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Vedolizumab safety in pregnancy and newborn outcomes
  1. Mette Julsgaard1,
  2. Jens Kjeldsen2,
  3. Daniel C Baumgart3
  1. 1 Department of Gastroenterology and Hepatology, Aarhus University Hospital, Aarhus C, Denmark
  2. 2 Department of Gastroenterology and Hepatology, Odense University Hospital, Odense, Denmark
  3. 3 Department of Gastroenterology and Hepatology, Charité Medical School, Humboldt-University of Berlin, Berlin, Germany
  1. Correspondence to Professor Daniel C Baumgart, Inflammatory Bowel Disease Center, Charité Medical Center, Virchow Hospital, Medical School of the Humboldt University, Berlin D-13344, Germany; daniel.baumgart{at}

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We read with interest the study by Colombel et al 1 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 …

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  • Contributors DCB wrote the first draft. All authors edited and approved the final manuscript.

  • Competing interests MJ, JK and DCB have served as paid speakers on medical education events supported by and/or scientific advisors to Takeda, manufacturer of vedolizumab.

  • Patient consent Obtained.

  • Ethics approval Patients granted approval.

  • Provenance and peer review Not commissioned; internally peer reviewed.

  • Data sharing statement This data can be shared according to international guidelines.