Relative Change in Itch Intensity Determines Treatment Satisfaction of Patients With CKD-Associated Pruritis

Document Type

Conference Proceeding

Publication Date

10-2024

Publication Title

Journal of the American Society of Nephrology

Abstract

Background: Four in ten patients on hemodialysis (HD) report suffering from moderate or severe CKD-associated pruritus (CKD-aP) and associated conditions such as: sleep problems, fatigue, depressive symptoms, and reduced quality of life. Burden of itch and itch relief are highly subjective. Methods:

HD patients in KALM-1 and -2 (NCT03422653 and NCT03636269) trials received either difelikefalin or placebo 3 times per week for 12 weeks. Itch intensity was assessed with the weekly mean of the Worst Itching Intensity Numerical Rating Scale (WI-NRS; range 0 [no itch] to 10 [worst itch imaginable]) as moderate (KALM-1: >4 to <7; KALM-2 ≥5 to <7) or severe (≥7) at baseline. Patient Global Impression of Change (PGIC) asked patients after 12 weeks how their itch changed (1 [very much improved] to 7 [very much worse]).

This exploratory analysis reports absolute and relative change in WI-NRS relative to PGIC-assessed treatment satisfaction stratified by baseline itch severity independent of treatment exposure. Results:

Patients with moderate or severe CKD-aP at baseline reporting their itch to be “much improved” had a mean reduction of ≥3 WI-NRS points. Those “very much improved” had a mean reduction of ≥4 WI-NRS points (see Figure 1a).

Relative improvement by PGIC category was highly consistent across baseline severity groups, independent of treatment received, with patients reporting their itch having “much improved” seeing a 50% reduction from their baseline WI-NRS value. Those “very much improved” saw a reduction of ~ 70% from baseline (see Figure 1b).

Spearman correlation (95% confidence interval) between the PGIC and relative change in WI-NRS in patients with moderate CKD-aP was 0.63 (0.55 – 0.69) and 0.71 (0.66 – 0.76) in patients with severe CKD-aP at baseline, respectively. Conclusion: While patient-reported treatment satisfaction should be the main goal in subjective conditions such as CKD-aP, this analysis demonstrates that the relative change on the validated WI-NRS scale can offer valuable decision support for nephrology professionals assessing treatment benefit.

Volume

35

Issue

10S

First Page

1238

Comments

Kidney Week, American Society of Nephrology, October 24-27, 2024, San Diego, CA

DOI

10.1681/ASN.2024aty0cxcc

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