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Kidney Week

Abstract: FR-PO423

Continued Improvement of Itch-Related Quality of Life in CKD-Associated Pruritis (CKD-aP) Patients Treated with Difelikefalin

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Topf, Joel M., Oakland University William Beaumont School of Medicine, Auburn Hills, Michigan, United States
  • Schaufler, Thilo, CSL Vifor, Glattbrugg, Switzerland
  • Jardine, Meg, NHMRC Clinical Trials Centre, Sydney, New South Wales, Australia
  • Ruessmann, Despina, CSL Vifor, Glattbrugg, Switzerland
  • Morin, Isabelle, CSL Vifor, Glattbrugg, Switzerland
  • Menzaghi, Frederique, Cara Therapeutics Inc, Stamford, Connecticut, United States
  • Mccafferty, Kieran, Barts Health NHS Trust, London, London, United Kingdom
Background

Chronic kidney disease-associated pruritus (CKD-aP) is a serious complication seen in patients with kidney failure. Difelikefalin (DFK) has been approved to treat moderate-to-severe CKD-aP in adults on hemodialysis (HD) based on KALM-1 and KALM-2 randomized, double-blind, placebo (Pbo)-controlled phase-3 trials.

Methods

In KALM trials HD patients received either IV DFK or Pbo 3x per week (wk) for 12 wks followed by an up to 52 wks open-label extension (OLE) with all patients receiving DFK. Baseline itch intensity was defined based on the weekly average 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). Itch-related quality of life (QoL) was assessed by the validated 5-D Itch scale (range 5 to 25). This analysis assesses the 5-D Itch total score at the end of the DB period and wk 12 of the OLE.

Results

At wk 12 patients treated with DFK achieved a significantly greater improvement of QoL compared to Pbo, independent of baseline itch intensity (p < .001). After an additional 12 wks therapy in the OLE patients continued to improve, independent of prior exposure to DFK or Pbo and those with severe vs. moderate itch at baseline saw a numerically greater improvement of 5-D Itch scores. Differences between the groups were no longer statistically significant.

Conclusion

Patients with severe CKD-aP benefit from continued treatment with DFK. After an additional 12 wks of treatment they achieve a similar level of benefit as patients with moderate itch severity.

Funding

  • Commercial Support – CSL Vifor