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Up to 25% of children are affected by atopic dermatitis – the most common inflammatory skin disorder in this population – and around one-third of these children have moderate-to-severe disease.11,12 Atopic dermatitis creates a high burden for both the patients and their loved ones, with persistent itch and recurrent skin lesions often disrupting sleep, school, and social confidence.2-8 Despite the high prevalence and significant burden, treatment options are limited in the pediatric setting for those with moderate-to-severe disease.3
“The burden of atopic dermatitis on children and their families remains considerable, with symptoms affecting quality of life, emotional wellbeing and day-to-day functioning. There is a continued need for treatment options that can deliver meaningful benefits for patients with moderate-to-severe disease. The results seen in this phase II study of nemolizumab are promising, with sustained improvements in itch severity, sleep disturbance and quality of life observed for up to one year.” LAWRENCE EICHENFIELD, M.D. PROFESSOR OF DERMATOLOGY AND PEDIATRICS AT THE UNIVERSITY OF CALIFORNIA SAN DIEGO SCHOOL OF MEDICINE AND CHIEF OF PEDIATRIC DERMATOLOGY AT RADY CHILDREN’S HOSPITAL SAN DIEGO, UNITED STATES |
Delivering sustained improvements in itch, sleep and quality of life in children with atopic dermatitis This phase II multicenter, open-label study assessed the pharmacokinetics, safety and efficacy of nemolizumab in pediatric patients aged 2 to 11 years with moderate-to-severe atopic dermatitis, as well as patient-reported outcomes and quality of life.1 Children were enrolled into three cohorts based on age and weight, and received weight-tiered nemolizumab dosing plus topical therapy. Patient-reported outcomes and quality of life results demonstrated meaningful improvements in itch, sleep disturbance, and quality of life, sustained through Week 52:1
- Improvements in itch were achieved early in treatment and sustained over one year of follow-up, with Peak Pruritus Numerical Rating Scale four point-response rates between 56%-72% across cohorts at Week 16, and similar and/or higher responses seen at Week 52.
- Reductions in sleep disturbance as measured by the Sleep Disturbance Numerical Rating Scale were similarly achieved early in treatment and maintained through Week 52, with scores improving by -70 to -78% across cohorts at Week 16, and further improvements at Week 52.
- Mean Children’s Dermatology Life Quality Index (for children ≥4 years) scores improved by -10.7, -12.0, and -12.0 from baseline at Week 52 across cohorts.
- Improvements were also observed in both age-appropriate quality of life measures, including the Infants’ Dermatitis Quality of Life index (for children <4 years) and Patient-Oriented Eczema Measure (for children ≥4 years).
Nemolizumab was well tolerated, with no new safety signals. These phase II findings are consistent with the previously established safety and efficacy of nemolizumab in adults and adolescents with moderate-to-severe atopic dermatitis.9,10
“At Galderma, we are committed to advancing science-based solutions for atopic dermatitis, supporting patients and their families through continued research and innovation, with the goal of delivering treatment options that can meaningfully improve quality of life. These new data further support the robust clinical evidence we have collected on nemolizumab and underscore its potential to address the needs of a broader patient population, including young children living with moderate-to-severe atopic dermatitis.” CHRISTOPHE PIKETTY, M.D., PH.D. STUDY AUTHOR AND GLOBAL PROGRAM HEAD, THERAPEUTIC DERMATOLOGY GALDERMA |
For more information about the impact of atopic dermatitis on children and families, read this article and watch this video.
