Efficacy and safety of anrikefon in the treatment of diabetic hemodialysis patients with pruritus: a post hoc analysis

Diabetic kidney disease (DKD) is a leading cause of chronic kidney disease worldwide and diabetes predisposes patients to pruritus. Anrikefon is a novel selective peripherally restricted kappa-opioid receptor agonist. This post hoc analysis utilized data from phase 3 anrikefon-302 study to investigate the efficacy and safety of anrikefon in the treatment of diabetic hemodialysis patients with pruritus. This is a post hoc analysis of data collected in a randomized, placebo-controlled phase 3 study. Diabetic hemodialysis patients were included (anrikefon n = 67 and placebo n = 79). The percentage of patients achieving at least a 4-point or 3-point reduction in weekly mean 24 hour worst itching intensity numerical rating scale (WI-NRS) score from baseline to week 12 were analyzed. The changes in itch related quality of life from baseline using the Skindex-10 and 5-D itch scales were also compared. The baseline demographics and characteristics were generally similar in the individual placebo and anrikefon treatment arms. Interestingly, significantly more patients reported a clinically meaningful ≥ 4-point (29.9% versus 15.2%; p = 0.033) and ≥3-point (41.8% versus 20.3%; p = 0.012) reduction from baseline to week 12 in WI-NRS for the anrikefon group versus placebo. Furthermore, the change in WI-NRS score was significantly greater in patients receiving anrikefon treatment than in those in the placebo control group [−2.86 (SE 0.26) versus −1.63 (SE 0.21); p = 0.001]. Moreover, the mean change from baseline in the Skindex-10 itch score at week 12 was −16.25 (SE 1.52) in the anrikefon group and −8.49 (SE 1.36) in the placebo group ( p < 0.001). The mean change from baseline in the 5-D itch score at week 12 was −5.41 (SE 0.45) in the anrikefon group and −3.20 (SE 0.38) in the placebo group. Moreover, the incidence of treatment emergent adverse events was comparable between the two groups. Anrikefon resulted in a noticeable reduction in itch intensity and an improvement in itch related quality of life in diabetic hemodialysis patients with pruritus.