OBJECTIVES: Primary biliary cholangitis (PBC) is a chronic, cholestatic liver disease characterized by injury of the intrahepatic bile ducts and has debilitating impacts on health and quality of life. The study objectives were to capture PBC patients’ pruritus experience and pruritus impacts and develop a conceptual model for PBC as a disease, including the main related symptoms.

METHODS: Physicians confirmed PBC diagnosis, specifying the stage of disease, and patients reported current and prior treatments. Qualitative concept elicitation interviews were conducted with patients diagnosed with PBC and with clinicians. Interviews were recorded and transcribed, then analyzed for qualitative insights.

RESULTS: Twenty patients (aged 28-68 years) from US and Canada, diagnosed with PBC (mean 10.7 years since diagnosis) and experiencing pruritus, and four clinicians from US and Canada were selected for semi-structured qualitative interviews conducted by qualified, independent researchers. Overall, 41 signs/symptoms and 31 impacts related to PBC were reported across clinicians and patients. Close to half of patients interviewed were in stage 1 (45%) of the disease, and 70% reported experiencing moderate or severe pruritus. Fatigue (95%) was common, and other symptoms included sensitivity to cold, dry eyes, dry mouth, headaches, pain, upper right abdominal pain, skin color change, and skin surface change. Patients also reported PBC was associated with physical, emotional, cognitive, role functioning, social, and other impacts (e.g., sleep, lifestyle changes).

CONCLUSIONS: Pruritus and fatigue have significant impact on quality of life of patients, making it difficult to sleep, leading to mental and physical fatigue. There is a high burden for patients living with PBC and experiencing pruritus, which underscores the unmet needs of this population.