The abstract is read at the publisher; the summary is JClub's.
One year of elafibranor normalized alkaline phosphatase in phase III ELSPIRE trial patients with primary biliary cholangitis who had incomplete response to ursodeoxycholic acid, targeting ALP ≤ULN (≤120 U/L).
- Why it matters: ALP above ULN reflects active PBC and is linked to worse transplant-free survival, while ALP normalization is associated with better complication-free survival.
- What they did: In the randomized phase III ELSPIRE trial, patients with PBC and ALP >1–1.33× ULN or >1.33–<1.67× ULN received elafibranor for one year, and ALP normalization (≤ULN; ≤120 U/L) was assessed.
- The result: The trial evaluates whether elafibranor can achieve ALP normalization as a treatment goal in this second-line, incomplete-response population.
The findingWhy it mattersWhat they didThe result
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