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Cited by 128Liver Diseases and ImmunityLiver Disease Diagnosis and TreatmentPediatric Hepatobiliary Diseases and Treatments

The DOI matches its Crossref record; 39 of the 40 references it cites were found in a registry or an index.

Liver stiffness measurement by vibration-controlled transient elastography improves outcome prediction in primary biliary cholangitis

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Corpechot, Christophe, Carrat, Fabrice, Gaouar, Farid, Chau, Frederic, Hirschfield, Gideon, Gulamhusein, Aliya, Montano-Loza, Aldo J., Lytvyak, Ellina, Schramm, Christoph, Pares, Albert, Olivas, Ignasi, Eaton, John E., Osman, Karim T., Dalekos, George, Gatselis, Nikolaos, Nevens, Frederik, Cazzagon, Nora, Zago, Alessandra, Russo, Francesco Paolo, Abbas, Nadir, Trivedi, Palak, Thorburn, Douglas, Saffioti, Francesca, Barkai, Laszlo, Roccarina, Davide, Calvaruso, Vicenza, Fichera, Anna, Delamarre, Adèle, Medina-Morales, Esli, Bonder, Alan, Patwardhan, Vilas, Rigamonti, Cristina, Carbone, Marco, Invernizzi, Pietro, Cristoferi, Laura, van der Meer, Adriaan, de Veer, Rozanne, Zigmond, Ehud, Yehezkel, Eyal, Kremer, Andreas E., Deibel, Ansgar, Dumortier, Jérôme, Bruns, Tony, Große, Karsten, Pageaux, Georges-Philippe, Wetten, Aaron, Dyson, Jessica, Jones, David, Chazouillères, Olivier, Hansen, Bettina, de Lédinghen, Victor·2022·Journal of Hepatology
DOI 10.1016/j.jhep.2022.06.017
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Abstract

Background & aims Liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) has been shown to predict outcomes of patients with primary biliary cholangitis (PBC) in small-size studies. We aimed to validate the prognostic value of LSM in a large cohort study. Methods We performed an international, multicentre, retrospective follow-up study of 3,985 patients with PBC seen at 23 centres in 12 countries. Eligibility criteria included at least 1 reliable LSM by VCTE and a follow-up ≥ 1 year. Independent derivation (n = 2,740) and validation (n = 568) cohorts were built. The primary endpoint was time to poor clinical outcomes defined as liver-related complications, liver transplantation, or death. Hazard ratios (HRs) with CIs were determined using a time-dependent multivariable Cox regression analysis. Results LSM was independently associated with poor clinical outcomes in the derivation (5,324 LSMs, mean follow-up 5.0 ± 3.1 years) and validation (1,470 LSMs, mean follow-up 5.0 ± 2.8 years) cohorts: adjusted HRs (95% CI) per additional kPa were 1.040 (1.026-1.054) and 1.042 (1.029-1.056), respectively (p <0.0001 for both). Adjusted C-statistics (95% CI) at baseline were 0.83 (0.79-0.87) and 0.92 (0.89-0.95), respectively. Between 5 and 30 kPa, the log-HR increased as a monotonic function of LSM. The predictive value of LSM was stable in time. LSM improved the prognostic ability of biochemical response criteria, fibrosis scores, and prognostic scores. The 8 kPa and 15 kPa cut-offs optimally separated low-, medium-, and high-risk groups. Forty percent of patients were at medium to high risk according to LSM. Conclusions LSM by VCTE is a major, independent, validated predictor of PBC outcome. Its value as a surrogate endpoint for clinical benefit in PBC should be considered. Lay summary Primary biliary cholangitis (PBC) is a chronic autoimmune disease, wherein the body's immune system mistakenly attacks the bile ducts. PBC progresses gradually, so surrogate markers (markers that predict clinically relevant outcomes like the need for a transplant or death long before the event occurs) are often needed to expedite the drug development and approval process. Herein, we show that liver stiffness measurement is a strong predictor of clinical outcomes and could be a useful surrogate endpoint in PBC trials.

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  1. Rigamonti, 2019, Liver stiffness dynamics predict survival in patients with primary biliary cholangitis treated with ursodeoxycholic acid, Hepatology, 70, 803A

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Metadata

Authors
Corpechot, C., Carrat, F., Gaouar, F., Chau, F., Hirschfield, G., Gulamhusein, A., Montano-Loza, A. J., Lytvyak, E., Schramm, C., Pares, A., Olivas, I., Eaton, J. E., Osman, K. T., Dalekos, G., Gatselis, N., Nevens, F., Cazzagon, N., Zago, A., Russo, F. P., Abbas, N., Trivedi, P., Thorburn, D., Saffioti, F., Barkai, L., Roccarina, D., Calvaruso, V., Fichera, A., Delamarre, A., Medina-Morales, E., Bonder, A., Patwardhan, V., Rigamonti, C., Carbone, M., Invernizzi, P., Cristoferi, L., van der Meer, A., de Veer, R., Zigmond, E., Yehezkel, E., Kremer, A. E., Deibel, A., Dumortier, J., Bruns, T., Große, K., Pageaux, G.-P., Wetten, A., Dyson, J., Jones, D., Chazouillères, O., Hansen, B., & de Lédinghen, V.
Affiliations
  • Inserm (FR)
  • Sorbonne Université (FR)
  • University Health Network (CA)
  • University of Alberta (CA)
  • Universität Hamburg (DE)
  • Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (ES)
  • Mayo Clinic (US)
  • University Hospital of Larissa (GR)
  • Universitair Ziekenhuis Leuven (BE)
  • University of Padua (IT)
  • University Hospitals Birmingham NHS Foundation Trust (GB)
  • The Royal Free Hospital (GB)
  • University of Palermo (IT)
  • Centre Hospitalier Universitaire de Bordeaux (FR)
  • Beth Israel Deaconess Medical Center (US)
  • Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT)
  • University of Milano-Bicocca (IT)
  • Erasmus MC (NL)
  • Tel Aviv Sourasky Medical Center (IL)
  • University Hospital Zurich (CH)
  • Hospices Civils de Lyon (FR)
  • Universitätsklinikum Aachen (DE)
  • Centre Hospitalier Universitaire de Montpellier (FR)
  • Newcastle upon Tyne Hospital (GB)
Corresponding author
Corpechot, Christophe
ORCID
Venue
Journal of Hepatology
Publisher
Elsevier BV
Published
2022-12
Volume
77
Issue
6
Pages
1545-1553
ISSN
0168-8278 (ISSN-L)
DOI
10.1016/j.jhep.2022.06.017
OpenAlex
W4283645165
Cited by
128
References
40
Citations by year
2026: 30 · 2025: 40 · 2024: 27 · 2023: 25 · 2022: 6
FWCI
14.61
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Hepatology (acceptedVersion)
  • PubMed (publishedVersion)
  • EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, cc-by-nc-nd)
  • Lirias (KU Leuven) (submittedVersion, other-oa)
  • EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, cc-by-nc-nd)
  • HAL (submittedVersion, other-oa)
  • BOA (University of Milano-Bicocca) (submittedVersion)
  • UCL Discovery (University College London) (submittedVersion)
  • Nova Science Publishers (Nova Science Publishers, Inc.) (submittedVersion)
  • RWTH Publications (RWTH Aachen) (submittedVersion)
  • Padua Research Archive (University of Padova) (submittedVersion)
  • Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
  • Newcastle University ePrints (Newcastle Univesity)
Funders
  • Falk Foundation
  • GlaxoSmithKline
  • Inventiva Pharma
  • National Institute for Health and Care Research (NIHR200243, NF-SI-0513-10091)
  • Swedish Orphan Biovitrum
  • Grifols
  • Medical Research Council (MR/L001489/1)
Topics
  • Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
  • Health Sciences › Medicine › Hepatology › Liver Disease Diagnosis and Treatment
  • Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
Keywords
primary biliary cirrhosis, liver stiffness measurement, vibration-controlled transient elastography, prognosis, liver complications, liver transplantation, mortality, liver fibrosis, surrogate endpoints, risk stratification, cut-off values, prognostic validation, fibrosis score, autoimmune liver disease, time-dependent Cox regression, concordance index
MeSH terms
Follow-Up Studies, Humans, Liver, Liver Cirrhosis, Liver Cirrhosis, Biliary, Prognosis, Retrospective Studies, Vibration, Cohort Studies, Elasticity Imaging Techniques

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