CHRONOS was a 52-week pivotal clinical trial evaluating the efficacy and safety of DUPIXENT in adult patients with uncontrolled moderate-to-severe atopic dermatitis. 421 adult patients were randomized to DUPIXENT + TCS or placebo + TCS.1
Disease severity was defined by an IGA score ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4, an EASI score ≥16 on a scale of 0 to 72, and a minimum body surface area involvement of ≥10%.1
CHRONOS results demonstrated significant improvement with DUPIXENT + TCS in achieving clear (IGA 0) or almost-clear skin (IGA 1) and ≥2-point improvement (the primary endpoint at 16 weeks) and lesion extent and severity (EASI) at Weeks 16 and 52 vs placebo + TCS.1,2,4
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.1
Additionally, the adult safety profile of DUPIXENT + TCS through Week 52 was generally consistent with the safety profile observed at Week 16 in adults.1
The pivotal clinical trial evaluating the efficacy and safety of DUPIXENT in adolescent patients aged 12 to 17 years with uncontrolled moderate-to-severe atopic dermatitis was a 16-week trial.1
The long-term safety of DUPIXENT was assessed in an open-label extension study that included adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD-1434). The safety profile of DUPIXENT in subjects followed through Week 52 was similar to the safety profile observed at Week 16 in AD-1526. The long-term safety profile of DUPIXENT observed in pediatric subjects 12 to 17 years of age was consistent with that seen in adults with atopic dermatitis.1
The pivotal clinical trial evaluating the efficacy and safety of DUPIXENT + TCS in children aged 6 to 11 years with uncontrolled severe atopic dermatitis was a 16-week trial.1
However, the long-term safety of DUPIXENT ± TCS was assessed in an open-label extension study of 368 subjects 6 to 11 years of age with atopic dermatitis (AD-1434). Among subjects who entered this study, 110 (30%) had moderate and 72 (20%) had severe atopic dermatitis at the time of enrollment in AD-1434. The safety profile of DUPIXENT ± TCS in children followed through Week 52 was similar to the safety profile observed at Week 16 in AD-1652. The long-term safety profile of DUPIXENT ± TCS observed in children was consistent with that seen in adults and adolescents with atopic dermatitis.1
The pivotal clinical trial evaluating the efficacy and safety of DUPIXENT ± TCS in infants to preschoolers aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis was a 16-week trial.1
However, the long-term safety of DUPIXENT ± TCS was assessed in an open-label extension study of 180 infants to preschoolers 6 months to 5 years of age with atopic dermatitis (AD-1434). The majority of subjects were treated with DUPIXENT 300 mg every 4 weeks. The safety profile of DUPIXENT ± TCS in infants to preschoolers through Week 52 was similar to the safety profile observed through Week 16 in AD-1539. 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
Review the Data in Infants
to Preschoolers
AD-HAFT was a 16-week randomized trial of 133 AD patients 12 years and older with uncontrolled moderate-to severe hand and/or foot involvement; therefore, there are currently no long-term safety data available.1,2
REVIEW THE DATA IN AD PATIENTS WITH HAND AND/OR FOOT INVOLVEMENT (AGES 12+ YEARS)