A combination of dupilumab and medium-potency topical corticosteroids (TCS) significantly improved signs and symptoms of atopic dermatitis (AD) and quality of life in children with severe AD, according to study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.
The LIBERTY AD PEDS phase 3 trial (NCT03345914) enrolled children from 6 to 11 years of age with severe AD. Participants were randomly assigned to receive 300 mg dupilumab every 4 weeks (n=61), 100mg/200mg every 2 weeks (baseline weight ≥30 kg: n=59), or placebo (baseline weight <30 kg: n=61; baseline weight ≥30 kg: n=62). Each treatment group also received concomitant medium-potency TCS.
Study investigators assessed the percentage of patients who reached the 16-week composite endpoint comprising achievement of 50% or greater improvement in Eczema Area and Severity Index (EASI-50), 3-point or greater improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) score, and 6-point or greater improvement in Children’s Dermatology Life Quality Index (CDLQI).
Nearly half of patients in the 300 mg (49.2%) and 200 mg (47.5%) dupilumab arms achieved all 3 clinically meaningful endpoints, while only 9.8% of patients under30 kg and 8.1% of patients 30 kg or more in the placebo groups achieved improvements in all 3 domains (P <.0001).
In addition, more patients assigned to dupilumab achieved EASI-50 or 3-points or greater improvement in PP-NRS or a 6-points or greater improvement in CDLQI by week 16 compared with those assigned to placebo (95.1%/62.3%, 300mg- q4w/placebo <30kg and 94.9%/59.7% 200mg-q2w/placebo ≥30kg; P <.0001 for both).
According to the investigators, the safety profile of dupilumab was consistent with its known safety reported in adult and adolescent patient populations.
Disclosure: This clinical trial was supported by Sanofi and Regeneron Pharmaceuticals. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Visit Dermatology Advisor‘s conference section for more coverage from AAD 2021.
Paller AS, Weidinger S, Cork MJ, et al. Dupilumab provides clinically meaningful improvement in atopic dermatitis (AD) signs, symptoms, and quality of life in children with severe AD: Results from the LIBERTY AD PEDS phase 3 clinical trial. Poster presented at: American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021; April 23-25, 2021. Abstract/Poster 27394.