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Combining bezafibrate with UDCA improves long-term PBC prognosis

Adding bezafibrate to ursodeoxycholic acid monotherapy for primary biliary cholangitis improved both GLOBE and UK-PBC scores as well as long-term prognosis, according to retrospective results from the Japan PBC Study Group.

“Our results strongly suggest that [bezafibrate (BF)] has beneficial effects on PBC patients who have an incomplete biochemical response to UDCA monotherapy,” Akira Honda, MD, PhD, from the Medical University Ibaraki Medical Center in Japan, and colleagues wrote. “Most of the biochemical improvement measured in response to BF treatment appears to occur within 1 year.”

Honda and colleagues reviewed data from 118 patients with PBC who had been treated with UDCA for 1 year or more followed by combination therapy with BF. Of the 101 patients with available histology, 88 had early stage PBC.

“BF has been used in Japan as a second-line treatment for more than a decade; and in Western countries, the efficacy of BF against PBC has also been recognized,” the researchers wrote.

After 1 year of combination therapy, the mean GLOBE score decreased from 0.508 to 0.115 (P < .0001). Based on GLOBE scores, the 3- and 5-year liver transplant-free rates increased significantly after the addition of BF (P < .0001).

Similarly, the risk for liver transplant or liver-related death within 5 years decreased significantly according to UK-PBC scores after combination therapy (P < .0001).

While BF did not reduce the risk for liver transplant or liver-related death in every type of patient, the risks were significantly reduced in patients with normal serum bilirubin (HR = 0.09; 95% CI, 0.01-0.6).

“In the lack of established agents to treat PBC patients who do not respond to UDCA monotherapy, BF has been used empirically for over a decade in Japan,” Honda and colleagues wrote. “These results validate the Japanese guideline that recommends BF as a second-line treatment for PBC that is unresponsive to UDCA monotherapy.” – by Talitha Bennett

Disclosure: The authors report no relevant financial disclosures.