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Kidney Week

Abstract: TH-PO1191

Long-Term Experience of Treating CKD-Associated Pruritus (CKD-aP) with Difelikefalin at a Large Dialysis Organization in the United States

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Lasky, Rachel A., Fresenius Medical Care, Waltham, Massachusetts, United States
  • Ruessmann, Despina, CSL Vifor Pharma Group, Glattbrugg, Switzerland
  • Ficociello, Linda, Fresenius Medical Care, Waltham, Massachusetts, United States
  • Gil Mir, Maria, Fresenius Medical Care, Bad Homburg, Germany
  • Arens, Hans-Juergen, Fresenius Medical Care, Bad Homburg, Germany
  • Anger, Michael S., Fresenius Medical Care, Waltham, Massachusetts, United States
Background

Difelikefalin (DFK), a selective κ-opioid receptor agonist, is the first medication approved for treatment of moderate-to-severe CKD-aP among patients (pts) on chronic hemodialysis. The ability of DFK to lower itch has been shown in clinical and real-world studies. However, long-term, real-world experience of DFK treatment has not been described. The current analysis aims to describe the routine clinical use of DFK in pts for up to 6 months.

Methods

The analysis included in-center hemodialysis pts aged 18-89 years having 1) DFK initiated between 12/1/2022 and 12/31/2023, 2) completed at least one Worst Itch Numeric Rating Scale (WI-NRS) assessment during the 90 days before DFK treatment start and one during DFK treatment, and 3) received ≥ 30 doses of DFK during the first 12 weeks. Pts were then categorized into groups based on their treatment experience after 12 weeks, including those who 1) continued DFK without a gap, 2) paused treatment for 14-44 days then restarted DFK (short gap), 3) paused treatment for > 44 days then restarted DFK (long gap), and 4) discontinued DFK. Each WI-NRS available was determined to be during treatment with DFK (within 14 days of last DFK treatment) or after DFK treatment.

Results

Of 619 pts included in the analysis (56% male, 44% female), 70 had baseline moderate itch and 549 had baseline severe itch. On average, pts were 66.2 years old with a dialysis vintage of 4.1 years. The mean itch score for all groups before DFK treatment ranged between 8.3 and 8.5. A mean itch reduction of at least 3 points on the WI-NRS assessment while being treated with DFK was observed for each group (Table 1). The mean itch score increased for all groups during a gap in DFK treatment or after discontinuation.

Conclusion

Despite differences in treatment patterns after initial 12 weeks of DFK treatment, all pt groups experienced a reduction in itch while receiving DFK. Mean itch scores also increased in all groups after pausing or discontinuing DFK treatment.

Funding

  • Commercial Support – CSL Vifor