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Elafibranor shows sustained improvements in liver biomarkers in patients with primary biliary cholangitis, particularly those with inadequate responses or intolerance to ursodeoxycholic acid.
In a recent analysis from the phase III ELATIVE trial, long-term treatment with Elafibranor (80 mg once daily) markedly improved key biomarkers of cholestasis in patients grappling with primary biliary cholangitis (PBC) beyond the 52-week mark.
PBC is a rare autoimmune liver disorder that arouses bile duct destruction and progressive liver damage. In the ELATIVE trial, patients who hadn’t responded well or couldn’t tolerate ursodeoxycholic acid were randomized to get either Elafibranor (80 mg once daily) or a placebo for at least 52 weeks. The study continued beyond week 52, with patients receiving their assigned treatment for up to 104 weeks. The primary efficacy endpoint at week 52 was biochemical response, defined by a reduction in alkaline phosphatase (ALP) and normalization of total bilirubin.
Efficacy outcomes were also assessed at week 78 for patients with available data. Out of 161 patients initially randomized, 30 patients on Elafibranor and 13 on placebo attended the week 78 visit. At week 78, 70% of patients receiving Elafibranor attained the biochemical response endpoint, compared to none (0%) in the placebo group. Additionally, 19% of patients on Elafibranor experienced ALP normalization, while none (0%) in the placebo group did. Those on Elafibranor depicted a mean decrease in ALP of −135.3 upper limit of normal (ULN), whereas those on placebo had an increase of 31.0 ULN.
Total bilirubin levels dropped by 1.2 μmol/L in the Elafibranor group, while placebo patients had a worsening with an increase of 3.1 μmol/L. Gamma-glutamyl transferase (GGT) levels also improved in the Elafibranor group with a mean reduction of −56.3 ULN, compared to −10.3 ULN in the placebo group. These results suggest that Elafibranor (dual peroxisome proliferator-activated receptor-alpha/delta agonist) continues to yield benefits beyond the initial treatment period, improving important prognostic markers of liver function in PBC-affected patients.
BMJ Journals
P23 Efficacy of elafibranor in primary biliary cholangitis: results from the variable double-blind period of ELATIVE®, a randomised, placebo-controlled phase III trial
Christopher L Bowlus et al.
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