Gastroenterology ·
Elafibranor Normalizes ALP in Phase III PBC Trial
In the phase III, double-blind ELSPIRE trial, 92 patients with primary biliary cholangitis and ALP levels above normal but below 1.67 times ULN were randomized to elafibranor or placebo for 52 weeks. ALP normalization occurred in 85.3% of patients receiving elafibranor and 23.3% receiving placebo; the study assessed biochemical rather than clinical outcomes.
- ALP normalized in 85.3% with elafibranor versus 23.3% with placebo.
- The trial randomized 92 patients for 52 weeks.
- Reported outcomes were biochemical; clinical outcome effects were not established.
Alkaline phosphatase (ALP) above the upper limit of normal (ULN) is associated with active primary biliary cholangitis (PBC), while normalization is associated with better complication-free survival. The phase III ELSPIRE trial evaluated elafibranor in patients with PBC whose ALP was >1 to <1.67 times ULN after an incomplete response to, or intolerance of, ursodeoxycholic acid (UDCA). Ninety-two patients were randomized double-blind, 2:1, to elafibranor 80 mg (n=62) or placebo (n=30) for 52 weeks.
At week 52, ALP had normalized (≤120 U/L) in 85.3% of the elafibranor group and 23.3% of the placebo group, a treatment difference of 62.0 percentage points (95% CI 44.3–79.7; p<0.0001). Mean percentage change in ALP was −36.5% with elafibranor and −4.2% with placebo. More elafibranor-treated patients also achieved a complete biochemical response. The treatment was described as well tolerated, with no new safety signals observed.
The findings support an effect on biochemical markers in this patient group. The 52-week trial was small and reported ALP and other laboratory endpoints; the supplied results do not establish effects on complications, transplant-free survival, or other clinical outcomes. The findings alone do not establish a change in treatment guidance.
In practice
For patients with PBC and ALP >1 to <1.67 times ULN after an incomplete response to or intolerance of UDCA, this 52-week randomized trial found substantially more ALP normalization with elafibranor than placebo. This is evidence of a biochemical effect in a relatively small study; the reported results do not establish improved clinical outcomes such as fewer complications or longer transplant-free survival. The findings alone do not justify changing treatment guidance.
AI-generated clinical interpretation · Not editor-reviewed
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Hepatology: Treatment with elafibranor to normalize alkaline phosphatase in patients with primary biliary cholangitis and incomplete response to ursodeoxycholic acid: Results from the phase III randomized controlled ELSPIRE trial ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.