Difelikefalin improved itch symptoms among patients with CKD-associated pruritus
Difelikefalin treatment reduced itching intensity among patients with chronic kidney disease-associated pruritus, according to data published in Kidney Medicine.
Further, difelikefalin also improved sleep and quality of life among patients.
“CKD-associated pruritus (CKD-aP) is an extremely unpleasant condition that causes unbearable itching, which frequently affects CKD patients undergoing hemodialysis. Difelikefalin, the only treatment approved for CKD-aP in the United States and Europe, has demonstrated reduction of itch severity in phase 3 clinical trials,” Daniel E. Weiner, MD, MS, from the department of medicine at Tufts Medical Center in Boston, and colleagues wrote. “We aimed to assess the expected real-world efficacy and safety of difelikefalin in an open-label study ... , where all participants were aware they were taking an active treatment.”
In an open-label, multicenter, single-arm intervention trial, researchers examined 255 patients (mean age was 58 years; 55% were men; mean dialysis duration was 5.9 years) with moderate to severe CKD-aP on maintenance HD.
Patients were administered 0.5 mcg/kg of difelikefalin through the venous line at the end of each HD session for up to 12 weeks. Researchers observed patients for adverse events, vital signs, 12-leaf electrocardiogram and clinical laboratory values. Patients reported the intensity of itching after taking difelikefalin, which was then measured with 5-D itch and Skindex-10 scales. Sleep after taking difelikefalin was also measured with the sleep quality numerical rating scale.
Among the 255 patients, 197 completed treatments. A total of 16 patients reported treatment-related adverse events, most common of which were somnolence (1.8%), hypoesthesia (1.4%), nausea (0.9%) and dizziness (0.9%).
Researchers observed a clinically meaningful reduction in itch intensity in 74% of patients, with 70% and 63% also reporting a clinically relevant improvement in quality of life. Additionally, 66% of patients reported sleep quality improvement.
“In conclusion, similarly to previous placebo-controlled trial, difelikefalin was well-tolerated and treatment was associated with clinically meaningful improvements in itch intensity, and substantial improvements in sleep quality in most patients, with corresponding improvements in itch-related quality of life among patients undergoing hemodialysis who had CKD-aP,” Weiner and colleagues wrote. “As the first approved treatment for moderate to severe pruritus associated with CKD in adults undergoing HD, difelikefalin appears to be a valuable treatment in this patient population, with [this study] providing important insights into expected real-world safety and effectiveness.”
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