April 18, 2018
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Obeticholic acid improved, stabilized fibrosis after incomplete response to UDCA

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PARIS — Most patients with primary biliary cholangitis who had an incomplete response to ursodeoxycholic acid achieved stabilization or regression of fibrosis after 3 years of treatment with obeticholic acid, according to a presentation at the International Liver Congress 2018.

“PBC, as you know, is an autoimmune liver disease which attacks the bile ducts and the liver and can lead to cirrhosis, liver failure and liver transplantation,” Christopher L. Bowlus, MD, from the University of California at Davis, Sacramento, told Healio Gastroenterology and Liver Disease. “Most patients are treated with ursodeoxycholic acid and many of them have a complete biochemical response, which essentially is normalization of their liver tests.”

The study followed the previous POISE trial and included 13 patients with PBC on UDCA treatment. After 3 years of OCA therapy, six patients improved and five patients maintained histological stage. Two patients’ fibrosis worsened. Of the four patients with baseline cirrhosis, three improved to fibrosis without cirrhosis.

“These data are important because they support the biochemical improvements we saw in the larger POISE trial and further support that obeticholic acid will lead to improved clinical outcomes, which hopefully will be demonstrated clearly in the ongoing COBALT study,” Bowlus said.

For more information:

Bowlus C, et al. LBP-014. Presented at: International Liver Congress; Apr. 11-15, 2018; Paris, France.

Disclosure: Bowlus reports he received grant support from Bristol-Myers Squibb, CymaBay, Genkyotex, Gilead, GlaxoSmithKline and Takeda; and served as an advisor to Conatus, GlaxoSmithKline, Intercept and Patara.