Scholarlink

Background <p>Chronic kidney disease-associated pruritus (CKD-aP) is a prevalent symptom in hemodialysis (HD) patients, negatively impacting quality of life and sleep. Difelikefalin, a selective κ-opioid receptor agonist, has shown efficacy in short-term trials. We hypothesized that Difelikefalin would demonstrate sustained efficacy and acceptable safety over 12&#xa0;months in a real-world setting for refractory CKD-aP.</p> Methods <p>This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP. Patients received intravenous Difelikefalin (0.5&#xa0;mcg/kg) after each HD session for up to 12&#xa0;months. Pruritus severity (Worst Itch Numeric Rating Scale, WI-NRS), pruritus-related sleep disturbance (Pruritus-Related Sleep Disturbance Scale, PSDS), quality of life (SF-12) and adverse events were assessed at baseline (T0), 6&#xa0;months (T6), and 12&#xa0;months (T12).</p> Results <p>A significant reduction in WI-NRS scores was observed from baseline (mean 8.00) to T12 (mean 3.92; p = 0.0001). PSDS scores also significantly improved from baseline (mean 2.90) to T12 (mean 1.17; p = 0.002). No significant changes were observed in SF-12 physical or mental component scores. Twelve patients (60%) completed 12&#xa0;months of treatment. Discontinuation (n = 8, 40%) was due to adverse events (n = 3, 15%; primarily diarrhoea, mild cognitive impairment), mortality (n = 3, 15%; unrelated cardiovascular events), and patient refusal (n = 2, 10%).</p> Conclusions <p>In this real-world cohort of HD patients with refractory CKD-aP, 12&#xa0;months of Difelikefalin treatment significantly reduced pruritus severity and associated sleep disturbance. Despite a 40% discontinuation rate, the safety profile was consistent with previous reports. These findings support Difelikefalin as a long-term therapeutic option, although larger studies are needed to confirm these results.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Real-world effectiveness and tolerability of difelikefalin over 12 months for hemodialysis-associated pruritus

  • 期刊论文

  • 发表日期：

    2025年12月23日

查看全文
  • M. Di Giovanni,
  • C. P. Piccinni,
  • F. Tagliente,
  • F. Urciuolo,
  • P. Fulignati,
  • B. Bonerba,
  • F. Pesce,
  • G. Grandaliano

摘要

Background

Chronic kidney disease-associated pruritus (CKD-aP) is a prevalent symptom in hemodialysis (HD) patients, negatively impacting quality of life and sleep. Difelikefalin, a selective κ-opioid receptor agonist, has shown efficacy in short-term trials. We hypothesized that Difelikefalin would demonstrate sustained efficacy and acceptable safety over 12 months in a real-world setting for refractory CKD-aP.

Methods

This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP. Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months. Pruritus severity (Worst Itch Numeric Rating Scale, WI-NRS), pruritus-related sleep disturbance (Pruritus-Related Sleep Disturbance Scale, PSDS), quality of life (SF-12) and adverse events were assessed at baseline (T0), 6 months (T6), and 12 months (T12).

Results

A significant reduction in WI-NRS scores was observed from baseline (mean 8.00) to T12 (mean 3.92; p = 0.0001). PSDS scores also significantly improved from baseline (mean 2.90) to T12 (mean 1.17; p = 0.002). No significant changes were observed in SF-12 physical or mental component scores. Twelve patients (60%) completed 12 months of treatment. Discontinuation (n = 8, 40%) was due to adverse events (n = 3, 15%; primarily diarrhoea, mild cognitive impairment), mortality (n = 3, 15%; unrelated cardiovascular events), and patient refusal (n = 2, 10%).

Conclusions

In this real-world cohort of HD patients with refractory CKD-aP, 12 months of Difelikefalin treatment significantly reduced pruritus severity and associated sleep disturbance. Despite a 40% discontinuation rate, the safety profile was consistent with previous reports. These findings support Difelikefalin as a long-term therapeutic option, although larger studies are needed to confirm these results.