Trauner M, et al. - Researchers used 3-year interim data from the 5-year open-label extension of the pivotal phase 3 POISE trial to assess the long-term effectiveness and safety of obeticholic acid for patients with primary biliary cholangitis. For this investigation, 217 patients with primary biliary cholangitis with insufficient ursodeoxycholic acid response or intolerance were randomized to receive placebo, 5 to 10 mg obeticholic acid or 10 mg obeticholic acid once daily for 12 months. According to interim analyses, in patients with primary biliary cholangitis who are intolerant to or inadequately responsive to ursodeoxycholic acid suggest long-term effectiveness and safety of obeticholic acid. In the double-blind phase of POISE, obeticholic acid was generally well tolerated and the most common adverse events were pruritus and fatigue. No serious adverse events related to obeticholic acid were considered.