CLINICAL TRIAL RESULTS IN INFANTS TO PRESCHOOLERS AND TRIAL DESIGNS

162 infants to preschoolers (6 months to 5 years) in AD-1539 (16 weeks) with moderate-to-severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT + TCS or placebo + TCS. Patients 15 kg but >30 kg received 300 mg Q4W. Patients 5 kg but <15 kg received 200 mg Q4W. 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, 23% of infants to preschoolers had an IGA score of 3 (moderate), 77% had an IGA of 4 (severe), mean EASI score was 34.1, and weekly average of daily Worst Scratch/Itch NRS was 7.6 on a scale of 0 to 10.1,3

The primary endpoint was the proportion of subjects with an IGA 0 (clear) or 1 (almost clear) at Week 16 (28% of patients treated with DUPIXENT + TCS vs 4% with placebo + TCS, P<0.0001). Other endpoints included the proportion of subjects with EASI-75 at Week 16 (53% of patients treated with DUPIXENT + TCS vs 11% with placebo + TCS, P<0.0001) and ≥4-point improvement in the Worst Scratch/Itch NRS at Week 16 (48% of patients treated with DUPIXENT + TCS vs 9% with placebo + TCS, P<0.0001).1,3

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 long-term safety profile of DUPIXENT ± TCS observed in infants to preschoolers was consistent with that seen in adults, adolescents and children with atopic dermatitis. In AD-1434, hand-foot-and-mouth disease and skin papilloma (incidence ≥2%) was reported in infants to preschoolers. These cases did not lead to study drug discontinuation.1

BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator’s Global Assessment; NRS, numerical rating scale; Q4W, once every 4 weeks; TCS, topical corticosteroids.

LILA’S JOURNEY: BEFORE DUPIXENT

STUCK IN A CYCLE OF FLARE,
TREAT, REPEAT

Despite treatment, flares would return and worsen
during certain seasons

  • Warmer weather seemed to trigger Lila’s flares
  • Being outdoors during the summertime was
    difficult for Lila and her parents
  • Application of topical Rxs was difficult, as she
    would often try to rub them off
  • After trying multiple topical Rxs, Lila was finally
    referred to a specialist
  • Her mother grew concerned about how
    other children and parents might react to
    her condition

“Many times, it felt like we would just get things under control and then she would have another flare. Some treatments would initially work, but then they would stop working for her.”

—Lila’s mom

Lila, an infant to preschooler with moderate-to-severe atopic dermatitis
NEXT: Beginning
DUPIXENT