Treatment of pruritus in primary biliary cholangitis

30 June, 2025

Linerixibat, a bile acid transport inhibitor, has shown significant benefits in the treatment of pruritus in primary biliary cholangitis, reducing itching and improving sleep with minimal side effects.

Primary biliary cholangitis is a liver disease that affects the small bile ducts within the liver. When these ducts are damaged, bile accumulates in the liver, causing inflammation and progressive damage that can lead to liver cirrhosis. The exact cause of the disease is unknown, but it is known to primarily affect women, who account for 90% of cases.

Primary biliary cholangitis is considered a rare disease that affects 2 to 40 people out of every 100,000 and accounts for 1-5% of all liver diseases. At the onset of the disease, patients may be asymptomatic, but fatigue, jaundice (yellowing of the eyes and skin), and itchy skin (pruritus) may later develop. Pruritus affects 50–70% of patients with primary biliary cholangitis and can be so severe that scratching can cause erosions on the body and make it difficult to sleep. It is thought to be caused by the accumulation of toxic substances (bile acids).

Various drugs are available for the treatment of itching in primary biliary cholangitis, such as cholestyramine, rifampicin, naltrexone, sertraline, etc., but their effectiveness is limited, so other drugs need to be developed and studied.

Linerixibat as new drug launched

At the Annual Meeting of the European Association for the Study of Liver Diseases, a paper was presented on the efficacy of a new drug (linerixibat) for the treatment of pruritus in primary biliary cholangitis. This drug inhibits the transport of bile acids, which cause pruritus. The study included 238 patients with primary biliary cholangitis who received either 40 mg of linerixibat orally (twice daily) or placebo.

It was found that pruritus decreased significantly in patients treated with the drug compared to those receiving placebo. Furthermore, patients treated with linerixibat also experienced significant improvements in sleep compared to those receiving placebo. Side effects were primarily gastrointestinal (diarrhea and abdominal pain), but only 4% of patients had to discontinue treatment.

Dr. Carreño and the Foundation’s team, think that these results are very promising and believe that linerixibat could be very useful in the treatment of pruritus in primary biliary cholangitis.

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