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  3. Challenges In Histological Endpoints For Mash Therapies: An Exercise In Statistical Modelling.
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  3. Challenges In Histological Endpoints For Mash Therapies: An Exercise In Statistical Modelling.

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Challenges in Histological Endpoints for MASH Therapies: An Exercise in Statistical Modelling.

Amrik Shah1, Leigh MacConell2, Alexander Liberman2

  • 1Karma Statistics LLC, Skillman, New Jersey, USA.

Alimentary Pharmacology & Therapeutics
|February 13, 2025

View abstract on PubMed

Summary
This summary is machine-generated.

Histologic scoring imprecision in metabolic-dysfunction associated steatohepatitis (MASH) trials dilutes true effect sizes by approximately 50%, impacting clinical benefit assessment and supporting non-invasive biomarkers.

Keywords:
MASHNASHhistologymetabolic dysfunction associated steatohepatitismodellingnonalcoholic steatohepatitissimulation

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Area of Science:

  • Hepatology
  • Clinical Trial Methodology
  • Biostatistics

Background:

  • Current nonalcoholic steatohepatitis (NASH) trial endpoints rely on liver biopsy histology, which has significant inter-/intra-reader variability.
  • This variability complicates the interpretation of trial results, as few studies have demonstrated positive outcomes using these endpoints.

Purpose of the Study:

  • To statistically evaluate the impact of imprecise histologic scoring on the results of NASH/MASH clinical trials.
  • To quantify the dilution of true effect size caused by scoring variability.

Main Methods:

  • Simulated kappa values based on the relationship between agreement measures and scoring sensitivity.
  • Utilized published kappa values from NASH trials to determine histology parameter sensitivities.
  • Conducted simulations with varying over/under-scoring probabilities to estimate effect size dilution.

    • Main Results:

    • Simulations indicated approximately 50% dilution of the true effect size for both fibrosis improvement and MASH resolution endpoints in 2-arm trials.
    • This dilution effect was observed to be constant regardless of the trial's sample size.

    Conclusions:

    • Imprecise histologic scoring disproportionately affects the 'superior' arm in clinical trials.
    • The observed dilution necessitates consideration in the risk-benefit assessment of MASH studies.
    • These findings advocate for the adoption of non-invasive biomarkers over traditional histologic endpoints.