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
© 2024. The Author(s)..
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.
Medienart: |
E-Artikel |
---|
Erscheinungsjahr: |
2024 |
---|---|
Erschienen: |
2024 |
Enthalten in: |
Zur Gesamtaufnahme - volume:17 |
---|---|
Enthalten in: |
The patient - 17(2024), 2 vom: 24. März, Seite 203-213 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Fotheringham, James [VerfasserIn] |
---|
Links: |
---|
Themen: |
Clinical Trial |
---|
Anmerkungen: |
Date Completed 26.02.2024 Date Revised 05.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT03998163 Citation Status MEDLINE |
---|
doi: |
10.1007/s40271-023-00668-1 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM366866141 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | NLM366866141 | ||
003 | DE-627 | ||
005 | 20240305232206.0 | ||
007 | cr uuu---uuuuu | ||
008 | 240114s2024 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1007/s40271-023-00668-1 |2 doi | |
028 | 5 | 2 | |a pubmed24n1317.xml |
035 | |a (DE-627)NLM366866141 | ||
035 | |a (NLM)38196014 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Fotheringham, James |e verfasserin |4 aut | |
245 | 1 | 0 | |a Impact of Difelikefalin on the Health-Related Quality of Life of Haemodialysis Patients with Moderate-To-Severe Chronic Kidney Disease-Associated Pruritus |b A Single-Arm Intervention Trial |
264 | 1 | |c 2024 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Completed 26.02.2024 | ||
500 | |a Date Revised 05.03.2024 | ||
500 | |a published: Print-Electronic | ||
500 | |a ClinicalTrials.gov: NCT03998163 | ||
500 | |a Citation Status MEDLINE | ||
520 | |a © 2024. The Author(s). | ||
520 | |a 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 | ||
520 | |a 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) | ||
520 | |a 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 | ||
520 | |a 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 | ||
520 | |a CLINICALTRIALS: gov registration number, NCT03998163; first submitted, 7 May 2019 | ||
650 | 4 | |a Clinical Trial | |
650 | 4 | |a Journal Article | |
650 | 4 | |a Multicenter Study | |
650 | 7 | |a difelikefalin |2 NLM | |
650 | 7 | |a NA1U919MRO |2 NLM | |
650 | 7 | |a Piperidines |2 NLM | |
700 | 1 | |a Guest, Julian |e verfasserin |4 aut | |
700 | 1 | |a Latus, Joerg |e verfasserin |4 aut | |
700 | 1 | |a Lerma, Edgar |e verfasserin |4 aut | |
700 | 1 | |a Morin, Isabelle |e verfasserin |4 aut | |
700 | 1 | |a Schaufler, Thilo |e verfasserin |4 aut | |
700 | 1 | |a Soro, Marco |e verfasserin |4 aut | |
700 | 1 | |a Ständer, Sonja |e verfasserin |4 aut | |
700 | 1 | |a Zeig, Steven |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t The patient |d 2008 |g 17(2024), 2 vom: 24. März, Seite 203-213 |w (DE-627)NLM192619098 |x 1178-1661 |7 nnns |
773 | 1 | 8 | |g volume:17 |g year:2024 |g number:2 |g day:24 |g month:03 |g pages:203-213 |
856 | 4 | 0 | |u http://dx.doi.org/10.1007/s40271-023-00668-1 |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 17 |j 2024 |e 2 |b 24 |c 03 |h 203-213 |