Efficacy and Safety of Dupilumab in Children Aged 6 months–11 years Old With Atopic Dermatitis: A Systematic Review and Meta‐Analysis

Background The efficacy and safety of dupilumab in adolescents and adults are well established, yet clinical data in young pediatric patients remain relatively scarce, and its management poses significant challenges. Objective To evaluate the efficacy and safety of dupilumab in pediatric patients aged 6 months–11 years with atopic dermatitis (AD), drawing on evidence from clinical trials and observational studies. Methods Systematic search of PubMed, Web of Science, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), China National Knowledge Infrastructure (CNKI), Wanfang Database, and SinoMed, with no restrictions on date or language. Randomized and nonrandomized clinical trials as well as cohort studies were included to evaluate the efficacy and safety of systemic treatments for moderate‐to‐severe AD in young pediatric patients. Results A total of 1217 infant and child patients with AD from four clinical trials and 10 observational studies were included for quantitative analysis. The overall pooled response rates were 87% (95% CI: 77%, 93%) for EASI‐50, 69% (95% CI: 61%, 77%) for Eczema Area and Severity Index (EASI)‐75%, and 39% (95% CI: 28%, 50%) for EASI‐90. Response rates in observational studies were significantly higher than those in clinical trials for EASI‐75 (73% vs. 63%, p < 0.001). However, comparable outcomes for EASI‐50 and EASI‐90 were observed across the two study types. The overall pooled Investigators Global Assessment (IGA) 0/1 response rate was 49% (95% CI: 37%, 61%). Similarly, the IGA 0/1 response rate was significantly higher in observational studies compared with clinical trials (66% vs. 37%, p < 0.001). The most common adverse events were skin‐related reactions (including infections and dermatitis), nasopharyngitis, conjunctivitis, injection site reactions, and upper respiratory tract infections. Conclusion Dupilumab demonstrates substantial clinical improvement and an acceptable safety profile in children aged 6 months–11 years with moderate‐to‐severe AD. Higher response rates in observational studies versus randomized controlled trials reflect real‐world effectiveness alongside methodological differences such as selection bias. The EASI response pattern indicates that while most patients achieve meaningful improvement, near‐complete clearance often requires extended treatment. Given limited evidence in infants, further real‐world studies are warranted.