Contribution of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography to Outcome Prediction in Primary Biliary Cholangitis
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...
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| creator | Corpechot, Christophe Carrat, Fabrice Gaouar, Farid Chau, Frédéric Hirschfield, Gideon Gulamhusein, Aliya Montano-Loza, Aldo Lytvyak, Ellina Schramm, Christoph Pares, Albert Olivas, Ignasi Eaton, John Osman, Karim 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 Deibel, Ansgar Dumortier, Jérôme Bruns, Tony Große, Karsten de Lédinghen, Victor Pageaux, Georges‐philippe Wetten, Aaron Dyson, Jessica Jones, David Chazouillères, Olivier Hansen, Bettina |
| description | 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 |
| doi_str_mv | 10.1016/j.jhep.2022.06.017 |
| format | Article |
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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.</description><identifier>ISSN: 0168-8278</identifier><identifier>EISSN: 1600-0641</identifier><identifier>DOI: 10.1016/j.jhep.2022.06.017</identifier><identifier>PMID: 35777587</identifier><language>eng</language><publisher>Elsevier</publisher><subject>Cohort Studies ; Elasticity Imaging Techniques ; Folllow-Up Studies ; Humans ; Life Sciences ; Liver ; Liver Cirrhosis ; Liver Cirrhosis, Biliary ; Prognosis ; Retrospectives Studies ; Santé publique et épidémiologie ; Vibration</subject><ispartof>Journal of hepatology, 2022-12, Vol.77 (6), p.1545-1553</ispartof><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><orcidid>0000-0001-5269-8373 ; 0000-0002-5576-6914 ; 0000-0002-4008-9770 ; 0000-0002-9263-948X ; 0000-0003-3262-1998 ; 0000-0002-7824-5396 ; 0000-0003-4989-9726 ; 0000-0001-6733-5225 ; 0000-0002-1224-5502 ; 0000-0001-5651-9010 ; 0000-0002-4264-1928 ; 0000-0001-6821-0416 ; 0000-0003-2089-4139 ; 0000-0001-9425-4228 ; 0000-0001-7635-9931 ; 0000-0002-9923-8531 ; 0000-0002-2412-2200 ; 0000-0002-8672-7918 ; 0000-0001-7075-8464 ; 0000-0002-9871-4022 ; 0000-0001-6208-9694 ; 0000-0002-3715-8640 ; 0000-0001-9846-7474 ; 0000-0002-5413-9687 ; 0000-0002-6937-8664 ; 0000-0003-3262-1998 ; 0000-0002-5576-6914 ; 0000-0002-6937-8664 ; 0000-0002-4264-1928 ; 0000-0002-5413-9687 ; 0000-0003-4989-9726 ; 0000-0002-1224-5502 ; 0000-0001-6733-5225 ; 0000-0001-6821-0416 ; 0000-0002-7824-5396 ; 0000-0002-8672-7918 ; 0000-0002-2412-2200 ; 0000-0001-9425-4228 ; 0000-0001-6208-9694 ; 0000-0001-7635-9931 ; 0000-0002-9263-948X ; 0000-0001-9846-7474 ; 0000-0001-5651-9010 ; 0000-0001-7075-8464 ; 0000-0001-5269-8373 ; 0000-0002-3715-8640 ; 0000-0002-4008-9770 ; 0000-0002-9923-8531 ; 0000-0002-9871-4022 ; 0000-0003-2089-4139</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://hal.sorbonne-universite.fr/hal-03786463$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Corpechot, Christophe</creatorcontrib><creatorcontrib>Carrat, Fabrice</creatorcontrib><creatorcontrib>Gaouar, Farid</creatorcontrib><creatorcontrib>Chau, Frédéric</creatorcontrib><creatorcontrib>Hirschfield, Gideon</creatorcontrib><creatorcontrib>Gulamhusein, Aliya</creatorcontrib><creatorcontrib>Montano-Loza, Aldo</creatorcontrib><creatorcontrib>Lytvyak, Ellina</creatorcontrib><creatorcontrib>Schramm, Christoph</creatorcontrib><creatorcontrib>Pares, Albert</creatorcontrib><creatorcontrib>Olivas, Ignasi</creatorcontrib><creatorcontrib>Eaton, John</creatorcontrib><creatorcontrib>Osman, Karim</creatorcontrib><creatorcontrib>Dalekos, George</creatorcontrib><creatorcontrib>Gatselis, Nikolaos</creatorcontrib><creatorcontrib>Nevens, Frederik</creatorcontrib><creatorcontrib>Cazzagon, Nora</creatorcontrib><creatorcontrib>Zago, Alessandra</creatorcontrib><creatorcontrib>Russo, Francesco Paolo</creatorcontrib><creatorcontrib>Abbas, Nadir</creatorcontrib><creatorcontrib>Trivedi, Palak</creatorcontrib><creatorcontrib>Thorburn, Douglas</creatorcontrib><creatorcontrib>Saffioti, Francesca</creatorcontrib><creatorcontrib>Barkai, Laszlo</creatorcontrib><creatorcontrib>Roccarina, Davide</creatorcontrib><creatorcontrib>Calvaruso, Vicenza</creatorcontrib><creatorcontrib>Fichera, Anna</creatorcontrib><creatorcontrib>Delamarre, Adèle</creatorcontrib><creatorcontrib>Medina-Morales, Esli</creatorcontrib><creatorcontrib>Bonder, Alan</creatorcontrib><creatorcontrib>Patwardhan, Vilas</creatorcontrib><creatorcontrib>Rigamonti, Cristina</creatorcontrib><creatorcontrib>Carbone, Marco</creatorcontrib><creatorcontrib>Invernizzi, Pietro</creatorcontrib><creatorcontrib>Cristoferi, Laura</creatorcontrib><creatorcontrib>van der Meer, Adriaan</creatorcontrib><creatorcontrib>de Veer, Rozanne</creatorcontrib><creatorcontrib>Zigmond, Ehud</creatorcontrib><creatorcontrib>Yehezkel, Eyal</creatorcontrib><creatorcontrib>Kremer, Andreas</creatorcontrib><creatorcontrib>Deibel, Ansgar</creatorcontrib><creatorcontrib>Dumortier, Jérôme</creatorcontrib><creatorcontrib>Bruns, Tony</creatorcontrib><creatorcontrib>Große, Karsten</creatorcontrib><creatorcontrib>de Lédinghen, Victor</creatorcontrib><creatorcontrib>Pageaux, Georges‐philippe</creatorcontrib><creatorcontrib>Wetten, Aaron</creatorcontrib><creatorcontrib>Dyson, Jessica</creatorcontrib><creatorcontrib>Jones, David</creatorcontrib><creatorcontrib>Chazouillères, Olivier</creatorcontrib><creatorcontrib>Hansen, Bettina</creatorcontrib><title>Contribution of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography to Outcome Prediction in Primary Biliary Cholangitis</title><title>Journal of hepatology</title><description>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.</description><subject>Cohort Studies</subject><subject>Elasticity Imaging Techniques</subject><subject>Folllow-Up Studies</subject><subject>Humans</subject><subject>Life Sciences</subject><subject>Liver</subject><subject>Liver Cirrhosis</subject><subject>Liver Cirrhosis, Biliary</subject><subject>Prognosis</subject><subject>Retrospectives Studies</subject><subject>Santé publique et épidémiologie</subject><subject>Vibration</subject><issn>0168-8278</issn><issn>1600-0641</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNqVjU1OwzAUhC0EouXnAqy8ZZHwnKR2WEJU1EURSFRsI6d1mhc5dmQ7lXIKrtymcAFWoxl9n4aQBwYxA8af2rhtVB8nkCQx8BiYuCBzxgEi4Bm7JPMTlEd5IvIZufG-BYAUnrNrMksXQohFLubkp7AmOKyGgNZQW9M1HpSjXwHr2ijv6buSfnCqUybQaqTfWDk5sdFZtFqrHd04aTxOxFJLH-zeyb4ZabD0Ywhb2yn66dQOt-cPNKeGnXQjfUWNUxaN1dLsMaC_I1e11F7d_-UteXxbbopV1Ehd9r9eaSWWq5d1OW2QipxnPD2w9D_sEWttZKQ</recordid><startdate>202212</startdate><enddate>202212</enddate><creator>Corpechot, Christophe</creator><creator>Carrat, Fabrice</creator><creator>Gaouar, Farid</creator><creator>Chau, Frédéric</creator><creator>Hirschfield, Gideon</creator><creator>Gulamhusein, Aliya</creator><creator>Montano-Loza, Aldo</creator><creator>Lytvyak, Ellina</creator><creator>Schramm, Christoph</creator><creator>Pares, Albert</creator><creator>Olivas, 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of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography to Outcome Prediction in Primary Biliary Cholangitis</title><author>Corpechot, Christophe ; Carrat, Fabrice ; Gaouar, Farid ; Chau, Frédéric ; Hirschfield, Gideon ; Gulamhusein, Aliya ; Montano-Loza, Aldo ; Lytvyak, Ellina ; Schramm, Christoph ; Pares, Albert ; Olivas, Ignasi ; Eaton, John ; Osman, Karim ; 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 ; Deibel, Ansgar ; Dumortier, Jérôme ; Bruns, Tony ; Große, Karsten ; de Lédinghen, Victor ; Pageaux, Georges‐philippe ; Wetten, Aaron ; Dyson, Jessica ; Jones, David ; Chazouillères, Olivier ; Hansen, Bettina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-hal_primary_oai_HAL_hal_03786463v13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Cohort Studies</topic><topic>Elasticity Imaging Techniques</topic><topic>Folllow-Up Studies</topic><topic>Humans</topic><topic>Life Sciences</topic><topic>Liver</topic><topic>Liver Cirrhosis</topic><topic>Liver Cirrhosis, Biliary</topic><topic>Prognosis</topic><topic>Retrospectives Studies</topic><topic>Santé publique et épidémiologie</topic><topic>Vibration</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Corpechot, Christophe</creatorcontrib><creatorcontrib>Carrat, Fabrice</creatorcontrib><creatorcontrib>Gaouar, Farid</creatorcontrib><creatorcontrib>Chau, Frédéric</creatorcontrib><creatorcontrib>Hirschfield, Gideon</creatorcontrib><creatorcontrib>Gulamhusein, Aliya</creatorcontrib><creatorcontrib>Montano-Loza, Aldo</creatorcontrib><creatorcontrib>Lytvyak, Ellina</creatorcontrib><creatorcontrib>Schramm, Christoph</creatorcontrib><creatorcontrib>Pares, Albert</creatorcontrib><creatorcontrib>Olivas, Ignasi</creatorcontrib><creatorcontrib>Eaton, John</creatorcontrib><creatorcontrib>Osman, Karim</creatorcontrib><creatorcontrib>Dalekos, George</creatorcontrib><creatorcontrib>Gatselis, Nikolaos</creatorcontrib><creatorcontrib>Nevens, Frederik</creatorcontrib><creatorcontrib>Cazzagon, Nora</creatorcontrib><creatorcontrib>Zago, Alessandra</creatorcontrib><creatorcontrib>Russo, Francesco Paolo</creatorcontrib><creatorcontrib>Abbas, Nadir</creatorcontrib><creatorcontrib>Trivedi, Palak</creatorcontrib><creatorcontrib>Thorburn, Douglas</creatorcontrib><creatorcontrib>Saffioti, Francesca</creatorcontrib><creatorcontrib>Barkai, Laszlo</creatorcontrib><creatorcontrib>Roccarina, Davide</creatorcontrib><creatorcontrib>Calvaruso, Vicenza</creatorcontrib><creatorcontrib>Fichera, Anna</creatorcontrib><creatorcontrib>Delamarre, Adèle</creatorcontrib><creatorcontrib>Medina-Morales, Esli</creatorcontrib><creatorcontrib>Bonder, Alan</creatorcontrib><creatorcontrib>Patwardhan, Vilas</creatorcontrib><creatorcontrib>Rigamonti, Cristina</creatorcontrib><creatorcontrib>Carbone, Marco</creatorcontrib><creatorcontrib>Invernizzi, Pietro</creatorcontrib><creatorcontrib>Cristoferi, Laura</creatorcontrib><creatorcontrib>van der Meer, Adriaan</creatorcontrib><creatorcontrib>de Veer, Rozanne</creatorcontrib><creatorcontrib>Zigmond, Ehud</creatorcontrib><creatorcontrib>Yehezkel, Eyal</creatorcontrib><creatorcontrib>Kremer, Andreas</creatorcontrib><creatorcontrib>Deibel, Ansgar</creatorcontrib><creatorcontrib>Dumortier, Jérôme</creatorcontrib><creatorcontrib>Bruns, Tony</creatorcontrib><creatorcontrib>Große, Karsten</creatorcontrib><creatorcontrib>de Lédinghen, Victor</creatorcontrib><creatorcontrib>Pageaux, Georges‐philippe</creatorcontrib><creatorcontrib>Wetten, Aaron</creatorcontrib><creatorcontrib>Dyson, Jessica</creatorcontrib><creatorcontrib>Jones, David</creatorcontrib><creatorcontrib>Chazouillères, Olivier</creatorcontrib><creatorcontrib>Hansen, Bettina</creatorcontrib><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><jtitle>Journal of hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Corpechot, Christophe</au><au>Carrat, Fabrice</au><au>Gaouar, Farid</au><au>Chau, Frédéric</au><au>Hirschfield, Gideon</au><au>Gulamhusein, Aliya</au><au>Montano-Loza, Aldo</au><au>Lytvyak, Ellina</au><au>Schramm, Christoph</au><au>Pares, Albert</au><au>Olivas, Ignasi</au><au>Eaton, John</au><au>Osman, Karim</au><au>Dalekos, George</au><au>Gatselis, Nikolaos</au><au>Nevens, Frederik</au><au>Cazzagon, Nora</au><au>Zago, Alessandra</au><au>Russo, Francesco Paolo</au><au>Abbas, Nadir</au><au>Trivedi, Palak</au><au>Thorburn, Douglas</au><au>Saffioti, Francesca</au><au>Barkai, Laszlo</au><au>Roccarina, Davide</au><au>Calvaruso, Vicenza</au><au>Fichera, Anna</au><au>Delamarre, Adèle</au><au>Medina-Morales, Esli</au><au>Bonder, Alan</au><au>Patwardhan, Vilas</au><au>Rigamonti, Cristina</au><au>Carbone, Marco</au><au>Invernizzi, Pietro</au><au>Cristoferi, Laura</au><au>van der Meer, Adriaan</au><au>de Veer, Rozanne</au><au>Zigmond, Ehud</au><au>Yehezkel, Eyal</au><au>Kremer, Andreas</au><au>Deibel, Ansgar</au><au>Dumortier, Jérôme</au><au>Bruns, Tony</au><au>Große, Karsten</au><au>de Lédinghen, Victor</au><au>Pageaux, Georges‐philippe</au><au>Wetten, Aaron</au><au>Dyson, Jessica</au><au>Jones, David</au><au>Chazouillères, Olivier</au><au>Hansen, Bettina</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Contribution of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography to Outcome Prediction in Primary Biliary Cholangitis</atitle><jtitle>Journal of hepatology</jtitle><date>2022-12</date><risdate>2022</risdate><volume>77</volume><issue>6</issue><spage>1545</spage><epage>1553</epage><pages>1545-1553</pages><issn>0168-8278</issn><eissn>1600-0641</eissn><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.</abstract><pub>Elsevier</pub><pmid>35777587</pmid><doi>10.1016/j.jhep.2022.06.017</doi><orcidid>https://orcid.org/0000-0001-5269-8373</orcidid><orcidid>https://orcid.org/0000-0002-5576-6914</orcidid><orcidid>https://orcid.org/0000-0002-4008-9770</orcidid><orcidid>https://orcid.org/0000-0002-9263-948X</orcidid><orcidid>https://orcid.org/0000-0003-3262-1998</orcidid><orcidid>https://orcid.org/0000-0002-7824-5396</orcidid><orcidid>https://orcid.org/0000-0003-4989-9726</orcidid><orcidid>https://orcid.org/0000-0001-6733-5225</orcidid><orcidid>https://orcid.org/0000-0002-1224-5502</orcidid><orcidid>https://orcid.org/0000-0001-5651-9010</orcidid><orcidid>https://orcid.org/0000-0002-4264-1928</orcidid><orcidid>https://orcid.org/0000-0001-6821-0416</orcidid><orcidid>https://orcid.org/0000-0003-2089-4139</orcidid><orcidid>https://orcid.org/0000-0001-9425-4228</orcidid><orcidid>https://orcid.org/0000-0001-7635-9931</orcidid><orcidid>https://orcid.org/0000-0002-9923-8531</orcidid><orcidid>https://orcid.org/0000-0002-2412-2200</orcidid><orcidid>https://orcid.org/0000-0002-8672-7918</orcidid><orcidid>https://orcid.org/0000-0001-7075-8464</orcidid><orcidid>https://orcid.org/0000-0002-9871-4022</orcidid><orcidid>https://orcid.org/0000-0001-6208-9694</orcidid><orcidid>https://orcid.org/0000-0002-3715-8640</orcidid><orcidid>https://orcid.org/0000-0001-9846-7474</orcidid><orcidid>https://orcid.org/0000-0002-5413-9687</orcidid><orcidid>https://orcid.org/0000-0002-6937-8664</orcidid><orcidid>https://orcid.org/0000-0003-3262-1998</orcidid><orcidid>https://orcid.org/0000-0002-5576-6914</orcidid><orcidid>https://orcid.org/0000-0002-6937-8664</orcidid><orcidid>https://orcid.org/0000-0002-4264-1928</orcidid><orcidid>https://orcid.org/0000-0002-5413-9687</orcidid><orcidid>https://orcid.org/0000-0003-4989-9726</orcidid><orcidid>https://orcid.org/0000-0002-1224-5502</orcidid><orcidid>https://orcid.org/0000-0001-6733-5225</orcidid><orcidid>https://orcid.org/0000-0001-6821-0416</orcidid><orcidid>https://orcid.org/0000-0002-7824-5396</orcidid><orcidid>https://orcid.org/0000-0002-8672-7918</orcidid><orcidid>https://orcid.org/0000-0002-2412-2200</orcidid><orcidid>https://orcid.org/0000-0001-9425-4228</orcidid><orcidid>https://orcid.org/0000-0001-6208-9694</orcidid><orcidid>https://orcid.org/0000-0001-7635-9931</orcidid><orcidid>https://orcid.org/0000-0002-9263-948X</orcidid><orcidid>https://orcid.org/0000-0001-9846-7474</orcidid><orcidid>https://orcid.org/0000-0001-5651-9010</orcidid><orcidid>https://orcid.org/0000-0001-7075-8464</orcidid><orcidid>https://orcid.org/0000-0001-5269-8373</orcidid><orcidid>https://orcid.org/0000-0002-3715-8640</orcidid><orcidid>https://orcid.org/0000-0002-4008-9770</orcidid><orcidid>https://orcid.org/0000-0002-9923-8531</orcidid><orcidid>https://orcid.org/0000-0002-9871-4022</orcidid><orcidid>https://orcid.org/0000-0003-2089-4139</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0168-8278 |
| ispartof | Journal of hepatology, 2022-12, Vol.77 (6), p.1545-1553 |
| issn | 0168-8278 1600-0641 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_03786463v1 |
| source | Elsevier ScienceDirect Journals |
| subjects | Cohort Studies Elasticity Imaging Techniques Folllow-Up Studies Humans Life Sciences Liver Liver Cirrhosis Liver Cirrhosis, Biliary Prognosis Retrospectives Studies Santé publique et épidémiologie Vibration |
| title | Contribution of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography to Outcome Prediction in Primary Biliary Cholangitis |
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