Dupilumab is Safe and Effective Across Pediatric Populations with Severe Atopic Dermatitis: New Meta-Analysis

Dupilumab demonstrated significant efficacy with a strong safety profile in children and adolescents with severe atopic dermatitis (AD) who had not responded adequately to conventional topical treatments, according to a new systematic review and meta-analysis.

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The analysis, by a group of Brazilian researchers, found that patients aged 6 months to 18 years experienced substantial improvement in skin lesions and pruritus compared with placebo, with no significant increase in adverse events.

The meta-analysis, which included 780 pediatric patients across 3 randomized clinical trials, showed 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 evidence, assessed as high quality across the studies included, with a low risk of bias across outcomes, further strengthens the authors' recommendation for use of dupilumab in pediatric populations.

"This is a breakthrough for dermatology, offering a safe and effective new approach to managing a chronic debilitating condition," the researchers noted in their analysis published in the Revista da Associação Médica Brasileira.

The researchers highlighted the consistent efficacy across all age groups studied (6 months to 6 years, 6-11 years, and 12-18 years), suggesting wide applicability throughout pediatric populations. Given reservations about utilizing biologic therapies, particularly in the youngest group, investigators emphasized the safety profile of dupilimab—with no significant difference in treatment-emergent adverse events compared with placebo across age groups.

The meta-analysis 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 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.

Meta-analysis Background

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 III 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 authors acknowledged limitations, including the relatively small number of available studies and the short follow-up period (16-28 weeks), which may not be sufficient to fully assess long-term effects. They also noted variability in dosing regimens and the use of concomitant therapies across the studies.

"Future studies should include a larger number of participants and extend the follow-up period to assess the long-term effects of dupilumab," the authors recommended. "Furthermore, standardizing the doses administered to reduce variability in results and including studies with different severities of AD would provide a more comprehensive view."

Source: Mollaco Navarro da Cruz MF, Schiliró Tristão L, Lucato Dos Santos C, Lopes Mattos E Dinato S, Bernardo WM. The use of dupilumab in children and adolescents with severe atopic dermatitis: a systematic review and meta-analysis. Rev Assoc Med Bras (1992). 2025;71(1):e2024D711. doi: 10.1590/1806-9282.2024D711.