Difelikefalin reduces itch intensity in patients on hemodialysis with pruritus

ByKristine Houck, MA, ELS

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Steven Fishbane

WASHINGTON — Difelikefalin significantly reduced itch intensity and was linked to an increase in quality of life for patients on hemodialysis who had moderate to severe pruritus, according to phase 3 data presented at ASN Kidney Week.

“KALM-1 study is a demonstration that we have the first drug available to be able to treat uremic pruritis. The drug was effective and well tolerated in this difficult population of patients with hemodialysis,” Steven Fishbane, MD, of The Feinstein Institutes for Medical Research at Northwell Health, said at a press conference, here.

In KALM-1, a double-blind, placebo-controlled trial at 56 sites in the United States, 378 patients with moderate to severe pruritus were randomized to receive either an IV bolus of 0.5 µg/kg difelikefalin (CR845, Cara Therapeutics) or placebo three times per week after dialysis. Patients had been on dialysis for more than 3 months.

After 12 weeks, patients who received difelikefalin had reduced itch intensity (51%) compared with placebo (28%) of at least 3 points from baseline in the weekly mean 24-hour daily worst itching intensity numerical rating scale score and at least 4-point improvement of 39% for difelikefalin compared with 18% for placebo. Patients had improved itch-related quality of life scores as measured on the 5-D Itch (35% compared with placebo) and Skindex-10 (43% improvement compared with placebo) questionnaires. Adverse events were similar between groups, with diarrhea, dizziness and vomiting the being the most common reported. – by Kristine Houck, MA, ELS

Reference:

Fishbane S, et al. Abstract FR-OR134. Presented at: ASN Kidney Week; Nov. 7-10, 2019; Washington, D.C.

Disclosure: Fishbane reports he is an investigator for and receives grants from Cara Therapeutics; is a consultant for AstraZeneca, Akebia and Corvidia; receives research funding from AstraZeneca, Corvidia, Akebia and Ardelyx; and receives honoraria from AstraZeneca and Akebia.