The safety and efficacy of DUPIXENT have been established in pediatric patients 6 months to 17 years of age with moderate-to-severe atopic dermatitis.1

Use of DUPIXENT in this age group (6-11 years of age) is supported by AD-1652, which included 367 children with severe atopic dermatitis.1

Use of DUPIXENT in this age group is supported by data from the following clinical trials1:

  • AD-1526 which included 251 adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis treated with DUPIXENT
  • AD-1652 which included 367 children 6 to 11 years of age with severe atopic dermatitis treated with DUPIXENT + TCS
  • AD-1539 which included 161 infants to preschoolers 6 months to 5 years of age with moderate-to-severe atopic dermatitis treated with DUPIXENT + TCS
  • AD-1434, an open-label extension study that enrolled 275 adolescents 12 to 17 years of age treated with DUPIXENT, 368 children 6 to 11 years of age treated with DUPIXENT ± TCS, and 180 infants to preschoolers 6 months to 5 years of age treated with DUPIXENT ± TCS

The safety and effectiveness were generally consistent between pediatric and adult patients. 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