Noninvasive criteria for pharmacotherapy in MASLD (Metabolic dysfunction-associated steatotic liver disease) have been a critical focus due to the limitations of existing diagnostic models. Current noninvasive clinical criteria for determining eligibility for resmetirom therapy in MASLD patients with F2–F3 fibrosis have shown significant inaccuracies and unreliability.
Noninvasive criteria for pharmacotherapy in MASLD (Metabolic dysfunction-associated steatotic liver disease) have been a critical focus due to the limitations of existing diagnostic models. Current noninvasive clinical criteria for determining eligibility for resmetirom therapy in MASLD patients with F2–F3 fibrosis have shown significant inaccuracies and unreliability. Studies reveal that only 39% (Expert Panel) to 56% (AASLD Guidance) of biopsy-confirmed eligible patients meet these criteria, leading to substantial under-diagnosis and under-treatment. Existing guidelines demonstrate low sensitivity and specificity, with false-positive rates ranging from 23–41% and false-negative rates of 44–60%, resulting in poor diagnostic accuracy (AUC <0.60). Consequently, nearly half of the patients requiring treatment are left untreated.
To address these limitations, researchers have developed a new two-step diagnostic strategy. This approach involves the initial selection of patients with FIB-4 ≥1.30 or, for those with FIB-4 <1.30, patients with diabetes and overweight. The second step uses liver stiffness measurement (LSM) via elastography (8–25 kPa) to confirm fibrosis stage and treatment eligibility. This refined model significantly improves diagnostic accuracy, achieving a positive predictive value of 55%, negative predictive value of 77%, and an AUC of 0.67, correctly identifying 74% of the true F2–F3 population.
The two-step strategy integrates metabolic risk factors with fibrosis assessment, offering a more accurate, accessible, and reproducible framework for identifying MASLD patients eligible for pharmacotherapy. This ensures better patient selection, addressing the under-treatment issue and improving real-world clinical outcomes for MASLD management.
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