A majority of patients with chronic kidney disease-associated pruritus treated with difelikefalin experience a clinically meaningful decrease in itch intensity by 4 weeks, according to new research presented at the European Renal Association (ERA) 59th Congress held in Paris, France, and virtually
In a post hoc analysis of the phase 3 KALM-1 and KALM-2 trials, at least 66% of patients treated with intravenous difelikefalin reported a clinically meaningful response within 4 weeks, Botond Csiky, MD, of the University of Pécs in Hungary, and colleagues reported. By 8 weeks, more than 90% of difelikefalin users had a response. Unlike in the original trials, a clinically meaningful response was defined as a 3 point or more decrease in the Worst-Itching Numerical Rating Scale (WI-NRS), which ranges from 0 to 10. Fewer patients receiving placebo reported a reduction in itch at any time (44% vs 57% of difelikefalin recipients), the investigators reported.
Difelikefalin, a selective kappa-opioid receptor agonist, was approved in 2021 for the treatment of moderate-to-severe pruritus in adults undergoing hemodialysis. It is not recommended for patients on peritoneal dialysis. A recent Japanese study suggests the optimal dose of difelikefalin is 0.5 μg/kg.
Adverse reactions include diarrhea, dizziness, nausea, gait disturbances, falls, hyperkalemia, headache, somnolence, and mental status change.
Csiky B, Walpen S, Schaufler T, Morin I, Wen W, Menzaghi G. Time to improvement of itch intensity in patients with chronic kidney disease-associated pruritus treated with difelikefalin. Presented at: ERA 59th Congress; May 19-22, 2022, Paris, France, and virtual. Abstract MO467.