Children with atopic dermatitis who were treated with dupilumab and topical corticosteroids showed improvements in treatment success compared with topical corticosteroids alone, according to results from a phase 3 study (ClinicalTrials.gov Identifier: NCT03345914) presented at the American Academy of Allergy, Asthma, & Immunology Virtual Annual Meeting, held February 26 to March 1, 2021.
Investigators evaluated the efficacy of dupilumab with concomitant topical corticosteroids in patients aged 6 to 11 years with severe atopic dermatitis. Participants were randomly assigned 1:1:1 to receive either 300 mg dupilumab every 4 weeks (q4w), weight-based 100/200 mg dupilumab every 2 weeks (q2w), or placebo for 16 weeks.
Baseline asthma rates and disease severity were comparable between treatment groups. After 16 weeks, both dupilumab groups had significantly more patients who achieved Investigator’s Global Assessment score of 0/1 compared with the control group that received only topical corticosteroids (with asthma: q4w, 37.9%; q2w, 27.0% vs placebo, 11.7%; without asthma: q4w, 28.1%; q2w, 32.2% vs placebo, 11.1%).
More patients who received dupilumab either every 4 weeks or every 2 weeks compared with placebo experienced at least a 75% improvement in the Eczema Area and Severity Index (with asthma: q4w, 65.5%; q2w, 58.7% vs placebo, 25.0% and without asthma: q4w, 73.4%; q2w, 76.3% vs placebo, 28.6%). In addition, more patients treated with dupilumab saw at least a 4-point reduction in the Peak Pruritus Numerical Rating Scale (with asthma; q4w, 48.3%; q2w, 50.8% vs placebo, 8.5% and without asthma: q4w, 53.2%; q2w, 66.1% vs placebo, 15.9%; P <.05 for all comparisons).
In the overall population, the safety was consistent with dupilumab’s known safety profile observed in adults and adolescents.
“Dupilumab with concomitant [topical corticosteroids] was equally efficacious in improving severe [atopic dermatitis] signs and symptoms in children aged 6-11 years with and without history of comorbid asthma,” the researchers concluded.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Boguniewicz M, Sher L, Paller A, et al. Dupilumab improves signs and symptoms of severe atopic dermatitis in children aged 6-11 years with and without comorbid asthma. Presented at: the American Academy of Allergy, Asthma, & Immunology Virtual Annual Meeting; February 26-March 1, 2021. Abstract 99.
This article originally appeared on Pulmonology Advisor