In patients with primary biliary cholangitis (PBC) with insufficient response to ursodeoxycholic acid, outcomes appear to improve following treatment with fenofibrate, as shown in a single-centre retrospective cohort study.
The study included 59 PBC patients who received a fenofibrate prescription for persistent elevations in alkaline phosphatase (ALP) despite ursodeoxycholic acid treatment. The mean duration of fenofibrate treatment was 44.8 months.
The median time to ALP normalization was 9.5 months in the overall population and 11.2 months among patients who did not meet Paris II criteria prior to fenofibrate therapy.
Following fenofibrate therapy, GLOBE prognostic scores improved significantly, while UK-PBC scores and fibrosis index scores (FIB-4) remained unchanged.
As for safety, fenofibrate was well-tolerated. Notably, only 5 percent of patients discontinued therapy due to liver enzyme elevation.
The findings support the consideration of fenofibrate in the second-line treatment of PBC, according to the researchers. This holds important implications, given that nearly 40 percent of patients with PBC show an incomplete response to initial treatment with ursodeoxycholic acid.
Fenofibrate is a peroxisome proliferator-activated receptor alpha (PPAR-α) agonist and may provide a more cost-effective and accessible alternative to the recently FDA-approved PPAR agonists, the researchers said.