Abstract
Abstract Background and Aims Pruritus associated with chronic kidney disease (CKD-aP) is a debilitating and common symptom in patients with chronic kidney disease on hemodialysis, with a prevalence of moderate to severe pruritus around 40–45%. The pathogenesis is not yet fully understood. It has been formally attributed mainly to abnormal levels of uremic toxins. The most recent data indicate a significant role for the dysregulation of the kappa opioid receptor (KOR) along with an imbalance in the mu-opioid receptor (MOR). Difelikefalin (DFK) is a KOR agonist approved for the treatment of moderate to severe CKD-aP in patients on hemodialysis in the USA, European Union (EU), Switzerland, Canada, Singapore, and Australia. It has shown rapid and sustained improvement in pruritus and is generally very well tolerated. Method We present the real-world experience of DFK in an early access program for patients in a hemodialysis (HD) program three times a week, diagnosed with CKD-aP, receiving the administration of DFK at 0.5 mcg/kg per HD session. A total of 14 HD patients with severe to very severe CKD-aP (WI-NRS >7) and (moderate-severe SADS) were treated with DFK. The severity of itching was assessed using the numerical rating scale (WI-NRS). Quality of life was assessed using the Self-Assessed Disease Severity Score (SADS). Results The results are shown in Table 1. 78.5% of the patients showed a reduction in WI-NRS of at least 3 points within the first 2 weeks and 92% showed a reduction of ≥ 5 points at 4 weeks, with positive effects on the patients' quality of life, describing a change from SADS C (severe deterioration of quality of life) to SADS A (mild deterioration). Conclusion Currently, 11 out of the 14 patients continue with Difelikefalin and maintain a sustained response in both itch intensity and quality of life. The availability of this new treatment, along with a new understanding of the impact of pruritus on our patients, has the potential to significantly improve the lives of patients living with CKD-aP. Sharing the clinical experience of DFK in series like this is important to raise awareness, not only of DFK but also of CKD-aP, particularly in the absence of specific treatments.
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