학술논문
Race Does Not Affect the Performance of Noninvasive Tests for the Discrimination of Advanced Fibrosis due to Non-Alcoholic Steatohepatitis(NASH)
Document Type
Article
Author
Won Young Tak; Vincent Wai-sun Wong; George Boon Bee Goh; Pin-nan Cheng; Eric J. Lawitz; Zobair M. Younossi; Raj Vuppalanchi; Natalie H. Bzowej; Ziad Younes; Naim Alkhouri; Ya Wang; Kathryn Kersey; Georgia Li; Marianne Camargo; Robert P. Myers; Stephen Djedjos; Stephen A. Harrison; Zachary Goodman; Michael H. Trauner; Manuel Romero-gomez; Quentin M. Anstee; Shiv Sarin; Mindie H. Nguyen; Takeshi Okanoue
Source
춘·추계 학술대회(The Liver Week). Aug 13, 2020 2020(1):259
Subject
Language
Korean
Abstract
Background: Routinely available noninvasive tests of fibrosis (NITs) can be used to identify patients with advanced fibrosis due to NASH, but their performance may vary by race. Our aim was to evaluate the effect of patient race on the diagnostic performance of NITs using data from the global phase 3 STELLAR studies of selonsertib. Methods: The STELLAR studies (NCT03053050 and NCT03053063) enrolled patients with bridging fibrosis (F3) or compensated cirrhosis (F4) due to NASH (NAFLD Activity Score [NAS] ≥3). Baseline liver biopsies were centrally read using the NASH Clinical Research Network classification and NITs, including the NAFLD fibrosis score (NFS), Fibrosis-4 (FIB-4) index, Enhanced Liver Fibrosis (ELF) test, and liver stiffness by transient elastography (LS by TE) were measured. The performance of these tests to discriminate advanced (F3-F4) fibrosis by self-reported patient race was evaluated using areas under the receiver operating characteristics curves (AUROCs) with 5-fold cross-validation repeated 100x. Results for White and Asian patients are presented; data for other races (5% of patients screened) are excluded. Results: Among 3202 patients screened for the STELLAR studies with evaluable liver histology, 24% were Asian and 71% were White. The median age was 58 years in both groups; 47% of Asians and 57% of Whites were female (p<0.0001). The prevalence of F3-F4 fibrosis was 67% in Asians and 72% in Whites (p=0.01). AUROCs for each of the NITS for the discrimination of advanced fibrosis were similar between Asian and White patients (Table). In general, literature-based thresholds for the NITs had similar sensitivity and specificity among the specific racial subgroups. Conclusion: In these large, global phase 3 trials, the diagnostic performance of routinely available NITs for the discrimination of advanced fibrosis due to NASH was acceptable and similar between Asian and White patients.