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The trial sponsor was involved in the study design, the collection, analysis, interpretation of data, and the decision to submit the article for publication. Maruho also paid for professional writing assistance. Nemolizumab and placebo were provided by the product manufacturer,

Introduction Atopic dermatitis (AD), with its signs and symptoms of pruritus, dryness, and erythema, severely reduces the quality of life (QOL) of affected patients. We investigated the impact of nemolizumab 60 mg on QOL in Japanese patients aged ≥ 13 years with AD and inadequately controlled moderate-to-severe pruritus, using data derived from patient-reported outcome (PRO) measures. Methods PROs were the Insomnia Severity Index (ISI), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), and Work Productivity and Activity Impairment: Atopic Dermatitis questionnaire (WPAI-AD). Correlations between PRO scores and symptom severity, assessed by the pruritus visual analog scale (VAS) and the Eczema Area and Severity Index (EASI), were explored. Results The mean percent change (standard error) from baseline in the pruritus VAS and EASI scores at week 16 was, respectively, −45.6% (2.7) and −46.0% (3.2) in the nemolizumab group, and −24.1% (3.7) and −33.2% (4.9) in the placebo group. By week 16, significantly more patients in the nemolizumab group versus the placebo group had an ISI score of 0 for difficulty falling asleep (41.6% versus 13.1%, nominal p < 0.01) or difficulty staying asleep (45.4% versus 10.9%; nominal p < 0.01). Similarly, more nemolizumab- than placebo-treated patients had a DLQI score of 0 for interference with shopping, or home/garden activities (45.2% versus 18.6%, nominal p < 0.01), and 0 days per week of nighttime sleep disturbance (50.8% versus 16.9%, nominal p < 0.01) or bleeding skin (43.4% versus 7.5%, nominal p < 0.01) measured by POEM at week 16. Based on WPAI-AD scores, long-term administration of nemolizumab also improved the ability to conduct work activities. Conclusions Subcutaneous administration of nemolizumab ameliorated pruritus and skin signs, and thereby produced improvement in patient QOL across multiple PRO measures, including sleep, interpersonal relationships, and the ability to conduct social or work activities. Clinical Trial Registration JapicCTI-173740 (registered 20 October 2017). Supplementary Information The online version contains supplementary material available at 10.1007/s13555-023-00901-7.

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Background Atopic dermatitis (AD) is a chronic, inflammatory skin condition affecting up to one-quarter of children. Uncontrolled pruritus associated with childhood AD, and the accompanying scratching, negatively impacts quality of life (QoL), sleep, and development. The humanised monoclonal antibody nemolizumab, used concomitantly with topical agents, was shown to reduce pruritus and improve QoL in patients with AD aged ≥13 years. However, data relating to its efficacy and safety in younger children (aged &lt;13 years) have been lacking. Objective To evaluate the efficacy and safety of nemolizumab, administered concomitantly with topical agents, in Japanese paediatric patients (aged 6–12 years) with AD and inadequately controlled moderate-to-severe pruritus. Method This was a randomised, placebo-controlled, double-blind, parallel-group, multicentre, 16-week, phase III study. Patients aged ≥6 and &lt;13 years, with confirmed AD, and an inadequate pruritic response despite treatment with topical agents and oral antihistamines were randomly assigned (1:1) to receive nemolizumab 30 mg or placebo every 4 weeks (Q4W). The primary efficacy end point was the change in the weekly mean 5-level itch score from baseline to week 16; secondary efficacy endpoints were related to pruritus, indicators for AD, and QoL. Safety was assessed via adverse events (AEs) and laboratory test results. Results In total, 89 patients were enrolled, received either nemolizumab 30 mg (n = 45) or placebo (n = 44) Q4W, and completed the study. Mean patient age was 9·1 (standard deviation 1·9) years, and mean duration of AD was 8·5 (2·7) years. The change in 5-level itch score from baseline to week 16 showed a statistically significant difference in the nemolizumab treatment group (−1·3) compared with placebo (−0·5; least-squares mean difference −0·8, 95% confidence interval, −1·1 to −0·5; P &lt; 0·0001). Improvements with nemolizumab were observed from the second day of administration. Secondary endpoints were in favour of nemolizumab. No AEs resulted in discontinuation, and the overall safety profile in patients aged 6–12 years was comparable with that in older patients (aged ≥13 years) with AD. Conclusions Nemolizumab is a potential new treatment option for paediatric AD patients whose pruritus has not been sufficiently improved with topical treatments and antihistamines.