Primary biliary cholangitis (PBC)-autoimmune hepatitis (AIH) overlap syndrome: Characteristics and response to obeticholic acid (OCA) in TARGET-PBC, a diverse, large United States (US) real- world cohort.

Challenge

PBC-AIH overlap syndrome is clinically important and potentially undertreated due to limited awareness, but the prevalence, clinical profile, and response to OCA in overlap patients had not been characterized in a large, real-world prospective US cohort.

Solution

The TARGET-PBC cohort was used to identify overlap syndrome patients based on clinical and serological criteria and compare their characteristics, fibrosis burden, and OCA response to non-overlap PBC patients using descriptive statistics and comparative testing.

Impact

Characterizing that overlap syndrome affects approximately 14% of real-world PBC patients, is associated with more advanced fibrosis, and shows comparable OCA response provides the clinical profile needed to support inclusive trial design and label language for second-line PBC therapies.