Abstract: PO0805
Safety and Efficacy of Difelikefalin in Black or African American Patients on Hemodialysis with CKD-Associated Pruritus: Pooled Analysis of KALM-1 and KALM-2
Session Information
- Dialysis Care: Epidemiology and the Patient Experience
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 701 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Fishbane, Steven, Northwell Health, Great Neck, New York, United States
- Clegg, Deborah J., Texas Tech Medical Center, Rick Francis School of Medicine, El Paso, Texas, United States
- Lerma, Edgar V., University of Illinois at Chicago, Chicago, Illinois, United States
- Rastogi, Anjay, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, United States
- Budden, Jeffrey J., Vifor Pharma Group, Redwood City, California, United States
- 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
- Topf, Joel M., Oakland University William Beaumont School of Medicine, Rochester, Michigan, United States
Background
Difelikefalin (DFK) is an investigational, peripherally restricted, selective kappa-opioid receptor agonist that significantly reduced itch intensity in hemodialysis (HD) pts with CKD–associated pruritus (CKD-aP) in the Phase 3 KALM-1 and KALM-2 trials. People of Black or African American (AA) race were well represented in these studies. This pooled analysis reports efficacy and safety of DFK in Black or AA pts.
Methods
HD pts with moderate-to-severe CKD-aP were randomized to intravenous DFK 0.5 mcg/kg or placebo (PBO) 3 times/wk for 12 wks. The primary endpoint was the proportion of pts achieving a clinically meaningful ≥3-point improvement from baseline (BL) in the weekly mean of 24-hr daily Worst Itching Intensity Numerical Rating Scale (WI-NRS) scores at wk 12. Secondary endpoints included proportion of pts achieving ≥4-point improvement in WI-NRS score and change in itch-related QoL score (5-D Itch and Skindex-10) from BL to wk 12. Adverse events (AE) through wk 12 were collected.
Results
Of 851 pts randomized in KALM-1 and KALM-2, 249 (29%) pts self-identified as Black or AA (DFK: 135; PBO: 114). Mean BL WI-NRS score was 7.2 and 7.3 in the DFK and PBO groups. A greater proportion of pts who received DFK vs PBO achieved clinically meaningful improvements in itch intensity and itch-related QoL (Figure). Most common treatment-emergent AEs (≥5%) with DFK occurring at ≥1% higher incidence vs PBO were diarrhea (10.4% vs 6.2%), dizziness (10.4% vs 2.7%), vomiting (7.4% vs 4.4%), headache (5.2% vs 0.9%), and hyperkalemia (5.2% vs 2.7%). Serious AE incidence was similar between groups.
Conclusion
DFK significantly reduced pruritus intensity and improved itch-related QoL in Black or AA HD pts with moderate-to-severe CKD-aP. DFK was well tolerated with an acceptable safety profile. The safety and efficacy of DFK in Black or AA pts was similar to the overall population.
Funding
- Commercial Support –