As second-line therapies for primary biliary cholangitis (PBC) have expanded in recent years, treatment plans should be tailored to the individual patient at an earlier stage, recommends a review recently published in Digestive Diseases and Science.
“In this rapidly evolving treatment landscape, adopting an individualized approach to treatment will become a key factor of care and ensure that patients with PBC who require second-line therapy start as early as possible,” noted the review’s authors.
Treatment in PBC is complicated by the fact that many patients have comorbidities, such as other autoimmune conditions; furthermore, many patients experience symptoms that are not well-controlled by the standard therapy, such as itching and fatigue.
The first-line therapy in PBC is ursodeoxycholic acid (UDCA). While this drug can offer significant symptomatic relief to patients, some do not respond adequately to the medication. After one year of treatment, up to 40% of patients with PBC are considered to have an inadequate response to UDCA, and studies estimate that only 20% of patients on UDCA for one to two years achieve normalization of alkaline phosphatase levels without other liver abnormalities.
Read more about PBC testing and diagnosis
While a patient’s response to UDCA has historically been evaluated after one year of treatment, the review’s authors suggest reducing this time would be beneficial. “After diagnosis, the treatment response to UDCA should be evaluated as early as six months, which would allow for prompt identification of patients with PBC who may benefit from the initiation of second-line therapy,” the review’s authors noted.
Two second-line therapies for PBC are approved by the U.S. Food and Drug Administration: elafibranor and seladelpar. Studies indicate that half of patients treated with elafibranor achieved the primary endpoints of the desired biochemical response. Studies of seladelpar have shown that 62% of patients who took the therapy achieved a composite biochemical response; seladelpar is also associated with reduced pruritus (itching), reduced fatigue and improvements in quality of sleep.
In addition to these therapies, fibrates are also sometimes used off-label to treat PBC.
The review’s authors suggest treatment guidelines should be adopted to reflect the changes in what can now be offered to patients should first-line therapies fail.
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