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Multiparametric US for Identifying Patients with High-Risk NASH: A Derivation and Validation Study.

Katsutoshi Sugimoto¹, Dong Ho Lee¹, Jae Young Lee¹

¹From the Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan (K. Sugimoto, H. Takahashi, T.K., Y.T., M.A., Y.Y., H. Takeuchi, T.I.); Departments of Radiology (D.H.L., J.Y.L.) and Internal Medicine, Division of Gastroenterology and Hepatology (S.J.Y.), Seoul National University, Seoul, Korea; Department of Gastroenterology and Hepatology, International University of Health and Welfare, Sanno Hospital, Tokyo, Japan (F.M.); Center for Data Science, Yokohama City University, Kanagawa, Japan (K. Sakamaki); Department of Pathology, Jichi Medical University, Tochigi, Japan (H.O.); Department of Radiology, Chung-Ang University Hospital, Seoul, Korea (B.I.C.).

|September 14, 2021

Summary

A new LAD NASH score combining three ultrasound markers can noninvasively identify patients with high-risk nonalcoholic steatohepatitis (NASH). This score aids in selecting patients for clinical trials and pharmacologic therapy for NASH.

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Area of Science:

Hepatology
Medical Imaging
Biomarkers

Background:

Nonalcoholic fatty liver disease (NAFLD) is prevalent, but identifying high-risk nonalcoholic steatohepatitis (NASH) for targeted therapy is challenging.
High-risk NASH is defined by significant fibrosis (stage F2 or higher) and an NAFLD activity score (NAS) of 4 or greater.

Purpose of the Study:

To develop and validate a noninvasive score for identifying patients with high-risk NASH.
The score aims to facilitate patient selection for clinical trials and pharmacologic interventions.

Main Methods:

Secondary analysis of prospectively collected data from patients with biopsy-proven NAFLD in Japan and Korea.
Utilized two-dimensional shear-wave elastography to measure liver stiffness (LS), attenuation coefficient (AC), and dispersion slope (DS).
Developed a multivariate logistic regression model incorporating US markers, AST, ALT, and AST/ALT ratio to create the LAD NASH score.

Main Results:

The LAD NASH score, combining LS, AC, and DS, demonstrated strong diagnostic performance in both derivation (AUC, 0.86) and validation (AUC, 0.88) datasets.
The score achieved a positive predictive value of 86.5% and a negative predictive value of 87.5% for high-risk NASH in the derivation sample.
The model effectively identified patients with NASH and significant fibrosis.

Conclusions:

A score integrating three ultrasound markers (LAD NASH score) offers a promising noninvasive method for identifying high-risk NASH.
This tool can aid in the efficient selection of candidates for clinical trials and pharmacologic treatments for NASH.
Further validation may support its routine clinical application in NAFLD management.