Difelikefalin effective against pruritis in CKD patients

The key findings of this study were:

1. A total of 269 participants were randomly assigned (mean [SD] baseline WI-NRS: 7.1 [1.2]).

2. At week 12, difelikefalin 1.0 mg substantially reduced weekly mean WI-NRS scores compared to placebo (P =.018), with numerical reductions seen with difelikefalin 0.25 and 0.5 mg.

3. At week 12, 38.6% of participants on difelikefalin 1.0 mg had a full response (WI-NRS 0-1) compared to 14.4% on placebo. Difelikefalin improved itch-related quality-of-life indicators by 20%.

4. Dizziness, falls, constipation, diarrhoea, gastroesophageal reflux disease, tiredness, hyperkalemia, hypertension, and urinary tract infection were the most prevalent treatment-emergent side events.

Over a 12-week period, oral difelikefalin 1.0 mg effectively decreased itch in participants with moderate-to-severe pruritus related to stage 3-5 CKD. The findings of this phase 2 trial support the use of kappa opioid receptor activation to treat systemic itch associated with CKD prior to dialysis. These findings support additional investigation of this group, notably advanced CKD patients, as well as the advancement of oral difelikefalin in ongoing phase 3 studies.

Reference: 

Yosipovitch, G., Awad, A., Spencer, R. H., Munera, C., & Menzaghi, F. (2023). A phase 2 study of oral difelikefalin in subjects with chronic kidney disease and moderate-to-severe pruritus. In Journal of the American Academy of Dermatology. Elsevier BV. https://doi.org/10.1016/j.jaad.2023.03.051