Natural history, characteristics, and treatment patterns in patients with primary biliary cirrhosis and cholestatic pruritis

Date of Approval
Application Number
16_012
Technical Summary

Primary biliary cirrhosis (PBC) is a relatively rare chronic cholestatic liver disease characterized by progressive bile-duct injury from portal and periportal inflammation resulting in progressive fibrosis and eventually cirrhosis. The two most common symptoms of the condition are fatigue and pruritus (itching), which are reported in more than 50% of symptomatic patients. Moderate to severe pruritus can impact activities of daily life and cause severe sleep deprivation resulting in lassitude, fatigue, depression and even suicidal ideation. The characteristics, natural history, and treatment patterns of PBC patients with cholestatic pruritus have not been well characterized in a large representative cohort. This study will provide information on the natural history of disease regarding the timing of occurrence of pruritus diagnoses in the diagnosed PBC population as well as the diagnosis of PBC and other liver conditions among those with pruritus/itching diagnoses, using Kaplan-Meier methods, in a relatively large and representative cohort of UK patients. Additionally, the treatment patterns and use of concomitant medications will be decribed in a contemporary cohort of prevalent PBC patients with and without cholestatic pruritus.

Collaborators

Julia DiBello - Chief Investigator - Merck & Co., Inc.
Kim Gilchrist - Collaborator - GSK