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

BACKGROUND & AIMS: The effect of race on routinely available noninvasive tests of fibrosis is incompletely under stood. This study evaluated the performance of noninvasive tests among white and Asian pa tients in the STELLAR trials (NCT03053050 and NCT03053063), which evaluated selonsertib in pa...

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Autores: Wong Wai Sun, Vincent, Tak, Won Young, Goh, George Boon Bee, Cheng, Pin Nan, Lawitz, Eric J., Younossi, Zobair M., Romero Gómez, Manuel, Okanoue, Takeshi
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/137968
Acceso en línea:https://hdl.handle.net/11441/137968
https://doi.org/10.1016/j.cgh.2022.01.015
Access Level:acceso abierto
Palabra clave:Noninvasive Tests of Fibrosis
STELLAR trials
White patiens
Asian patiens
White non-Hispanic patients
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spelling Performance of Noninvasive Tests of Fibrosis Among Asians, Hispanic, and non-Hispanic Whites in the STELLAR TrialsWong Wai Sun, VincentTak, Won YoungGoh, George Boon BeeCheng, Pin NanLawitz, Eric J.Younossi, Zobair M.Romero Gómez, ManuelOkanoue, TakeshiNoninvasive Tests of FibrosisSTELLAR trialsWhite patiensAsian patiensWhite non-Hispanic patientsBACKGROUND & AIMS: The effect of race on routinely available noninvasive tests of fibrosis is incompletely under stood. This study evaluated the performance of noninvasive tests among white and Asian pa tients 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.ELSEVIER SCIENCE INCMedicina2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/137968https://doi.org/10.1016/j.cgh.2022.01.015reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésCLINICAL GASTROENTEROLOGY AND HEPATOLOGY, 1-13e6.https://www.sciencedirect.com/science/article/pii/S1542356522000696?via%3Dihubinfo:eu-repo/semantics/openAccessoai:idus.us.es:11441/1379682026-06-17T12:51:07Z
dc.title.none.fl_str_mv Performance of Noninvasive Tests of Fibrosis Among Asians, Hispanic, and non-Hispanic Whites in the STELLAR Trials
title Performance of Noninvasive Tests of Fibrosis Among Asians, Hispanic, and non-Hispanic Whites in the STELLAR Trials
spellingShingle Performance of Noninvasive Tests of Fibrosis Among Asians, Hispanic, and non-Hispanic Whites in the STELLAR Trials
Wong Wai Sun, Vincent
Noninvasive Tests of Fibrosis
STELLAR trials
White patiens
Asian patiens
White non-Hispanic patients
title_short Performance of Noninvasive Tests of Fibrosis Among Asians, Hispanic, and non-Hispanic Whites in the STELLAR Trials
title_full Performance of Noninvasive Tests of Fibrosis Among Asians, Hispanic, and non-Hispanic Whites in the STELLAR Trials
title_fullStr Performance of Noninvasive Tests of Fibrosis Among Asians, Hispanic, and non-Hispanic Whites in the STELLAR Trials
title_full_unstemmed Performance of Noninvasive Tests of Fibrosis Among Asians, Hispanic, and non-Hispanic Whites in the STELLAR Trials
title_sort Performance of Noninvasive Tests of Fibrosis Among Asians, Hispanic, and non-Hispanic Whites in the STELLAR Trials
dc.creator.none.fl_str_mv Wong Wai Sun, Vincent
Tak, Won Young
Goh, George Boon Bee
Cheng, Pin Nan
Lawitz, Eric J.
Younossi, Zobair M.
Romero Gómez, Manuel
Okanoue, Takeshi
author Wong Wai Sun, Vincent
author_facet Wong Wai Sun, Vincent
Tak, Won Young
Goh, George Boon Bee
Cheng, Pin Nan
Lawitz, Eric J.
Younossi, Zobair M.
Romero Gómez, Manuel
Okanoue, Takeshi
author_role author
author2 Tak, Won Young
Goh, George Boon Bee
Cheng, Pin Nan
Lawitz, Eric J.
Younossi, Zobair M.
Romero Gómez, Manuel
Okanoue, Takeshi
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
dc.subject.none.fl_str_mv Noninvasive Tests of Fibrosis
STELLAR trials
White patiens
Asian patiens
White non-Hispanic patients
topic Noninvasive Tests of Fibrosis
STELLAR trials
White patiens
Asian patiens
White non-Hispanic patients
description BACKGROUND & AIMS: The effect of race on routinely available noninvasive tests of fibrosis is incompletely under stood. This study evaluated the performance of noninvasive tests among white and Asian pa tients 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.
publishDate 2022
dc.date.none.fl_str_mv 2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/137968
https://doi.org/10.1016/j.cgh.2022.01.015
url https://hdl.handle.net/11441/137968
https://doi.org/10.1016/j.cgh.2022.01.015
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, 1-13e6.
https://www.sciencedirect.com/science/article/pii/S1542356522000696?via%3Dihub
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv ELSEVIER SCIENCE INC
publisher.none.fl_str_mv ELSEVIER SCIENCE INC
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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