Dupilumab (Dupixent), given once every 4 weeks in combination with low-potency topical corticosteroids, resulted in a rapid and significant improvement in the incidence and symptoms of atopic dermatitis in the youngest children eligible for therapy, new data show.
In research presented this week at the Society of Dermatology Physician Assistants (SDPA) 2022 Annual Meeting in Miami, FL, a team of U.S. researchers reported that biologic therapy with interleukin 4 and 13 (IL-4; IL-13) inhibitors from Sanofi and Regeneron demonstrated a significant efficacious profile and similar safety to treated adult patients compared to placebo in children aged 6 months to 5 years with moderate to severe atopic dermatitis.
The results support the benefit of dupilumab, which received US Food and Drug Administration (FDA) approval earlier this year for the treatment of pediatric atopic dermatitis in the youngest pediatric age group.
Led by Amy S. Paller, MD, chair of the Department of Dermatology at Northwestern Feinberg School of Medicine, researchers conducted an evaluation of the 16-week efficacy and safety of dupilumab in combination with topical corticosteroids in younger pediatric patients whose Eczema is inadequately controlled with topical therapies.
In conversation with HCPLive® at the 2022 American Academy of Dermatology (AAD) Annual Meeting, Paller described the challenges of navigating previously available systemic therapies for pediatric eczema patients, who presented more uncertainties regarding benefit-risk.
“Now it’s a lot easier because we have a drug that really doesn’t need laboratory monitoring, that has conjunctivitis, which is generally fairly easily treated, a mild reaction at the injection site – but otherwise really none in the vast majority of children has side effects of whatever kind,” Paller said of dupilumab.
Previous Phase 3 study data showed that biological therapy was associated with “significantly improved” measures of atopic dermatitis signs, symptoms and quality of life in children aged 6 to <12 years. Part B of the LIBERTY AD PRESCHOOL study by Paller and colleagues was a phase 3, double-blind, placebo-controlled evaluation in children aged 6 months to <5 years with moderate to severe atopic dermatitis, defined as an Investigator's Global Assessment (IGA) ≥3 and Ezzema Area Severity Index (EASI) ≥ 16, and weekly mean daily Numerical Rating Score (NRS) ≥ 4 for worst pruritus and body surface area involvement (BSA) ≥ 10%.
Patients were randomized to 1 of 2 dupilumab arms (200 mg; 300 mg) plus topical corticosteroids based on baseline body weight or placebo plus topical corticosteroids for 16 weeks. They then entered a 12-week open-label extension or safety follow-up period through week 28.
A total of 83 patients received either dupilumab arm versus 79 patients randomized to placebo. The mean patient age was 3.8 years; only 11 patients in total were < 2 years old. The mean duration of atopic dermatitis was 3.4 years; the mean EASI score was 34.1. Approximately two-thirds of all patients (68.5%) were white; 61.1% were male.
At week 16, investigators observed that 28% of dupilumab-treated patients achieved clear or almost clear skin by IGA 0/1 versus 4% of placebo patients (P <.0001). An additional 53% of patients on dupilumab achieved EASI 75 at week 16 versus 11% of patients on placebo (P <.0001). The mean percent change in EASI from baseline at week 16 was -70.0% in dupilumab patients versus -19.6% in placebo patients (P <.0001).
The researchers also observed a mean percent change in weekly mean itch NRS score of -49.4% in dupilumab patients compared to -2.2% in placebo patients.
Regarding safety, investigators observed ≥1 treatment-emergent adverse event (TEAE) in 63.9% of patients who received dupilumab versus 74.4% who received placebo. Only 1 patient in each arm discontinued therapy due to an adverse event. Ten (12.0%) patients receiving dupilumab reported skin infection.
Indeed, in patients receiving therapy, infections were by far the most frequently reported adverse events (42.2%), followed by skin and subcutaneous tissue disorders (20.5%), and respiratory, thoracic, and mediastinal disorders ( 10.3%). Nonetheless, the investigators described the 28-week safety profile as that observed in adult patients with atopic dermatitis who received dupilumab.
The researchers concluded that the results support a fast-acting, highly effective and overall safe profile of dupilumab when used in combination with topical steroids in the young child age group with eczema.
“In children aged 6 months to 5 years with moderate to severe atopic dermatitis, dupilumab plus low-potency topical corticosteroids rapidly and significantly improved signs and symptoms of atopic dermatitis,” they wrote. “Dupilumab has demonstrated an acceptable safety profile, similar to that observed in older children and adults.”
The study “Efficacy and safety of dupilumab in children aged 6 months to 5 years with moderate to severe atopic dermatitis” was presented at SDPA 2022.