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

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Liver stiffness measurement by vibration-controlled transient elastography improves outcome prediction in primary biliary cholangitis. / 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; Global & ERN Rare-Liver PBC Study Groups.

in: J HEPATOL, Jahrgang 77, Nr. 6, 12.2022, S. 1545-1553.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Corpechot, C, Carrat, F, Gaouar, F, Chau, F, Hirschfield, G, Gulamhusein, A, Montano-Loza, AJ, Lytvyak, E, Schramm, C, Pares, A, Olivas, I, Eaton, JE, Osman, KT, Dalekos, G, Gatselis, N, Nevens, F, Cazzagon, N, Zago, A, Russo, FP, 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, AE, Deibel, A, Dumortier, J, Bruns, T, Große, K, Pageaux, G-P, Wetten, A, Dyson, J, Jones, D, Chazouillères, O, Hansen, B, de Lédinghen, V & Global & ERN Rare-Liver PBC Study Groups 2022, 'Liver stiffness measurement by vibration-controlled transient elastography improves outcome prediction in primary biliary cholangitis', J HEPATOL, Jg. 77, Nr. 6, S. 1545-1553. https://doi.org/10.1016/j.jhep.2022.06.017

APA

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., ... Global & ERN Rare-Liver PBC Study Groups (2022). Liver stiffness measurement by vibration-controlled transient elastography improves outcome prediction in primary biliary cholangitis. J HEPATOL, 77(6), 1545-1553. https://doi.org/10.1016/j.jhep.2022.06.017

Vancouver

Corpechot C, Carrat F, Gaouar F, Chau F, Hirschfield G, Gulamhusein A et al. Liver stiffness measurement by vibration-controlled transient elastography improves outcome prediction in primary biliary cholangitis. J HEPATOL. 2022 Dez;77(6):1545-1553. https://doi.org/10.1016/j.jhep.2022.06.017

Bibtex

@article{0cc0926ea16b4f5caa36b19e507288ba,
title = "Liver stiffness measurement by vibration-controlled transient elastography improves outcome prediction in primary biliary cholangitis",
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.",
author = "Christophe Corpechot and Fabrice Carrat and Farid Gaouar and Frederic Chau and Gideon Hirschfield and Aliya Gulamhusein and Montano-Loza, {Aldo J} and Ellina Lytvyak and Christoph Schramm and Albert Pares and Ignasi Olivas and Eaton, {John E} and Osman, {Karim T} and George Dalekos and Nikolaos Gatselis and Frederik Nevens and Nora Cazzagon and Alessandra Zago and Russo, {Francesco Paolo} and Nadir Abbas and Palak Trivedi and Douglas Thorburn and Francesca Saffioti and Laszlo Barkai and Davide Roccarina and Vicenza Calvaruso and Anna Fichera and Ad{\`e}le Delamarre and Esli Medina-Morales and Alan Bonder and Vilas Patwardhan and Cristina Rigamonti and Marco Carbone and Pietro Invernizzi and Laura Cristoferi and {van der Meer}, Adriaan and {de Veer}, Rozanne and Ehud Zigmond and Eyal Yehezkel and Kremer, {Andreas E} and Ansgar Deibel and J{\'e}r{\^o}me Dumortier and Tony Bruns and Karsten Gro{\ss}e and Georges-Philippe Pageaux and Aaron Wetten and Jessica Dyson and David Jones and Olivier Chazouill{\`e}res and Bettina Hansen and {de L{\'e}dinghen}, Victor and {Global & ERN Rare-Liver PBC Study Groups}",
note = "Copyright {\textcopyright} 2022 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.",
year = "2022",
month = dec,
doi = "10.1016/j.jhep.2022.06.017",
language = "English",
volume = "77",
pages = "1545--1553",
journal = "J HEPATOL",
issn = "0168-8278",
publisher = "Elsevier",
number = "6",

}

RIS

TY - JOUR

T1 - Liver stiffness measurement by vibration-controlled transient elastography improves outcome prediction in primary biliary cholangitis

AU - Corpechot, Christophe

AU - Carrat, Fabrice

AU - Gaouar, Farid

AU - Chau, Frederic

AU - Hirschfield, Gideon

AU - Gulamhusein, Aliya

AU - Montano-Loza, Aldo J

AU - Lytvyak, Ellina

AU - Schramm, Christoph

AU - Pares, Albert

AU - Olivas, Ignasi

AU - Eaton, John E

AU - Osman, Karim T

AU - Dalekos, George

AU - Gatselis, Nikolaos

AU - Nevens, Frederik

AU - Cazzagon, Nora

AU - Zago, Alessandra

AU - Russo, Francesco Paolo

AU - Abbas, Nadir

AU - Trivedi, Palak

AU - Thorburn, Douglas

AU - Saffioti, Francesca

AU - Barkai, Laszlo

AU - Roccarina, Davide

AU - Calvaruso, Vicenza

AU - Fichera, Anna

AU - Delamarre, Adèle

AU - Medina-Morales, Esli

AU - Bonder, Alan

AU - Patwardhan, Vilas

AU - Rigamonti, Cristina

AU - Carbone, Marco

AU - Invernizzi, Pietro

AU - Cristoferi, Laura

AU - van der Meer, Adriaan

AU - de Veer, Rozanne

AU - Zigmond, Ehud

AU - Yehezkel, Eyal

AU - Kremer, Andreas E

AU - Deibel, Ansgar

AU - Dumortier, Jérôme

AU - Bruns, Tony

AU - Große, Karsten

AU - Pageaux, Georges-Philippe

AU - Wetten, Aaron

AU - Dyson, Jessica

AU - Jones, David

AU - Chazouillères, Olivier

AU - Hansen, Bettina

AU - de Lédinghen, Victor

AU - Global & ERN Rare-Liver PBC Study Groups

N1 - Copyright © 2022 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

PY - 2022/12

Y1 - 2022/12

N2 - 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.

AB - 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.

U2 - 10.1016/j.jhep.2022.06.017

DO - 10.1016/j.jhep.2022.06.017

M3 - SCORING: Journal article

C2 - 35777587

VL - 77

SP - 1545

EP - 1553

JO - J HEPATOL

JF - J HEPATOL

SN - 0168-8278

IS - 6

ER -