Fluctuating biomarkers in primary sclerosing cholangitis: A longitudinal comparison of alkaline phosphatase, liver stiffness, and ELF.

ALP, alkaline phosphatase ALT, alanine aminotransferase AST, aspartate aminotransferase Alkaline phosphatase Biomarker CRP, C-reactive protein ELF, enhanced liver fibrosis Elastography Enhanced liver fibrosis test FIB-4, Fibrosis-4 Index for Liver Fibrosis GGT, gamma-glutamyl transferase HA, hyaluronic acid ICC, intraclass correlation INR, international normalised ratio IgG4, immunoglobulin G4 LSM, liver stiffness measurement Liver stiffness PIIINP, propeptide of type III procollagen PSC, primary sclerosing cholangitis Primary sclerosing cholangitis ROI, region of interest Risk stratification TE, transient elastography TIMP-1, tissue inhibitor of metalloproteinases-1 UDCA, ursodeoxycholic acid ULN, upper limit of normal pSWE, point shear wave elastography

Journal

JHEP reports : innovation in hepatology
ISSN: 2589-5559
Titre abrégé: JHEP Rep
Pays: Netherlands
ID NLM: 101761237

Informations de publication

Date de publication:
Oct 2021
Historique:
received: 18 12 2020
revised: 25 05 2021
accepted: 16 06 2021
entrez: 6 9 2021
pubmed: 7 9 2021
medline: 7 9 2021
Statut: epublish

Résumé

Primary sclerosing cholangitis (PSC) is a progressive liver disease characterised by fluctuating liver biochemistries and highly variable disease progression. The Enhanced Liver Fibrosis (ELF®) test and liver stiffness measurements (LSMs) reflect fibrosis and predict clinical outcomes in PSC; however, longitudinal assessments are missing. We aimed to characterise the systematic change in ELF and LSM over time in a prospective cohort of patients with PSC, along with their longitudinal relationship to alkaline phosphatase (ALP) and bilirubin. We included 113 non-transplant PSC patients (86 males [76.1%]; mean age 43.3 ± 15.7 years) with annual study visits between 2013 and 2019 at 2 Norwegian centres. ELF test, LSM, clinical data, liver biochemistries, and revised Mayo risk score were measured. We used linear mixed-effects models to estimate change over time, intraclass correlations (ICCs), and their relationship with ALP and bilirubin. At baseline, the median (range) ELF test was 9.3 (7.5-12.9) and median LSM 1.26 m/s (0.66-3.04 m/s). ELF and LSM increased over time (0.09 point/year, 95% CI [0.03, 0.15], ELF and LSM increased over a 5-year period. Longitudinal analyses demonstrated differences regarding within- and between-patient effects, suggesting that the ELF test may have superior reliability for risk stratification compared with LSM in PSC. Primary sclerosing cholangitis (PSC) is characterised by substantial disease variability between patients and fluctuating liver biochemistries. Hence, new biomarkers are needed to identify individuals with an increased risk of developing end-stage liver disease. We explore the change over time of 2 putative prognostic biomarkers in PSC, the serum Enhanced Liver Fibrosis (ELF®) test and LSMs by ultrasound, demonstrating differences that may reflect differing abilities to discriminate risk.

Sections du résumé

BACKGROUND & AIMS OBJECTIVE
Primary sclerosing cholangitis (PSC) is a progressive liver disease characterised by fluctuating liver biochemistries and highly variable disease progression. The Enhanced Liver Fibrosis (ELF®) test and liver stiffness measurements (LSMs) reflect fibrosis and predict clinical outcomes in PSC; however, longitudinal assessments are missing. We aimed to characterise the systematic change in ELF and LSM over time in a prospective cohort of patients with PSC, along with their longitudinal relationship to alkaline phosphatase (ALP) and bilirubin.
METHODS METHODS
We included 113 non-transplant PSC patients (86 males [76.1%]; mean age 43.3 ± 15.7 years) with annual study visits between 2013 and 2019 at 2 Norwegian centres. ELF test, LSM, clinical data, liver biochemistries, and revised Mayo risk score were measured. We used linear mixed-effects models to estimate change over time, intraclass correlations (ICCs), and their relationship with ALP and bilirubin.
RESULTS RESULTS
At baseline, the median (range) ELF test was 9.3 (7.5-12.9) and median LSM 1.26 m/s (0.66-3.04 m/s). ELF and LSM increased over time (0.09 point/year, 95% CI [0.03, 0.15],
CONCLUSIONS CONCLUSIONS
ELF and LSM increased over a 5-year period. Longitudinal analyses demonstrated differences regarding within- and between-patient effects, suggesting that the ELF test may have superior reliability for risk stratification compared with LSM in PSC.
LAY SUMMARY BACKGROUND
Primary sclerosing cholangitis (PSC) is characterised by substantial disease variability between patients and fluctuating liver biochemistries. Hence, new biomarkers are needed to identify individuals with an increased risk of developing end-stage liver disease. We explore the change over time of 2 putative prognostic biomarkers in PSC, the serum Enhanced Liver Fibrosis (ELF®) test and LSMs by ultrasound, demonstrating differences that may reflect differing abilities to discriminate risk.

Identifiants

pubmed: 34485881
doi: 10.1016/j.jhepr.2021.100328
pii: S2589-5559(21)00104-X
pmc: PMC8403583
doi:

Types de publication

Journal Article

Langues

eng

Pagination

100328

Informations de copyright

© 2021 The Authors.

Déclaration de conflit d'intérêts

W. Rosenberg is one of the inventors and patent holders of the ELF test. Please refer to the accompanying ICMJE disclosure forms for further details.

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Auteurs

Guri Fossdal (G)

Norwegian PSC Research Centre, Department of Transplantation Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Department of Clinical Science, University of Bergen, Bergen, Norway.
Department of Medicine, Haraldsplass Deaconess Hospital, Bergen, Norway.

Anders B Mjelle (AB)

Department of Clinical Medicine, University of Bergen, Bergen, Norway.

Kristine Wiencke (K)

Norwegian PSC Research Centre, Department of Transplantation Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Section of Gastroenterology, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.
Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.

Ida Bjørk (I)

Department of Radiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.

Odd Helge Gilja (OH)

Department of Clinical Medicine, University of Bergen, Bergen, Norway.
National Centre for Ultrasound in Gastroenterology, Department of Medicine, Haukeland University Hospital, Bergen, Norway.

Trine Folseraas (T)

Norwegian PSC Research Centre, Department of Transplantation Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Section of Gastroenterology, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.
Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.

Tom Hemming Karlsen (TH)

Norwegian PSC Research Centre, Department of Transplantation Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Section of Gastroenterology, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway.
Research Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

William Rosenberg (W)

UCL Institute for Liver and Digestive Health, University College London & Royal Free London NHS Foundation Trust, London, UK.

Lasse M Giil (LM)

Department of Medicine, Haraldsplass Deaconess Hospital, Bergen, Norway.

Mette Vesterhus (M)

Norwegian PSC Research Centre, Department of Transplantation Medicine, Division of Surgery, Inflammatory Diseases and Transplantation, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Department of Clinical Science, University of Bergen, Bergen, Norway.
Department of Medicine, Haraldsplass Deaconess Hospital, Bergen, Norway.

Classifications MeSH