Ursodeoxycholic acid treatment-induced GLOBE score changes are associated with liver transplantation-free survival in patients with primary biliary cholangitis

Rozanne C de Veer, Maria C van Hooff, Christophe Corpechot, Douglas Thorburn, Pietro Invernizzi, Willem J Lammers, Harry L A Janssen, Pier M Battezzati, Frederik Nevens, Keith D Lindor, Annarosa Floreani, Cyriel Y Ponsioen, Marlyn J Mayo, Albert Parés, Andrew L Mason, Kris V Kowdley, Palak J Trivedi, Gideon M Hirschfield, Jorn C Goet, Tony BrunsGeorge N Dalekos, Nikolaos K Gatselis, Xavier Verhelst, Bettina E Hansen, Maren H Harms, Adriaan J van der Meer*

*Corresponding author for this work

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Abstract

INTRODUCTION:Treatment of primary biliary cholangitis (PBC) can improve the GLOBE score. We aimed to assess the association between changes in the GLOBE score (ΔGLOBE) and liver transplantation (LT)-free survival in patients with PBC who were treated with ursodeoxycholic acid (UDCA).METHODS:Among UDCA-treated patients within the Global PBC cohort, the association between ΔGLOBE (ΔGLOBE 0-1: during the first year of UDCA, ΔGLOBE 1-2: during the second year) and the risk of LT or death was assessed through Cox regression analyses.RESULTS:Overall, 3,775 UDCA-treated patients were included; 3,424 (90.7%) were female, the median age was 54.0 (interquartile range [IQR] 45.9-62.4) years, and the median baseline GLOBE score was 0.25 (IQR -0.47 to 0.96). During a median follow-up of 7.2 (IQR 3.7-11.5) years, 730 patients reached the combined end point of LT or death. The median ΔGLOBE 0-1was -0.27 (IQR -0.56 to 0.02). Cox regression analyses, adjusted for pretreatment GLOBE score and ΔGLOBE 0-1 2, showed that ΔGLOBE was associated with LT or death (adjusted hazard ratio 2.28, 95% confidence interval 1.81-2.87, P < 0.001). The interaction between baseline GLOBE score and ΔGLOBE 0-1was not statistically significant (P = 0.296). The ΔGLOBE 1-2was associated with LT or death (adjusted hazard ratio 2.19, 95% confidence interval 1.67-2.86, P < 0.001), independently from the baseline GLOBE score and the change in GLOBE score during the first year of UDCA.DISCUSSION:UDCA-induced changes in the GLOBE score were significantly associated with LT-free survival in patients with PBC. While the relative risk reduction of LT or death was stable, the absolute risk reduction was heavily dependent on the baseline prognosis of the patient.

Original languageEnglish
Pages (from-to)1196-1203
Number of pages8
JournalThe American journal of gastroenterology
Volume118
Issue number7
Early online date8 Dec 2022
DOIs
Publication statusPublished - 1 Jul 2023

Bibliographical note

Funding Information:
Financial support: This investigator-initiated study was supported by an unrestricted grant from Intercept Pharmaceuticals and was funded by the Foundation for Liver and Gastrointestinal Research (a not-for-profit foundation) in Rotterdam, the Netherlands. The supporting parties had no influence on the study design, data collection and analyses, writing of the manuscript, or on the decision to submit the manuscript for publication.

Publisher Copyright:
© 2023 Wolters Kluwer Health. All rights reserved.

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