Evaluating Elafibranor as a Treatment for Primary Biliary Cholangitis
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on April 26th, 2024
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The destruction of biliary duct in patients with primary biliary cholangitis lead to accumulation of bile which can cause inflammation and ultimately hepatic fibrosis. Ursodeoxycholic acid and obeticholic acid are two approved treatments for the conditions that protect hepatocytes and cholangiocytes from bile acid-induced damage. However, approximately half of the treatment recipient did not respond to the medication. Thus, a study was conducted to assess the possibility of using elafibranor, a PPAR agonist that can reduce the toxicity of bile and decrease inflammation, to manage primary biliary cholangitis.
The phase 3 clinical trial included 161 patients who had been diagnosed with primary biliary cholangitis which either had not been improved by the treatment of ursodeoxycholic acid, or cannot be treated with the first-line therapy due to unacceptable side effects. The average age of the participants were 57 years old and they had been experiencing the disease for an average duration of 8 years. The average alkaline phosphatase, aspartate aminotransferase and alanine aminotransferase level of the population was 321.9 U/liter, 45.7 U/liter and 49.6 U/liter, respectively. Dermatological manifestations of the condition were assessed using the WI-NRS scale, and the participants’ mean score was 3.3 - with 0 indicating no itch, and 10 indicating the worst itch imaginable. The participants were randomly assigned to be treated orally with either placebo or 80 mg of elafibranor daily. After 52 weeks of treatment, the researchers observed that the alkaline phosphatase level had been normalized in 15% of the participants who were treated with elafibranor, and there were no significant changes in those in the placebo group. After the first 4 weeks of treatment, the alkaline phosphatase level had reduced to 40% below the baseline level. In addition, usage of elafibranor was associated with significant improvement in pruritus; however, there was no significant difference in ALT and AST between the two groups.
The phase 3 clinical trial included 161 patients who had been diagnosed with primary biliary cholangitis which either had not been improved by the treatment of ursodeoxycholic acid, or cannot be treated with the first-line therapy due to unacceptable side effects. The average age of the participants were 57 years old and they had been experiencing the disease for an average duration of 8 years. The average alkaline phosphatase, aspartate aminotransferase and alanine aminotransferase level of the population was 321.9 U/liter, 45.7 U/liter and 49.6 U/liter, respectively. Dermatological manifestations of the condition were assessed using the WI-NRS scale, and the participants’ mean score was 3.3 - with 0 indicating no itch, and 10 indicating the worst itch imaginable. The participants were randomly assigned to be treated orally with either placebo or 80 mg of elafibranor daily. After 52 weeks of treatment, the researchers observed that the alkaline phosphatase level had been normalized in 15% of the participants who were treated with elafibranor, and there were no significant changes in those in the placebo group. After the first 4 weeks of treatment, the alkaline phosphatase level had reduced to 40% below the baseline level. In addition, usage of elafibranor was associated with significant improvement in pruritus; however, there was no significant difference in ALT and AST between the two groups.