PTU-097 Long-term effect of obeticholic acid on transient elastography and ast to platelet ratio index in patients with pbc

IntroductionThe AST to Platelet ratio (APRI) and transient elastography (TE) have both been identified as being predictive of adverse outcomes in primary biliary cholangitis (PBC). Obeticholic acid (OCA) is a farnesoid X receptor (FXR) agonist indicated for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. Using the randomised, double-blind (DB), placebo (PBO)-controlled Phase 3 study investigating OCA in patients with PBC, along with data from the ongoing open-label extension (OLE) we sought to investigate the effects of OCA on established non-invasive measures of liver fibrosis and outcomes in PBC.MethodWe re-evaluated patients randomised and dosed in OCA 10 mg (n=73), OCA 5–10 mg (n=70, 33 patients titrated from 5 to 10 mg at Month 6), or PBO (n=73) groups during DB treatment. In the OLE, all patients were initially treated with 5 mg OCA with the option to increase to 10 mg (or later decrease) based on response and tolerability every 3 months. Non-invasive measures of liver fibrosis that were assessed were APRI and liver stiffness measurements (LSM) by transient elastography.ResultsAPRI was significantly reduced from baseline to DB Month 12 in both OCA–treated groups compared to PBO (p