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Kidney Week

Abstract: FR-PO425

Real-World Experience with Difelikeaflin to Treat CKD-Associated Pruritus at a Large Dialysis Organization

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Ruessmann, Despina, Vifor Pharma Management Ltd, Glattbrugg, Zurich, Switzerland
  • Oliveira, Juliana H., Vifor Pharma Management Ltd, Glattbrugg, Zurich, Switzerland
  • Arens, Hans-Juergen, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
  • Lasky, Rachel A., Fresenius Medical Care Holdings Inc, Waltham, Massachusetts, United States
  • Anger, Michael S., Fresenius Medical Care Holdings Inc, Waltham, Massachusetts, United States
  • Ficociello, Linda, Fresenius Medical Care Holdings Inc, Waltham, Massachusetts, United States
Background

Chronic kidney disease-associated Pruritus (CKD-aP), is a common and burdensome symptom in dialysis patients, however it is often overlooked and underestimated. Difelikefalin (DFK) has been shown in phase 3 clinical trials to decrease pruritus among hemodialysis (HD) patients with moderate to severe CKD-aP after 12 weeks of treatment. The goal of this retrospective database analysis is to assess the effectiveness and prescription pattern of DFK in reducing pruritus in HD pts in routine clinical care.

Methods

Patients (Pts) included in the analysis were Fresenius Kidney Care in-center HD pts aged 18-89 who received >1 dose of DFK before 11/15/2022 and were administered >1 Worst Itching Intensity Numerical Rating Scale (WI-NRS) assessment before first DFK administration. Pts who received >30 DFK administrations within 74-84 days were classified as Complete Regimen Group (CRG), while pts with fewer administrations were Incomplete Regimen Group (IRG). Changes in itch were measured by WI-NRS at 12 weeks compared to the baseline (before DFK start). Safety events were collected through routine post-marketing pharmacovigilance reporting methods.

Results

Patients (Pts) included in the analysis were Fresenius Kidney Care in-center HD pts aged 18-89 who received >1 dose of DFK before 11/15/2022 and were administered >1 Worst Itching Intensity Numerical Rating Scale (WI-NRS) assessment before first DFK administration. Pts who received >30 DFK administrations within 74-84 days were classified as Complete Regimen Group (CRG), while pts with fewer administrations were Incomplete Regimen Group (IRG). Changes in itch were measured by WI-NRS at 12 weeks compared to the baseline (before DFK start). Safety events were collected through routine post-marketing pharmacovigilance reporting methods.

Conclusion

At 12 weeks there is a significant difference in WI-NRS scores between CRG and IRG patients (p<0.0001), moreover CRG pts are more likely to continue treatment beyond 12 weeks. Confirming that treatment as prescribed in the pivotal studies ensure more pronounced itch relief and therapy adherence. A better understanding of the reasons for IRG is needed for better patient support.

Funding

  • Commercial Support – CSL Vifor