What is the role of obeticholic acid in the treatment of primary biliary cholangitis (PBC)?

Updated: Nov 08, 2017
  • Author: Nikolaos T Pyrsopoulos, MD, PhD, MBA, FACP, AGAF; Chief Editor: BS Anand, MD  more...
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In May 2016, the FDA approved obeticholic acid to be used in combination with UDCA for primary biliary cholangitis (PBC) in adult patients with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA. [12] Approval was based on the international phase 3 POISE trial of patients (n = 216) with PBC. The trial included patients who had not shown a reduction in alkaline phosphatase (ALP) levels with UDCA at optimal dosage for at least 1 year or as monotherapy in those who were intolerant to UDCA. The primary endpoint (ie, ALP <1.67 × ULN) was met in 47% of the obeticholic acid 10 mg group and 46% in the titration group (ie, 5-10 mg) compared to 10% in the placebo plus UDCA group (p<0.0001).<ref>13</ref>

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