부산대학교 도서관

Background and Objective: Current regulatory labeling recommends avoiding live vaccine use in dupilumab‐treated patients. Clinical data are not available to support more specific guidance for live or live attenuated vaccines administration in dupilumab‐treated patients. Methods: Children (6 months–5 years old) with moderate‐to‐severe atopic dermatitis (AD) enrolled in a phase 2/3 clinical trial of dupilumab (LIBERTY AD PRESCHOOL Part A/B; NCT03346434) and subsequently participated in the LIBERTY AD PED‐OLE (NCT02612454). During these studies, protocol deviations occurred in nine children who received measles, mumps, rubella (MMR) vaccine with or without varicella vaccine; five with a ≤12‐week gap between dupilumab administration and vaccination and four with a >12‐week gap after discontinuing dupilumab. Results: Nine children (1 female; 8 male) had severe AD at baseline (8–56 months old). Of the nine children, five had a ≤12‐week gap ranged 1–7 weeks between dupilumab administration and vaccination who received MMR vaccine (n = 2) or MMR and varicella vaccines (n = 3); among these, one resumed dupilumab treatment as early as 2 days and four resumed treatment 18–43 days after vaccination. No treatment‐emergent adverse events, including serious adverse events and infections, were reported within the 4‐week post‐vaccination period in any children. Conclusions: In this case series of dupilumab‐treated children with severe AD who received MMR vaccine with or without varicella vaccine, no adverse effects (including vaccine‐related infection) were reported within 4 weeks after vaccination. Further studies are warranted to evaluate the safety, tolerability, and immune response to live attenuated vaccines in dupilumab‐treated patients. [ABSTRACT FROM AUTHOR]