Dupilumab Effective for Atopic Dermatitis in Patients Aged 6 Months to 11 Years

Dupilumab treatment of moderate-to-severe atopic dermatitis is effective and safe among children unresponsive to conventional therapies who are in the age ranges of 6 months - 18 years of age, according to new findings.1

These data resulted from a recent analysis conducted by such investigators as Maria Fernanda Mollaco Navarro da Cruz, from Centro Universitário Lusíada’s Faculty of Medical Sciences of Santos in Brazil. Navarro da Cruz and her team of investigators carried out a systematic review and meta-analysis of available data on dupilumab for pediatric patients with atopic dermatitis.

The investigative team highlighted that while the skin disease is chronic, treatment among children is commonly limited to short-term topical corticosteroids (TCSs). They added that a potential medication for those with severe atopic dermatitis that is also inadequately controlled by topical drugs is dupilumab, a medication derived from a monoclonal antibody which is designed to inhibit the interleukin (IL)-4 and IL-13 receptors.2

“The objective of this study was to assess the efficacy and safety of dupilumab in the treatment of [atopic dermatitis] in children aged 6 months to 11 years and in adolescents,” Navarro da Cruz and colleagues wrote.1

Analysis and Findings on Dupilumab Efficacy and Safety

The investigative team's Guidelines Project was designed as an initiative led by the Brazilian Medical Association, with those involved seeking to consolidate medical knowledge. The long-term aim is to establish standardized clinical practices and to support clinicians in their decision-making.

Effectiveness and safety of dupilumab in pediatric patients with atopic dermatitis was evaluated by the team via a systematic review of available literature. Searches involved the Embase, Medline, ClinicalTrials, and Google Scholar databases.

A stratification of evidence quality was done by the investigators, with categories being 4 levels of quality: very low, low, moderate, and high. The GRADEpro software was used to evaluate the studies, with investigators basing their assessment of quality on factors such as level of consistency, bias risk, precision, indirect evidence, and possible publication bias. Research that was determined to qualify for their analysis would be required to meet the following criteria:

• Population: Children and/or adolescents
• Intervention: Dupilumab therapy
• Time and Restrictions on Language: None if data had been made available in full-text articles or abstracts.
• Comparison: Placebo
• Outcome: Treatment efficacy and safety
• Trial Design: Phase 3 randomized clinical trials (RCTs)

A total of 533 publications were identified with search limits set for analyses in pediatric populations. There were 58 studies which met the criteria for inclusion after the screening period, with 3 RCTs being ultimately included in the investigators' analysis.

Data the team collected from these RCTs included Eczema Area and Severity Index (EASI) 50 and 75 scores, Investigator’s Global Assessment (IGA) responses, dips in pruritus (assessed via the Numeric Rating Scale [NRS]), level of atopic dermatitis severity, age of subjects, the number in the dupilumab and placebo arms, regimen of dosage and administration, the follow-up duration, and adverse events associated with the use of dupilumab.

The 3 identified RCTs involved children and adolescents who were across the age spectrum:

• 6 months - 6 years (N=162)
• 6 - 11 years (N=367)
• 12 - 18 years (N=251)

There were 780 pediatric patients in total who were evaluated, with 493 being given dupilumab and 287 in the placebo cohorts. Dupilumab had been provided to study subjects through subcutaneous injections (100–300 mg) on a basis of every 2 or 4 weeks over a 16-week period. It was noted that follow-up ranged from 16 - 28 weeks.

Among the 493 patients treated with dupilumab and 495 in the placebo arms:

IGA scores were shown to have improved by 20% (range: 16–25%, 95% CI), with a number needed to treat (NNT) of 5 to attain an improvement of at least 2 points or attain an IGA score of 0–1. The investigative team also found that EASI 75 scores improved by 39% (range: 33–44%, 95% CI), adding that there was an NNT of 3 to reach a ≥75% improvement in one child or adolescent.

EASI 50 scores were shown by the investigators to have risen by 45% (range: 40–50%, 95% CI), with an NNT of 2 being identified to achieve a ≥50% improvement. Itch as measured by NRS was noted as having dipped by 39% (range: 34–45%), with an NNT of 3 to achieve a ≥3-point reduction.

Furthermore, between dupilumab and placebo, the investigative team did not identify significant differences in adverse effects, reinforcing the treatment's safety profile among pediatric individuals. All of the reported findings were classified by the team as high-quality evidence with a low risk of bias, with NNTs ranging from 2 - 5 across various clinical outcomes.

“To strengthen the conclusions, future studies should include a larger number of participants and extend the follow-up period to assess the long-term effects of dupilumab,” they wrote.1 “Furthermore, standardizing the doses administered to reduce variability in results and including studies with different severities of [atopic dermatitis] would provide a more comprehensive view of the efficacy and safety of dupilumab.”

References

1. 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 Mar 17;71(1):e2024D711. doi: 10.1590/1806-9282.2024D711. PMID: 40105568; PMCID: PMC11918844.

2. Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, et al. Dupilumab efficacy and safety in atopic dermatitis: a review. Lancet. 2022 doi: 10.1016/S0140-6736(21)01790-3.