Dupilumab Reduces Lesions, Severity of Atopic Dermatitis in Children Over 12 Years of Age

Children under the age of 12 years with moderate-to-severe atopic dermatitis who are treated with dupilumab (DUPIXENT) show a greater improvement in their disease and lesion severity, recent findings suggest, along with a lower cumulative discontinuation rate versus those on methotrexate or cyclosporine.1

These data were the result of a recent 4-year analysis authored by such investigators as Alan Irvine, MD, DSc, a consultant dermatologist and professor of dermatology at Trinity College in Dublin, Ireland. Irvine and coauthors’ findings were presented as a poster at the 2025 SDPA Annual Summer Dermatology Conference in Washington, DC.

The investigators sought to “report the long-term effect of systemic treatments on the mean [Eczema Area and Severity Index] scores of the head and neck, trunk, upper extremities, and lower extremities at therapy start and last observation.”1

A previous HCPLive interview with investigator Amy S. Paller, MD, chair of the department of dermatology, director of Skin Biology and Diseases Resource-Based Center, and Walter J. Hamlin Professor of Dermatology at Northwestern University’s Feinberg School of Medicine, was conducted on the PEDISTAD study’s findings regarding children under 6 years of age.2 In the current poster, those under the age of 12 were evaluated.

This recent 4-year interim analysis of this age cohort was drawn from PEDISTAD (Pediatric Study in Atopic Dermatitis), the ongoing 10-year global, observational registry assessing the long-term safety and effectiveness of systemic medications in children with moderate-to-severe atopic dermatitis. This latest analysis by Irvine and colleagues included data from 541 pediatric patients.

The investigative team looked at patient outcomes using the Eczema Area and Severity Index (EASI), a standardized tool for measuring the extent and severity of patients' eczema. Their analysis evaluated EASI component scores for the neck, head, trunk, upper extremities, and lower extremities, comparing individuals treated with dupilumab to those give either methotrexate or cyclosporine.

Irvine et al evaluated safety by using exposure-adjusted event rates per 100 patient-years, and they also documented any treatment discontinuations and the rate of such discontinuations All of their analyses were descriptive in nature.

Across each body region, it was determined that patients given dupilumab treatment for their atopic dermatitis showed numerically greater improvements in their EASI scores compared with those receiving cyclosporine or methotrexate.1 This pattern was consistent for the neck and head, upper limbs, lower limbs, and trunk, highlighting the medication's broad efficacy across affected regions of the body.

Notably, dupilumab-treated children were shown by Irvine and coauthors to have a particularly marked improvement in their lower extremity scores compared to the other 2 treatment cohorts in the PEDISTAD interim analysis. The results of the safety assessments further supported the favorable profile of dupilumab.

Specifically, the investigators found that those on dupilumab reported fewer adverse events (AEs), and the rate of discontinuation was highlighted as significantly lower compared to participants being given methotrexate or cyclosporine. Such data would indicate that dupilumab could be considered not only more efficacious but also better tolerated over time.

In pediatric populations, patients may require prolonged or continuous treatment for management of chronic conditions. The current analysis broadens the scope to include patients up to age 12, offering a more comprehensive look at how systemic therapies perform across a wider pediatric age range.

This 4-year analysis from the PEDISTAD registry adds to the growing body of evidence supporting dupilumab’s safety and its efficacy among children living with moderate-to-severe atopic dermatitis. Compared to methotrexate and cyclosporine, the medication was shown not only to provide more consistent improvements in atopic dermatitis severity but also presents fewer safety concerns, supporting its role as a leading systemic treatment option.

“Patients receiving dupilumab had a greater improvement in EASI component scores in all anatomic regions, a lower cumulative discontinuation rate, and a lower exposure-adjusted AE rate compared with patients receiving methotrexate or cyclosporine,” the investigators summarized.1

References

1. Irvine A, Lee L, Zhang A, et al. Dupilumab Reduces Severity and Lesion Extent in Children < 12 Years With Moderate-to-Severe AD: 4 Year Results From the PEDISTAD Registry. Poster presented at: 2025 SDPA Annual Summer Dermatology Conference; June 25-28, 2025; Washington, DC.

2. Smith T. Atopic Dermatitis Burden Among Families of Children Under 6 Years, with Amy S. Paller, MD. HCPLive. June 11, 2025. Accessed June 29, 2025. https://www.hcplive.com/view/atopic-dermatitis-burden-among-families-children-under-6-years-amy-s-paller-md.