Contribution of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography to Outcome Prediction in Primary Biliary Cholangitis - Inserm - Institut national de la santé et de la recherche médicale Accéder directement au contenu
Article Dans Une Revue Journal of Hepatology Année : 2022

Contribution of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography to Outcome Prediction in Primary Biliary Cholangitis

1 CRSA - Centre de Recherche Saint-Antoine
2 CHU Saint-Antoine [AP-HP]
3 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
4 University of Toronto
5 University of Alberta
6 UKE - Universitaetsklinikum Hamburg-Eppendorf = University Medical Center Hamburg-Eppendorf [Hamburg]
7 IDIBAPS - Institut d'Investigacions Biomèdiques August Pi i Sunyer
8 CIBERehd - Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas
9 University of Barcelona
10 Mayo Clinic [Rochester]
11 University Hospital of Larissa
12 University Hospitals Leuven [Leuven]
13 AOUP - Azienda Ospedale Università di Padova = Hospital-University of Padua
14 University of Birmingham [Birmingham]
15 Royal Free Hospital [London, UK]
16 Università degli studi di Palermo - University of Palermo
17 CHU Bordeaux
18 BIDMC - Beth Israel Deaconess Medical Center [Boston]
19 Università del Piemonte Orientale - Dipartimento DISIT Italy
20 UNIMIB - Università degli Studi di Milano-Bicocca = University of Milano-Bicocca
21 Erasmus MC - Erasmus University Medical Center [Rotterdam]
22 Tel Aviv Sourasky Medical Center [Te Aviv]
23 University hospital of Zurich [Zurich]
24 Service d'Hépatologie et de Gastroentérologie [Lyon]
25 UKA - Universitätsklinikum RWTH Aachen - University Hospital Aachen [Aachen, Germany]
26 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
27 Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB)
28 Newcastle University [Newcastle]
Ellina Lytvyak
George Dalekos
Nikolaos Gatselis
Nadir Abbas
Francesca Saffioti
Davide Roccarina
Adèle Delamarre
  • Fonction : Auteur
Andreas Kremer
Ansgar Deibel
Aaron Wetten
Jessica Dyson

Résumé

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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Dates et versions

hal-03786463 , version 1 (23-09-2022)

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Christophe Corpechot, Fabrice Carrat, Farid Gaouar, Frédéric Chau, Gideon Hirschfield, et al.. Contribution of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography to Outcome Prediction in Primary Biliary Cholangitis. Journal of Hepatology, 2022, 77 (6), pp.1545-1553. ⟨10.1016/j.jhep.2022.06.017⟩. ⟨hal-03786463⟩
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