Safety Study Evaluates Dupilumab in Pediatric Patients with Severe AD

A recent randomized, placebo-controlled, phase 3 trial (NCT03345914) explored 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 matching placebo, with concomitant topical corticosteroids (TCS) for 16 weeks.¹ Blood samples were collected at baseline and at week 4, 8, and 16 with urine samples taken at baseline, week 4, and 16, according to the study’s researchers.

A total of 367 pediatric patients were enrolled in the study, with 362 in the safety analysis and 351 made it to the end of the study treatment. There were 4 patients that withdrew from the trial 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 group. These changes did not lead to symptoms or clinically meaningful AEs or treatment modification. Also, no measured laboratory parameters had significant changes or trends.

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

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

Reference:

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