#5500 THE IMPACT OF CHRONIC KIDNEY DISEASE-ASSOCIATED PRURITUS RELIEF ON SKINDEX-10 DISEASE AND SOCIAL FUNCTIONING DOMAINS

Abstract Background and Aims Chronic kidney disease-associated pruritus (CKD-aP) is a serious condition that greatly impacts patients’ quality of life (QoL). Moderate-severe affects up to 47% patients undergoing haemodialysis (HD) [1]. The aim this analysis was assess the impact itch relief on disease social functioning domains Skindex-10 questionnaire in post hoc difelikefalin (DFK) Phase 3 studies with CKD-aP HD. Method Patients moderate-to-severe (mean Worst Itch Numerical Rating Scale [WI-NRS] score ≥4 [KALM-1] or ≥5 [Study 3105 KALM-2]) HD were enrolled randomised 1:1 receive intravenous DFK 0.5 µg/kg placebo (KALM-1 -2) open-label (Study 3105) times/week for 12 weeks. Data from all who completed included present irrespective study drug exposure; data pooled receiving KALM studies. 12-week change baseline subdomains assessed (Q1–3) (Q7–10). Change mood/emotional distress domain has previously been reported (Q4–6) [2]. Results scores available 914 (KALM studies: n = 720; Study 3105: 194). At Week 12, clinically relevant (WI-NRS ≥3-point) (decrease) (KALM: 305; 143) relative mean (± standard error) corresponding improvement 59.7%±2.0 (KALM) 65.9%±2.6 (3105) Skindex-10, compared 18.4%±2.3 30.7%±4.4 <3-point WI-NRS 415 [Figure A]; 51 B]). In addition, much greater QoL ≥3-point improvement, (66.2%±3.5 vs 11%±7.6 studies; 75.5%±4.0 49.4%±8.5 3105). Overall, ranging 64%±2.3 70.2%±2.6 across total scale 15.1%±4.8 35.4%±5.5 at Conclusion analysis, meaningful reduction intensity also achieved substantially both as well overall itch-related QoL.