There were no negative safety signals in postnatal outcomes of exposed children in terms of growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.
Despite being a relatively new class of treatment for inflammatory bowel disease, research continues to show biologics like ustekinumab and vedolizumab are safe and effective, even during pregnancy.
A team, led by Katarina Mitrova, Clinical and Research Centre for Inflammatory Bowel Disease, ISCARE a.s., Charles University, assessed maternal and offspring pregnancy outcomes for pregnant women with IBD treated with ustekinumab or vedolizumab.
With more and more biologics emerging for the treatment of IBD, research on the safety of some of the newer treatments are limited.
In the prospective, multicenter, observational study, the investigators examined consecutive women with IBD exposed to ustekinumab or vedolizumab 2 months prior to conception or during pregnancy. They then evaluated pregnancy, neonatal, and infant outcomes and compared to the outcomes to a cohort of similar patients exposed to anti-TNF medications.
They also assessed drug levels in maternal and cord blood at delivery.
The study included 54 women exposed to ustekinumab and 39 women exposed to vedolizumab.
For the pregnancy women treated with ustekinumab,79.9% (n = 43) resulted in live births, while 20.4% (n = 11) led to spontaneous abortions.
On the other hand, 89.7% (n = 35) of pregnancies on vedolizumab ended in a live birth, while 5.1% (n = 2) ended in spontaneous abortions and 5.1% (n = 2) ended in therapeutic abortions.
Overall there was no significant difference in pregnancy outcomes between either biologic group and the anti-TNF control group (P >0.05).
There was also no negative safety signals in postnatal outcomes of exposed children in terms of growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.
The median infant-to-maternal ratio of ustekinumab levels was 1.67, compared to 0.59 for the vedolizumab group.
“Use of ustekinumab and vedolizumab in pregnancy seems to be safe, with favorable pregnancy and postnatal infant outcomes,” the authors wrote. “Placental transfer differed between these two drugs, with ustekinumab having similar and vedolizumab having inverse infant-to-maternal ratio of drug levels compared to anti-TNF preparations.”
Last year, investigators found different biological agents for IBD yield different placental pharmacokinetics.
A team, led by Katarina Mitrova, Department of Pediatrics, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital, assessed the placental transfer of ustekinumab and vedolizumab in pregnant patients with inflammatory bowel disease.
Vedolizumab is different for placental pharmacokinetics than other immunoglobulin G1 antibodies, which leads to lower drug levels in cord blood in contrast to maternal blood at the time of delivery.
The investigators found the ustekinumab levels in cord blood positively correlated with the maternal levels at delivery (P = 0.751; P = 0.001).
On the other hand, there was no correlation with the timing of the last drug administration.
For vedolizumab, the levels in cord blood demonstrated significant positive correlation with the maternal levels (P = 0.831; P <0.001), as well as the gestational week of the last infusion (P = 0.736; P = 0.001).
The study, “Safety of ustekinumab and vedolizumab during pregnancy – pregnancy, neonatal and infant outcome: a prospective multicenter study,” was published online in the Journal of Crohn’s and Colitis.