Ursodeoxycholic Acid Treatment-Induced GLOBE Score Changes Are Associated With Liver Transplantation-Free Survival in Patients With Primary Biliary Cholangitis

INTRODUCTION: Treatment of primary biliary cholangitis (PBC) can improve the GLOBE score. We aimed to assess the association between changes in the GLOBE score (?GLOBE) 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 ?GLOBE (?GLOBE(0-1): during the first year of UDCA, ?GLOBE1-2: 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 (9 0.7%) 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 ?GLOBE(0-1) was-0.27 (IQR-0.56 to 0.02). Cox regression analyses, adjusted for pretreatment GLOBE score and ?GLOBE(0-1)(2), showed that ?GLOBE 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 ?GLOBE(0-1) was not statistically significant (P = 0.296). The ?GLOBE(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.