1University of Texas Southwestern Medical Center, Dallas, TX, USA.
2Mayo Clinic, Phoenix, AZ, USA.
3GlaxoSmithKline, Brentford, Middlesex, UK.
4Target RWE, Durham, NC, USA.
5GlaxoSmithKline, Collegeville, PA, USA.
6GlaxoSmithKline, RTP, Raleigh, NC, USA.
7Stanford University, Stanford, CA, USA.
8University of California, Davis, Sacramento, CA, USA.
9University of Miami, Miami, FL, USA. CLevy@Med.Miami.edu.
Background and aims: Patients with primary biliary cholangitis (PBC) often suffer with pruritus. We describe the impact of pruritus on quality of life and how it is managed in a real-world cohort.
Methods: TARGET-PBC is a longitudinal observational cohort of patients with PBC across the USA. Data include information from medical records for three years prior to the date of consent up to 5 years of follow-up. Enrolled patients were asked to complete patient-reported outcome surveys: PBC-40, 5-D itch, and the PROMIS fatigue survey. Kruskal-Wallis tests were used to compare differences in symptoms between groups.
Results: A total of 211 patients with completed PRO surveys were included in the current study. PRO respondents were compared with non-respondents in the TARGET-PBC population and were broadly similar. Pruritus was reported in 170 patients (81%), with those reporting clinically significant pruritus (30%) scoring worse across each domain of the PBC-40 and 5-D itch, more frequently having cirrhosis, and having significantly greater levels of fatigue. Patients reporting clinically significant pruritus were more likely to receive treatment, but 33% had never received treatment (no itch = 43.9%, mild itch = 38.3%).
Conclusions: The prevalence of pruritus was high in this population, and those reporting clinically significant pruritus had a higher likelihood of having advanced disease and worse quality of life. However, this study found that pruritus in PBC is under-treated. This may be due in part to ineffectiveness of current treatments, poor tolerance, or the lack of FDA-approved medications for pruritus.