Clinical Data
The late-breaking presentation at EADV included the following data:The co-primary endpoint outside of the U.S. was 75% improvement in Eczema Area and Severity Index (EASI-75) at 16 weeks. In the U.S., the primary endpoint was the proportion of patients achieving Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear):

• 41.5% of patients who received Dupixent every two weeks and 38% of patients who received Dupixent every four weeks achieved 75% or greater skin improvement (EASI-75) compared to 8% with placebo (p less than 0.001).
• 24% of patients who received weight-based dosing of Dupixent every two weeks (200 mg or 300 mg) and 18% of patients who received a fixed dose of Dupixent every four weeks (300 mg) achieved the primary endpoint – clear or almost-clear skin (IGA; score of 0 or 1) – compared with 2% with placebo (p less than 0.001).

With regard to key secondary endpoints at 16 weeks:

• There was a 66% improvement in the Dupixent every two weeks group and 65% improvement in the Dupixent every four weeks group in average percent change from baseline in EASI score compared with a 24% improvement in the placebo group (p less than 0.001).
• There was a 48% improvement in the Dupixent every two weeks group and 45.5% improvement in the Dupixent every four weeks group in average percent change from baseline in the pruritus numerical rating scale (NRS) compared with a 19% improvement in the placebo group (p less than 0.001).
• 49% of patients who received Dupixent every two weeks and 39% of patients who received Dupixent every four weeks achieved at least a 3-point improvement on the peak pruritus numerical rating scale (pp-NRS) compared to 9% with placebo (p less than 0.001). At the beginning of the trial, patients reported a mean itch score of 7.6 on the 10-point pp-NRS scale.

Also at 16 weeks, additional secondary endpoints were:

• The majority of patients who received Dupixent (61% of patients treated every two weeks and 55% of patients treated every four weeks) achieved at least a 50% improvement in EASI (EASI-50) compared to 13% with placebo (p less than 0.001).
• There was a 52% improvement in the Dupixent every two weeks group and 47.5% improvement in the Dupixent every four weeks group compared to an 18% improvement in the placebo group in mean percent change from baseline in SCORing Atopic Dermatitis (SCORAD), a combined measure of area and severity of atopic dermatitis on the skin as well as patient-reported symptoms of itch and sleeplessness (p less than 0.001).
• Patients who received Dupixent every two weeks or every four weeks significantly improved quality of life measured by the Children's Dermatology Life Quality Index (CDLQI) and patient-reported symptoms measured by the Patient-Oriented Eczema Measure (POEM) compared with placebo (p less than 0.001).

Additionally in the 16-week trial, 59% of patients on placebo used rescue medications compared with 21% of patients receiving Dupixent every two weeks and 32.5% of patients receiving Dupixent every four weeks.The overall rate of adverse events was 72% for Dupixent every two weeks, 64% for Dupixent every four weeks and 69% for placebo.Adverse events that were observed more frequently with Dupixent included injection site reactions (8.5% for Dupixent every two weeks, 6% for Dupixent every four weeks compared with 3.5% for placebo) and conjunctivitis (10% for Dupixent every two weeks, 11% for Dupixent every four weeks compared with 5% for placebo). Skin infections were numerically lower in the Dupixent groups (11% for Dupixent every two weeks, 13% for Dupixent every four weeks compared with 20% for placebo).The safety and efficacy of Dupixent in the adolescent atopic dermatitis population have not been fully evaluated by any regulatory authority.