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Kidney Week

Abstract: FR-OR26

Itch Reduction with Difelikefalin Correlates with Improved Sleep Quality in Hemodialysis Patients with Pruritus

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Weiner, Daniel E., Tufts Medical Center, Boston, Massachusetts, United States
  • Walpen, Sebastian, Vifor Pharma Ltd, Glattbrugg, Zurich, Switzerland
  • Schaufler, Thilo, Vifor Pharma Ltd, Glattbrugg, Zurich, Switzerland
  • Morin, Isabelle, Vifor Pharma Ltd, Glattbrugg, Zurich, Switzerland
  • Wen, Warren, Cara Therapeutics Inc, Stamford, Connecticut, United States
  • Menzaghi, Frederique, Cara Therapeutics Inc, Stamford, Connecticut, United States
  • Bhaduri, Sarbani, Bhaduri Biotech Consulting, El Paso, Texas, United States
  • Germain, Michael J., Baystate Medical Center, Springfield, Massachusetts, United States
Background

CKD–associated pruritus (CKD-aP) may impair sleep of hemodialysis (HD) patients. This analysis of a Phase 3 open-label study evaluated if itch reduction in HD patients treated with the investigational, peripherally restricted kappa opioid receptor agonist, difelikefalin (DFK), correlated with improved sleep quality.

Methods

222 patients with moderate-to-severe CKD-aP received intravenous DFK 0.5 mcg/kg thrice weekly for up to 12 weeks. Change in itch intensity from baseline to week 12 was evaluated by weekly mean of the 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) score (range 0 [no itch] to 10 [worst itch imaginable]). Impact of pruritus on sleep quality was evaluated by the change from baseline to week 12 in weekly mean of the 24-hour Sleep Quality Questionnaire (SQQ) score (0 [did not interfere] to 10 [completely interfered]), and the sleep disability question score from the 5-D Itch (1 [never affects sleep] to 5 [delays falling asleep and frequently wakes me up at night]) at baseline and week 12. Spearman’s correlation analysis was performed.

Results

At week 12, most patients achieved a ≥3-point reduction in WI-NRS (74%) and SQQ score (66%). Patients with a ≥3-point (vs <3-point) reduction in WI-NRS had greater reductions in mean SQQ score (−5.22 vs −1.53) and 5-D Itch sleep question score (−1.83 vs −0.78) from baseline to week 12. There was a strong correlation between changes in WI-NRS and SQQ scores from baseline to week 12 (r=0.78) (Figure) and a moderate correlation between changes in WI-NRS and 5-D Itch sleep question scores during this period (r=0.48). Week 12 SQQ and 5-D Itch sleep disability question scores were strongly correlated (r=0.64).

Conclusion

Itch reduction with DFK correlated with improvements in sleep quality as evaluated by the SQQ and 5-D Itch sleep disability question.

Funding

  • Commercial Support