The Pervasive Impact of Pruritus on Quality of Life in Patients with Primary Biliary Cholangitis (PBC): Real World Experience in TARGET-PBC (APASL)

PBC patients report severe pruritus as a primary driver of quality of life impairment, but the multi-domain nature of this burden—across fatigue, cognitive, social, emotional, and other symptom dimensions assessed with validated instruments—had not been quantified in a prospective real-world US cohort.

The TARGET-PBC cohort was analyzed using PBC-40, 5D-Itch, and PROMIS Fatigue instruments to compare domain-level quality of life scores across no-itch, mild-itch, and clinically significant itch patient groups, with covariates adjusted in multivariable analysis.

Demonstrating that clinically significant PBC pruritus is associated with pervasive, multi-domain quality of life impairment—particularly cognitive and social—provides the clinical meaningfulness evidence for anti-pruritic endpoints and supports regulatory arguments for PRO-based benefit demonstration in PBC trials.

PRO-based clinical meaningfulness evidence for PBC pruritus endpoints, Multi-domain quality of life burden characterization in PBC for regulatory strategy, Patient burden data supporting anti-pruritic drug development and label claims