#1857 Difelikefalin experience in a large dialysis organization in the US: one year follow-up on patients after completion of 12 weeks

Abstract

Abstract Background and Aims Chronic kidney disease associated pruritis (CKD-aP) is a common disorder that negatively impacts a patient's quality of life. Itch can be self-reported using the Worst Itching Intensity Numerical Rating Scale (WI-NRS) where higher numbers indicate more severe itch. Difelikefalin (DFK) has been shown to reduce itch in hemodialysis (HD) patients with moderate to severe CKD-aP in clinical trials. Previously, we reported the real-world results of patients who completed 12 weeks of DFK treatment as part of routine clinical care. This current analysis describes the long-term treatment of these 295 patients. Method Fresenius Kidney Care (FKC) in-center HD patients aged 18-89 who received at least 1 dose of DFK before 15 Nov 2022 and were administered a WI-NRS before first DFK administration were assessed. Patients who received 30+ DFK administrations within 74-84 days were classified as complete and are the focus of this analysis. The current analysis focuses on the 3- to 12-month follow-up after first DFK administration to monitor for DFK discontinuation and severity of itch when DKF therapy is discontinued. Results Eighty-one percent of patients (238/295) were administered DFK doses beyond 90 days. These patients treated included 167 patients who received DFK continuously (doses between days 91-101) and 71 who restarted DFK after day 101. Most patients (62%, 148/238) were treated with DKF between days 354 and 365 and 90 (38%, 90/238) stopped before 354 days. Out of those not treated with DFK beyond 90 days (19%, 57/295), 26 patients died or were transferred outside of FKC and 1 received a kidney transplant. Out of the 84 patients previously reported with WI-NRS measured before DFK and during DFK WI-NRS, 29 had follow up WI-NRS scores during times without DFK doses. We observed a decrease in mean itch severity from 8.0 before DFK to 3.2 during DFK and then a return to higher itch severity after DFK was discontinued (7.3). Conclusion In a real-world analysis of patients who completed 12 weeks of DFK therapy, 81% of patients received further DKF administrations. Most patients were treated with DFK between days 354 and 365, although not all patients received continuous DFK therapy. In a subset 29 patients with WI-NRS scores before DFK, during DFK, and after discontinuation, improvements in itch were noted during DFK treatment and a return to severe itch after DFK discontinuation.