Primary biliary cholangitis (PBC) is a chronic liver disease characterized by inflammation and destruction of the intrahepatic bile ducts, which transport bile from the liver. Its etiology has an autoimmune component, and if left untreated, it can lead to liver cirrhosis.
This disease has a prevalence of 40 to 50 cases per 100,000 inhabitants. PBC is ten times more common in women than in men and usually manifests between the ages of 35 and 60. This disparity in incidence according to sex is estimated to be due to a greater reactivity of the female immune system, which would lead to a loss of tolerance to biliary autoantigens.
Between 60% and 80% of people with PBC are asymptomatic; the remainder may experience fatigue, pruritus, jaundice, and abdominal pain. The usual treatment consists of administering ursodeoxycholic acid at a dose of about 15 mg per kilogram of body weight. The response rate, defined as the normalization of liver function tests, is approximately 50%. In patients who do not respond to ursodeoxycholic acid, adding bezafibrates to the treatment, achieves a response rate of 30%.
Clinical results of elafibranor in PBC patients
Since September 2024, elafibranor has been approved as a new drug for the treatment of primary biliary cholangitis (PBC) resistant to conventional medications. A study presented at the European Association for the Study of the Liver (EASL) Congress evaluated the use of elafibranor in patients who did not respond adequately to ursodeoxycholic acid. The study included 261 patients with PBC, of whom 28,5% were receiving a combination of bezafibrates and ursodeoxycholic acid. The results showed that 41% of patients achieved normalization of liver function parameters. Elafibranor was generally well tolerated, although abdominal discomfort, diarrhea, and nausea were observed in some cases, leading to treatment discontinuation in only 5% of participants.
In summary, elafibranor is a new drug available for the treatment of PBC that does not respond to standard medications. Both Dr. Carreño and the physicians at the foundation take these results into account and will use elafibranor when indicated for PBC.
