Primary biliary cholangitis: adding bezafibrate to UA improves response

  • Corpechot C & al.
  • N Engl J Med
  • 7 Jun 2018

  • curated by Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • The biochemical efficacy of bezafibrate, an agonist of peroxisome proliferator-activated receptors (PPARs), plus ursodeoxycholic acid (UA) is superior to placebo plus UA in patients with primary biliary cholangitis who have inadequate response to UA.

Why this matters

  • 40% of patients with primary biliary cholangitis have inadequate response to UA.
  • This study represents the first treatment advance in 2 decades.

Study design

  • Randomized, double-blind, multicenter, placebo-controlled 24-month phase 3 trial of 100 patients with inadequate response to UA, randomly assigned to add-on bezafibrate (400 mg daily) or placebo.
  • Primary outcome was complete biochemical response, defined as normal levels of total bilirubin, alkaline phosphatase, aminotransferases, albumin, and normal prothrombin index.
  • Funding:  Ministry of Health, France;  Arrow Generiques, France.

Key results

  • The bezafibrate group had higher rates of complete biochemical response than the placebo group (31% vs 0%, respectively; P<.001>
  • The bezafibrate group was more likely to have normal levels of alkaline phosphatase (67% vs 2%; difference of 65 percentage points; 95% CI, 47-79).
  • The bezafibrate group had improvements in pruritus, fatigue, noninvasive measures of liver fibrosis similar in extent to the primary outcome (P values not given).
  • Safety:  the bezafibrate group had slightly higher levels of creatinine.

Limitations

  • Clinical outcomes less studied.

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