB-4/VCTE showed a good diagnostic performance for referral of intermediate/high-risk AF in specialized care in hepatology. An alternative FIB-4/ELF strategy showed a high NPV (88-89%) and a lower PPV (39-46%) at a threshold of 9.8. The FIB-4/2D-SWE strategy had a NPV of 91% and a PPV of 58-62%. Age-adapted FIB-4 threshold resulted in lower NPV and PPV in all algorithms

Conclusion: The FIB-4/VCTE algorithm showed an excellent diagnostic performance demonstrating its applicability for routine screening in diabetology. ELF using an adapted low threshold at 9.8 may be used as alternative to VCTE.