Clin Gastroenterol Hepatol. 2024 Jul 30:S1542-3565(24)00677-3. doi: 10.1016/j.cgh.2024.07.007. Online ahead of print.
ABSTRACT
BACKGROUND: Biologic therapies in the context of IBD and pregnancy lead to improved maternal and fetal outcomes. Placental transfer results in detectable drug concentrations in infants. Rotavirus infection results in diarrheal related hospitalizations, however, the live oral vaccine is not currently recommended in biologic exposed infants.
AIMS: To assess the effect of maternal biologic therapies on the infant immune system and safety of live rotavirus vaccination in biologic-exposed infants.
METHODS: Biologic-exposed infants underwent standardized clinical assessments, drug concentration, and immune function testing (complete blood count, differential, immunoglobulin levels, extended B-cell and T-cell subset enumeration, Recent Thymic Emigrants, regulatory T-cell numbers, mitogen stimulation assays, and review of T-cell Receptor Excision Circles in the newborn screen). Rotavirus vaccine-specific adverse effects following immunizations up to 42 days post the last dose of the vaccine series were recorded.
RESULTS: There were 57 infants born to 52 mothers with IBD exposed to infliximab (n=21), adalimumab (n=19), vedolizumab (n=10), and ustekinumab (n=7) in the third trimester. Median 39 (IQR 38-39) weeks at delivery. Immunologic assessments validated for age were normal in all infants despite median infliximab concentrations of 6.1 ug/mL (range 0.4-28.8), adalimumab 1.7 ug/mL (range 0.7-7.9), ustekinumab 0.6 ug/mL (range 0-1.1) and undetectable for vedolizumab at 10.7 weeks (IQR 9.4-12.4) of age. The live oral rotavirus vaccine series was provided to 50 infants with the first dose given at a median of 13 weeks of age. No adverse effects following immunization were reported.
CONCLUSION: Immune function testing was normal and administration of live rotavirus vaccination appeared low-risk in biologic-exposed infants irrespective of circulating drug levels.
PMID:39089515 | DOI:10.1016/j.cgh.2024.07.007
