Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
Can Non-Invasive Test Dynamics Serve as Surrogate Endpoints for Histological Improvement in MASH? A Systematic Review and Bayesian Meta-Analysis.
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Costa Passos Pedro Robson, Costa Filho Valbert Oliveira, de Faria Moraes Bernardo, Silveira Igor Boechat, Süffert Leonardo Corrêa, Lopes Cançado Guilherme Grossi
Аннотация
BACKGROUND: Trials on metabolic dysfunction-associated steatohepatitis (MASH) use biopsy for efficacy assessment, despite invasiveness and cost. We aimed to assess the trial-level surrogacy and association of changes in non-invasive tests (NITs), namely liver stiffness measurement (LSM), liver fat content (LFC) by magnetic resonance imaging, fibrosis-4 score (FIB-4), and Enhanced Liver Fibrosis (ELF) with histology in MASH.
METHODS: We searched PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov up to February 2026 for MASH randomized controlled trials (RCTs) reporting serial NIT data and histological endpoints (fibrosis improvement without MASH worsening or MASH resolution without fibrosis worsening). NIT trial-level surrogacy of histological improvement was quantified through squared Bayesian posterior correlation of treatment effects.
RESULTS: Thirty-five RCTs and 3 post-hoc analyses were included. At the trial level, treatment effects on all NITs showed probable weak correlations with histological improvement, with the exception of LFC, which displayed probable moderate surrogacy for MASH resolution without fibrosis worsening (R2 = 62%, 95%CrI 10%-95%). In contrast, variations in LSM were near-certainly associated with fibrosis improvement without MASH worsening in F4-excluded studies (OR 2.67, 95%CrI 1.33-5.12 per 30% decrease) and near-certainly associated with MASH resolution without fibrosis worsening (OR 2.46, 1.16-4.66 per 30% decrease). LFC was near-certainly associated with MASH resolution without fibrosis worsening (OR 1.92, 1.14-3.20 per 30% decrease).
CONCLUSION: LFC and LSM dynamics were associated with histological response at the outcome level, but surrogacy was limited and imprecise across biomarkers. This supports a lack of consistent trial-level surrogacy, although context-specific utility remains plausible.
METHODS: We searched PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov up to February 2026 for MASH randomized controlled trials (RCTs) reporting serial NIT data and histological endpoints (fibrosis improvement without MASH worsening or MASH resolution without fibrosis worsening). NIT trial-level surrogacy of histological improvement was quantified through squared Bayesian posterior correlation of treatment effects.
RESULTS: Thirty-five RCTs and 3 post-hoc analyses were included. At the trial level, treatment effects on all NITs showed probable weak correlations with histological improvement, with the exception of LFC, which displayed probable moderate surrogacy for MASH resolution without fibrosis worsening (R2 = 62%, 95%CrI 10%-95%). In contrast, variations in LSM were near-certainly associated with fibrosis improvement without MASH worsening in F4-excluded studies (OR 2.67, 95%CrI 1.33-5.12 per 30% decrease) and near-certainly associated with MASH resolution without fibrosis worsening (OR 2.46, 1.16-4.66 per 30% decrease). LFC was near-certainly associated with MASH resolution without fibrosis worsening (OR 1.92, 1.14-3.20 per 30% decrease).
CONCLUSION: LFC and LSM dynamics were associated with histological response at the outcome level, but surrogacy was limited and imprecise across biomarkers. This supports a lack of consistent trial-level surrogacy, although context-specific utility remains plausible.