Safety profile of elafibranor versus placebo in primary biliary cholangitis: A systematic review, meta-analysis, and trial sequential analysis of randomized controlled trials.
Naveed Ahmed Khan, Hunain Shahbaz, Muhammad Talha et al.
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In 30 seconds
This systematic review and meta-analysis evaluated the safety profile of elafibranor compared to placebo in patients with primary biliary cholangitis (PBC) who did not adequately respond to first-line therapy. Analyzing data from three randomized controlled trials involving 274 patients, the study found no significant difference in any adverse events (RR 1.06; 95% CI: 0.97-1.16), indicating a reassuring safety profile for elafibranor.
Key findings
- Elafibranor showed no significant difference from placebo for any adverse event (RR 1.06; 95% CI: 0.97-1.16).
- Trends favored elafibranor for pruritus (RR 0.77) and fatigue (RR 0.71).
- GRADE certainty was moderate across outcomes, downgraded for imprecision.
- Trial sequential analysis confirmed futility for any adverse event, indicating underpowered outcomes.
Why it matters
Understanding the safety profile of elafibranor is crucial for clinicians managing PBC patients who do not respond to standard treatments. This study provides evidence that elafibranor is generally safe, which may influence treatment decisions.