2797 Fenofibrate and PSC: A Case Series From a Single Center Liver Registry

Abstract

INTRODUCTION: Background: Primary sclerosing cholangitis (PSC) is a cholestatic liver disease with no current effective therapy. Ursodeoxycholic acid (UDCA) is often used, however it does not slow disease progression despite improvement in serum alkaline phosphatase (ALP). Fenofibrate (FF) improves cholestasis in patients with primary biliary cholangitis (PBC). We present a retrospective single-center case series of Fenofibrate in PSC patients. METHODS: Methods: Patients were identified within a Liver Registry with large-duct PSC on FF. Overlap cases with PBC or autoimmune hepatitis were excluded. The mean age at diagnosis was 39.7 ± 19.2 years; 4 were males, 5 Caucasian and 2 Hispanic. Five had inflammatory bowel disease, five had intra/extrahepatic disease and two had intrahepatic disease. All patients received UDCA. FF was added 5-396 months post diagnosis. RESULTS: Mean ALP pre-FF was 654 U/L ± 646 and after 4-6 months improved by a mean of 176 ± 263.4 U/L; 4/7 patients had ALP reduction with FF and 3 achieved a normal ALP level (Figure 1). MRI post FF was available in five patients; 3 had worsening of strictures after 6-12 months of FF while 2/5 were stable). ERCP was performed for stricture management on 4 patients and 2 required repeat ERCP. One patient developed cirrhosis; no patients developed ascites, encephalopathy, cholangiocarcinoma or hepatocellular carcinoma. One patient had a transplant evaluation for refractory pruritus. Of four with pruritus pre-FF, 1; one had moderate improvement. Of 6 patients with fatigue, 3 had persistence post-FF and 1 had new fatigue. Of 3 patients who had cholangitis pre-FF, 2 had recurrent episodes post-FF. No patients developed myopathy or acute kidney injury. FF was discontinued in one patient due to lack of ALP improvement at 6 months. Amsterdam-Oxford Risk Score (Figure 2) was calculated at time of FF, 4-6 months after FF, and at 1- and 2- years for those with data beyond 6 months. Among the 4 patients with ALP improvement, there was mild improvement in the risk score (not sustained beyond 2 years in 3 patients). CONCLUSION: Conclusion: This case series suggests a potential use for FF in the treatment of PSC. However, despite reduction in ALP, fatigue, pruritus, and recurrent cholangitis persisted and FF did not improve strictures, similar to UDCA studies in PSC. Future aims of this study involve examining elastography data pre- and post-FF. The role of FF in PSC treatment should be examined in larger, longitudinal studies.