Diabetes and obesity reduce FIB-4 accuracy in MASLD referral pathways

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Background & Aims Primary care referral pathways often use FIB-4 to triage metabolic dysfunction-associated steatotic liver disease (MASLD), but its accuracy may vary by patient characteristics. We aimed to evaluate FIB-4 performance against elastography, compare it with other non-invasive tests, assess effect modification by BMI, diabetes, sex, ALT, and age, and calibrate 2D shear-wave elastography (2D-SWE) and vibration-controlled transient elastography (VCTE) thresholds. Methods We analyzed two cohorts with paired serum scores and elastography: Calgary (2D-SWE; N=8,126) and Edmonton (VCTE; N=985). We summarized fibrosis-risk distributions and used exceedance probabilities to align 2D-SWE with guideline-recommended VCTE cut-offs. Results In the Calgary cohort, median 2D-SWE was 4.6 kPa (IQR 3.9–5.8) and 9% had liver stiffness ≥8 kPa; FIB-4 was <1.30 in 70% and ≥2.67 in 5%. In the Edmonton cohort, median VCTE was 5.3 kPa (4.4–6.6) and 14% had liver stiffness ≥8 kPa; FIB-4 was <1.30 in 77% and ≥2.67 in 3%. In exceedance models, at a FIB-4 of 1.30, the probability of liver stiffness ≥8 kPa was significantly higher in individuals with diabetes or BMI ≥30 kg/m 2 than in those without these risk factors. Regression analyses showed that BMI and diabetes materially increased the probability of liver stiffness ≥8 kPa at a given FIB-4, whereas sex, elevated ALT, and age had smaller effects. Using the recommended 2D-SWE thresholds of 9, 13, 17 kPa, we observed an expected stepwise correspondence with VCTE 15, 20, 25 kPa, supporting harmonised elastography cut-offs across modalities. Conclusion FIB-4 alone under-triages patients with diabetes and/or obesity. These patients should be fast-tracked to elastography even when FIB-4 is <1.30. We recommend validating these findings in other cohorts, as they may affect triaging practices. Impact and implications Recent guidelines recommend clinical care pathways for risk stratification of patients with MASLD (metabolic dysfunction-associated steatotic liver disease) using sensitive serum-based markers ( e.g . fibrosis 4 index [FIB-4]) as a first step, with a cut-off of <1.30 to rule out advanced fibrosis. In patients with diabetes or obesity, the interpretation of a FIB-4 threshold of <1.30 is different than in patients without these conditions. This finding suggests the need to refine referral pathways in which FIB-4 is used as a first test. New referral models incorporating patient characteristics could improve risk stratification of patients with MASLD who need specialized liver care.

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