1Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong. Electronic address: email@example.com.
2School of Medicine Kyungpook National University, Kyungpook National University Hospital, Daegu, Republic of Korea.
3Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore.
4Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.
5Texas Liver Institute, University of Texas Health San Antonio, San Antonio, Texas.
6Inova Fairfax Hospital, Falls Church, Virginia.
7Indiana University Medical Center, Indianapolis, Indiana.
8Gastro One, Germantown, Tennessee.
9Arizona Liver Health, Chandler, Arizona.
10Gilead Sciences, Inc, Foster City, California.
11Pinnacle Clinical Research, San Antonio, Texas.
12Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
13Hospital Universitario Virgen del Rocio, Sevilla, Spain.
14Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle-upon-Tyne, UK; Newcastle NIHR Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
15Division of Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto, California.
16Saiseikai Suita Hospital, Suita City, Osaka, Japan.
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.