TY - JOUR
T1 - Dynamics of Liver Stiffness Measurement and Clinical Course of Primary Biliary Cholangitis
AU - Global & ERN Rare-Liver PBC Study Groups
AU - Lam, Laurent
AU - Soret, Pierre Antoine
AU - Lemoinne, Sara
AU - Hansen, Bettina
AU - Hirschfield, Gideon
AU - Gulamhusein, Aliya
AU - Montano-Loza, Aldo J.
AU - Lytvyak, Ellina
AU - Parés, Albert
AU - Olivas, Ignasi
AU - Londono, Maria Carlota
AU - Rodríguez-Tajes, Sergio
AU - Eaton, John E.
AU - Osman, Karim T.
AU - Schramm, Christoph
AU - Sebode, Marcial
AU - Lohse, Ansgar W.
AU - Dalekos, George
AU - Gatselis, Nikolaos
AU - Nevens, Frederik
AU - Cazzagon, Nora
AU - Zago, Alessandra
AU - Russo, Francesco Paolo
AU - Floreani, Annarosa
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 - Sobenko, Natalia
AU - Villamil, Alejandra Maria
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 - Bruns, Tony
AU - Große, Karsten
N1 - Publisher Copyright:
© 2024 The Author(s)
PY - 2024/12
Y1 - 2024/12
N2 - Background & Aims: In primary biliary cholangitis (PBC), static liver stiffness measurement (LSM) has proven prognostic value. However, the added prognostic value of LSM time course in this disease remains uncertain. Methods: We conducted an international retrospective cohort study among patients with PBC treated with ursodeoxycholic acid and followed by vibration-controlled transient elastography between 2003 and 2022. Using joint modeling, the association of LSM trajectory and the incidence of serious clinical events (SCE), defined as cirrhosis complications, liver transplantation, or death, was quantified using the hazard ratio and its confidence interval. Results: A total of 6362 LSMs were performed in 3078 patients (2007 on ursodeoxycholic acid alone; 13% with cirrhosis), in whom 316 SCE occurred over 14,445 person-years (median follow-up, 4.2 years; incidence rate, 21.9 per 1000 person-years). LSM progressed in 59% of patients (mean, 0.39 kPa/year). After adjusting for prognostic factors at baseline, including LSM, any relative change in LSM was associated with a significant variation in SCE risk (P < .001). For example, the adjusted hazard ratios (95% confidence interval) associated with a 20% annual variation in LSM were 2.13 (1.89–2.45) for the increase and 0.40 (0.33–0.46) for the decrease. The association between LSM trajectory and SCE risk persisted regardless of treatment response or duration, when patients with cirrhosis were excluded, and when only death or liver transplantation was considered. Conclusions: Tracking longitudinal changes in LSM using vibration-controlled transient elastography provides valuable insights into PBC prognosis, offering a robust predictive measure for the risk of SCE. LSM could be used as a clinically relevant surrogate end point in PBC clinical trials.
AB - Background & Aims: In primary biliary cholangitis (PBC), static liver stiffness measurement (LSM) has proven prognostic value. However, the added prognostic value of LSM time course in this disease remains uncertain. Methods: We conducted an international retrospective cohort study among patients with PBC treated with ursodeoxycholic acid and followed by vibration-controlled transient elastography between 2003 and 2022. Using joint modeling, the association of LSM trajectory and the incidence of serious clinical events (SCE), defined as cirrhosis complications, liver transplantation, or death, was quantified using the hazard ratio and its confidence interval. Results: A total of 6362 LSMs were performed in 3078 patients (2007 on ursodeoxycholic acid alone; 13% with cirrhosis), in whom 316 SCE occurred over 14,445 person-years (median follow-up, 4.2 years; incidence rate, 21.9 per 1000 person-years). LSM progressed in 59% of patients (mean, 0.39 kPa/year). After adjusting for prognostic factors at baseline, including LSM, any relative change in LSM was associated with a significant variation in SCE risk (P < .001). For example, the adjusted hazard ratios (95% confidence interval) associated with a 20% annual variation in LSM were 2.13 (1.89–2.45) for the increase and 0.40 (0.33–0.46) for the decrease. The association between LSM trajectory and SCE risk persisted regardless of treatment response or duration, when patients with cirrhosis were excluded, and when only death or liver transplantation was considered. Conclusions: Tracking longitudinal changes in LSM using vibration-controlled transient elastography provides valuable insights into PBC prognosis, offering a robust predictive measure for the risk of SCE. LSM could be used as a clinically relevant surrogate end point in PBC clinical trials.
KW - Elastography
KW - FibroScan
KW - Liver Stiffness
KW - PBC
KW - Prognosis
KW - Time Course
UR - http://www.scopus.com/inward/record.url?scp=85206695807&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2024.06.035
DO - 10.1016/j.cgh.2024.06.035
M3 - Article
C2 - 39019421
AN - SCOPUS:85206695807
SN - 1542-3565
VL - 22
SP - 2432-2441.e2
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 12
ER -