Research Communication: Real‐World Clinical Experience With Seladelpar in Primary Biliary Cholangitis

Seladelpar 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.

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Publication Details

Journal
Alimentary Pharmacology & Therapeutics
Published
2025-10-29
DOI
https://doi.org/10.1111/apt.70435
Primary Topic
Liver Diseases and Immunity
Type
article
Field-Weighted Citation Impact
0.00

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article

Research Communication: Real‐World Clinical Experience With Seladelpar in Primary Biliary Cholangitis

Jeffrey Yin, Rohit Seth Loomba, Selena Z. Kuo
Alimentary Pharmacology & Therapeutics
Liver Diseases and Immunity
article

Research Communication: Real‐World Clinical Experience With Seladelpar in Primary Biliary Cholangitis

Jeffrey Yin, Rohit Seth Loomba, Selena Z. Kuo
article en

Abstract

Seladelpar 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.

Alimentary Pharmacology & TherapeuticsVol. 63(5)
University of California San Diego (US)
National Heart, Lung, and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases, National Center for Advancing Translational Sciences
Openalex Percentile: Top 58%
Liver Diseases and Immunity
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