Research Communication: Real-World Clinical Experience With Seladelpar in Primary Biliary Cholangitis.
Selena Z Kuo, Jeffrey Yin, Rohit Loomba
Abstract
Open AccessSeladelpar recently received accelerated FDA approval for the treatment of primary biliary cholangitis (PBC) but there is limited knowledge regarding its efficacy in real-world clinical practice. This is a study of a cohort of adults with PBC who were started on seladelpar as second-line therapy between October 2024 and March 2025. Of the 18 patients, 11 were trialed on a second-line therapy prior to switching to seladelpar, whereas 7 of the patients started seladelpar as initial second-line therapy. Biochemical response was achieved in 56.3% of patients and normalisation of alkaline phosphatase levels in 31.3% of patients after 1 month of treatment. This study demonstrates the efficacy of seladelpar as a second-line agent in a real-world clinical setting.