Expanding the Largest Clinical Development Program in Atopic Dermatitis With a Trial in Children (6 to 11 Years)

A total of 367 children (6-11 years of age) in Trial 8 (16 weeks) with severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT + TCS or placebo + TCS. This study compared both weight-tiered and non-weight-tiered dosing regimens. From these results, the recommended dosing for children aged 6-11 years is as follows: Patients ≥30 kg but <60 kg received 200 mg Q2W after a 400 mg loading dose. Patients 15 kg but <30 kg received 300 mg Q4W after a 600 mg loading dose.1

DUPIXENT was evaluated in children whose severe atopic dermatitis was inadequately controlled on topical Rx therapies1,a

Disease severity was defined by an IGA score of ≥4 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, an EASI score ≥21 on a scale of 0 to 72, and a minimum body surface area involvement of ≥15%.1

Primary endpoint in the study in children was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 161

Clinical trials in children included 1 trial with concomitant TCS (Trial 8) and 1 open-label extension trial (Trial 7); both trials initiated with 2 DUPIXENT (200 mg or 300 mg) or placebo subcutaneous injections at Week 0 based on the child’s weight. Emollient background regimen was required.1,2

EASI, Eczema Area and Severity Index: IGA, Investigator’s Global Assessment; NRS, numerical rating
scale; Q2W, once every 2 weeks; Q4W, once every 4 weeks; SC, subcutaneous; TCS, topical corticosteroids.

aThese baseline characteristics are not meant for comparison.

bAt baseline, mean disease duration was ≈7 years. Mean age was 8.5 years.

cEmollient background regimen was required. The study design tested both weight-tiered and non–weight-tiered dosing. Based on results, the approved dosing was weight-tiered.

dStudied vs placebo.

eWeekly averaged Peak Pruritus NRS score (10 indicates the most severe).

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References:
  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.