Trauner M, et al. - Utilizing 3-year interim data from the 5-year open-label extension of the pivotal phase 3 POISE trial, researchers assessed the long-term safety and effectiveness of obeticholic acid for patients with primary biliary cholangitis. Two hundred seventeen subjects 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. Obeticholic acid was generally well tolerated and the most common adverse events were pruritus and fatigue. No serious adverse events related to obeticholic acid have been considered. According to interim analyses, in patients with primary biliary cholangitis who are intolerant to or inadequately responsive to ursodeoxycholic acid, long-term effectiveness and safety of obeticholic acid were suggested.