Obeticholic acid is associated with improvements in AST-to-platelet ratio index and GLOBE score in patients with primary biliary cholangitis

Abstract Background & Aims Biochemical markers, including GLOBE score and aspartate aminotransferase-to-platelet ratio index (APRI), are used to stratify risk in patients with primary biliary cholangitis. This study aimed to evaluate the effects of obeticholic acid (OCA) on categorical shifts in GLOBE score, APRI, and both combined, based on data from POISE, a phase 3 placebo-controlled trial that demonstrated significant improvement with OCA in markers of cholestasis and hepatocellular damage in patients with primary biliary cholangitis who had an incomplete response to or were intolerant of ursodeoxycholic acid. Methods In a post hoc analysis, baseline and Month 12 data from POISE were used to calculate APRI and GLOBE score. Patients were stratified into 3 risk groups based on a combination of APRI (0.54) and GLOBE (0.3 or age-specific) thresholds. Results The analysis included 215 patients (47 low-risk; 79 moderate-risk; 89 high-risk). Using the combined GLOBE score (threshold of 0.3) and APRI thresholds, there was improvement in ≥1 risk stage in 37% and 35% of patients in the OCA 5-10 mg and 10 mg groups, respectively, versus 12% in the placebo group (both p Conclusions Based on change in APRI and GLOBE score at 12 months, OCA treatment is associated with reduction in the predicted risk of liver-related complications in patients with primary biliary cholangitis. ( ClinicalTrials.gov , NCT01473524)