Abstract
Abstract not available.
Highlights
Children with severe atopic dermatitis (AD) have limited treatment options with an acceptable benefit–risk profile1–3 –– Systemic corticosteroids are strongly discouraged in children4 –– Other systemic agents are used off-label and do not have an acceptable benefit–risk profile for children who use these therapies on a long-term basis[5]
We report dupilumab pharmacokinetics (PK), safety, and efficacy in children aged ≥ 6 to < 12 years who participated in the phase 2a study, and continued into the phase 3 open-label extension (OLE) study
The first study was a phase 2a, multicenter, open-label, ascending dose, sequential cohort study (NCT02407756) –– The study had 2 treatment parts: in Part A, patients received a single dose of dupilumab (2mg/kg or 4mg/kg), followed by an 8-week follow-up sampling period for systemic drug concentration without treatment; this was followed by Part B, where patients received 4 weekly doses, followed by an 8-week safety follow-up period (Figure 1A) –– An initial cohort of adolescents with moderate-to-severe AD was enrolled; upon safety review of part A, a cohort of children was enrolled for the corresponding dose group (Figure 1A)
Summary
Children with severe atopic dermatitis (AD) have limited treatment options with an acceptable benefit–risk profile1–3 –– Systemic corticosteroids are strongly discouraged in children4 –– Other systemic agents are used off-label and do not have an acceptable benefit–risk profile for children who use these therapies on a long-term basis[5]. Dupilumab, a fully human monoclonal antibody,[6,7] blocks the shared receptor component for interleukin (IL)-4 and IL-13, inhibiting signaling of both IL-4 and IL-13, key cytokines involved in atopic diseases such as AD. Adolescents with moderate-to-severe AD who received dupilumab in a phase 2a study and continued in an open-label extension (OLE) phase 3 study showed improvement in AD signs with an acceptable safety profile with over 52 weeks of total treatment[8]
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