Noninvasive assessment of liver disease severity in patients with nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes

Pennisi G 1 , Enea M 1 , Falco V 2 , Aithal GP 3 , Palaniyappan N 3 , Yilmaz Y 4 Show all authors , Boursier J 5 , Cassinotto C 6 , de Lédinghen V 7 , Chan WK 8 , Mahadeva S 8 , Eddowes P 3 , Newsome P 3 , Karlas T 9 , Wiegand J 9 , Wong VW 10 , Schattenberg JM 11 , Labenz C 11 , Kim W 12 , Lee MS 12 , Lupsor-Platon M 13 , Cobbold JFL 14 , Fan JG 15 , Shen F 15 , Staufer K 16 , Trauner M 16 , Stauber R 17 , Nakajima A 18 , Yoneda M 18 , Bugianesi E 19 , Younes R 19 , Gaia S 19 , Zheng MH 20 , Cammà C 1 , Anstee QM 21 , Mózes FE 22 , Pavlides M 14 , Petta S 1

Affiliations 

  • 1 Sezione di Gastroenterologia, PROMISE, University of Palermo, Italy
  • 2 Department of Economics and Statistics, University of Palermo, Palermo, Italy
  • 3 NIHR Nottingham Biomedical Research Centre (BRC), Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, UK
  • 4 Department of Gastroenterology, School of Medicine, Recep Tayyip Erdogan University, Rize, Turkey
  • 5 Hepato-Gastroenterology Department, Angers University Hospital, Angers, France
  • 6 Department of Diagnostic and Interventional Radiology, Saint-Eloi Hospital, University Hospital of Montpellier, Montpellier, France
  • 7 Hepatology Unit, University Hospital Bordeaux and INSERM U-1053, Bordeaux University, Pessac, France
  • 8 Department of Medicine, Faculty of Medicine, University of Malaya, Malaysia
  • 9 Department of Oncology, Gastroenterology, Hepatology, Pulmonology and Infectious Diseases, University Hospital Leipzig, Leipzig, Germany
  • 10 Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong
  • 11 Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg-University, Mainz, Germany
  • 12 Division of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul Metropolitan Government Boramae Medical Center, Seoul, Korea
  • 13 Department of Medical Imaging, Iuliu Hatieganu, University of Medicine and Pharmacy, Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor", Cluj-Napoca, Romania
  • 14 Translational Gastroenterology Unit, University of Oxford, Oxford, UK
  • 15 Department of Gastroenterology, Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
  • 16 Division of Gastroenterology & Hepatology, Department of Internal Medicine III, Medical University of Vienna, Austria
  • 17 Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz, Austria
  • 18 Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan
  • 19 Division of Gastroenterology and Hepatology, Department of Medical Sciences, University of Turin, Italy
  • 20 Department of Hepatology, MAFLD Research Center, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
  • 21 Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK
  • 22 Radcliffe Department of Medical Sciences, Cardiovascular Medicine, University of Oxford, Oxford, UK
Hepatology, 2023 Jul 01;78(1):195-211.
PMID: 36924031 DOI: 10.1097/HEP.0000000000000351

Abstract

BACKGROUND AND AIMS: We evaluated the diagnostic accuracy of simple, noninvasive tests (NITs) in NAFLD patients with type 2 diabetes (T2D).

METHODS AND RESULTS: This was an individual patient data meta-analysis of 1780 patients with biopsy-proven NAFLD and T2D. The index tests of interest were FIB-4, NAFLD Fibrosis Score (NFS), aspartate aminotransferase-to-platelet ratio index, liver stiffness measurement (LSM) by vibration-controlled transient elastography, and AGILE 3+. The target conditions were advanced fibrosis, NASH, and fibrotic NASH(NASH plus F2-F4 fibrosis). The diagnostic performance of noninvasive tests. individually or in sequential combination, was assessed by area under the receiver operating characteristic curve and by decision curve analysis. Comparison with 2278 NAFLD patients without T2D was also made. In NAFLD with T2D LSM and AGILE 3+ outperformed, both NFS and FIB-4 for advanced fibrosis (area under the receiver operating characteristic curve:LSM 0.82, AGILE 3+ 0.82, NFS 0.72, FIB-4 0.75, aspartate aminotransferase-to-platelet ratio index 0.68; p < 0.001 of LSM-based versus simple serum tests), with an uncertainty area of 12%-20%. The combination of serum-based with LSM-based tests for advanced fibrosis led to a reduction of 40%-60% in necessary LSM tests. Decision curve analysis showed that all scores had a modest net benefit for ruling out advanced fibrosis at the risk threshold of 5%-10% of missing advanced fibrosis. LSM and AGILE 3+ outperformed both NFS and FIB-4 for fibrotic NASH (area under the receiver operating characteristic curve:LSM 0.79, AGILE 3+ 0.77, NFS 0.71, FIB-4 0.71; p < 0.001 of LSM-based versus simple serum tests). All noninvasive scores were suboptimal for diagnosing NASH.

CONCLUSIONS: LSM and AGILE 3+ individually or in low availability settings in sequential combination after FIB-4 or NFS have a similar good diagnostic accuracy for advanced fibrosis and an acceptable diagnostic accuracy for fibrotic NASH in NAFLD patients with T2D.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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