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Difelikefalin in Chinese patients with chronic kidney disease-associated pruritus
Li Zuo1, Liangying Gan1, Tianjun Guan2
1Department of Nephrology, Peking University People's Hospital, Beijing, China.
Insights
Difelikefalin effectively reduced itching and improved quality of life for Chinese patients with chronic kidney disease-associated pruritus (CKD-aP) undergoing haemodialysis. This study supports difelikefalin as a safe and effective treatment option for this patient group.
Area of Science:
- Nephrology
- Dermatology
- Clinical Pharmacology
Background:
- Chronic kidney disease-associated pruritus (CKD-aP) is a prevalent and distressing condition among patients undergoing haemodialysis.
- Difelikefalin, an intravenous treatment, is approved globally for moderate-to-severe CKD-aP.
Purpose of the Study:
- To evaluate the efficacy and safety of difelikefalin in a Chinese population with CKD-aP receiving haemodialysis.
- To assess the impact of difelikefalin on pruritus intensity and health-related quality of life.
Main Methods:
- A Phase 3, multicentre, randomized, placebo-controlled study with a 12-week double-blind period and an optional 14-week open-label extension.
- Primary endpoint: change in Worst Itching Intensity Numerical Rating Scale (WI-NRS) at Week 4.
- Secondary endpoints included WI-NRS response rates, quality of life measures (5-D itch, Skindex-10), and adverse events.
Main Results:
- Difelikefalin demonstrated a statistically significant reduction in pruritus intensity compared to placebo at Week 4 (mean difference -0.81, P=.0003).
- A higher proportion of patients achieved a clinically relevant ≥3-point improvement in WI-NRS at Week 12 with difelikefalin (48.7%) versus placebo (33.8%).
- Improvements in health-related quality of life were observed, with significant changes in 5-D itch and Skindex-10 scores during the open-label extension.
Conclusions:
- Difelikefalin effectively alleviates pruritus and enhances quality of life in Chinese haemodialysis patients with CKD-aP.
- The safety profile of difelikefalin in this population was consistent with previous findings, with mostly mild to moderate adverse events.
Background:
Chronic kidney disease-associated pruritus (CKD-aP) is a common and debilitating condition in patients receiving in-centre haemodialysis. This study evaluated the efficacy and safety of difelikefalin (a new, intravenous treatment for moderate-to-severe CKD-aP approved in >40 countries) in a Chinese population receiving haemodialysis.
Methods:
This Phase 3, multicentre, randomized placebo-controlled study included a 12-week double-blind treatment period, during which patients received either difelikefalin or placebo, followed by an optional 14-week open-label extension, in which all patients received difelikefalin. Endpoints included change from baseline in the Worst Itching Intensity Numerical Rating Scale (WI-NRS) at Week 4 (primary endpoint), the percentage of patients achieving a clinically relevant ≥3-point change in WI-NRS, patient-reported health-related quality-of-life measures, and incidence of adverse events.
Results:
Difelikefalin-treated patients showed significantly greater improvements in least squares mean change from baseline in WI-NRS at Week 4 of the double-blind period compared with placebo [difelikefalin minus placebo: -0.81 (95% confidence interval: -1.25, -0.37); P = .0003], and patients with ≥3-point improvement in WI-NRS at Week 12 (48.7% versus 33.8%, nominal P = .0235). Difelikefalin also improved health-related quality of life, with clinically relevant changes observed in 5-D itch and Skindex-10 in most patients at Week 4 of the open-label extension (estimated ≥62% and ≥56%, respectively). Adverse events were mostly mild or moderate in severity and generally consistent with the known safety profile of difelikefalin.
Conclusion:
Difelikefalin effectively reduced pruritus intensity and improved quality of life in Chinese patients with CKD-aP receiving haemodialysis, supporting its use in this population.
