CLINICAL TRIAL RESULTS IN CHILDREN AND TRIAL DESIGN

The primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 16 (39% of patients ≥30 kg treated with DUPIXENT + TCS vs 10% with placebo + TCS, and 30% of patients <30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS). Other endpoints included the proportion of subjects with EASI-75 at Week 16 (75% of patients ≥30 kg treated with DUPIXENT + TCS vs 26% with placebo + TCS, and 75% of patients <30 kg treated with DUPIXENT + TCS vs 28% with placebo + TCS) and ≥4-point improvement in the Peak Pruritus NRS at Week 16 (61% of patients ≥30 kg treated with DUPIXENT + TCS vs 13% with placebo + TCS, and 54% of patients <30 kg treated with DUPIXENT + TCS vs 12% with placebo + TCS).2,6

367 children (6-11 years) in AD-1652 (16 weeks) with severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT + TCS or placebo + TCS. 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. Patients had an IGA score of 4, an EASI score ≥21, and BSA involvement ≥15%. Mean EASI score was 37.9 and weekly averaged Peak Pruritus NRS was 7.8 on a scale of 0 to 10.2

BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q2W, once every 2 weeks; TCS, topical corticosteroids.

Harper

Age 8

Struggling with uncontrolled moderate-
to-severe
atopic dermatitis since
early
childhood

Currently taking DUPIXENT

Before DUPIXENT, Harper’s hands were a big problem. Topical Rxs just weren’t enough.
—Harper’s parents

Real patient
being treated with DUPIXENT.
Individual results may vary.

Real patient
being treated with DUPIXENT.
Individual results may vary.

My story

After struggling with moderate-to-severe atopic dermatitis since early childhood, Harper was referred to a specialist by her primary care doctor when topical prescription therapies were not enough. We saw an allergist and a dermatologist. Now on DUPIXENT, Harper has less itching.

My signs and symptoms

  • Constant burning and itching that never went away
  • Scratching throughout the night
  • Puffy swollen eyes during a flare
  • Her fingers and toes would bleed regularly

My treatment and goals

  • Treatments from oral and topical prescriptions to bleach baths and light therapy—all were unsuccessful
  • We needed a treatment that could help reduce her itch and clear her skin