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. 2024 Mar-Apr;41(2):204-209.
doi: 10.1111/pde.15518. Epub 2024 Feb 2.

A case series of live attenuated vaccine administration in dupilumab-treated children with atopic dermatitis

Elaine C Siegfried  1   2 , Lara Wine Lee  3 , Jonathan M Spergel  4 , Randy Prescilla  5 , Sumeet Uppal  6 , Anna Coleman  7 , Ashish Bansal  6 , Sonya L Cyr  6 , Brad Shumel  6
Affiliations

A case series of live attenuated vaccine administration in dupilumab-treated children with atopic dermatitis

Elaine C Siegfried et al. Pediatr Dermatol. 2024 Mar-Apr.

Abstract

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.

Keywords: atopic dermatitis; children; dupilumab; live attenuated vaccines; safety.

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References

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