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Dialysis Discussion => Dialysis: News Articles => Topic started by: cassandra on December 15, 2019, 08:43:07 AM

Title: Pruritus
Post by: cassandra on December 15, 2019, 08:43:07 AM
Novel Drug Eases Uremic Pruritus   

Jody A. Charnow (https://www.renalandurologynews.com/author/jody-a-charnow-editor-50/)

In a phase 3 trial, difelikefalin, a kappa opioid receptor agonist, significant decreased itching and improved itching-related quality of life among dialysis patients suffering from pruritus.[/font]
WASHINGTON— Difelikefalin, an investigational kappa opioid receptor agonist that acts peripherally, is an effective treatment for pruritus in dialysis patients that leads to improvement in quality of life, according to the findings of the phase 3 KALM-1 trial presented at the American Society of Nephrology’s Kidney Week 2019 meeting.Difelikefalin is the first drug “that has demonstrated efficacy for this frustrating condition,” lead investigator Steven Fishbane, MD, a professor of medicine at the Feinstein Institutes for Medical Research at Northwell Health in Great Neck, New York, told attendees. No recognized standard of care exists for uremic pruritus.For the trial, Dr Fishbane and his collaborators randomly assigned 189 dialysis patients with pruritus to receive treatment with difelikefalin (0.5 mcg/kg) and 188 to receive placebo. The drug is administered intravenously at the end of a dialysis session, and its effects persist until the next dialysis treatment. Dr Fishbane explained that the difelikefalin cannot lead to abuse. “This drug is a small synthetic peptide. It is fully peripherally restricted so it doesn’t get into the CNS [central nervous system],” Dr Fishbane said. The drug has a high affinity for kappa opioid receptors and does not bind to the MU receptor to which the opioid drugs of abuse bind.From baseline to week 12, the proportion of patients achieving a 3-point or greater improvement in weekly mean score on the daily Worst Itch Numeric Rating Scale (WI-NRS) was significantly higher in the difelikefalin than placebo arm (51% vs 28%), Dr Fishbane reported. The difelikefalin group also had a greater proportion of patients who had a 4-point or greater improvement (39% vs 18%).Dr Fishbane also noted that the drug improved itch-related quality of life on 2 validated scales. From baseline to week 12, difelikefalin-treated patients experienced a 35% improvement over placebo using the 5-D Itch Scale and a 43% improvement over placebo using the Skindex-10 instrument.With regard to safety, the drug had a similar adverse event (AE) profile to placebo and was generally well tolerated. An AE of any type occurred in 68.8% of the difelikefalin group and 62.2% of the placebo group. AEs leading to treatment discontinuation occurred in 7.9% and 4.8% of patients, respectively. Serious AEs occurred in 25.9% and 21.8%, respectively.
Title: Re: Pruritus
Post by: Hereware on December 20, 2020, 08:03:17 PM
Is it effective? I'm not sure about it.