ITCH-E: Pruritus Linked to Worse Health-Related Quality of Life in PBC

Cynthia Levy, MD

Credit: AASLD

Adult patients with primary biliary cholangitis (PBC) who also have pruritus face a significantly greater health-related quality of life burden and activity impairment compared with patients who have no/mild itch, according to findings from a recent study.¹

Results from ITCH-E were presented at The Liver Meeting 2024 from the American Association for the Study of Liver Diseases (AASLD) in San Diego, California, by Cynthia Levy, MD, a professor of medicine in the division of digestive health and liver diseases and associate director of the Schiff Center for Liver Diseases at the University of Miami, and call attention to the various negative effects of moderate/severe itch in patients with PBC.¹

“Individuals living with PBC are commonly impacted by pruritus, which may cause issues with sleep, fatigue, pain, and social isolation,” Levy and colleagues wrote.¹ “About 70% of PBC patients endure pruritus that may be severe, with inadequate treatment options to reduce pruritus.”

The PBC treatment landscape has undergone significant advancements in 2024 with the addition of 2 new second-line therapies, elafibranor (Iqirvo) and seladelpar (Livdelzi). Both were granted accelerated approval by the US Food and Drug Administration as second-line treatment options in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. Historically, available PBC treatments have not been effective in treating pruritus, but early data for the newly approved next-generation peroxisome proliferator-activated receptor agonists suggest they may have a significant impact on itch.^2,3

To assess the impact of pruritus on patients’ health-related quality of life, activity, and work productivity, investigators recruited adults with PBC from a PBC patient advocacy group and a physician panel between December 2023 and March 2024. Enrolled participants were categorized as having no/mild pruritus or moderate/severe pruritus based on the Pruritus Numerical Rating Scale (NRS), using a cutoff of NRS ≥ 4 for the latter.¹

Participants additionally completed the PBC-40, Chronic Liver Disease Questionnaire (CLDQ-PBC), 5-D Itch, EQ-5D-5L, Functional Assessment of Chronic Illness Therapy – Fatigue Short Form (FACIT-Fatigue), and Work Productivity and Activity Impairment (WPAI) questionnaires. A subset of the moderate/severe pruritus group also answered open-ended questions via voice response.¹

In total, the study enrolled 40 patients with no/mild pruritus and 50 patients with moderate/severe pruritus. In the no/mild pruritus group, the mean age was 56.7 years and 85% of patients were female. In the moderate/severe pruritus group, the mean age was 52.1 years and 80% of patients were female.¹

After controlling for confounders, investigators noted the moderate/severe pruritus group had statistically significantly worse mean PBC-40 scores in Symptom, Itch, Fatigue, Cognitive, and Social (all P <.05), but not Emotional (P = .239), domains. This group also had worse scores on FACIT-fatigue (P <.001) and 5D-Itch (P <.001) as well as CLDQ-PBC Total (P <.001) and EQ-5D Index (P = .005).¹

The moderate/severe pruritus group reported statistically significantly greater WPAI activity impairment (P <.001) and lower work status compared with the no/mild pruritus group group (42% vs 53%). Among participants who were employed, the moderate/severe pruritus group reported more work time missed, greater impairment while working, and overall work impairment due to PBC, although investigators pointed out differences in these scores were not significant, potentially attributable to less than half of participants being employed.¹

In the moderate/severe pruritus group, patient voice data highlighted the unrelenting, painful nature of itching and its negative impact on emotional/social health and productivity.¹

“Adults with PBC and moderate/severe itch have a significant burden on HRQoL and impaired activity compared to those with no/mild itch, emphasizing the need for safe and efficacious PBC treatments that can improve pruritus,” investigators concluded.¹

References

1. ^{Levy C, Younossi Z, Ieyoub J, et al. Assessing the Health-related Quality of Life, Impairment and Productivity among Individuals with PBC and Pruritus: Results from the ITCH-E Study. Paper presented at: AASLD’s The Liver Meeting 2024. San Diego, California. November 15-19, 2024.}
2. ^{Brooks, A. FDA Grants Accelerated Approval to Elafibranor (Iqirvo) for PBC. HCPLive. June 10, 2024. Accessed November 17, 2024. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-elafibranor-iqirvo-for-pbc}
3. ^{Brooks, A. FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis. HCPLive. August 14, 2024. Accessed November 17, 2024. https://www.hcplive.com/view/fda-grants-accelerated-approval-to-seladelpar-livdelzi-for-primary-biliary-cholangitis}