Seladelpar Effective for Primary Biliary Cholangitis, With or Without Cirrhosis: Presented at EASL

By Alex Morrisson

VIENNA, Austria -- April 16, 2019 -- In a small study of 25 patients with primary biliary cholangitis, treatment with seladelpar reduced levels of alkaline phosphatase, researchers reported here at The International Liver Meeting, the 54th Annual Meeting of the European Association for the Study of the Liver (EASL).

Reductions in alkaline phosphatase were also observed in patients with primary biliary cholangitis who had progressed to Child-Pugh class A cirrhosis, said Marlyn Mayo, MD, University of Texas Southwestern Medical Center, Dallas, Texas.

Patients who received seladelpar 5 mg (uptitration to 10 mg allowed if warranted) were able to reduce alkaline phosphatase by 36% from baseline over the course of 1 year.

Patients who initiated treatment with seladelpar 10 mg achieved a 43% reduction in alkaline phosphatase by the end of 1 year.

“Multiple studies have shown that the lower the alkaline phosphatase is, the better is the patient’s prognosis,” said Dr. Mayo. “Historically these are patients who respond the least to any kind of treatment.

“We found that seladelpar was equally well-tolerated and efficacious in patients with cirrhosis as in those who had primary biliary cholangitis but had not yet progressed to cirrhosis,” she said.

The current study looked at a subset of patients from an earlier trial that included patients with and without cirrhosis. The patients had been diagnosed with primary biliary cholangitis for an average of 11 years.

“The other measurement of successful treatment is how the patient is feeling, so that is why we pay attention to itching or pruritus,” said Dr. Mayo. “About half of patients with primary biliary cholangitis will experience itching -- we don’t understand exactly why it occurs.”

She said that there did not appear to be an association between treatment and pruritus, but she said that since there was no placebo arm, she could not definitively say that the treatment did not exacerbate itching.

Funding for this study was provided by CymaBay Therapeutics.

[Presentation title: Seladelpar for the Treatment of Primary Biliary Cholangitis: Experience With 25 Cirrhotic Patients. Abstract PS-122]

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