S2677 Real-World Clinical Experience With Seladelpar in Primary Biliary Cholangitis

Introduction: Ursodeoxycholic acid is the only first-line therapy for primary biliary cholangitis (PBC). However, up to 40% of patients do not achieve an adequate biochemical response with ursodeoxycholic acid, which increases risk of disease progression and liver-related death. Seladelpar, a peroxisome proliferator-activated receptor delta agonist, recently received approval for treatment of PBC but there is limited knowledge regarding its efficacy in real-world clinical practice. Methods: This is a longitudinal study of a cohort of adults with PBC who were started on seladelpar as second-line therapy. The primary end point evaluated was biochemical response and the secondary endpoint was normalization of the alkaline phosphatase level. Results: 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 56.2% of patients and normalization of alkaline phosphatase levels in 31.3% of patients after one month of treatment. Conclusion: In this cohort study of PBC patients, with a subset of patients who have been exposed to prior second-line therapy, we demonstrate that seladelpar elicited biochemical responses in real-world clinical practice.