A Case Series of Live Attenuated Vaccine Administration in Dupilumab-Treated Children With Atopic Dermatitis

Dupilumab, a human monoclonal antibody which inhibits interleukin-4 and interleukin-13 signaling, is used to treat children with atopic dermatitis (AD) and asthma. Current product labeling recommends avoiding live vaccine administration during dupilumab treatment. This retrospective case series aims to contribute clinical data to further advance our knowledge of the administration of live vaccines in pediatric patients receiving dupilumab.Nine children, ranging from 8- to 56-months-old, from the LIBERTY AD PRESCHOOL Part A/B (NCT03346434) and the LIBERTY AD PED-OLE (NCT02612454) clinical trials were included in this retrospective case series. The 9 children received live attenuated measles, mumps, rubella (MMR) vaccine with or without the varicella vaccine during their respective clinical trials, which were protocol deviations. Six children were from study sites located in the United States, and the other 3 were from study sites located in the United Kingdom and Poland. Eight of the 9 children were male, 7 of the 9 children were white, and 2 of the 9 children were Black or African American. All 9 children had atopic medical histories, ranging from environmental allergy to asthma, and had severe eczema (Investigator’s Global Assessment score was 4; the Eczema Area and Severity Index score between 21.2 to 49.8).This retrospective case series presents 9 children from the aforementioned dupilumab pediatric clinical trials. Treatment-emergent adverse events, treatment-emergent serious adverse events, and treatment-emergent infestations and infections within 4 weeks after live vaccination were evaluated. Demographics (age, sex, race, and ethnicity), duration of AD, treatments used previously for AD, and other atopic history were also examined.Five of the 9 children received the MMR vaccine with or without the varicella vaccine (2 received MMR and 3 received MMR with varicella) between 1 to 7 weeks after dupilumab administration. One child restarted dupilumab 2 days after vaccination, and 4 children restarted dupilumab 18 to 43 days after. Among the 4 children who had a greater than 12-week interval between dupilumab and live attenuated vaccine administration, there was a range of 4 to 98 weeks between vaccination and the resumption of dupilumab. During the 4-week postvaccination period, there were no treatment-emergent adverse events, serious adverse events, or infections reported in any children. All 9 children continued to have greater than or equal to a 75% reduction in EASI score. After the 4-week postvaccination period, treatment-emergent infestations and infections, including croup, hand-foot-and-mouth disease, and coronavirus disease 2019 infections, were reported. Additionally, 2 episodes of asthma classified as moderate severity occurred in the same patient.During the 4-week postvaccination period, there were no treatment-emergent adverse events among the 9 dupilumab-treated children who received live vaccinations. Additionally, it appears that live vaccination did not decrease the efficacy of dupilumab exemplified by maintenance of reduced EASI scores.This retrospective case series addresses a clinically relevant and timely question as more young children are treated with dupilumab. Given the small number of pediatric patients included in this retrospective case series, prospective studies with larger numbers of pediatric patients of diverse racial and ethnic backgrounds, from different locations, are necessary to further evaluate the safety of live vaccines administered in patients treated with dupilumab. Additionally, further information evaluating the optimal duration of time between dupilumab administration and live vaccination, and resumption of dupilumab administration, is needed.