Influence of Baseline Itch Severity on Treatment Outcomes With Difelikefalin in Adults With Moderate-to-Severe Pruritus Receiving Maintenance Haemodialysis: An Exploratory Analysis

IF 1.5 4区医学 Q3 NURSING

Journal of renal care Pub Date : 2025-05-06 DOI:10.1111/jorc.70017

Kieran McCafferty, Thilo Schaufler, Pablo Molina, Murray Lowe, Warren Wen, Daniel E. Weiner

{"title":"Influence of Baseline Itch Severity on Treatment Outcomes With Difelikefalin in Adults With Moderate-to-Severe Pruritus Receiving Maintenance Haemodialysis: An Exploratory Analysis","authors":"Kieran McCafferty, Thilo Schaufler, Pablo Molina, Murray Lowe, Warren Wen, Daniel E. Weiner","doi":"10.1111/jorc.70017","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Difelikefalin is well-tolerated and reduces itch among adults undergoing haemodialysis (HD), with chronic kidney disease-associated pruritus (CKD-aP).</p>\n </section>\n \n <section>\n \n <h3> Objective</h3>\n \n <p>This study aims to explore the influence of baseline itch severity on difelikefalin treatment outcomes.</p>\n </section>\n \n <section>\n \n <h3> Design</h3>\n \n <p>Study 3105 (NCT03998163) was a 12-week, phase 3, single-arm, open-label trial assessing safety and effectiveness of difelikefalin 0.5 µg/kg. We report key endpoints from 3105 by baseline itch severity, determined using the Worst Itching Intensity Numerical Rating Scale (WI-NRS [moderate: WI-NRS < 7; severe: WI-NRS ≥ 7]).</p>\n </section>\n \n <section>\n \n <h3> Participants</h3>\n \n <p>Adult participants undergoing maintenance HD (<i>n</i> = 222) with mild-to-moderate CKD-aP (WI-NRS score ≥ 5 at baseline).</p>\n </section>\n \n <section>\n \n <h3> Measurements</h3>\n \n <p>The primary endpoint of 3105 was safety; secondary endpoints included reduction in itch intensity (WI-NRS), and improvements in itch-related quality of life (QoL; 5-D itch scale) and sleep quality (Sleep Quality Numerical Rating Scale).</p>\n </section>\n \n <section>\n \n <h3> Findings</h3>\n \n <p>Mean (SD) age was 57.1 (13.3) years; mean (SD) baseline WI-NRS scores were 6.0 (0.5) and 8.3 (0.9) for participants with moderate (<i>n</i> = 70/222) or severe (<i>n</i> = 152/222) itch, respectively. No treatment-related deaths occurred, and there were no safety concerns according to baseline itch severity. By week 12, both groups reported residual ‘mild itch’ according to mean (SD) WI-NRS scores (moderate: 2.9 [2.2]; severe: 3.1 [2.3]). Approximately one in four participants demonstrated ‘complete response’ in itch reduction (moderate: 27.1%; severe: 25.0%). Clinically relevant improvements in itch-related QoL and sleep quality occurred among both subgroups.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Difelikefalin was well-tolerated and effective in reducing itch in participants with moderate and severe baseline itch, supporting its broad use in a range of individuals on HD with CKD-aP.</p>\n </section>\n </div>","PeriodicalId":16947,"journal":{"name":"Journal of renal care","volume":"51 2","pages":""},"PeriodicalIF":1.5000,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jorc.70017","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of renal care","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/jorc.70017","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"NURSING","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Difelikefalin is well-tolerated and reduces itch among adults undergoing haemodialysis (HD), with chronic kidney disease-associated pruritus (CKD-aP).

Objective

This study aims to explore the influence of baseline itch severity on difelikefalin treatment outcomes.

Design

Study 3105 (NCT03998163) was a 12-week, phase 3, single-arm, open-label trial assessing safety and effectiveness of difelikefalin 0.5 µg/kg. We report key endpoints from 3105 by baseline itch severity, determined using the Worst Itching Intensity Numerical Rating Scale (WI-NRS [moderate: WI-NRS < 7; severe: WI-NRS ≥ 7]).

Participants

Adult participants undergoing maintenance HD (n = 222) with mild-to-moderate CKD-aP (WI-NRS score ≥ 5 at baseline).

Measurements

The primary endpoint of 3105 was safety; secondary endpoints included reduction in itch intensity (WI-NRS), and improvements in itch-related quality of life (QoL; 5-D itch scale) and sleep quality (Sleep Quality Numerical Rating Scale).

Findings

Mean (SD) age was 57.1 (13.3) years; mean (SD) baseline WI-NRS scores were 6.0 (0.5) and 8.3 (0.9) for participants with moderate (n = 70/222) or severe (n = 152/222) itch, respectively. No treatment-related deaths occurred, and there were no safety concerns according to baseline itch severity. By week 12, both groups reported residual ‘mild itch’ according to mean (SD) WI-NRS scores (moderate: 2.9 [2.2]; severe: 3.1 [2.3]). Approximately one in four participants demonstrated ‘complete response’ in itch reduction (moderate: 27.1%; severe: 25.0%). Clinically relevant improvements in itch-related QoL and sleep quality occurred among both subgroups.

Conclusions

Difelikefalin was well-tolerated and effective in reducing itch in participants with moderate and severe baseline itch, supporting its broad use in a range of individuals on HD with CKD-aP.

Abstract Image

查看原文本刊更多论文

基线瘙痒严重程度对接受维持性血液透析的中度至重度瘙痒成人患者用异花铁素治疗结果的影响：一项探索性分析

在接受血液透析（HD）并伴有慢性肾脏疾病相关瘙痒（CKD-aP）的成人中，Difelikefalin耐受性良好，可减轻瘙痒。目的探讨痒痒基线严重程度对异蝇虫素治疗效果的影响。Design Study 3105 （NCT03998163）是一项为期12周的3期、单臂、开放标签试验，评估了异花蓟花素0.5µg/kg的安全性和有效性。我们报告了3105个基线瘙痒严重程度的关键终点，使用最严重瘙痒强度数值评定量表(WI-NRS[中度：WI-NRS < 7；重度：WI-NRS≥7])。接受维持性HD的成人受试者（n = 222）伴有轻度至中度CKD-aP（基线WI-NRS评分≥5）。3105的主要终点是安全性；次要终点包括瘙痒强度降低（WI-NRS）和瘙痒相关生活质量改善(QoL；5维瘙痒量表)和睡眠质量（睡眠质量数值评定量表）。平均（SD）年龄为57.1（13.3）岁；中度瘙痒（n = 70/222）和重度瘙痒（n = 152/222）受试者的WI-NRS基线平均（SD）评分分别为6.0（0.5）和8.3（0.9）。没有治疗相关的死亡发生，根据基线瘙痒严重程度也没有安全性问题。到第12周，两组均根据WI-NRS平均（SD）评分报告残余“轻度瘙痒”(中度：2.9 [2.2]；重度：3.1[2.3])。大约四分之一的参与者在瘙痒减轻方面表现出“完全缓解”(中度：27.1%；严重:25.0%)。两个亚组在瘙痒相关生活质量和睡眠质量方面均有临床相关改善。Difelikefalin在中度和重度基线瘙痒患者中耐受性良好，可有效减少瘙痒，支持其在HD合并CKD-aP患者中的广泛应用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of renal care Nursing-Advanced and Specialized Nursing

CiteScore

3.50

自引率

5.30%

发文量

期刊介绍： The Journal of Renal Care (JORC), formally EDTNA/ERCA Journal, is the official publication of the European Dialysis and Transplant Nursing Association/European Renal Care Association (EDTNA/ERCA). The Journal of Renal Care is an international peer-reviewed journal for the multi-professional health care team caring for people with kidney disease and those who research this specialised area of health care. Kidney disease is a chronic illness with four basic treatments: haemodialysis, peritoneal dialysis conservative management and transplantation, which includes emptive transplantation, living donor & cadavaric transplantation. The continuous world-wide increase of people with chronic kidney disease (CKD) means that research and shared knowledge into the causes and treatment is vital to delay the progression of CKD and to improve treatments and the care given. The Journal of Renal Care is an important journal for all health-care professionals working in this and associated conditions, such as diabetes and cardio-vascular disease amongst others. It covers the trajectory of the disease from the first diagnosis to palliative care and includes acute renal injury. The Journal of Renal Care accepts that kidney disease affects not only the patients but also their families and significant others and provides a forum for both the psycho-social and physiological aspects of the disease.