Effectiveness of seladelpar in primary biliary cholangitis patients

A recent study suggests that seladelpar notably decreased pruritus in individuals with moderate to severe pruritus at the baseline. The study’s findings  were published in The New England Journal of Medicine.

In this phase 3, double-blind, placebo-controlled trial, a total of 193 patients (who had an inadequate response to or had a previous medical history of adverse side effects with ursodeoxycholic acid) were randomly assigned in a 2:1 ratio to either receive oral seladelpar at a daily dose of 10 mg or placebo. The primary endpoint of the study was a biochemical response, characterized by an alkaline phosphatase level < 1.67 times the upper limit of normal, showing a reduction of 15% or greater from the baseline, and a normal total bilirubin level by the end of the 12^th month. Key secondary endpoints included the normalization of alkaline phosphatase level at 12^th month  and the change in pruritus numerical rating scale score from baseline to 6^th month among patients with a baseline score of at least 4 (denoting moderate-to-severe pruritus).

A higher proportion of patients in the seladelpar group experienced a biochemical response compared to those in the placebo group (61.7% vs. 20.0%). Additionally, a larger percentage of patients who were treated with seladelpar saw normalization of alkaline phosphatase levels in comparison to those who received a placebo (25.0% vs. 0%). Seladelpar also led to a more significant decrease in pruritus numerical rating scale scores than the placebo (-3.2 vs. -1.7).

Therefore, it can be concluded that the proportion of patients achieving a biochemical response and normalization of alkaline phosphatase was significantly higher with seladelpar compared to placebo. Additionally, seladelpar demonstrated a significant reduction in pruritus for primary biliary cholangitis patients experiencing moderate-to-severe pruritus at the baseline.