TOPLINE:

Among children with atopic dermatitis or persistent asthma, treatment with dupilumab was associated with an increased risk of developing cutaneous autoimmune diseases compared with no treatment.

METHODOLOGY:

• Researchers analyzed data of 178,977 children with atopic dermatitis and/or persistent asthma (median age, 11.8 years; 47.2% girls) from PEDSnet, a pediatric clinical research network in the US, to evaluate whether pediatric use of dupilumab was linked to an increased risk of being diagnosed with an autoimmune disease.
• Children were stratified by treatment with dupilumab. After inverse probability of treatment weighting, researchers compared 4189 children treated with dupilumab with 4195 untreated children and followed them up for up to 4 years to assess autoimmune outcomes.
• Treated children had one or more dupilumab prescriptions within 4 years following their earliest diagnosis of an atopic disease (a median of six unique prescription dates per patient), whereas untreated children had no dupilumab prescription record prior to or during this timeframe.

TAKEAWAY:

• The adjusted incidence rate difference for any autoimmune disease was 2.47 (95% CI, 0.82-4.30) per 1000 person-years; this difference was primarily driven by cutaneous autoimmune diseases, which showed a rate difference of 2.18 (95% CI, 0.67-3.66) per 1000 person-years in the dupilumab-treated vs untreated groups.
• Dupilumab treatment was associated with an increased risk of being diagnosed with any autoimmune disease (adjusted hazard ratio [aHR], 1.45; 95% CI, 1.18-1.80) and cutaneous autoimmune disease (aHR, 1.57; 95% CI, 1.22-2.03), with psoriasis and alopecia the most frequently observed cutaneous diseases.
• After excluding psoriasis and alopecia from the analysis, the increase in risk of being diagnosed with cutaneous autoimmune diseases was not statistically significant in children treated with dupilumab.
• No significant associations were found between dupilumab treatment and the risk for autoimmune endocrinologic, gastrointestinal, or rheumatologic diseases in children with atopic dermatitis and/or persistent asthma.

IN PRACTICE:

“Our findings support longitudinal monitoring of children being treated with dupilumab, which is already the standard of care. Prospective studies will be valuable in confirming the accuracy of EHR [electronic health record]-based diagnoses and more comprehensively understanding dupilumab’s side-effect profile, which must be weighed with its established safety and efficacy in managing treatment-refractory atopic diseases,” the authors of the study wrote.

SOURCE:

Stanislaw J. Gabryszewski, MD, PhD, University of Pennsylvania, Philadelphia, was the corresponding author of the study, which was published online on March 25, 2026, in The Journal of Allergy and Clinical Immunology.

LIMITATIONS:

The study was limited by its retrospective design and by reliance on diagnosis codes and prescription records to define outcomes and disease severity. Prescription records may have overestimated the actual medication use, and findings may not have been generalizable to children younger than 6 years.

DISCLOSURES:

PEDSnet was developed with funding from the Patient-Centered Outcomes Research Institute. The authors disclosed receiving research funding from the Mondre and Lane families, the National Institutes of Health, and the Consortium of Eosinophilic Gastrointestinal Disease Researchers. The authors declared having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.