Global Medical Affairs Director Sanofi Cambridge, Massachusetts, United States
Background: Atopic dermatitis (AD) is a common childhood inflammatory skin disease; however, children with moderate-to-severe AD have limited long-term treatment options. Objective: To report dupilumab efficacy and safety in children aged from 6 months to 5 years with moderate-to-severe AD treated for up to 1 year. Design/Methods: Children aged from 6 months to 5 years with moderate-to-severe AD who had participated in the 16-week, double-blind, phase 3 LIBERTY AD PRESCHOOL trial (NCT03346434, part B; parent study) were enrolled into an open-label extension (OLE) study (NCT02612454). Patients received subcutaneous dupilumab every 4 weeks: 200mg for children weighing 5 to < 15kg (n=39); 300mg for 15 to < 30kg (n=103). Topical AD treatments were allowed. Data presented as observed. Results: Relative to parent study baseline, mean (SE) percentage changes in EASI score were −52.7(5.5) and −56.6 (3.4) at OLE baseline, −81.0(3.3) and −82.6(1.8) at Week 16, and −87.6(3.7) and −86.2(2.6) at Week 52 in the 200mg and 300mg dupilumab groups, respectively. The number of patients (%) achieving an Investigator’s Global Assessment score of 0/1 increased from OLE baseline (6/39[15.4] and 15/103[14.6]), to Week 16 (17/38[44.7] and 33/101[32.7]), and at Week 52 (7/17[41.2] and 14/41[34.1]) in the 200mg and 300mg dupilumab groups, respectively. Mean (SE) change from baseline of parent study in Children’s Dermatology Life Quality Index (for patients ≥4 years at baseline) was −13.3(4.2) and −7.5(0.8) at OLE baseline and −24.0(NE) and −13.4(1.1) at Week 52 for the 200mg and 300mg groups, respectively. Mean (SE) change from baseline of parent study in Infant Dermatitis Quality of Life Index (for patients < 4 years at baseline) was −7.2(1.2) and −7.8(1.6) at OLE baseline and −15.7(1.8) and −13.3(1.7) at Week 52 for the 200mg and 300mg groups, respectively. Overall safety of dupilumab treatment administered for up to 1 year was consistent with the known dupilumab safety profile.
Conclusion(s): Dupilumab treatment for 1 year provides sustained improvement in signs of AD and quality of life with an acceptable safety profile in patients aged from 6 months to 5 years with moderate-to-severe AD.
