Impact of Difelikefalin on the Health-Related Quality of Life of Haemodialysis Patients with Moderate-To-Severe Chronic Kidney Disease-Associated Pruritus: A Single-Arm Intervention Trial

James Fotheringham (), Julian Guest, Joerg Latus, Edgar Lerma, Isabelle Morin, Thilo Schaufler, Marco Soro, Sonja Ständer and Steven Zeig
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James Fotheringham: University of Sheffield
Julian Guest: Catalyst Consultants
Joerg Latus: Robert-Bosch-Hospital
Edgar Lerma: University of Illinois at Chicago
Isabelle Morin: CSL Vifor
Thilo Schaufler: CSL Vifor
Marco Soro: CSL Vifor
Sonja Ständer: University Hospital Münster
Steven Zeig: Pines Clinical Research

The Patient: Patient-Centered Outcomes Research, 2024, vol. 17, issue 2, No 8, 203-213

Abstract: Abstract Objective Chronic kidney disease-associated pruritus (CKD-aP) can have a substantial negative impact on health-related quality of life (HRQoL), including an increased risk of depression, anxiety and sleep disturbance. This trial aimed to assess the impact of intravenous difelikefalin on HRQoL in haemodialysis patients with moderate-to-severe CKD-aP. Methods Post hoc analysis of an open-label, multicentre, single-arm intervention trial assessed pruritus severity and HRQoL at baseline and at 12 weeks of difelikefalin treatment using Worst Itching Intensity Numerical Rating Scale (WI–NRS), Sleep Quality Numeric Rating Scale (SQ–NRS), 5-D itch scale, Skindex-10 scale, EQ-5D-5L with Pruritus Bolt-On (EQ-PSO). Results A total of 222 patients received ≥ 1 dose of difelikefalin, and 197 patients completed 12 weeks of difelikefalin treatment. Clinically meaningful changes from baseline to 12 weeks were observed in all disease-specific measures: 73.7% of patients achieved a ≥ 3-point reduction in the weekly mean of 24 h WI–NRS scores and 66% of patients experienced ≥ 3-point improvements in SQ–NRS scores. Improvements were also observed in all Skindex-10 scale and 5-D itch scale domain scores. The percentage of patients reporting no problems in all EQ-PSO domains increased from 1.4 to 24.7% (p

Date: 2024
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DOI: 10.1007/s40271-023-00668-1

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