Vedolizumab safety in pregnancy and newborn outcomes

We read with interest the study by Colombel et al1 on vedolizumab (VDZ) safety in Crohn's disease (CD) and ulcerative colitis (UC). These data were derived from pivotal clinical trials which naturally exclude pregnant women, leaving this important area of pharmacovigilance unaddressed. Epidemiologically, the first age peak of IBD frequently overlaps with family planning. Thus, there is considerable interest among couples and healthcare providers on how VDZ impacts on pregnant women and newborns. Here we report the first four fully VDZ exposed and documented pregnancies and newborns.

VDZ (MLN0002, MLN02, LDP-02, anti-α₄β₇) is a humanised monoclonal IgG₁ antibody targeting α₄β₇ integrin. IgG₁ is the predominant means of fetal immunity and maternal–fetal transport across the placenta, which increases linearly throughout pregnancy.2 Therefore, it can be expected that the fetuses are increasingly VDZ exposed towards the delivery date.

The first two patients display typical IBD demographics, while...

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