Change in Lipids: Characteristics and Response to Obeticholic Acid (OCA) in TARGET-PBC, a Diverse, Large United States (US) Real-world Cohort.

Challenge

OCA and fenofibrate affect lipid metabolism in PBC, but real-world data on lipid changes—both direction and magnitude—associated with these therapies in a diverse, real-world US population with PBC had not been characterized, creating uncertainty for prescribers and sponsors about metabolic safety.

Solution

The TARGET-PBC cohort was analyzed to characterize lipid parameter changes associated with OCA and fenofibrate use, with descriptive and comparative analyses across patient subgroups defined by treatment type and baseline lipid status.

Impact

Providing real-world data on lipid changes associated with OCA and fenofibrate in PBC supports the metabolic safety context for these therapies, informs prescriber guidance, and contributes to the post-authorization safety evidence base for second-line PBC treatments.