{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T18:39:56Z","timestamp":1793471996639,"version":"4.5.0"},"reference-count":23,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2025,2,19]],"date-time":"2025-02-19T00:00:00Z","timestamp":1739923200000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,9,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Chronic kidney disease\u2013associated pruritus (CKD-aP), defined as moderate to severe itching directly related to kidney disease, affects about one-third of haemodialysis patients and has been associated with poor quality of life, poor sleep, depression and increased mortality. Difelikefalin (DFK) is the first-in-class therapy approved by Food and Drug Administration and European Medicines Agency for this condition. The aim of the present study was to evaluate DFK efficacy and safety in a real-world setting in Italy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We retrospectively collected data for 20 patients treated with DFK in a compassionate manner, before the drug was commercialized, after obtaining approval by the relevant Ethics Committee for each individual case. Mean age and dialysis vintage were 72\u00a0\u00b1\u00a011 years and 54\u00a0\u00b1\u00a044 months, respectively; basal WI-NRS (24-h Worst Itching Intensity Numerical Rating Scale) score was 8.2 and 5D-ITCH was 18.6. Scratching lesions were detected in 15\/20 patients. DFK was administered intravenously with weight-based dosing at the end of each dialysis session.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Eighteen of 20 patients were treated for 12 weeks; 2 patients stopped treatment for dizziness (n \u00a0=\u00a01) and discomfort (n\u00a0=\u00a01). WI-NRS score improved &amp;gt;3 in 11\/18 (61%) at Week 4 and in 16\/18 (88%) at Week 12. 5D-ITCH decreased from basal 18.6 to 10.5 at Week 12, while sleep quality at the same time points changed from 2.6 to 5.8; scratching lesions disappeared in 12\/15 (80%). Except for the two early therapy breaks, no other side effects were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In haemodialysis patients affected by CKD-aP, DFK is an effective and safe treatment that might clearly improve this distressing and overlooked condition.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ckj\/sfaf050","type":"journal-article","created":{"date-parts":[[2025,2,11]],"date-time":"2025-02-11T15:19:38Z","timestamp":1739287178000},"source":"Crossref","is-referenced-by-count":6,"title":["Difelikefalin for CKD-aP: real world evidence of efficacy and safety in Italian patients"],"prefix":"10.1093","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1027-7049","authenticated-orcid":false,"given":"Filippo","family":"Aucella","sequence":"first","affiliation":[{"name":"Nephrology and Dialysis Unit, Research Hospital \u201cFondazione Casa Sollievo della Sofferenza\u201d Department of Medical Sciences, , San Giovanni Rotondo, FG , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona","family":"Zerbi","sequence":"additional","affiliation":[{"name":"UO Nefrologia e Dialisi, Ospedale di Treviglio \u2013 Asst Bergamo Ovest , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Pia","family":"Monaco","sequence":"additional","affiliation":[{"name":"SS. Annunziata Hospital, G. d'Annunzio University Nephrology and Dialysis Unit, Department of Medicine, , Chieti , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Bonomini","sequence":"additional","affiliation":[{"name":"SS. Annunziata Hospital, G. d'Annunzio University Nephrology and Dialysis Unit, Department of Medicine, , Chieti , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1686-5709","authenticated-orcid":false,"given":"Federico","family":"Alberici","sequence":"additional","affiliation":[{"name":"Nephrology Unit, Spedali Civili Hospital, ASST Spedali Civili of Brescia , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenzo","family":"Losappio","sequence":"additional","affiliation":[{"name":"University of Foggia Nephrology, Dialysis and Transplantation Unit, Department of Medical and Surgical Sciences, , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Stallone","sequence":"additional","affiliation":[{"name":"University of Foggia Nephrology, Dialysis and Transplantation Unit, Department of Medical and Surgical Sciences, , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Tagliente","sequence":"additional","affiliation":[{"name":"U.O.C. Nefrologia, Fondazione Policlinico Universitario A. Gemelli IRCCS Dipartimento di Scienze Mediche e Chirurgiche, , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Urciuolo","sequence":"additional","affiliation":[{"name":"U.O.C. Nefrologia, Fondazione Policlinico Universitario A. Gemelli IRCCS Dipartimento di Scienze Mediche e Chirurgiche, , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Grandaliano","sequence":"additional","affiliation":[{"name":"U.O.C. Nefrologia, Fondazione Policlinico Universitario A. Gemelli IRCCS Dipartimento di Scienze Mediche e Chirurgiche, , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-1643-5213","authenticated-orcid":false,"given":"Francesco","family":"Aucella","sequence":"additional","affiliation":[{"name":"Nephrology and Dialysis Unit, Research Hospital \u201cFondazione Casa Sollievo della Sofferenza\u201d Department of Medical Sciences, , San Giovanni Rotondo, FG , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Nardella","sequence":"additional","affiliation":[{"name":"Nephrology and Dialysis Unit, Research Hospital \u201cFondazione Casa Sollievo della Sofferenza\u201d Department of Medical Sciences, , San Giovanni Rotondo, FG , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4144-2142","authenticated-orcid":false,"given":"Lucio","family":"Manenti","sequence":"additional","affiliation":[{"name":"Azienda Socio-Sanitaria Liguria 5, Nephrology Unit , La Spezia ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,2,18]]},"reference":[{"key":"2025092206121102100_bib1","doi-asserted-by":"crossref","first-page":"185","DOI":"10.1038\/s41581-021-00518-z","article-title":"Patient-centred approaches for the management of unpleasant symptoms in kidney disease","volume":"18","author":"Kamyar","year":"2022","journal-title":"Nat Rev Nephrol"},{"key":"2025092206121102100_bib2","doi-asserted-by":"publisher","first-page":"294","DOI":"10.1080\/0886022X.2020.1744449","article-title":"Could symptom burden predict subsequent healthcare use in patients with end stage kidney disease on hemodialysis care? 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