Dupilumab Effective, Safe for Severe Pediatric Atopic Dermatitis: Daily Dose
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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
On March 31, 2025, we reported on a study published in the Journal of the Brazilian Medical Association that examined the efficacy and safety of dupilumab in the treatment of atopic dermatitis (AD) in children aged 6 months to 18 years.
The study
Researchers conducted the meta-analysis, which was part of the Guidelines Project, spearheaded by the Brazilian Medical Association, which seeks to help standardize clinical care by critically assessing and compiling research findings. The systematic review retrieved 533 publications but ultimately included only 3 studies meeting the strict eligibility criteria. The final analysis included 493 patients who received dupilumab and 287 who received placebo, with follow-up periods ranging from 16 to 28 weeks.
The researchers conducted a systematic review using PRISMA guidelines and registered the protocol with PROSPERO (CRD42024585551). They searched Medline, Embase, ClinicalTrials, and Google Scholar databases using a comprehensive search strategy for atopic dermatitis and dupilumab.
Only phase 3 randomized clinical trials comparing dupilumab with placebo in pediatric populations were included. Data were meta-analyzed using RevMan 5.4 software, with results expressed as risk differences with 95% confidence intervals.
The quality of evidence was assessed using GRADEpro, and all outcomes analyzed were rated as high-quality evidence. Risk of bias assessment using RoB 2.0 showed low risk for 1 study and some concerns for the other 2. Dupilumab doses in the included studies ranged from 100 to 300 mg administered subcutaneously every 2 or 4 weeks, with a treatment duration of 16 weeks.
The findings
Results showed that dupilumab achieved a number needed to treat (NNT) of just 3 for a 75% improvement in the Eczema Area and Severity Index (EASI 75) score, and an NNT of 2 for a 50% improvement. For pruritus reduction of at least 3 points on the Numerical Rating Scale (NRS), the NNT was 3. The investigators found that dupilumab produced a 39% improvement in EASI 75 scores (95% CI, 33%-44%) compared with placebo. For EASI 50, the improvement was 45% (95% CI, 40%-50%). The Investigator Global Assessment (IGA) scores (0-1 and/or improvement ≥2 points) showed a 20% improvement (95% CI, 16%-24%) with an NNT of 5. Pruritus reduction, often a primary concern for patients and their families, showed a 39% improvement (95% CI, 34%-45%) compared with placebo, representing significant symptomatic relief. The team also noted that the beneficial effects observed in pediatric populations were comparable to those seen in adult studies.
Authors' comments
"The results highlight that dupilumab is a safe and effective treatment option for children and adolescents with moderate to severe AD who do not respond to conventional treatments. This is a breakthrough for dermatology that offers a safe and effective new approach to managing a chronic debilitating condition. Overall, the approval and use of dupilumab can significantly improve the quality of life of young patients by reducing disease severity and associated impacts, such as ongoing discomfort and comorbidities related to AD without adequate response to topical treatment."
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