Response to Low Dose of Obeticholic Acid in Primary Biliary Cholangitis in the Real-World Population

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The objective of this study is to assess the real-world efficacy and safety of a 5 mg/day dose of obeticholic acid (OCA) in patients with primary biliary cholangitis (PBC). For this, a retrospective observational study was carried out. The primary endpoint was defined as alkaline phosphatase (AP) levels below the 1.67 upper limit of normal (ULN) with more than a 15% reduction from baseline, along with normal total bilirubin (TB) levels. The ‘secondary endpoint’ was the biochemical response of alanine (ALT) and aspartate (ASP) aminotransferases. The sample was composed of 26 patients who received 5 mg of OCA daily. Baseline ALP levels were below1.67 ULN in 33% of patients. After 48 months of treatment, the proportion of patients with ALP <1.67 ULN increased to 45%, from a basal percentage of 33%, remaining stable throughout the 50-month study period. Regarding ALT and AST, 30-40% of patients had levels <1.67 ULN at baseline. By month 36, 100% of patients had normalized these levels. In conclusion, treatment with 5 mg/day of OCA achieved ALP improvement in 12% (from a basal percentage of 33% to 45% at the end of study period) of patients over 50 months. The treatment also normalized ALT and AST levels in a high proportion of patients.