P2373 - The Addition of Fenofibrate to Ursodiol Improves Levels of Alkaline Phosphatase Among Patients with Primary Biliary Cholangitis That Do Not Respond to Ursodeoxycholic Acid Monotherapy

Award: Presidential Poster Award

Oreoluwa Adekunle, MD, Udita Gupta, MD, Malcolm Chapman, MD, Joshua Richman, MD, PhD, Meagan Gray, MD, Sujan Ravi, MD
University of Alabama at Birmingham, Birmingham, AL

Introduction: Primary biliary cholangitis(PBC) is a progressive liver disease with immune-mediated destruction of small bile ducts. Ursodeoxycholic acid(UDCA) is the standard therapy with inadequate response described in 30-40% of patients. Elevated alkaline phosphatase(AP) and bilirubin are poor prognostic markers for these patients. Peroxisome proliferator–activated receptor(PPAR) agonists, like fenofibrate, are used off-label for patients with inadequate response and associated with transaminase elevation. This study evaluates the role of fenofibrate in patients with inadequate response to UDCA monotherapy and its influence on transaminases.

Methods: We performed a retrospective chart review of patients with PBC at our institution. Demographic data and labs were collected at 12 and 24 months from initial diagnosis, presentation, or initiation of UDCA monotherapy. Primary outcome was a change in AP levels. Secondary outcomes were changes in bilirubin, Alanine transaminase(ALT), and Aspartate transaminase(AST) levels.

Results: A total of 138 patients were included in the study and were predominantly female (91.3%) and Caucasian(81.9%). 12 months post UDCA monotherapy - mean AP, bilirubin, ALT, and AST were 186U/L,1.23U/L, 33.6U/L, and 41.4U/L respectively. 20 patients(14.5%) were started on fenofibrate after 12 months of monotherapy with UDCA. Patients started on fenofibrate had higher AP levels (242U/L vs 176U/L, p = 0.02) compared to those on UDCA alone, but bilirubin (1.16mg/dL vs 1.24mg/dL, p=0.81) ALT (34U/L vs. 31U/L, p=0.73), and AST (38 U/L vs.42 U/L, p = 0.65) were similar. 24 months after therapy, there were no differences in AP(174U/L vs. 149U/L, p=0.40), bilirubin(0.78mg/dL vs 1.44mg/dL, p=0.44), ALT(30U/L vs. 30U/L, p=0.98), and AST(33U/L vs.40U/L, p = 0.52) in patients who received fenofibrate in addition to UDCA compared to those with UDCA monotherapy. Patients on combination therapy with fenofibrate had a higher decrease in their AP levels than those on UDCA(63.4U/L vs 19.1U/L, p = 0.0462). The change was not significant for bilirubin (-0.30mg/dL vs. 0.38mg/dL, p=0.3971) ALT (4.07U/L vs. 1U/L, p=0.6791), or AST (2.02U/L vs. 3.25U/L, p = 0.9203).

Discussion: The addition of fenofibrate to UDCA improves biochemical response among patients with poor response to UDCA, with no significant changes in transaminases. Further larger prospective studies to evaluate the dosing, safety, and effectiveness of fenofibrate would assist in enhancing the therapeutic options for the management of PBC.


Disclosures:


Oreoluwa Adekunle, MD, Udita Gupta, MD, Malcolm Chapman, MD, Joshua Richman, MD, PhD, Meagan Gray, MD, Sujan Ravi, MD. P2373 - The Addition of Fenofibrate to Ursodiol Improves Levels of Alkaline Phosphatase Among Patients with Primary Biliary Cholangitis That Do Not Respond to Ursodeoxycholic Acid Monotherapy, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.