Patients from this diverse cohort experienced improvements in atopic dermatitis (AD) clinical scores after a year or more of treatment with dupilumab.
Dupilumab was shown to be well-tolerated and effective in treating pediatric and adolescent atopic dermatitis (AD) regardless of age, sex, or ethnicity in a study recently published in The Journal of Allergy and Clinical Immunology: In Practice.
There was also an observed association between prior history of atopy and greater improvement in body surface area post-treatment. Though previous clinical trials have shown dupilumab to be safe and effective in children and adolescents with AD, real-world studies in the pediatric population are limited, the authors noted.
The study was conducted to characterize the long-term treatment responses and adverse events of dupilumab-treated children and adolescents with AD during dermatology follow-up assessments.
Electronic medical records from March 2017 to September 2021 of moderate-to-severe AD patients starting dupilumab at < 18 years of age were reviewed. AD scores and safety data were collected.
The role of age, sex, atopy comorbidities, and race and ethnicity in treatment efficacy and safety were considered, given the clinical and immunological heterogeneity of AD across these demographic subgroups.
The study included 89 patients—50 (56.2%) female and 39 (43.8%) male—with a mean (SD) treatment duration of 1.3 (0.9) years. Score assessments at baseline and weeks 12 to 24 were compared for 73 patients.
The mean (SD) improvement was 63.1% (29.2%) in body surface area (BSA), 39.6% (29.95%) in Eczema Area and Severity Index (EASI), and 59.6% (30.7%) in Investigator’s Global Assessment (IGA).
All 23 patients who received dupilumab for ≥ 1 year achieved 75% improvement in EASI, and 60.8% of patients achieved 90% improvement in EASI. Additionally, 100% of patients receiving dupilumab for 1 year or more achieved an IGA 0/1, described as "clear" or "almost clear" alleviation of AD symptoms.
Positive history of atopy was found to be associated with greater percent improvement in BSA at week 12-24 (P < .05).
Adverse events occurred for 12 (13.5%) patients, though there were no serious adverse events. Conjunctivitis (5.6%) and joint pain (2.2%) were the most common.
A reduction in IgE levels was observed in a small subset of 6 children with IgE level evaluations before and after dupilumab treatment. For this subset, a mean (SD) percentage decrease of 73% (19.3%) was observed after dupilumab initiation.
The findings of this study are in line with previous clinical trials and studies of dupilumab in pediatric populations.
The cohort of this study was diverse, representative of the overall US pediatric population, the authors noted. No significant differences between clinical outcomes and age, sex, or race/ethnicity were found.
Though the study faced limitations in retrospective design and single-site cohort, the authors asserted that the IGA0/1 achievement for all patients within the cohort and the low-incidence of adverse events indicates the effectiveness and tolerability of dupilumab in children and adolescents with moderate-to-severe AD.
Additional long-term and multicenter studies in the pediatric population are warranted, the authors note.
Pagan AD, David E, Ungar B, Ghalili S, He H, Guttman-Yassky E. Dupilumab improves clinical scores in children and adolescents with moderate-to-severe atopic dermatitis: a real-world, single-center study. The Journal of Allergy and Clinical Immunology: In Practice. Published online June 23, 2022. doi:10.1016/j.jaip.2022.06.014