Randomized controlled study of nemolizumab in patients with chronic kidney disease-associated pruritus: NIKAIA-1

Managing pruritus in hemodialysis patients is challenging. Nemolizumab, a monoclonal antibody targeting IL-31, has demonstrated efficacy in atopic dermatitis and prurigo nodularis with fast reduction of pruritus.

To evaluate nemolizumab safety and efficacy for treatment of chronic kidney disease-associated pruritus.

This was a 12-week randomized, placebo-controlled study of nemolizumab (30 mg or 60 mg) Q4W in 258 hemodialysis patients with chronic kidney disease-associated pruritus. Endpoints assessed safety, and efficacy on pruritus, sleep disturbances, and quality of life.

The primary endpoint (proportion of patients with ≥4-point-improvement in Worst Itch-Numerical Rating Scale at week 12) was not met for either nemolizumab dose (60 mg: 47.7% [P = .0686], 30 mg: 38.5% [P = .37]) versus placebo (32.4%). Patient-reported itch-related quality of life improved on Skindex-10 in the 60 mg group vs placebo (nominal P < .01). Onset of action on itch was rapid. At week 4, ≥4-point-improvement in Worst Itch-Numerical Rating Scale was achieved in 24.3% to 26.6% (nemolizumab) compared with 7.4% (placebo). Adverse events related to study drug were comparable among groups.

The primary limitation was the relatively small sample size and duration of follow-up (12 weeks); longer studies would be required to evaluate safety and efficacy of long-term treatment.

Although the primary endpoint was not met, the trial demonstrated a favorable safety profile and signals of reduced pruritus and improved itch-related quality of life in patients with chronic kidney disease-associated pruritus over 12 weeks.