CLINICAL TRIAL RESULTS IN ADOLESCENTS AND TRIAL DESIGNS

The primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement at Week 16 (24% of patients treated with DUPIXENT vs 2% with placebo, P<0.001). Other endpoints included the proportion of subjects with EASI-75 at Week 16 (42% of patients treated with DUPIXENT vs 8% with placebo, P<0.001) and ≥4-point improvement in the Peak Pruritus NRS at Week 16 (37% of patients treated with DUPIXENT vs 5% with placebo, P<0.001).2,5

251 adolescents (12-17 years) in AD-1526 (16 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT or placebo. Adolescents ≥60 kg received DUPIXENT 300 mg Q2W after a 600 mg loading dose, and adolescents <60 kg received 200 mg Q2W after a 400 mg loading dose. Patients had an IGA score ≥3 on a scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and BSA involvement of ≥10%. At baseline, 46% had an IGA score of 3 (moderate), 54% had an IGA of 4 (severe), mean EASI score was 36, and weekly averaged Peak Pruritus NRS was 8 on a scale of 0 to 10.2

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 in adolescents through Week 16 was similar to that of adults with atopic dermatitis. In an open-label extension study, the long-term safety profile of DUPIXENT in adolescents observed through Week 52 was consistent with that seen in adults with atopic dermatitis.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.

Tyler

Age 14

Has struggled with
uncontrolled moderate-to-
severe
atopic dermatitis
since infancy

Currently taking DUPIXENT—started in 2020

Topical Rxs weren’t
enough. With DUPIXENT,
his rashes faded, even his
feet are looking great!  
—Tyler’s parents

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

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

My story

Tyler has struggled to find control for his moderate-to-severe atopic dermatitis since infancy. Before DUPIXENT, despite using topical Rx therapies, nonstop itching and flares defined his childhood. We wanted his skin to get better with another treatment option.

My signs and symptoms

  • Itching throughout the day
  • Extremely dry, scaly skin with severe rashes—sensitive areas such as his feet were a real problem
  • He had oozing and crusting skin

My treatment and goals

  • Topical prescription therapies worked for a while, but they stopped working and were damaging to his skin
  • Chlorine baths and wet wraps were also ineffective
  • We had to find another treatment that was appropriate for long-term use