RANDOMIZED CONTROLLED STUDY OF NEMOLIZUMAB IN PATIENTS WITH CHRONIC KIDNEY DISEASE AND ASSOCIATED PRURITUS: NIKAIA-1.

BACKGROUND: 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. OBJECTIVE: To evaluate nemolizumab safety and efficacy for treatment of chronic kidney disease-associated pruritus (CKD-aP). METHODS: This was a 12-week randomized, placebo-controlled study of nemolizumab (30 mg or 60 mg) Q4W in 258 hemodialysis patients with CKD-aP. Endpoints assessed safety, and efficacy on pruritus, sleep disturbances and quality of life (QoL). RESULTS: The primary endpoint (proportion of patients with ≥4-point-improvement in Worst Itch-Numerical Rating Scale [WI-NRS] at week 12) was not met for either nemolizumab dose (60 mg: 47.7% [P=0.0686], 30 mg: 38.5% [P=0.37]) versus placebo (32.4%). Patient-reported itch-related QoL improved on Skindex-10 in the 60 mg group vs placebo (nominal P<0.01). Onset of action on itch was rapid. At week 4, ≥4-point-improvement in WI-NRS was achieved in 24.3% to 26.6% (nemolizumab) compared with 7.4% (placebo). Adverse events related to study drug were comparable among groups. LIMITATIONS: 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. CONCLUSIONS: Although the primary endpoint was not met, the trial demonstrated a favorable safety profile and signals of reduced pruritus and improved itch-related QoL in patients with CKD-aP over 12 weeks.