Published On: 7/20/2022

Real-World Data Finds High Prevalence of Pruritus (Itching) and Fatigue, Low Levels of Treatment in Primary Biliary Cholangitis Population

DURHAM, N.C., July 20, 2022 /PRNewswire/ -- New data from Target RWE's TARGET-PBC cohort found that pruritus (itching) was reported in 81% of patients with Primary Biliary Cholangitis (PBC), with those reporting clinically significant pruritus (30%) scoring worse on each domain of the PBC-40 and 5-D itch, more frequently having cirrhosis, and having significantly greater levels of fatigue. The study, "Impact of Pruritus on Quality of Life and Current Treatment Patterns in Patients with Primary Biliary Cholangitis," was published in the peer-reviewed journal Digestive Diseases and Sciences.

PBC is a chronic liver disease in which bile ducts are slowly destroyed. PBC is associated with debilitating symptoms that affect quality of life, including pruritus and fatigue. The new research from Target RWE and funded by GSK explored the impact of pruritus on quality of life and how it is treated in a real-world setting.

Key findings include:

• 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%).
• When itch medication was used, current treatment guidelines were not usually followed; in this cohort, 69.4% of patients with itch were currently treated with antihistamines despite data that cholestatic itch is not histamine-mediated.
• Only 24% of those with any itch who were receiving treatment for pruritus, and 9% of all patients with any itch reported, were treated with bile acid binding resins, which are recommended as first line therapy by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver.

"Clinically significant itch was associated with worse cognition, fatigue, emotional health, sleep, social life (including isolation, guilt, neglect, and sex life). The impact of itch on quality of life was truly pervasive! It is shocking to see that a third of patients with clinically significant itching have never been on any specific therapy despite the negative impact on quality of life," said Cynthia Levy, M.D., Associate Director for the Schiff Center for Liver Diseases, University of Miami, and study co-author.

"These eye-opening data illustrate the real-world extent, impact, and current management practice patterns of pruritus in PBC patients within the United States. Unfortunately, debilitating itch is prevalent but underestimated, and current options for medical treatment are not fully utilized," said Marlyn Mayo, M.D., Professor of Internal Medicine, University of Texas Southwestern, and study co-author.

"Current treatment options are only partially effective, and none are FDA-approved specifically for the treatment of cholestatic pruritus in patients with PBC. Rigorously designed clinical trials, as well as greater research efforts, are needed to better evaluate and communicate the debilitating impact of pruritus in PBC patients and to identify highly effective therapies needed to provide effective solutions to this significant problem," said Michael W. Fried, M.D., FAASLD, Co-Founder and Chief Medical Officer, Target RWE.

A total of 211 patients with completed patient-reported outcomes (PRO) surveys were included in the study. PRO respondents were compared with non-respondents in the TARGET-PBC population and were broadly similar. Dr. Levy and Dr. Mayo are current members of the TARGET-PBC steering committee, which includes Dr. Levy serving as Chair of the committee.

TARGET-PBC is a longitudinal, observational cohort sponsored by Target RWE of patients with PBC across the U.S., enrolling over 700 participants to date. Real world data is collected from consented participants, who may also provide patient-reported outcome measures and biospecimens. Learn about TARGET-PBC publications here.