ALFASIGMA SPA | MedPath

Obeticholic Acid Shows Long-Term Benefit in Primary Biliary Cholangitis

9 months ago

• COBALT trial data, published in *The American Journal of Gastroenterology*, shows obeticholic acid (OCA) significantly reduces adverse outcomes in PBC patients. • The study compared OCA-treated patients to an external control arm derived from real-world U.S. claims data. • OCA treatment was associated with a 61% lower relative risk of death, liver transplant, or hepatic decompensation (HR, 0.39; P=0.0010). • Findings support the use of external control arms in rare disease trials, where placebo groups pose ethical and practical challenges.