Author information

Collaborators

• TARGET-PBC Investigators: 

Victor Ankoma-Sey, David Bernstein, Brian Borg, Christopher Bowlus, Robert Brown, Elizabeth Carey, Virginia Clark, Jama Darling, Jonathan Dranoff, Hany Elbeshbeshy, Lisa Forman, Aparna Goel, James Hanje, Stephen Harrison, Sujit Janardhan, Randhir Jesudoss, David Kim, Lindsay King, Charles Landis, Cynthia Levy, Anna Lok, Michael Lucey, Velmir Luketic, Richard Manch, Wong Mark, Marlyn Mayo, Edward Mena, Apurva Modi, Gautham Reddy, K Rajender Reddy, Fedja Rochling, Sergio Rojter, Raymond Rubin, Mark Russo, Mitchell Shiffman, Marina Silveira, Carmen Stanca, Paul Thuluvath, Elizabeth Verna, L Michael Weiss

Affiliations

• 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.

Abstract

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.