Vedolizumab is a gut-selective immunoglobulin G1 monoclonal antibody to α4β7 integrin for the treatment of Crohn's disease, and ulcerative colitis.
Prospective clinical studies of vedolizumab in pregnancy have not been conducted.
Therefore, existing safety data of vedolizumab in pregnancy were examined.
Dr Mahadevan and colleagues from California, USA assessed pregnancy outcomes in females and partners of males who received vedolizumab.
All pregnancy data collected during the clinical program, and in the post-marketing setting were analyzed.
Across 6 studies, there were 27 pregnancies in female participants and 19 pregnancies in partners of male participants.
|Post-marketing reports recorded 81 pregnancies, resulting in 4 live births|
|Alimentary Pharmacology & Therapeutics|
Among 24 vedolizumab-treated females, the team reported that there were 11 live births, 5 elective terminations, 4 spontaneous abortions and 4 undocumented outcomes.
The research team found that a congenital corpus callosum agenesis anomaly was reported in one live birth from a healthy volunteer with extensive obstetric history exposed to single-dose vedolizumab 79 days before estimated conception.
Of 19 pregnancies in partners of male participants, the research team found that there were 11 live births, 2 spontaneous abortions, 3 elective terminations and 3 undocumented outcomes.
The researchers observed that post-marketing reports recorded 81 pregnancies, resulting in 4 live births, 11 spontaneous abortions, and 66 pregnancies that were on-going or reported undocumented outcomes.
Dr Mahadevan's team concludes, "Initial analysis, limited by sample size and follow-up, identified no new safety concerns for pregnancy outcomes in females directly or indirectly exposed to vedolizumab."
"However, vedolizumab should be used during pregnancy only if the benefits to the mother outweigh the risks to the mother/unborn child."