دورية
Diagnostic performance of circulating biomarkers for non-alcoholic steatohepatitis
| العنوان: | Diagnostic performance of circulating biomarkers for non-alcoholic steatohepatitis |
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| المؤلفون: | Sanyal, Arun J., Shankar, Sudha S., Yates, Katherine P., Bolognese, James, Daly, Erika, Dehn, Clayton A., Neuschwander-Tetri, Brent, Kowdley, Kris, Vuppalanchi, Raj, Behling, Cynthia, Tonascia, James, Samir, Anthony, Sirlin, Claude, Sherlock, Sarah P., Fowler, Kathryn, Heymann, Helen, Kamphaus, Tania N., Loomba, Rohit, Calle, Roberto A. |
| المصدر: | Nature Medicine; October 2023, Vol. 29 Issue: 10 p2656-2664, 9p |
| مستخلص: | There are no approved diagnostic biomarkers for at-risk non-alcoholic steatohepatitis (NASH), defined by the presence of NASH, high histological activity and fibrosis stage ≥2, which is associated with higher incidence of liver-related events and mortality. FNIH-NIMBLE is a multi-stakeholder project to support regulatory approval of NASH-related biomarkers. The diagnostic performance of five blood-based panels was evaluated in an observational (NASH CRN DB2) cohort (n= 1,073) with full spectrum of non-alcoholic fatty liver disease (NAFLD). The panels were intended to diagnose at-risk NASH (NIS4), presence of NASH (OWLiver) or fibrosis stages >2, >3 or 4 (enhanced liver fibrosis (ELF) test, PROC3 and FibroMeter VCTE). The prespecified performance metric was an area under the receiver operating characteristic curve (AUROC) ≥0.7 and superiority over alanine aminotransferase for disease activity and the FIB-4 test for fibrosis severity. Multiple biomarkers met these metrics. NIS4 had an AUROC of 0.81 (95% confidence interval: 0.78–0.84) for at-risk NASH. The AUROCs of the ELF test, PROC3 and FibroMeterVCTE for clinically significant fibrosis (≥stage 2), advanced fibrosis (≥stage 3) or cirrhosis (stage 4), respectively, were all ≥0.8. ELF and FibroMeter VCTE outperformed FIB-4 for all fibrosis endpoints. These data represent a milestone toward qualification of several biomarker panels for at-risk NASH and also fibrosis severity in individuals with NAFLD. |
| قاعدة البيانات: | Supplemental Index |
| تدمد: | 10788956 1546170X |
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| DOI: | 10.1038/s41591-023-02539-6 |