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).1,4

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 10.1,4

The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis are injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia. The safety profile of DUPIXENT ± TCS in children followed through Week 52 was similar to the safety profile observed at Week 16 in AD-1652. The long-term safety profile of DUPIXENT ± TCS observed in children was consistent with that seen in adults and adolescents with atopic dermatitis.1

BSA, body surface area; 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; TCS, topical corticosteroids.

BECKETT’S JOURNEY: BEFORE DUPIXENT

A DAILY FIGHT WITH ITCH

Beckett experienced constant, widespread itching

  • His lesions seemed to be everywhere, including on his face, wrists, arms, legs, ankles, and lower back
  • Participating in youth sports was challenging for Beckett, as well as swimming, because the water stung his skin
  • From topical Rxs to wet wraps to moisturizing ointments, Beckett’s parents tried several different treatments but his disease remained uncontrolled
  • The minimal progress Beckett would make would quickly become undone by his aggressive itching

“I was feeling like a failure that I couldn’t find a way to help him.”

—Beckett's mom

Beckett's moderate-to-severe atopic dermatitis at seven years old
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DUPIXENT