Sandra Silvestri, MD, PhD, Chief Medical Officer at Ipsen, discusses the effect of elafibranor on fatigue in patients with primary biliary cholangitis (PBC).
PBC is a chronic, progressive, autoimmune, liver disease in which the bile ducts become inflamed and damaged. This leads to the buildup of bile and causes scarring, cirrhosis, and eventual liver failure. PBC is more common in women. Early symptoms may include fatigue, pruritus, and abdominal pain. As the disease progresses, people with PBC may develop weakness, nausea, diarrhea, swelling in the legs and feet, bone and joint pain, jaundice, dark urine, and xanthomas. It is thought to be caused by a combination of genetic susceptibility and environmental triggers.
Elafibranor Clinical Trial
New data on elafibranor and the ELATIVE clinical trial was recently presented at the 2025 European Association for the Study of the Liver congress. Iqirvo (elafibranor) is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR) agonist that targets PPARα and PPARδ. The activation of these receptors leads to decreased bile toxicity, improves cholestasis, and produces anti-inflammatory effects. ELATIVE (NCT04526665) is a phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of elafibranor 80mg once daily for the treatment of patients with PBC with inadequate response or intolerance to first-line therapy UDCA.
The trial enrolled 161 patients who showed greater improvements in fatigue with elafibranor versus placebo after 52 weeks. This was measured by both the PROMIS Fatigue Short Form 7a questionnaire, which showed 42.9% elafibranor and 31.3% placebo, and the PBC-40 fatigue domain, which showed 22.6% elafibranor and 15.4% placebo. Among patients who had moderate-to-severe fatigue at baseline, 66.7% achieved clinically meaningful improvements with elafibranor compared to 31.3% with placebo. The positive effects of elafibranor on fatigue appear to occur independently of its effect on pruritus.
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To learn more about PBC and other rare autoimmune conditions, visit https://checkrare.com/diseases/autoimmune-and-auto-inflammatory-disorders/