Bezafibrate after UDCA improves survival in PBC

Patients with primary biliary cholangitis who received bezafibrate after incomplete response to ursodeolxycholic acid showed lower risk for death or liver transplant, according to a presenter at the Digital International Liver Congress.

“Ursodeoxycholic acid is a first-line treatment for primary biliary cholangitis. As you know, 20% to 30% of patients exhibit incomplete response to UDCA, resulting in poor outcome including death or liver transplantation. Second-line treatment for PBC has been long awaited for these patients,” Atsushi Tanaka, MD, of Teikyo University School of Medicine, Tokyo, Japan, said in his presentation. “Bezafibrate combination therapy in PBC with incomplete response to UDCA is significantly associated with reduced mortality or need for liver transplant”

In Japan, there is a nationwide cohort of patients with PBC who are surveyed regularly and whose data are updated every 3 years by the Japan PBC Study Group.

Tanaka said that bezafibrate is used as “de facto second-line treatment” in those patients with PBC who have an incomplete response to UDCA. In this retrospective study looking at long-term efficacy of bezafibrate, a dual PPARs/PXR agonist with potent anti-cholestatic efficacy, Tanaka and colleagues looked at 8,180 patients, 6,087 of whom received UDCA only and 960 of whom received bezafibrate.

“Overall, patients who had been exposed to bezafibrate were diagnosed in more recent years at a younger age and with higher ALP levels than those who received UDCA only,” Tanaka said.

When comparing those receiving UDCA only with those receiving bezafibrate, Tanaka showed a significant improvement in all-cause mortality (12% vs. 3%), liver-related death (7% vs. 2%) and liver transplant (1% vs. 0.1%; P < .001 for all).

Using Cox regression, Tanaka showed a reduced likelihood of death or transplant when patients received bezafibrate (all-cause death or LT HR = 0.23; 95% CI, 0.15-0.35 and liver-related death or LT HR = 0.21; 95% CI, 0.12-0.37).

“These results indicated that bezafibrate treatment reduced a risk for death or LT by approximately one-fifth compared to UDCA alone,” Tanaka said.

Editor's note: On September 9, we corrected this article to appropriately retract an incorrect brand named with the drug UDCA. The editors regret this error.