Applicability of Non‐Invasive Eligibility Criteria for MASH Pharmacotherapy: A Multicentre Cohort Study

ABSTRACT Background and Aims Non‐invasive tests (NITs) are increasingly used to guide patient selection for pharmacological treatment of metabolic dysfunction‐associated steatohepatitis (MASH). We aimed to quantify and compare real‐world treatment eligibility according to the AASLD and expert panel‐derived criteria and to evaluate classification of patients with available liver histology. Methods We retrospectively included 897 adults with MASLD from four Italian referral centres. Eligibility was assessed using AASLD criteria, defined by liver stiffness measurement (LSM) 8–15 kPa without cirrhosis, and expert panel‐derived criteria, defined by LSM 10–19.9 kPa, platelet count ≥ 140 × 10 9 /L, and no cirrhosis. A subgroup of 175 patients underwent liver biopsy within ±3 months of first referral. Results Median age was 62 years, 57.1% were men, 48.4% had obesity, and 36.0% had Type 2 diabetes. Overall, 202 patients (22.5%) met AASLD criteria and 114 (12.7%) met expert panel‐derived criteria. Eighty‐six patients were eligible according to both criteria, whereas 144 were classified differently. Type 2 diabetes and obesity were independently associated with eligibility under both criteria. In the biopsy subgroup, 73 patients had histological F2–F3 fibrosis; 35 (47.9%) did not meet AASLD criteria and 49 (67.1%) did not meet expert panel‐derived criteria. Conclusions The AASLD and expert panel‐derived criteria identified different real‐world populations potentially suitable for MASH pharmacotherapy. In the biopsy subgroup, NIT‐based eligibility classification only partly aligned with histological F2–F3 fibrosis.