Suboptimal response to ursodeoxycholic acid among patients with primary biliary cholangitis and fenofibrate as add-on therapy: a single-centre retrospective study.

INTRODUCTION

Ursodeoxycholic acid (UDCA) is the first-line treatment for primary biliary cholangitis. We aimed to determine the prevalence of suboptimal response to UDCA and to examine the use of fenofibrate as an add-on therapy.

METHODS

This was a retrospective study on all patients with primary biliary cholangitis seen at Gastroenterology and Hepatology Clinic between January 2019 and December 2024.

RESULTS

Data for 59 patients were analysed (median age 62.5 [range 51.0-72.3] years, 78.0% female). More than half (54.2%) of the patients had suboptimal response (i.e. failure to achieve alkaline phosphatase [ALP] ≤1.67 times the upper limit of normal [ULN], total bilirubin less than ULN and ALP decreased by ≥15%) after 1 year of UDCA. Among them, 73.1% continued UDCA monotherapy, whereas the remaining 26.9% received fenofibrate add-on therapy. A significantly greater proportion of patients who received fenofibrate add-on therapy achieved biochemical response (83.3% vs. 14.3%, P = 0.003), ALP normalisation (66.7% vs. 14.3%, P = 0.019) and deep response (i.e. ALP normalisation and total bilirubin ≤0.6 ULN) (33.3% vs. 0%, P = 0.023) compared with patients who continued UDCA monotherapy. After a median follow-up of 56 (19-122) months, seven patients developed cirrhosis, eight patients developed decompensated cirrhosis and three patients had liver-related mortality. There were no liver-related events among patients who achieved a biochemical response after 1 year of UDCA therapy and among patients who were on fenofibrate add-on therapy.

CONCLUSION

Suboptimal response to UDCA is common among patients with primary biliary cholangitis, and fenofibrate add-on therapy can improve biochemical response in these patients.