For patients with primary biliary cholangitis (PBC) needing a second-line treatment, elafibranor was found to be more effective at improving liver test results, seladelpar lowered the risk of itching, and obeticholic acid showed similar effectiveness to both elafibranor and seladelpar but was linked to a higher risk of severe side effects, according to a study published recently in Liver International.
The standard treatment for PBC is ursodeoxycholic acid (UDCA), which prevents progression of PBC and liver damage. But UDCA is not fully effective for everyone: Up to 40% of patients do not have a complete response to the treatment, and some patients cannot tolerate the medication due to its side effects. In these cases, a second therapy (called a “second-line treatment”) is needed.
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Research comparing these second-line treatments is limited. “As of today, no direct, head-to-head study compared the safety and efficacy of second-line treatments for patients with PBC, and therefore there is no evidence that may potentially guide treatment decisions,” the study’s authors noted.
To better understand the effectiveness and safety of second-line treatments for PBC, researchers analyzed data from three clinical trials involving patients who had an incomplete response to or could not tolerate UDCA. Each trial compared a different second-line treatment — elafibranor, obeticholic acid (OCA) or seladelpar — to a placebo. In total, 570 patients participated across the three studies.
The researchers found that all second-line treatments for PBC helped improve liver test results, but there were some important differences:
- Elafibranor was slightly more effective than seladelpar in improving liver test results at 52 weeks.
- Seladelpar was the only treatment that reduced the risk of itching.
- OCA was about as effective as the other two drugs, but was more likely to cause itching and serious side effects.
The authors suggested that until more research is available, the best second-line treatment for a patient depends on that patient’s individual case. “While waiting for evidence generated by real-world comparison studies … we feel that the results of this [analysis] may inform decisions regarding second-line treatment of patients with PBC and help better tailor treatment to patients’ needs,” the authors noted.
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