Real-world experience with obeticholic acid in patients with primary biliary cholangitis.

ABSTRACT:

Background & aims

Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions.

Methods

Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria; the secondary endpoint was the biochemical response according to normal range criteria, defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) at 12 months. Safety and tolerability were also assessed.

R

SUBMITTER: D'Amato D 

PROVIDER: S-EPMC7930359 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature