While second-line therapy options for patients with primary biliary cholangitis (PBC) have expanded in recent years, more research on their long-term use is needed, according to a recent review published in Biomedicines.
Ursodeoxycholic acid (UDCA) is considered the first-line treatment for PBC, meaning it is typically the initial treatment offered when patients are diagnosed with the disease. However, 30% to 40% of patients continue to experience symptoms after taking the drug, necessitating the use of a second-line therapy.
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Obeticholic acid (OCA) was the first second-line therapy to be approved for patients with PBC in 2016. Although some clinical trials have shown that OCA can reduce markers of disease, the drug has also been linked to side effects including itchiness and severe liver damage. These concerns led to the eventual withdrawal of OCA from the U.S. market in September 2025.
Fibrates, a class of drug including fenofibrate, gemfibrozil and bezafibrate, are an alternative treatment that works by reducing inflammation and regulating liver detoxification. Currently, fibrates can be used off-label for patients with PBC, as they have not yet been approved for the disease. However, evidence has shown that this therapy may improve both symptoms and biochemical markers of PBC.
Long-term safety data on fibrates remains limited, the authors explained. Currently, the American Association for the Study of Liver Diseases advises that patients with decompensated liver disease (a severe, advanced form of liver damage) do not take fibrates until more data is collected.
Seladelpar received accelerated approval in 2024 for individuals with PBC, as several clinical trials have demonstrated that the drug can promote sustained responses. Many patients reported seladelpar improved itching, one of the most common symptoms of PBC.
Lastly, the authors investigated elafibranor, which was approved in 2024 for patients with PBC who do not respond to UDCA. However, formal guidelines do not yet offer recommendations for its use. Studies have shown that it is well-tolerated in most patients and may improve liver function.
The authors noted that until more long-term data is available, treatment choices should be based on an individual patient’s case. “Treatment selection must be tailored, incorporating disease stage, comorbidities, and patient preferences,” the authors concluded. “Regular therapy reassessment and participation in trials or registries remain essential to advance outcome-based care.”
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