Hepatology
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See the full rubric →Dose Reduction of Ursodeoxycholic Acid in Primary Biliary Cholangitis Patients With Complete Biochemical Response: An Open-Label Randomized Clinical Trial.
Clinical takeawayContinue standard UDCA dose (13-15 mg/kg/day) in PBC patients with complete biochemical response; reduction to 5 mg/kg/day is unsafe due to high relapse risk. Consider monitoring 10 mg/kg/day cautiously in select patients (future studies needed). Do not reduce below 10 mg/kg/day in remission.
What it foundIn PBC patients with complete biochemical response (Paris-II criteria), reducing UDCA to 5 mg/kg/day increased 12-month relapse to 19.4% vs 0% on standard dose (13-15 mg/kg/day), while 10 mg/kg/day showed no significant difference (2.9% relapse).
ContextChallenges prior uncertainty about UDCA dose reduction safety in remission; confirms standard dose remains gold standard but introduces 10 mg/kg/day as a potential future option if validated.
Refinessuggested applicable standard· American Association for the Study of Liver Diseases, 'Primary Biliary Cholangitis: 2021 Practice Guidance', 2021
Decision at stakethe optimal UDCA dosing strategy in PBC after biochemical remission
American Association for the Study of Liver Diseases, 'Primary Biliary Cholangitis: 2021 Practice Guidance', 2021 · reviewed 2026-07-21 ↗Treat with first-line ursodeoxycholic acid (UDCA) 13-15 mg/kg/d divided, and assess biochemical response at 12 months using Paris-II plus continuous risk scores (Globe, UK-PBC). Escalate to a second-line agent (obeticholic acid [contraindicated in cirrhosis with portal hypertension or prior decompensation], seladelpar, elafibranor, or a fibrate) when response is inadequate, guided by a Child-Pugh/portal-hypertension hard gate, and manage pruritus with a stepwise ladder (cholestyramine → rifampin → sertraline → naltrexone). Refer for transplant evaluation for decompensation, refractory pruritus, or rising bilirubin.
He C … Zhang F · Journal of Gastroenterology and Hepatology · IF 3.5 · PubMed ↗