Regeneron (REGN) and Sanofi (SNY) announce Dupixent (dupilumab) pivotal trial primary and secondary endpoints data for moderate-to-severe atopic dermatitis in children as young as 6 months
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53% achieved 75% or greater overall disease improvement from baseline compared to 11% with placebo (p<0.0001), the co-primary endpoint outside of the U.S.
70% average improvement from baseline in overall disease severity (EASI) compared to 20% improvement with placebo (p<0.0001).
49% average improvement from baseline in itch compared to 2% improvement with placebo (p<0.0001).
Significantly improved measures of observed patient outcomes (including sleep, skin pain and health-related quality of life), as well as caregiver-reported health-related quality of life.
The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis. For the 16-week treatment period, overall rates of adverse events (AEs) were 64% for Dupixent and 74% for placebo. Most common AEs and AEs of special interest included nasopharyngitis (8% Dupixent, 9% placebo), upper respiratory tract infection (6% Dupixent, 8% placebo), conjunctivitis (5% Dupixent, 0% placebo), herpes viral infections (6% Dupixent, 5% placebo) and injection site reactions (2% Dupixent, 3% placebo).
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