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Bezafibrate shows efficacy used in combination with UDCA for PBC

AMSTERDAM — Bezafibrate induced an additional biochemical response in patients with primary biliary cholangitis, improving pruritus and other markers, when used as a complementary therapy in patients who do not respond to ursodeoxycholic acid, according to an expert at the International Liver Congress.

“We show for the first time that co-treatment with fibrate could improve the surrogate markers and especially to prevent liver stiffness progression,” Christophe Corpechot, MD, of Saint-Antoine Hospital, France, said during a press conference. “It’s a point in favor of bezafibrate use.”

Corphechot and colleagues conducted a 2-year, multicenter, double-blind, randomized, placebo-controlled trial of bezafibrate used off-label in conjunction with ursodeoxycholic acid (UDCA). They randomized patients to either receive UDCA with placebo (n = 44) or UDCA with bezafibrate (n = 48). The two groups were similar at baseline.

None of the placebo recipients showed a complete biochemical response but that response was seen in 30% of bezafibrate recipients (P < .0001). Bezafibrate was associated with a number of other biochemical responses, including:

• Bilirubin decreased by 14% with bezafibrate and increased 18% with placebo (P < .0001);
• Alkaline phosphatase decreased by 60% with bezafibrate and did not change with placebo (P < .001);
• Gamma-glutamyl transferase decreased by 38% with bezafibrate and increased by 7% with placebo (P < .001);
• Aspartate aminotransferase decreased by 8% with bezafibrate and increased by 8% with placebo (P < .05);
• Alanine aminotransferase decreased by 36% with bezafibrate and did not change with placebo (P < .0001);
• Albumin remained the same with bezafibrate and decreased by 3% with placebo (P < .05); and
• Cholesterol decreased by 16% with bezafibrate and remained the same with placebo (P < .001).

Corpechot showed that the itch score for participants receiving bezafibrate decreased by 75% while those receiving placebo reported no change in their pruritus.

In looking at fibrosis markers, the bezafibrate group demonstrated a 10% reduction in liver stiffness while the placebo group demonstrated a 14% increase (P < .01). Though not as dramatic, the enhanced liver fibrosis scores decreased by 1% in the bezafibrate arm and increased by 3% with placebo (P < .05).

End-stage liver complications and serious adverse events were similar for the two groups, Corpechot said.

“In PBC patients with inadequate biochemical response to UDCA, adjunctive therapy with bezafibrate is safe, improves pruritus, normalizes biochemical prognostic markers and prevents liver stiffness progression,” Corpechot said. “This supports the use of bezafibrate in combination with UDCA as an effective second-line therapy for PBC.” – by Katrina Altersitz

Reference:

Corpechot C. LBO-01. Presented at: International Liver Congress; April 19-24, 2017; Amsterdam.

Disclosures: Corpechot reports consulting for Intercept Pharma and delivering sponsored lectures for GlaxoSmithKline France.