- Difelikefalin (DFK) reduced itching in patients undergoing dialysis 3 times more than placebo, with significant improvement in QoL.
- DFK was well-tolerated and represents an option for the treatment of pruritus in hemodialysis patients.
Why this matters
- Uremic pruritus is prevalent in hemodialysis patients, with no effective treatment.
- DFK is a novel, peripheral kappa opioid receptor-specific agonist for the treatment of pruritus.
- Patients (n=377) were randomly assigned to receive DFK 0.5 mcg/kg or placebo 3 times weekly for 12 weeks.
- The primary endpoint was the proportion of patients achieving ≥3 points improvement from baseline to week 12, in weekly mean 24-hour worst itching intensity numerical rating scale (WI-NRS) scores.
- Secondary endpoints included change in itch-related QoL measured by patient questionnaires and the proportion of patients achieving ≥4 point improvement in WI-NRS score.
- Significantly more patients in the DFK than placebo groups had a ≥3 point improvement (51% vs 28%, respectively; P<.001 or in wi-nrs score and a point improvement vs p reflecting change itch-related qol.>
- Improvement with DFK was detected starting week 1, and QoL measures improved significantly (P<.001>
- Most common adverse events in both groups were diarrhea, dizziness, and vomiting.