Elafibranor Efficacy and Safety in People with Primary Biliary Cholangitis

Primary biliary cholangitis (PBC) is a rare, chronic liver disease characterized by the inflammation and destruction of bile ducts, leading to cholestasis and liver fibrosis. The most common symptoms of PBC include pruritus (itching) and fatigue. If untreated, PBC can progress to cirrhosis, the need for liver transplant, and premature death. The only licensed first-line therapy for PBC is ursodeoxycholic acid (UDCA), however, up to 40% of patients with PBC have an inadequate response to this treatment or are intolerant to it.  

Peroxisome-proliferator-activated receptors (PPARs) regulate bile acid metabolism and inflammation and are a therapeutic target for PBC. Elafibranor is a PPAR agonist exerting effects on both PPARα and PPARδ.  

In this animated video article, we present the findings of the global, double-blind, randomized, placebo-controlled, phase III ELATIVE® clinical trial (NCT04526665), which examined the efficacy and safety of elafibranor in patients with PBC with an inadequate response or intolerance to UDCA. 

Meet the author:

Dr. Kris Kowdley, is Director of Liver Institute Northwest and professor, Elson S. Floyd College of Medicine at Washington State University. He received his B.S. in Biology and Anthropology from Columbia University, and his medical degree from Mount Sinai School of Medicine. He completed his internship and residency at Oregon Health Science University and a Fellowship in Gastroenterology and Hepatology at Tufts University School of Medicine. 

Dr. Kowdley is internationally recognized as a clinician, educator, and researcher in liver disease. He has led several major international clinical trials of new treatments for hepatitis C, primary biliary cholangitis, primary sclerosing cholangitis and metabolic-associated steatohepatitis. 

Dr. Kowdley is the author of more than 1,000 articles, book chapters, reviews, abstracts and commentaries, and his scholarly work has been cited more than 68,000 times (h-index 121), according to Google Scholar. He is on the Web of Science list of “Highly Cited Researchers” (top 1% by citations for field) for 2019−2023. 

Original article:

Kowdley KV, Bowlus CL, Levy C, et al. Efficacy and safety of elafibranor in primary biliary cholangitis. N Eng J Med. 2024;390(9):795–805. doi: 10.1056/NEJMoa2306185.