Safety Study Evaluates Dupilumab in Pediatric Patients with Severe AD

A recent phase 3 randomized placebo-controlled study (NCT03345914) investigated the safety of dupilumab (Dupixent; Sanofi and Regeneron) as a treatment for severe atopic dermatitis (AD) in pediatric patients aged 6-11 years.1

In the study, patients were randomized 1:1:1 to receive dupilumab 300 mg every 4 weeks, 100 or 200 mg every 2 weeks, or a corresponding placebo, with concomitant topical corticosteroids (TCS) for 16 weeks.1 Blood samples were collected at baseline and at weeks 4, 8 and 16 with urine samples taken at baseline, weeks 4 and 16, according to the study researchers.

A total of 367 pediatric patients participated in the study, of which 362 were in the safety analysis and 351 made it to the end of study treatment. There were 4 patients who withdrew from the study due to treatment-emergent adverse events (TEAEs).

The dupilumab and TCS treatment groups saw increases in mean blood levels of eosinophils and alkaline phosphatase, and decreases in mean blood levels of platelets, neutrophils, and lactate dehydrogenase levels.

There were no corresponding mean changes in the placebo and TCS groups. These changes did not lead to symptoms or clinically relevant adverse events or treatment adjustments. Also, no laboratory parameters measured had significant changes or trends.

According to the authors, the change in platelet counts and lactate dehydrogenase levels likely reflects reduced inflammation.

“These results confirm similar findings in adults and adolescents and suggest that there is no need for routine laboratory monitoring of children ages 6-11 treated with dupilumab + TCS for severe AD,” the researchers wrote.


1. Paller AS, Wollenberg A, Siegfried E, et al. Laboratory safety of dupilumab in patients 6-11 years of age with severe atopic dermatitis: results of a phase III clinical trial. Pediatric Medicines. Published online August 31, 2021. doi:10.1007/s40272-021-00459-x

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