The POISE randomized double-blind placebo-controlled trial demonstrated that obeticholic acid (OCA) reduced biomarkers associated with adverse clinical outcomes (ALP, bilirubin, AST, ALT) in patients with primary biliary cholangitis (PBC). The objective of this study was to evaluate time to first occurrence of liver transplant or death in OCA-treated patients in the POISE trial and open label extension versus comparable non-OCA-treated external controls.