DUPIXENT (dupilumab) performed well in a Phase 3 Trial of inadequately controlled moderate-to-severe atopic dermatitis in adolescents, Regeneron and Sanofi report.

In the trial, treatment with DUPIXENT as monotherapy significantly improved measures of overall disease severity, skin clearing, itching and certain health-related quality of life measures.

DUPIXENT is the first and only biologic to show positive results in this patient population. In 2016, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for DUPIXENT for the treatment of moderate-to-severe (12 to 17 years of age) and severe (6 months to 11 years of age) atopic dermatitis

Patients treated with DUPIXENT had significant improvement in disease severity at 16 weeks.
The primary endpoints were the proportion of patients achieving Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75 percent improvement in Eczema Area and Severity Index (EASI-75, co-primary endpoint outside of the U.S.) at 16 weeks. Results included:

• 24 percent of patients who received weight-based dosing of DUPIXENT every two weeks (200 mg or 300 mg) and 18 percent 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 percent with placebo (p less than 0.0001, and p=0.0007, respectively).
• 41.5 percent of patients who received DUPIXENT every two weeks and 38 percent of patients who received DUPIXENT every four weeks achieved 75 percent or greater skin improvement (EASI-75) compared to 8 percent with placebo (p less than 0.0001).
• There was a 66 percent improvement in the DUPIXENT every two weeks group and 65 percent improvement in the DUPIXENT every four weeks group in average percent change from baseline in EASI score compared with a 24 percent improvement in the placebo group (p less than 0.0001).
• There was a 48 percent improvement in the DUPIXENT every two weeks group and 45.5 percent 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 percent improvement in the placebo group (p less than 0.0001).

Moreover, DUPIXENT’s safety profile was consistent with that seen in adults.

For the 16-week treatment period, the overall rate of adverse events was comparable between the DUPIXENT groups and placebo (72 percent for DUPIXENT every two weeks, 64 percent for DUPIXENT every four weeks and 69 percent for placebo). There were no serious adverse events or events leading to treatment discontinuation in either DUPIXENT treatment group. Adverse events that were observed at a higher rate with DUPIXENT included injection site reactions (8.5 percent for DUPIXENT every two weeks, 6 percent for DUPIXENT every four weeks compared with 3.5 percent for placebo) and conjunctivitis (10 percent for DUPIXENT every two weeks, 11 percent for DUPIXENT every four weeks compared with 5 percent for placebo). Skin infections were numerically lower in the DUPIXENT groups (11 percent for DUPIXENT every two weeks, 13 percent for DUPIXENT every four weeks compared with 20 percent for placebo).

Detailed results from this trial will be presented at a future medical meeting. These data will be submitted to regulatory authorities later this year.