Long-term (68 weeks) administration of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: efficacy and safety data from a phase III study.

Abstract

Background: A phase III clinical trial in Japanese children aged 6-12 years with atopic dermatitis (AD) and inadequately controlled moderate-to-severe pruritus found that 16 weeks of nemolizumab treatment (30 mg every 4 weeks [Q4W]) was clinically effective and tolerable, with early improvement in pruritus and associated skin signs and a positive impact on patient quality of life (QoL).

Objective: To report the findings from the long-term extension period of the study, and evaluate the efficacy and safety profiles of nemolizumab when administered concomitantly with topical agents over 68 weeks.

Methods: The study included a 16-week, randomized, placebo-controlled, double-blind, parallel-group period during which patients received nemolizumab 30 mg or placebo Q4W; those who completed this period could enter a 52-week, long-term treatment period during which all patients received nemolizumab Q4W. Efficacy endpoints assessed treatment impact on pruritus, AD signs, and QoL. Treatment-emergent adverse events (TEAEs) were tabulated to evaluate long-term safety.

Results: Among the 89 paediatric patients evaluated, efficacy outcome measures showed a tendency towards improvement between weeks 16 and 68, and sustained efficacy during the subsequent follow-up period after treatment cessation. At week 68, among patients who received nemolizumab treatment throughout the study, the mean change from baseline in the 5-level itch score was -1.8 (standard deviation [SD] 0.8), the mean percentage change from baseline in the Average Pruritus Numerical Rating Scale score was -65.9 (SD 25.0), and the mean percentage change from baseline in the Eczema Area and Severity Index score was -77.1 (SD 23.1). Data from the Dermatitis Family Impact questionnaire indicated that the burden of housework on family members was reduced, parent/caregiver fatigue was reduced, and sleep of family members was improved by week 16, with further improvement at week 68. The overall safety profile was similar to that recorded in nemolizumab-treated patients aged ≥13 years, with no late-onset TEAEs observed during long-term treatment.

Conclusions: These data confirm the safety of long-term nemolizumab for paediatric patients with AD, and demonstrate improvements in pruritus, skin symptoms, and both patient and caregiver QoL over 68 weeks of treatment. (Funded by Maruho; Japan Registry of Clinical Trials identifier: jRCT2080225289).