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Dose Reduction of Ursodeoxycholic Acid in Primary Biliary Cholangitis Patients With Complete Biochemical Response: An
Chengmei He1,2, Yi Wei1, Kunyu Zheng1
1Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, National Clinical Research Center for Dermatologic and Immunologic Diseases, Beijing, China.
Reducing ursodeoxycholic acid (UDCA) dosage in primary biliary cholangitis (PBC) patients in remission is feasible. A 10 mg/kg/day UDCA dose showed similar relapse rates to standard therapy, suggesting a potential dose-reduction strategy.
Area of Science:
- Hepatology
- Clinical Trials
- Pharmacology
Background:
- Ursodeoxycholic acid (UDCA) is the standard treatment for primary biliary cholangitis (PBC).
- Limited evidence exists regarding UDCA dose reduction after achieving biochemical remission in PBC patients.
- This study investigated the safety and feasibility of lowering UDCA dosage in PBC.
Purpose of the Study:
- To assess the safety and feasibility of reducing ursodeoxycholic acid (UDCA) dosage in patients with primary biliary cholangitis (PBC) who have achieved biochemical remission.
- To compare biochemical relapse rates and clinical outcomes at different UDCA doses.
Main Methods:
- An open-label, randomized controlled trial enrolled 96 PBC patients in remission.
- Patients were randomized to continue standard UDCA (13-15 mg/kg/day), reduce to 10 mg/kg/day, or reduce to 5 mg/kg/day.
- The primary endpoint was the biochemical relapse rate within 12 months; secondary endpoints included liver biochemistry, symptoms, and disease scores.
Main Results:
- Biochemical relapse rates within 12 months were 0% for standard dose, 2.9% for 10 mg/kg/day, and 19.4% for 5 mg/kg/day (p=0.008).
- No significant differences were observed in secondary outcomes between groups.
- Prompt re-treatment with standard UDCA doses effectively restored liver function in relapsed patients, with no severe adverse events reported.
Conclusions:
- A 5 mg/kg/day UDCA dose led to a significantly higher relapse rate in PBC patients, requiring close monitoring.
- A 10 mg/kg/day UDCA dose demonstrated no significant difference in relapse rates compared to the standard dose.
- Lowering UDCA to 10 mg/kg/day may represent a viable dose-reduction strategy for PBC, warranting further investigation.