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Performance of Noninvasive Tests of Fibrosis Among Asians, Hispanic, and non-Hispanic Whites in the STELLAR Trials

Lookup NU author(s): Professor Quentin AnsteeORCiD

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This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).


Abstract

© 2022 AGA Institute. Background & Aims: The effect of race on routinely available noninvasive tests of fibrosis is incompletely understood. This study evaluated the performance of noninvasive tests among white and Asian patients in the STELLAR trials (NCT03053050 and NCT03053063), which evaluated selonsertib in patients with advanced (F3-F4) fibrosis due to nonalcoholic steatohepatitis (NASH). Methods: Baseline liver biopsies were centrally read using the NASH Clinical Research Network system, and 4 noninvasive tests (Nonalcoholic fatty liver disease fibrosis score [NFS], Fibrosis-4 index [FIB-4], Enhanced Liver Fibrosis test [ELF], and liver stiffness by vibration-controlled transient elastography) were measured. The performance of these tests to discriminate advanced fibrosis was evaluated using areas under the receiver operating characteristics curves with 5-fold cross-validation repeated 100 times. Results: Among 3207 patients screened with evaluable liver histology, 2281 were whites and 762 were Asians. Seventy-two percent of whites and 67% of Asians had advanced fibrosis. The areas under the receiver operating characteristics curves of the noninvasive tests for advanced fibrosis were similar in whites and Asians: 0.73 and 0.75 for NFS, 0.78 and 0.80 for FIB-4, 0.79 and 0.81 for ELF, and 0.80 and 0.83 for liver stiffness, respectively. At the published cutoffs, the tests had similar sensitivities and specificities in the 2 groups. However, the sensitivities of NFS, FIB-4, and ELF were low in both white and Asian patients younger than 40 years. Conclusions: In the global phase III STELLAR trials, the diagnostic performance of routinely available noninvasive tests for the detection of advanced fibrosis due to NASH was acceptable and similar between white and Asian patients.


Publication metadata

Author(s): Wong VW-S, Tak WY, Goh GBB, Cheng P-N, Lawitz EJ, Younossi ZM, Vuppalanchi R, Younes Z, Alkhouri N, Wang L, Liu J, Kersey K, Myers RP, Harrison SA, Goodman Z, Trauner M, Romero-Gomez M, Anstee QM, Nguyen MH, Okanoue T

Publication type: Article

Publication status: Published

Journal: Clinical Gastroenterology and Hepatology

Year: 2022

Pages: Epub ahead of print

Online publication date: 22/01/2022

Acceptance date: 02/04/2018

Date deposited: 21/04/2022

ISSN (print): 1542-3565

ISSN (electronic): 1542-7714

Publisher: Elsevier Inc.

URL: https://doi.org/10.1016/j.cgh.2022.01.015

DOI: 10.1016/j.cgh.2022.01.015

PubMed id: 35074532


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Funding

Funder referenceFunder name
Gilead Sciences, Inc

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