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      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

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          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 < 0.001), respectively. Patients’ generic HRQoL EQ-5D-5L mean utility and EQ-5D visual analogue scale scores increased from baseline to 12 weeks: mean changes 0.04 ( p = 0.001) and 2.8 ( p = 0.046), respectively.

          Conclusions

          Patients undergoing haemodialysis with moderate-to-severe CKD-aP receiving difelikefalin reported experiencing clinically meaningful improvements in both their pruritus symptoms and itch-related QoL.

          ClinicalTrials.gov registration number, NCT03998163; first submitted, 7 May 2019.

          Supplementary Information

          The online version contains supplementary material available at 10.1007/s40271-023-00668-1.

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          Most cited references31

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          World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

          (2013)
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            The 5-D itch scale: a new measure of pruritus.

            L Hynan, Gwenda Mayo, V Gabriel … (2010)
            Itching is a subjective and multidimensional experience which is difficult to quantify. Most methodologies to assess itching suffer from being unidimensional, for example only measuring intensity without impact on quality of life, or only measuring scratching activity. None has actually been demonstrated to be able to detect change over time, which is essential to using them as an outcome measure of response to an intervention. The 5-D itch scale was developed as a brief but multidimensional questionnaire designed to be useful as an outcome measure in clinical trials. The five dimensions are degree, duration, direction, disability and distribution. To study the 5-D with respect to validity, reliability and response to change. The 5-D was administered to 234 individuals with chronic pruritus due to liver disease (n = 63), kidney disease (n = 36), dermatological disorders (n = 56), HIV/AIDS (n = 28) and burn injuries (n = 51). The 5-D was administered at baseline and after a 6-week follow-up period. A subset of 50 untreated patients was retested after 3 days to assess test-retest reliability. The 5-D score correlated strongly with a visual analogue score: r = 0.727 at baseline (P < 0.0001), r = 0.868 at the 3-day repeat (P < 0.0001), and r = 0.892 at the 6-week follow-up (P < 0.0001). There was no change in mean 5-D score between day 1 and day 3 in untreated individuals (intraclass correlation coefficient = 0.96, P < 0.0001). The 5-D did, however, detect significant changes in pruritus over the 6-week follow-up period (P < 0.0001). Subanalysis of the different patient groups revealed similar response patterns and scores, with the exception of lower total scores for the burn victims due to lower scores on the distribution domain because they itched only at the site of their burn. The 5-D, therefore, is a reliable, multidimensional measure of itching that has been validated in patients with chronic pruritus to able to detect changes over time. The 5-D should be useful as an outcome measure in clinical trials.
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              Pruritus in haemodialysis patients: International results from the Dialysis Outcomes and Practice Patterns Study (DOPPS).

              Björn Wikström, Jock W. Young, D Mendelssohn … (2006)
              Pruritus affects many haemodialysis (HD) patients. In this study, pruritus and its relationship to morbidity, mortality, quality of life (QoL), sleep quality and patient laboratory measures were analysed in >300 dialysis units in 12 countries. Pruritus data were collected from 18 801 HD patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS) (1996-2004). Analyses were adjusted for age, gender, black race, Kt/V, haemoglobin, serum albumin, albumin-corrected serum calcium, serum phosphorus, 13 comorbidities, depression, years on dialysis, country and facility clustering effects. Moderate to extreme pruritus was experienced by 42% of prevalent HD patients in DOPPS during 2002/2003. Many patient characteristics were significantly associated with pruritus, but this did not explain the large differences in pruritus between countries (ranging from 36% in France to 50% in the UK) and between facilities (5-75%). Pruritus was slightly less common in patients starting HD than in patients on dialysis >3 months. Pruritus in new end-stage renal disease (ESRD) patients likely results from pre-existing conditions and not haemodialysis per se, indicating the need to understand development of pruritus before ESRD. Patients with moderate to extreme pruritus were more likely to feel drained [adjusted odds ratio (AOR) = 2.3-5.2, P < 0.0001] and to have poor sleep quality (AOR = 1.9-4.1, P < or = 0.0002), physician-diagnosed depression (AOR = 1.3-1.7, P < or = 0.004), and QoL mental and physical composite scores 3.1-8.6 points lower (P < 0.0001) than patients with no/mild pruritus. Pruritus in HD patients was associated with a 17% higher mortality risk (P < 0.0001), which was no longer significant after adjusting for sleep quality measures. The pruritus/mortality relationship may be substantially attributed to poor sleep quality. The many poor outcomes associated with pruritus underscore the need for better therapeutic agents to provide relief for the 40-50% of HD patients affected by pruritus.
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                Author and article information

                Contributors
                James Fotheringham:
                ORCID: http://orcid.org/0000-0002-8980-2223
                j.fotheringham@sheffield.ac.uk
                Journal
                Journal ID (nlm-ta): Patient
                Journal ID (iso-abbrev): Patient
                Title: The Patient
                Publisher: Springer International Publishing (Cham )
                ISSN (Print): 1178-1653
                ISSN (Electronic): 1178-1661
                Publication date (Electronic): 9 January 2024
                Publication date PMC-release: 9 January 2024
                Publication date (Print): 2024
                Volume: 17
                Issue: 2
                Pages: 203-213
                Affiliations
                [1 ]School of Health and Related Research, University of Sheffield, ( https://ror.org/05krs5044) Sheffield, UK
                [2 ]Sheffield Kidney Institute, Sheffield Teaching Hospitals NHS Trust, ( https://ror.org/03hwje554) Sheffield, UK
                [3 ]Catalyst Consultants, Poole, UK
                [4 ]Robert-Bosch-Hospital, ( https://ror.org/034nkkr84) Stuttgart, Germany
                [5 ]GRID grid.185648.6, ISNI 0000 0001 2175 0319, Department of Nephrology, Advocate Christ Medical Center, , University of Illinois at Chicago, ; Oak Lawn, IL USA
                [6 ]CSL Vifor, Glattbrugg, Switzerland
                [7 ]CSL Vifor, Rome, Italy
                [8 ]Department of Dermatology, Center for Chronic Pruritus, University Hospital Münster, ( https://ror.org/01856cw59) Münster, Germany
                [9 ]Pines Clinical Research, Pembroke Pines, Hollywood, FL USA
                Author information
                http://orcid.org/0000-0002-8980-2223
                Article
                Publisher ID: 668
                DOI: 10.1007/s40271-023-00668-1
                PMC ID: 10894140
                PubMed ID: 38196014
                SO-VID: 5d64e353-2b7d-4054-a517-d0efb9a5f520
                Copyright © © The Author(s) 2024
                License:

                Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date accepted : 10 December 2023
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100006484, Vifor Pharma;
                Categories
                Subject: Original Research Article
                Custom metadata
                issue-copyright-statement © Springer Nature Switzerland AG 2024

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