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Non-Response to Obeticholic Acid Is Associated With Heightened Risks of Developing Clinical Events in Primary Biliary
Nadir Abbas1,2,3, Rachel Smith4, Ellina Lytvyak5
1National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, Centre for Liver and Gastrointestinal Research, University of Birmingham, UK.
Alimentary Pharmacology & Therapeutics
|September 22, 2025
Summary
Biochemical non-response to obeticholic acid (OCA) in primary biliary cholangitis (PBC) patients predicts a higher risk of clinical events. Early identification of non-response is crucial for managing PBC progression and improving patient outcomes.
Area of Science:
- Hepatology
- Clinical Pharmacology
- Gastroenterology
Background:
- Primary biliary cholangitis (PBC) is a chronic liver disease.
- Ursodeoxycholic acid (UDCA) is a first-line therapy for PBC.
- Biochemical non-response to UDCA is linked to poor clinical outcomes.
Purpose of the Study:
- To investigate if biochemical non-response to second-line obeticholic acid (OCA) therapy predicts long-term event-free survival in PBC patients.
- To identify predictors of clinical events in PBC patients treated with OCA.
Main Methods:
- Retrospective analysis of 336 PBC patients initiating OCA across UK, Italy, and Canada (2017-2024).
- Biochemical non-response defined by POISE criteria.
- Clinical events included hepatic decompensation, liver transplantation referral, hepatocellular carcinoma, or death.
Main Results:
- Over 4 years, 64 patients experienced a clinical event.
- Twelve-month biochemical non-response to OCA was associated with a significantly heightened risk of clinical events (HR: 4.50).
- Cirrhosis, hyperbilirubinemia, hypoalbuminemia, and thrombocytopenia were also associated with increased event risk.
Conclusions:
- Biochemical response to OCA stratifies the risk of clinical events in PBC patients.
- While response rates improve over time, discontinuation rates highlight the need for novel treatment strategies.
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