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. 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.
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).
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.
"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.
The study was funded by Cara Therapeutics, the manufacturer of difelikefalin.