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

Date of Approval: 
2016-03-08 00:00:00
Lay Summary: 
Primary biliary cirrhosis (PBC) is a relatively rare liver disease that causes damage to the bile ducts in the liver leading to serious liver damage. The two most common symptoms of the disease are fatigue and itching. Moderate to severe itching related to PBC can cause severe sleep deprivation resulting in fatigue, depression and even suicidal thoughts. In rare cases, patients with persistent severe pruritus may receive a liver transplant to relieve their symptoms. Not much is known about the characteristics of PBC patients with related itching, the treatment patterns for their itching and use of medications for other conditions, or the time from the appearance of diagnosis of PBC to diagnosis of itching. This disease epidemiology study will describe these characteristics in PBC patients with related itching in a large cohort of patients representative of the UK population.
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.
Application Number: 

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