Phase 3 data suggest children aged <6 months to 5 years old have benefit in itch relief and skin clearance as soon as 1 week into systemic therapy regimens.
Dupilumab (Dupixent) administered once every 4 weeks in combination with low-potency topical corticosteroids provided rapid and significant improvement of atopic dermatitis presentation and symptoms in the youngest children eligible to receive the therapy, according to new data.
In research presented at the Society of Dermatology Physician Assistants (SDPA) 2022 Annual Meeting in Miami, FL this week, a team of US investigators reported that the interleukin 4 and 13 (IL-4; IL-13) inhibitor biologic therapy from Sanofi and Regeneron provided a significantly efficacious profile and similar safety to that observed in treated adult patients versus placebo in children aged 6 months to 5 years old with moderate to severe atopic dermatitis.
The findings further support the utility of dupilumab, which earlier this year received US Food and Drug Administration (FDA) approval 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, investigators conducted an evaluation of 16-week efficacy and safety outcomes of dupilumab in combination with topical corticosteroids in younger pediatric patients whose eczema is inadequately controlled with topical therapies.
In an interview with HCPLive® at the American Academy of Dermatology (AAD) 2022 Annual Meeting, Paller described the challenges of navigating previously available systemic therapies for pediatric eczema patients—which possessed more uncertainties regarding benefit-risk.
“Now it’s much easier, because we have a medication that really doesn’t need any lab monitoring, that has some conjunctivitis that can generally be treated pretty easily, some mild injection site reaction—but otherwise really in the vast majority of children has no side effect whatsoever,” Paller said about dupilumab.
Previous phase 3 trial data showed the biologic therapy was associated with “substantially improved” measures of atopic dermatitis signs, symptoms and quality of life in children aged 6 to <12 years old. Part B of Paller and colleagues’ LIBERTY AD PRESCHOOL trial was a phase 3, double-blind, placebo-controlled assessment featuring children aged 6 months to <5 years old with moderate to severe atopic dermatitis defined as Investigator’s Global Assessment (IGA) ≥3 and Ezcema Area Severity Index (EASI) ≥16, as well as weekly average daily worst itch Numerical Rating Score (NRS) ≥4 and body surface involvement (BSA) ≥10%.
Patients were randomized to 1 of 2 dupilumab arms (200 mg; 300 mg) plus topical corticosteroids based on baseline bodyweight, or placebo plus topical cortiosteroids, for 16 weeks. They were then admitted into a 12-week open-label extension or safety follow-up period to week 28.
A total of 83 patients received either dupilumab arm, versus 79 patients randomized to placebo. Mean patient age was 3.8 years old; only 11 total patients were <2 years old. Mean duration of atopic dermatitis was 3.4 years; 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 28% of dupilumab-treated patients achieved clear or almost clear skin per IGA 0/1, versus 4% of placebo patients (P <.0001). Another 53% of patients on dupilumab achieved EASI 75 at week 16, versus 11% of placebo patients (P <.0001). Mean percent change in EASI was -70.0% from baseline to week 16 among dupilumab patients, versus -19.6% for placebo patients (P <.0001).
Investigators additionally observed a -49.4% mean percent change in weekly average itch NRS score among dupilumab patients, versus -2.2% in placebo patients.
Regarding safety, investigators observed ≥1 treatment-emergent adverse event (TEAE) in 63.9% of patients receiving dupilumab, versus 74.4% receiving placebo. Only 1 patient in either arm discontinued therapy due to an adverse event. Ten (12.0%) patients receiving dupilumab reported a skin infection.
Indeed, infections were by far the most commonly reported adverse event in patients receiving therapy (42.2%), followed by skin and subcutaneous tissue disorders (20.5%) and respiratory, thoracic and mediastinal disorders (10.3%). Nonetheless, investigators described the 28-week safety profile as that observed in adult patients with atopic dermatitis receiving dupilumab.
Investigators concluded the findings support a fast-acting, highly efficacious, and overall safe profile of dupilumab when used in combination with topical steroids in the young eczema pediatric age group.
“In children aged 6 months to 5 years with moderate-to- severe atopic dermatitis, dupilumab plus low-potency topical corticosteroids rapidly and significantly improved atopic dermatitis signs and symptoms,” 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.