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Kidney Week

Abstract: FR-PO419

Patient-Perceived Benefit of Relief from CKD-Associated Pruritus

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Fishbane, Steven, Northwell Health, Great Neck, New York, United States
  • Schaufler, Thilo, CSL Vifor, Glattbrugg, Switzerland
  • Ruessmann, Despina, CSL Vifor, Glattbrugg, Switzerland
  • Morin, Isabelle, CSL Vifor, Glattbrugg, Switzerland
  • Menzaghi, Frederique, Cara Therapeutics Inc, Stamford, Connecticut, United States
  • Burton, James, University of Leicester Department of Cardiovascular Sciences, Leicester, United Kingdom
Background

Chronic kidney disease-associated pruritus (CKD-aP) is a substantial burden for the physical and mental well-being of patients with kidney failure. Various instruments have been utilized to assess the impact of itch relief in clinical trials, but regular use in dialysis practice is still uncommon.

Methods

Phase-3 double-blind, placebo-controlled clinical studies KALM-1 and KALM-2 evaluated the use of IV difelikefalin (DFK) after each dialysis session for 12 weeks compared to placebo (Pbo).
Itch intensity at baseline was assessed with the weekly average of the Worst Itching Intensity Numerical Rating Scale (WI-NRS, range 0 [no itch] to 10 [worst itch imaginable]) and defined as moderate (KALM-1: >4 to <7; KALM-2 ≥5 to <7; N=378) or severe (≥7; N=473). The 5-D Itch scale (range 5 to 25) assessed itch-related quality of life (QoL) and the Patient Global Impression of Change (PGIC) asked patients after 12 weeks how their itch changed (1 [very much improved] to 7 [very much worse]).

Results

A greater percentage of patients achieved a clinically meaningful improvement on the WI-NRS and 5-D Itch with DFK vs. Pbo. More patients with moderate compared to severe CKD-aP at baseline reported an improvement on the PGIC. While PGIC benefit was relatively consistent with WI-NRS and 5-D Itch for severe patients, it was 1.3 to 1.5 times higher for patients with moderate CKD-aP.

Conclusion

While relatively fewer patients with moderate vs. severe CKD-aP reported clinically meaningful improvements on validated scales WI-NRS and 5-D Itch, the share reporting that they feel very much or much improved is notably higher. Asking patients verbally for their perceived improvement could therefore be more meaningful than clinical scales in daily dialysis practice.

Funding

  • Commercial Support – CSL Vifor