Author information
1Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, the Netherlands.
2Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, European Reference Network on Hepatological Diseases (ERN Rare-Liver), Saint-Antoine Hospital, Assistance Publique-Hôpitaux de Paris; Inserm UMR_S938, Saint-Antoine Research Center, Sorbonne University, Paris, France.
3The Sheila Sherlock Liver Centre, and UCL Institute of Liver and Digestive Health, The Royal Free Hospital, London, UK.
4Division of Gastroenterology and Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.
5European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy.
6Toronto Centre for Liver Disease, Toronto General Hospital, University Health Network, Toronto, Canada.
7Department of Health Sciences, Università degli Studi di Milano, Milan, Italy.
8Department of Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
9Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
10Arizona State University, College of Health Solutions, Phoenix, Arizona, USA.
11Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
12Scientific Institute for Research, Hospitalization and Healthcare, Negrar, Verona, Italy.
13Department of Gastroenterology and Hepatology, Amsterdam University Medical Centres, location Academic Medical Center, Amsterdam, the Netherlands.
14Digestive and Liver Diseases, UT Southwestern Medical Center, Dallas, Texas, USA.
15Liver Unit, Hospital Clínic, CIBERehd, IDIBAPS, University of Barcelona, Barcelona, Spain.
16Division of Gastroenterology and Hepatology, University of Alberta, Edmonton, Alberta, Canada.
17Liver Care Network and Organ Care Research, Swedish Medical Center, Seattle, Washington, USA.
18Birmingham NIHR Biomedical Research Centre, and Centre for Liver Research, University of Birmingham, Birmingham, UK.
19Department of Internal Medicine IV, Jena University Hospital, Friedrich Schiller University, Jena, Germany.
20Department of Internal Medicine III, University Hospital RWTH Aachen, Aachen, Germany.
21Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, General University Hospital of Larissa, Larissa, Greece.
22European Reference Network on Hepatological Diseases (ERN RARE-LIVER), General University Hospital of Larissa, Larissa, Greece.
23Department of Gastroenterology and Hepatology, Ghent University Hospital, Belgium.
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 0-1 was -0.27 (IQR -0.56 to 0.02). Cox regression analyses, adjusted for pretreatment GLOBE score and ΔGLOBE 0-12 , 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 0-1 was not statistically significant ( P = 0.296). The ΔGLOBE 1-2 was 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.