Data Demonstrate Safety, Efficacy of Dupilumab for AD in Patients as Young as Six Months

December 10, 2021
FDA Approves New Dupixent Prefilled Pen Designed to Support More Convenient SelfAdministration image

Conference marks the first presentation of data for use of dupilumab in children as young as 6 months

Data demonstrating the safety and efficacy of Sanofi and Regeneron’s Dupixent® (dupilumab) in pediatric patients as young as six months old will be presented for the first time this weekend at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference.

Amy S. Paller, MD presents results of a trial showing that dupilumab significantly improved signs and symptoms of moderate-to-severe AD in children aged 6 months to 5 years with a favorable safety profile. In an open-label extension trial of dupilumab in children aged 6 to 11 years, treatment resulted in substantial and sustained long-term reduction in AD signs and symptoms, as well a favorable safety profile. This marks the first presentation of data for use of dupilumab in children as young as 6 months and the first presentation of longer-term (one year) data in children 6-11 years.

Several poster presentations addressed the influence of dupilumab treatment on various aspects of atopic dermatitis. Joseph Merola, MD and colleagues show that dupilumab significantly improved overall sleep vs placebo in adults with moderate-to-severe AD. The team used a novel scale to measure sleep quality.

Stephan Weidinger, MD, PhD and colleagues report on AD severity and outcomes in infants/preschoolers (aged 6 months to six years) in 18 countries from five regions, including North America, Latin America, Europe, Middle East/Eurasia, and East Asia, from the EPI-CARE study.

One or more atopic comorbidity was reported in 88.3%, 92.1%, and 95.8% of patients with mild, moderate, and severe AD, respectively. Infants/preschoolers with moderate or severe AD had worse itch, skin pain, and sleep disturbances over the past 24 hours, compared with those with mild AD across regions. The majority (78.3%) of preschoolers aged 4 to <6 years missed at least one school day in the past four weeks, with a mean (SD) of 5.1 (5.7) days lost in mild AD, 7.3 (7.1) days in moderate AD, and 12.1 (7.8) days in those with severe AD.

Robert Bissonnette, MD led a team that assessed the effects of dupilumab treatment on rates of transepidermal water loss (TEWL) in individuals with AD. At Week 16, there were no statistically significant differences in the adjusted mean TEWL distribution between lesional and non-lesional skin in AD patients and matched healthy volunteers.

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