Patients with primary biliary cholangitis (PBC) who respond well to ursodeoxycholic acid (UDCA) may be able to take a lower dose without losing disease control, suggests a small randomized trial — but cutting the dose too far could substantially increase the risk of relapse.
Over 12 months, patients who reduced UDCA from the standard 13-15 mg/kg/day to 10 mg/kg/day had outcomes similar to those who stayed on the standard dose, while nearly 20% of those taking 5 mg/kg/day experienced a return of disease activity, researchers reported in the Journal of Gastroenterology and Hepatology.
Stopping UDCA altogether does not appear to be a viable option. In an earlier prospective study cited by the authors, disease activity returned in 92% of patients who discontinued the drug, compared with 15% who continued treatment. The new trial instead explored whether patients could reduce their medication burden while remaining on therapy.
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Researchers assigned 117 patients who had achieved remission to one of three UDCA doses: the standard 13-15 mg/kg/day, 10 mg/kg/day, or 5 mg/kg/day. They followed patients for a year, checking them at six and 12 months for signs that the disease was becoming active again.
The lowest dose appeared to be too little for some patients. Six of 31 patients taking 5 mg/kg/day experienced a return of disease activity; in comparison, only one of the 35 patients taking 10 mg/kg/day had disease relapse, and none of the 30 patients who remained on the standard dose saw disease activity return.
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Despite the numerical difference, the gap between the 10 mg/kg/day and standard-dose groups was not statistically significant, meaning the authors couldn’t definitively say if the relapses among the 10 mg/kg/day group were due to the dose size or random chance.
Patients with clear liver enzyme elevations improved after resuming the standard UDCA dose, with their levels returning to the study’s target range within three months.
The authors wrote that a modest reduction “may be a potential dose-reduction strategy, though further studies are needed for confirmation.” They noted that a larger group of patients and longer follow-up period would help provide clearer information.
