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Abstract: SA-PO463

Impact of CKD-Associated Pruritus Relief on Mood and Emotional Distress

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Ständer, Sonja, Center for Chronic Pruritus, University of Münster, Münster, Germany
  • Fishbane, Steven, Northwell Health, Great Neck, New York, New York, United States
  • Schaufler, Thilo, Vifor Pharma Ltd, Glattbrugg, Zurich, Switzerland
  • Morin, Isabelle, Vifor Pharma Ltd, Glattbrugg, Zurich, Switzerland
  • Menzaghi, Frederique, Cara Therapeutics Inc, Stamford, Connecticut, United States
  • Wen, Warren, Cara Therapeutics Inc, Stamford, Connecticut, United States
  • Kalantar-Zadeh, Kamyar, University of California Irvine, Irvine, California, United States
Background

Chronic kidney disease-associated pruritus (CKD-aP) is a frequent, unpleasant symptom and a cause of suffering in patients undergoing hemodialysis (HD). The aim of this analysis was to assess the impact of itch relief on mood and depression in patients with CKD-aP based on data from clinical trials with difelikefalin (DFK).

Methods

DFK studies enrolled HD patients with moderate-to-severe CKD-aP (mean worst itching numerical rating scale [WI-NRS] score >4 [KALM-1] or ≥5 [KALM-2 and 3105]). Patients were randomized 1:1 to intravenous DFK 0.5 µg/kg or placebo (KALM) or received open-label DFK (3105) 3 times/week for 12 weeks. The present analysis reports data from all patients completing the studies irrespective of study drug exposure; data were pooled for patients receiving DFK and placebo from the KALM trials. Change from baseline of the mood and depression sub-domain of Skindex-10 was assessed.

Results

Skindex-10 scores were available for 549 patients in KALM and 194 patients in 3105. Patients reporting clinically relevant (≥3-point) change in itch (KALM: n=305; 3105: n=143) reported a corresponding improvement of 72% (3105) and 67% (KALM) in the mood/emotional distress domain of Skindex-10, compared with 33% and 26% for patients with <3-point improvement (KALM: n=244; 3105: n=51) in WI-NRS.

Conclusion

In this study we found that achieving clinically meaningful reductions in itch severity to be associated with significantly greater improvements in mood and depression, as well as in overall itch-related quality of life, for patients with CKD-aP.

Funding

  • Commercial Support –