Long-Term Safety and Efficacy of Obeticholic Acid in Patients With Primary Biliary Cholangitis: Final Results of the POISE Long-Term Safety Extension.
Aliment Pharmacol TherJul 14, 2026 (epub)
Clinical ResearchGastroenterology
Christopher L Bowlus, Frederik Nevens, Kris V Kowdley et al.
✦ AI-curated · Sources linked
In 30 seconds
The study evaluated the long-term safety and efficacy of obeticholic acid (OCA) in patients with primary biliary cholangitis (PBC) who had inadequate response or intolerance to ursodeoxycholic acid (UDCA). This multicenter, phase III randomized controlled trial included 193 patients over five years. The primary endpoint response rate was 63% at Month 72, with a favorable safety profile.
Key findings
- The most common treatment-emergent adverse event was pruritus, occurring in 70% of patients.
- Serious hepatic-related treatment-emergent adverse events were reported in 3% of patients.
- The response rate for the primary endpoint was 63% at Month 72.
- Liver stiffness remained stable throughout the study duration.
Why it matters
Understanding the long-term safety and efficacy of OCA is crucial for clinicians managing patients with PBC, particularly those who do not respond adequately to UDCA. This data can inform treatment decisions and patient management strategies.