Evidence map›Paper›PMID 37679433›Full record

ArticleNature medicine2023

Diagnostic performance of circulating biomarkers for non-alcoholic steatohepatitis.

Arun J Sanyal, Sudha S Shankar, Katherine P Yates, James Bolognese, Erika Daly, Clayton A Dehn, Brent Neuschwander-Tetri, Kris Kowdley, Raj Vuppalanchi, Cynthia Behling and 9 more

Open access · hybridAbstract read
In one paragraph

Article in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 3 pooled it
21.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 3 syntheses or guidelines pooled it, 103 citations in OpenAlex.

  1. Pooled it
  2. Clinical Outcomes and Non-Invasive Testing in Metabolic Dysfunction-Associated Steatohepatitis With Cirrhosis: A Systematic Review.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Pooled it
  3. Guideline
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Liver Biopsy in Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials: Potential Pitfalls and Solutions.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. Review

7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 11 institutions in 1 country.

Arun J SanyalVirginia Commonwealth University School of Medicine, Richmond, VA, USA. arun.sanyal@vcuhealth.org.ORCID http://orcid.org/0000-0001-8682-5748
Sudha S ShankarPfizer, Inc., Sacramento, CA, USA.
Katherine P YatesBloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
James BologneseCytel, Inc., Waltham, MA, USA.
Erika DalyCytel, Inc., Waltham, MA, USA.
Clayton A DehnP Value Communications, LLC, Cedar Knolls, NJ, USA.
Brent Neuschwander-TetriSaint Louis University, St. Louis, MO, USA.ORCID http://orcid.org/0000-0002-8520-7398
Kris KowdleyLiver Institute Northwest, Seattle, WA, USA.
Raj VuppalanchiIndiana University School of Medicine, Indianapolis, IN, USA.ORCID http://orcid.org/0000-0003-0637-1577
Cynthia BehlingDepartment of Pathology, University of California San Diego School of Medicine, San Diego, CA, USA.
James TonasciaBloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
Anthony SamirCenter for Ultrasound Research & Translation, Department of Radiology, Massachusetts General Hospital,Harvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0002-7801-8724
Claude SirlinDeptartment of Radiology, University of California San Diego School of Medicine, San Diego, CA, USA.ORCID http://orcid.org/0000-0002-6639-9072
Sarah P SherlockPfizer, Inc., Boston, MA, USA.
Kathryn FowlerDeptartment of Radiology, University of California San Diego School of Medicine, San Diego, CA, USA.
Helen HeymannUS Food and Drug Administration, Silver Springs, MD, USA.
Tania N KamphausUS Food and Drug Administration, Silver Springs, MD, USA.
Rohit Loomba *NAFLD Research Center, Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla, CA, USA.ORCID http://orcid.org/0000-0002-4845-9991
Roberto A Calle *Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.ORCID http://orcid.org/0000-0001-6577-5657
University of California San Diego · USCytel (United States) · USJohns Hopkins University · USPfizer (United States) · USUnited States Food and Drug Administration · USHarvard University · USIndiana University School of MedicineLiver Institute Northwest · USRegeneron (United States) · USSaint Louis University · USVirginia Commonwealth University · US

Funding

Continuation of the Non-Alcoholic Steatohepatitis Clinical Research Network (NASHU01DK061730 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI TONASCIA, JAMES A · 2002 to 2018
$23.2M
Research Supplement to Promote Diversity in Health Related ResearchUL1TR002649 · NCATS · VIRGINIA COMMONWEALTH UNIVERSITY · PI MOELLER, FREDERICK GERARD · 2018 to 2022
$19.1M
Non Alcoholic Steatohepatitis Clinical Research NetworkU01DK061732 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI Srinivasan Dasarathy · 2002 to 2026
$12.2M
VEDS Year2-Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Data Coordinating CenterU24DK061730 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI JEANNE M CLARK, David M Shade · 2019 to 2026
$11.3M
Nonalcoholic Steatohepatittis Clinical Research Network (NASH CRN)U01DK061731 · NIDDK · VIRGINIA COMMONWEALTH UNIVERSITY · PI ARUN J SANYAL · 2002 to 2026
$11.2M
NCATS NIH HHS UL1 TR002649NIDDK NIH HHS U01 DK061730NIDDK NIH HHS U01 DK061731NIDDK NIH HHS U01 DK061732NIDDK NIH HHS U24 DK061730
6 · The paper itself

Abstract

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.

Indexed as

Non-alcoholic Fatty Liver DiseaseBiomarkersBiopsyFibrosisHumansLiverLiver CirrhosisBiomarkers

Identifiers

PMID37679433
PMCPMC10579051
OpenAlexW4386498686

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.