Safety profile of elafibranor versus placebo in primary biliary cholangitis: A systematic review, meta-analysis, and trial sequential analysis of randomized controlled trials.

What was studied

This was a pooled analysis of safety for elafibranor in primary biliary cholangitis (PBC). PBC is a long-term autoimmune liver disease of the small bile ducts. Elafibranor, approved in 2024, is a second-line drug. No pooled randomized safety data had been gathered. The team pooled 3 trials. They had 274 patients, 183 on elafibranor and 91 on placebo.

What they found

Elafibranor did not differ significantly from placebo on any safety outcome. The main outcome was any adverse event, with a risk ratio of 1.06. Trends favored elafibranor for itching and fatigue. Nausea and treatment-related events rose a little, but not significantly. Certainty was moderate, lowered only for imprecision. Sequential analysis found futility for any adverse event, but 9 outcomes were underpowered.

What it means for patients

The authors said elafibranor shows a broadly reassuring safety profile. They saw encouraging trends toward less itching and fatigue. They said the evidence is not enough for firm conclusions on rare or long-term safety. They called for larger trials with enough power.

Why it is not certain yet

Only 3 trials were pooled, with 274 patients. 9 of 10 outcomes lacked enough information. Rare and long-term safety signals cannot be judged yet. A pooled review is only as strong as the trials in it.

Source

Safety profile of elafibranor versus placebo in primary biliary cholangitis: A systematic review, meta-analysis, and trial sequential analysis of randomized controlled trials.

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