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Vedolizumab Exposure in Newborns

September 18, 2021 9:00 am

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.

Related blog posts:

Real-World Vedolizumab: Better Than Expected
PIANO Study Update (2021)
IBD Highlights from Recent Meetings with Commentary by Dr. Sandborn Explains Why Vedolizumab Should Be Considered a First Line Agent (2019)
VICTORY Consortium Data for Vedolizumab 2018
Vedolizumab More Effective Than Adalimumab for Ulcerative Colitis (Part 2)
Vedolizumab More Effective Than Adalimumab for Ulcerative Colitis

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