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TUESDAY, Nov. 12, 2019 (HealthDay News) — For patients undergoing hemodialysis who have moderate-to-severe pruritus, difelikefalin is associated with a significant reduction in itch intensity and improvement in itch-related quality of life, according to a study published online Nov. 8 in the New England Journal of Medicine<\/i>. The research was published to coincide with Kidney Week, the annual meeting of the American Society of Nephrology, held from Nov. 5 to 10 in Washington, D.C.<\/p>\n
Steven Fishbane, M.D., from Donald and Barbara Zucker School of Medicine at Hofstra-Northwell in Great Neck, New York, and colleagues conducted a randomized, double-blind phase 3 trial in which 378 patients undergoing hemodialysis with moderate-to-severe pruritus were randomly assigned to receive either intravenous difelikefalin or placebo three times per week for 12 weeks (158 and 165 patients, respectively).<\/p>\n
The researchers found that 51.9 and 30.9 percent of patients in the difelikefalin and placebo groups, respectively, had a decrease of at least 3 points on the 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS). The imputed percentage of patients with at least a 3-point decrease in the WI-NRS score was 49.1 and 27.9 percent in the difelikefalin and placebo groups, respectively. From baseline to week 12, difelikefalin resulted in significant improvement in itch-related quality of life as measured by the 5-D itch scale and the Skindex-10 scale.<\/p>\n
“Treatment with difelikefalin for 12 weeks resulted in a marked and rapid reduction in itch intensity among patients undergoing hemodialysis who had chronic kidney disease-associated pruritus,” the authors write.<\/p>\n
The study was funded by Cara Therapeutics, the manufacturer of difelikefalin.<\/p>\n
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