ArticleJHEP reports : innovation in hepatology2025
Non-invasive tests for fibrotic MASH for reducing screen failure in therapeutic trials.
Article in JHEP reports : innovation in hepatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Incidence of Cirrhosis in Fibrotic Metabolic Dysfunction-Associated Steatohepatitis: A Meta-Analysis of Placebo Arms from Randomized Clinical Trials.Digestive diseases and sciences · 2026Pooled it
- Review
- Noninvasive surrogate endpoints in MASH trials: current perspectives and challenges.Hepatology international · 2026Review
- The Prevalence and Risk Factors for at-Risk MASH and Advanced Liver Fibrosis in People With Metabolic Risk Factors in Primary Care.Alimentary pharmacology & therapeutics · 2026Article
- Hepatology: Emerging Paradigms in MASLD, Viral Hepatitis, Cholestatic Liver Disease, Portal Hypertension and Hepatocellular Carcinoma: Summary of the First Annual Paris International Liver Meeting 2026.Liver international : official journal of the International Association for the Study of the Liver · 2026Review
- Review
- Liver Biopsy in Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials: Potential Pitfalls and Solutions.Liver international : official journal of the International Association for the Study of the Liver · 2026Review
- A precision-constrained framework for evaluating noninvasive biomarkers in MASLD and beyond.Nature communications · 2026Article
- Quantitative MR biomarkers in identifying steatohepatitis and fibrosis associated with metabolic dysfunction associated liver disease-a single center cross-sectional study.Abdominal radiology (New York) · 2026Article
- Discordance Between FIB-4 and BAST Fibrosis Risk Classifications in Obese Patients with MASLD: Results from the OBREDI-TR Study.Diagnostics (Basel, Switzerland) · 2026Article
- Non-Invasive Tests for the Detection of MASLD: Biomarkers and Imaging for Staging Steatosis, MASH, and Fibrosis.International journal of general medicine · 2026Review
- Associations Between Systemic Inflammatory Markers, Metabolic Dysfunction, and Liver Fibrosis Scores in Patients with MASLD.Metabolites · 2025Article
- Predicting Fibrosis Stage in MASH: The Role of Total Metabolic Syndrome Score and MMP-1.Medicina (Kaunas, Lithuania) · 2025Article
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background & Aims: Therapeutic trials in metabolic dysfunction-associated steatohepatitis (MASH) are hampered by a high 70-80% screen failure rate mostly because of the absence of fibrotic MASH on baseline liver biopsies, underscoring the need for better selection of candidates. We compared the performance of eight non-invasive tests, designed or not for the diagnosis of fibrotic MASH. Methods: A total of 1,005 patients with histologically proven MASLD were included in five tertiary care centers. Three non-invasive tests developed for fibrotic MASH were evaluated: the simple blood test Fibrotic NASH Index (FNI), the specialized blood test MACK-3, and the elastography-based test FAST. Five non-invasive tests recommended for advanced fibrosis were evaluated as well: the simple blood test FIB-4, the specialized blood tests FibroTest and Enhanced Liver Fibrosis test (ELF™), and the elastography-based tests FibroScan and Agile3+. Fibrotic MASH was defined as MASH with MASLD activity score ≥4 and fibrosis score F ≥2. Results: Among simple blood tests (n = 1,005), FNI had a significantly higher area under the receiver operating characteristic (AUROC) for fibrotic MASH than FIB-4 (0.709 [0.677-0.741] Conclusions: Sequential combinations using first-line tests designed for fibrotic MASH improves the identification of candidates for MASH therapeutic trials. Impact and implications: Drug development in metabolic dysfunction-associated steatohepatitis (MASH) is hampered by a high screen failure rate, one of the main reasons being the absence of MASH and significant fibrosis (fibrotic MASH) on the baseline liver biopsy, a key inclusion criterion in MASH therapeutic trials. Non-invasive tests represent an attractive opportunity to better select candidates for these trials, but most of them have been developed for advanced fibrosis and the new tests designed for the diagnosis of fibrotic MASH remain poorly validated. In this work, we demonstrate that the tests specifically designed for fibrotic MASH are more accurate for this diagnostic target than the tests currently recommended and initially developed for advanced fibrosis. We propose sequential combinations that will facilitate the identification of patients with fibrotic MASH in need of treatment, and their inclusion in MASH therapeutic trials.
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