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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Answer

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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