Ustekinumab, vedolizumab ‘seem perfectly safe’ during pregnancy in IBD patients
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CHARLOTTE, N.C. — Exposure to ustekinumab and vedolizumab during pregnancy did not increase maternal and fetal complications, and researchers recommend continued use in pregnant mothers with inflammatory bowel disease.
“There is some conflicting data regarding the safety of vedolizumab and ustekinumab in pregnancy,” Rishika Chugh, MD, assistant professor of medicine at the University of California, San Francisco, told Healio. “There are also specific concerns regarding potential placental events related to vedolizumab. It is a humanized monoclonal antibody that prevents leukocyte trafficking to the gut by inhibiting the binding of alpha 4 beta 7 to MAdCAM-1, and while MAdCAM-1 is primarily located in gastrointestinal lymphoid tissue, it has also been identified in human placental vessels and was demonstrated to play an integral role in placenta development. There was concern that potentially inhibiting MAdCAM-1 through the use of vedolizumab would result in the increase of placental events.”
Chugh added, “Ustekinumab inhibits IL-12 and IL-23, which certainly plays a role in IBD, but also plays a role in uterine angiogenesis. There was a concern that potentially inhibiting those cytokines could result in adverse pregnancy outcomes.”
In a multicenter, prospective observational study, Chugh and colleagues updated data on maternal and fetal outcomes in patients exposed to ustekinumab (UST) and vedolizumab (VDZ) using the Pregnancy IBD And Neonatal Outcomes (PIANO) registry. To determine independent effects of specific drug classes, pregnant mothers with IBD completed questionnaires at study intake, each subsequent trimester and delivery, as well as at 4, 9 and 12 months after birth.
Cohorts included those exposed to VDZ, UST, anti-tumor necrosis factor-alpha and a combination of biologics and immunomodulators, all of whom were compared with patients not exposed to biologics or immunomodulators.
Among 1,642 completed pregnancies and 1,581 live births (mean age at delivery, 32.1 years), in utero VDZ (n = 62) and UST (n = 43) exposure did not correlate with an increased risk for spontaneous abortion (1.6% and 4.7%, respectively), small for gestational age (5.7% and 7.1%), low birth weight (10.9% and 2.6%), neonatal ICU stay (14.5% and 10.8%), congenital malformations (13.6% and 17.9%) or intrauterine growth restriction (1.6% and 0%). Compared with the preterm birth rate among those in the unexposed cohort (9.7%), the rate of preterm birth was 0% in the UST group, 12.7% in the VDZ group and 8.2% in the anti-TNF group.
“Based on everything that we have seen, we believe that ustekinumab and vedolizumab should be continued without interruption in pregnancy and that they do not lead to adverse pregnancy outcomes or fetal outcomes,” Chugh said.
Additionally, Chugh noted during her presentation at the ACG Annual Scientific Meeting that there were increased UST infant concentrations at birth and decreased VDZ concentrations compared with maternal serum drug concentrations.
“Thankfully, because of the PIANO registry and other registries out there, we have a lot of data demonstrating safety,” Chugh concluded. “At the same time, it has been very clearly shown that if patients have active disease during their pregnancy, that leads to adverse outcomes. The most important thing is achieving disease control, and if being on these medications is the way to get disease control, it seems like it’s perfectly safe.”
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Chugh R, et al. Maternal and neonatal outcomes in vedolizumab and ustekinumab exposed pregnancies: Results from the PIANO registry. Presented at: ACG Annual Scientific Meeting; Oct. 21-26, 2022; Charlotte, N.C. (hybrid meeting).
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