S108 Safety and Efficacy of Obeticholic Acid in Primary Biliary Cholangitis: A Systematic Review and Meta-Analysis

Introduction: Primary biliary cholangitis (PBC) is a rising autoimmune disease involving the intralobular bile ducts which predominantly affects women. While ursodeoxycholic acid has shown to prevent progression, nearly 40% patients do not show complete biochemical response to ursodeoxycholic acid. Obeticholic acid (OCA) is a second line drug, approved by the FDA for PBC which requires biochemical monitoring, as cases of liver injury have been reported when OCA was used in those without cirrhosis. This meta-analysis evaluates the biochemical response and adverse events associated with use of OCA, thus attempting to evaluate its safety profile when used as a second-line drug for PBC. Methods: A systematic search was conducted using PubMed, Google Scholar, and Scopus. PRISMA guidelines were followed. A Boolean expression was constructed to retrieve and select articles from major medical databases. Articles that included the assessment of biochemical response following obethocholic acid for PBC were included in the study. The primary outcome was the odds ratio of the Biochemical Response following OCA therapy and the control group. Secondary outcomes included change of ALP levels and bilirubin levels, and major adverse events following OCA therapy. The Mantel-Haenszel method (common effect model), and the Inverse variance method (random effects model) were utilised to analyse the odds ratio. The I2 test was used to assess the heterogeneity. Results: The study included a total of 6 different groups, where 668 subjects received OCA therapy and 475 subjects received standard treatment. The biochemical response rate was significantly higher in the OCA group in comparison to the control group. (OR = 3.75 (1.47; 9.58) , I2 = 93% , P < 0.01). The risk of adverse events was statistically insignificant between the 2 groups. (RR = 2.42 (0.77;7.59), I2 = 58%, P = 0.07). Conclusion: The conducted analysis highlights the clinical efficacy of obeticholic acid in effective management of primary biliary cholangitis. Improved biochemical response rate following OCA therapy and similar safety profiles in comparison to the control groups indicate need for further studies to validate its role in management of biliary cholangitis.