Vedolizumab Exposure in Newborns

M Juulsgard et al. AP&T 2021: https://doi.org/10.1111/apt.16593. Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones: a prospective multicentre population-based cohort study

Key findings:

  • In 50 vedolizumab-exposed pregnancies, we observed 43 (86%) live births, seven (14%) miscarriages, no congenital malformations and low risk of adverse pregnancy outcomes
  • 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

My take: Given the good safety profile of vedolizumab, this small study provides additional reassurance regarding use of vedolizumab during pregnancy.

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