A

METHODS FOR DIAGNOSING FIBROTIC NASH

Espacenet Family 87514259

Abstract

The present invention provides methods for diagnosing, staging, or monitoring fibrotic non-alcoholic steatohepatitis (NASH) in a subject. The invention also provides monitoring a subject's compliance to a prescribed treatment for fibrotic NASH, as well as monitoring therapeutic effect of a prescribed treatment for fibrotic NASH. The invention also provides a kit suitable for use in the methods of the present invention.

Inventors 8

  1. Tamás Pongrácz Aachen author as filed: Pongracz, Tamas
  2. Manfred Wuhrer Aachen author as filed: Wuhrer, Manfred
  3. Maarten E. Tushuizen Aachen author as filed: Tushuizen, Maarten
  4. Noortje de Haan Aachen author as filed: de Haan, Noortje
  5. Tamas, Pongracz
  6. Manfred, Wuhrer
  7. Maarten, Tushuizen
  8. Noortje, de Haan

Inventors are linked to an Aachen author when surname and first name match exactly one author.

Applicants

  • ACADEMISCH ZIEKENHUIS LEIDEN (H.O.D.N. LUMC) GBS Leiden

Cited papers 28 in the database

Non-patent literature as cited (66)
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  • - FERNANDEZ-POZA, S. ET AL.: "Tailor-made recombinant prokaryotic lectins for characterisation of glycoproteins.", ANAL CHIM ACTA, vol. 1155, 2021, pages 338352, Retrieved from the Internet <URL:https://doi.org:10.1016/j.aca.2021.338352>
  • - RUHAAK, L. R. ET AL.: "Optimized workflow for preparation of APTS-labeled N-glycans allowing high-throughput analysis of human plasma glycomes using 48-channel multiplexed CGE-LlF.", J PROTEOME RES, vol. 9, 2010, pages 6655 - 6664, Retrieved from the Internet <URL:https://doi.org:10.1021/pr100802f>
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  • - BEDOSSA, P: "Intraobserver and Interobserver Variations in Liver Biopsy Interpretation in Patients with Chronic Hepatitis C", HEPATOLOGY, vol. 20, 1994, pages 15 - 20, Retrieved from the Internet <URL:https://doi.org:10.1002/hep.1840200104>
  • - RUISSEN, M. MMAK, A. LBEUERS, UTUSHUIZEN, M. EHOLLEBOOM, A. G: "Non-alcoholic fatty liver disease: a multidisciplinary approach towards a cardiometabolic liver disease", EUR J ENDOCRINOL, vol. 183, 2020, pages R57 - R73, Retrieved from the Internet <URL:https://doi.org:10.1530/EJE-20-0065>
  • - LOOMBA, RFRIEDMAN, S. LSHULMAN, G. I: "Mechanisms and disease consequences of nonalcoholic fatty liver disease", CELL, vol. 184, 2021, pages 2537 - 2564, Retrieved from the Internet <URL:https://doi.org:10.1016/j.cell.2021.04.015>
  • - YOUNOSSI, Z ET AL.: "Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention", NAT REV GASTROENTEROL HEPATOL, vol. 15, 2018, pages 11 - 20, Retrieved from the Internet <URL:https://doi.org:10.1038/nrgastro.2017.109>
  • - ESTES, C ET AL.: "Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030", J HEPATOL, vol. 69, 2018, pages 896 - 904, Retrieved from the Internet <URL:https://doi.org:10.1016/j.jhep.2018.05.036>
  • - TAYLOR, R. S ET AL.: "Association Between Fibrosis Stage and Outcomes of Patients With Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-Analysis", GASTROENTEROLOGY, vol. 158, 2020, pages 1611 - 1625, Retrieved from the Internet <URL:https://doi.org:10.1053/j.gastro.2020.01.043>
  • - DULAI, P. S ET AL.: "Increased risk of mortality by fibrosis stage in nonalcoholic fatty liver disease: Systematic review and meta-analysis", HEPATOLOGY, vol. 65, 2017, pages 1557 - 1565, Retrieved from the Internet <URL:https://doi.org:10.1002/hep.29085>
  • - BYRNE, C. DTARGHER, G: "EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease: is universal screening appropriate?", DIABETOLOGIA, vol. 59, 2016, pages 1141 - 1144, XP036204635, Retrieved from the Internet <URL:https://doi.org:10.1007/s00125-016-3910-y> DOI: 10.1007/s00125-016-3910-y
  • - GILMORE, I. T ET AL.: "Indications, methods, and outcomes of percutaneous liver biopsy in England and Wales: an audit by the British Society of Gastroenterology and the Royal College of Physicians of London", GUT, vol. 36, 1995, pages 437 - 441, Retrieved from the Internet <URL:https://doi.org:10.1136/gut.36.3.437>
  • - SEEFF, L. B ET AL.: "Complication rate of percutaneous liver biopsies among persons with advanced chronic liver disease in the HALT-C trial", CLIN GASTROENTEROL HEPATOL, vol. 8, 2010, pages 877 - 883, Retrieved from the Internet <URL:https://doi.org:10.1016/j.cgh.2010.03.025>
  • - EDDOWES, P. J ET AL.: "Accuracy of FibroScan Controlled Attenuation Parameter and Liver Stiffness Measurement in Assessing Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease", GASTROENTEROLOGY, vol. 156, 2019, pages 1717 - 1730, Retrieved from the Internet <URL:https://doi.org:10.1053/j.gastro.2019.01.042>
  • - TROELSTRA, M. A ET AL.: "Assessment of Imaging Modalities Against Liver Biopsy in Nonalcoholic Fatty Liver Disease: The Amsterdam NAFLD-NASH Cohort", J MAGN RESON IMAGING, vol. 54, 2021, pages 1937 - 1949, Retrieved from the Internet <URL:https://doi.org:10.1002/jmri.27703>
  • - VAN DIJK, A. MSCHATTENBERG, J. MHOLLEBOOM, A. GTUSHUIZEN, M. E: "Referral care paths for non-alcoholic fatty liver disease-Gearing up for an ever more prevalent and severe liver disease", UNITED EUROPEAN GASTROENTEROL J, vol. 9, 2021, pages 903 - 909, Retrieved from the Internet <URL:https://doi.org:10.1002/ueg2.12150>
  • - BALKHED, WABERG, F. ONASR, PEKSTEDT, MKECHAGIAS, S: "Repeated measurements of non-invasive fibrosis tests to monitor the progression of non-alcoholic fatty liver disease: A long-term follow-up study", LIVER INT, vol. 42, 2022, pages 1545 - 1556, Retrieved from the Internet <URL:https://doi.org:10.1111/liv.15255>
  • - VREEKER, G. C. M ET AL.: "Automated Plasma Glycomics with Linkage-Specific Sialic Acid Esterification and Ultrahigh Resolution MS", ANAL CHEM, vol. 90, 2018, pages 11955 - 11961, XP055661394, Retrieved from the Internet <URL:https://doi.org:10.1021/acs.analchem.8b02391> DOI: 10.1021/acs.analchem.8b02391
  • - DOTZ, V ET AL.: "Plasma protein N-glycan signatures of type 2 diabetes", BIOCHIMICA ET BIOPHYSICA ACTA (BBA) - GENERAL SUBJECTS, vol. 1862, 2018, pages 2613 - 2622, Retrieved from the Internet <URL:https://doi.org:https://doi.org/10.1016/j.bbagen.2018.08.005>
  • - CLERC, F ET AL.: "Human plasma protein N-glycosylation", GLYCOCONJJ, vol. 33, 2016, pages 309 - 343, Retrieved from the Internet <URL:https://doi.org:10.1007/s10719-015-9626-2>
  • - WONG, G. L: "Non-invasive assessments for liver fibrosis: The crystal ball we long for", J GASTROENTEROL HEPATOL, vol. 33, 2018, pages 1009 - 1015
  • - PARK, E. IYILLING, MUNVERZAGT, CGABIUS, H.-JBAENZIGER, J. U: "The asialoglycoprotein receptor clears glycoconjugates terminating with sialic acida2,6GaINAc", PNAS, vol. 102, 2005, pages 17125 - 17129, Retrieved from the Internet <URL:https://doi.org:https://doi.org/10.1073/pnas.050853710>
  • - OSWALD, D. MJONES, M. BCOBB, B. A: "Modulation of hepatocyte sialylation drives spontaneous fatty liver disease and inflammation", GLYCOBIOLOGY, 2019, Retrieved from the Internet <URL:https://doi.org:10.1093/glycob/cwz096>
  • - CUMMINGS, R. DDARVILL, A. GETZLER, M. EHAHN, M. G. ET AL., ESSENTIALS OF GLYCOBIOLOGY, 2015, pages 611 - 625
  • - VERHELST, X ET AL.: "Protein Glycosylation as a Diagnostic and Prognostic Marker of Chronic Inflammatory Gastrointestinal and Liver Diseases", GASTROENTEROLOGY, vol. 158, 2020, pages 95 - 110, XP085946079, Retrieved from the Internet <URL:https://doi.ora:10.1053/i.aastro.2019.08.060> DOI: 10.1053/j.gastro.2019.08.060
  • - HANAMATSU, H ET AL.: "Comparative Glycomic Analysis of Sialyl Linkage Isomers by Sialic Acid Linkage-Specific Alkylamidation in Combination with Stable Isotope Labeling of alpha2,3-Linked Sialic Acid Residues", ANAL CHEM, vol. 91, 2019, pages 13343 - 13348, XP055660961, Retrieved from the Internet <URL:https://doi.org:10.1021/acs.analchem.9b03617> DOI: 10.1021/acs.analchem.9b03617
  • - RAMACHANDRAN, P ET AL.: "Serum Glycoprotein Markers in Nonalcoholic Steatohepatitis and Hepatocellular Carcinoma", J PROTEOME RES, vol. 21, 2022, pages 1083 - 1094, Retrieved from the Internet <URL:https://doi.org:10.1021/acs.jproteome.1c00965>
  • - VANDERSCHAEGHE, D ET AL.: "GlycoFibroTest is a highly performant liver fibrosis biomarker derived from DNA sequencer-based serum protein glycomics", MOL CELL PROTEOMICS, vol. 8, 2009, pages 986 - 994, XP055229576, Retrieved from the Internet <URL:https://doi.org:10.1074/mcp.M800470-MCP200> DOI: 10.1074/mcp.M800470-MCP200
  • - SCOTT, D. A ET AL.: "GlycoFibroTyper: A Novel Method for the Glycan Analysis of IgG and the Development of a Biomarker Signature of Liver Fibrosis", FRONT IMMUNOL, vol. 13, 2020, pages 797460, Retrieved from the Internet <URL:https://doi.org:10.3389/fimmu.2022.797460>
  • - FERNANDEZ-POZA, S ET AL.: "Tailor-made recombinant prokaryotic lectins for characterisation of glycoproteins", ANAL CHIM ACTA, vol. 1155, 2021, pages 338352, Retrieved from the Internet <URL:https://doi.org:10.1016/j.aca.2021.338352>
  • - RUHAAK, L. R ET AL.: "Optimized workflow for preparation of APTS-labeled N-glycans allowing high-throughput analysis of human plasma glycomes using 48-channel multiplexed CGE-LlF", J PROTEOME RES, vol. 9, 2010, pages 6655 - 6664, Retrieved from the Internet <URL:https://doi.org:10.1021/pr100802f>
  • - MITRA, I ET AL.: "Structural Characterization of Serum N-Glycans by Methylamidation, Fluorescent Labeling, and Analysis by Microchip Electrophoresis", ANAL CHEM, vol. 88, 2016, pages 8965 - 8971, Retrieved from the Internet <URL:https://doi.org:10.1021/acs.analchem.6b00882>
  • - HUISMAN TSIPORA M ET AL: "Experimental and Investigational Targeted Therapies for the Management of Fibrosis in NASH: An Update", JOURNAL OF EXPERIMENTAL PHARMACOLOGY, vol. Volume 13, 23 February 2021 (2021-02-23), Auckland, N.Z., pages 329 - 338, XP093109035, ISSN: 1179-1454, Retrieved from the Internet <URL:https://www.dovepress.com/getfile.php?fileID=67776> DOI: 10.2147/JEP.S265286
  • - OGAWA KOJI ET AL: "Tri-antennary tri-sialylated mono-fucosylated glycan of alpha-1 antitrypsin as a non-invasive biomarker for non-alcoholic steatohepatitis: a novel glycobiomarker for non-alcoholic steatohepatitis", SCIENTIFIC REPORTS, vol. 10, no. 1, 15 January 2020 (2020-01-15), XP093105929, Retrieved from the Internet <URL:https://www.nature.com/articles/s41598-019-56947-1> DOI: 10.1038/s41598-019-56947-1

Cited patents 0