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Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones: a prospective multicentre population-based cohort study. | LitMetric

AI Article Synopsis

  • The study investigated the levels of vedolizumab in umbilical cord blood and its clearance in newborns, focusing on its correlation with maternal drug levels, infection risk, and developmental milestones.
  • Out of 50 pregnancies, there were 43 live births with no congenital malformations or significant adverse outcomes, and the ratio of vedolizumab in infants at birth was 0.44.
  • Clearance of vedolizumab in infants occurred rapidly, with none showing detectable levels by 6 months, and no increased infection risk was observed in relation to maternal vedolizumab use during pregnancy.

Article Abstract

Background: Little is known about the consequences of intrauterine exposure to, and the post-natal clearance of, vedolizumab.

Aims: To investigate the levels of vedolizumab in umbilical cord blood of newborns and rates of clearance after birth, as well as how these correlated with maternal drug levels, risk of infection and developmental milestones during the first year of life METHODS: Vedolizumab-treated pregnant women with inflammatory bowel disease were prospectively recruited from 12 hospitals in Denmark and Canada in 2016-2020. Demographics were collected from medical records. Infant developmental milestones were evaluated by the Ages and Stages Questionnaire (ASQ-3). Vedolizumab levels were measured at delivery and, in infants, every third month until clearance. Non-linear regression analysis was applied to estimate clearance.

Results: In 50 vedolizumab-exposed pregnancies, we observed 43 (86%) live births, seven (14%) miscarriages, no congenital malformations and low risk of adverse pregnancy outcomes. Median infant:mother vedolizumab ratio at birth was 0.44 (95% confidence interval [CI], 0.32-0.56). The mean time to vedolizumab clearance in infants was 3.8 months (95% CI, 3.1-4.4). No infant had detectable levels of vedolizumab at 6 months of age. Developmental milestones at 12 months were normal or above average. Neither vedolizumab exposure in the third trimester (RR 0.54, 95% CI, 0.28-1.03) nor combination therapy with thiopurines (RR 1.29, 95% CI, 0.60-2.77) seemed to increase the risk of infections in the offspring.

Conclusions: Neonatal vedolizumab clearance following intrauterine exposure is rapid. Infant vedolizumab levels did not correlate with the risk of infections during the first year of life. Continuation of vedolizumab throughout pregnancy is safe.

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Source
http://dx.doi.org/10.1111/apt.16593DOI Listing

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