Intravenous Difelikefalin may improve pruritus in hemodialysis patients

The key findings of the study are

• A total of 230 patients were screened, of whom 178 were randomly assigned to receive placebo (n=89) or difelikefalin (n=89).

• The change from baseline in the weekly adjusted mean NRS score (95% confidence interval) at week 4 in the placebo and difelikefalin groups was −1.09 (−1.47 to −0.70) and −2.06 (−2.45 to −1.66), respectively.

• The difference between the groups was −0.97 (−1.52 to −0.42), demonstrating that difelikefalin was superior to placebo (P<0.001).

• Prespecified secondary quality-of-life end points showed consistent improvement associated with difelikefalin.

• The incidence of treatment-related adverse events in the placebo and difelikefalin groups was 3 of 89 patients (3%) and 13 of 89 patients (15%), respectively, of which the majority in the difelikefalin group were gastrointestinal (e.g., constipation and abdominal discomfort).

Researchers concluded that “Intravenous difelikefalin reduced itching and improved quality of life in patients with moderate to severe pruritus who were undergoing maintenance hemodialysis.”

Reference: Ichiei Narita, M.D., Ph.D. naritai@med.niigata-u.ac.jp et al; Difelikefalin for Hemodialysis Patients with Pruritus in Japan; NEJM Evid 2023;2(11); DOI: 10.1056/EVIDoa2300094