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.