Ustekinumab, Vedolizumab Exposure During Pregnancy Not Linked With Complications

By Andrew John, MD /alert Contributor
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Exposure to ustekinumab and vedolizumab during pregnancy did not appear to cause an increase in complications compared with TNF inhibitors, immunomodulators or combinations of immunomodulators and biologics among women with inflammatory bowel disease, according to findings presented at the 2022 American College of Gastroenterology annual meeting.

“Pregnancy outcomes in IBD patients with quiescent disease are similar to the general population,” Rishika Chugh, MD, of the University of California, San Francisco, and colleagues wrote in an abstract of their findings. “Data from the Pregnancy Inflammatory bowel disease And Neonatal Outcomes (PIANO) registry have demonstrated the safety of anti-tumor necrosis factor alpha (TNFs) and thiopurines in pregnancy. The objective of this study is to provide updated information from the PIANO registry on maternal and fetal outcomes in patients exposed to ustekinumab and vedolizumab.”

The researchers performed a multicenter, prospective observational study of pregnant women with inflammatory bowel disease carrying singleton pregnancies. Chugh and colleagues administered questionnaires to study participants at the time of intake, followed by another questionnaire at each following trimester, as well as the time of delivery and 4, 9 and 12 months post-delivery. Researchers used bivariate analyses to examine the ways specific classes of drugs impacted outcomes in pregnancy. Patients fell into several different cohorts: those exposed to vedolizumab, ustekinumab, TNF inhibitors, immunomodulators and those exposed to combinations of immunomodulators and biologics. The researchers compared each cohort to those who were not exposed to biologics or immunomodulators.

In total, patients had 1,642 pregnancies, in which there were 1,581 live births, the researchers reported. The women were, on average, 32.1 years old at the time of delivery. Sixty-two patients were exposed to vedolizumab, whereas 43 were exposed to ustekinumab. Those who took ustekinumab were more likely than other patients to have Crohn’s disease.

Neither exposure to ustekinumab nor vedolizumab was linked with an increased risk for low birth weight, small for gestational age, spontaneous abortion, intrauterine growth restriction, congenital malformations or neonatal intensive care unit stays, the researchers reported. The rate of preterm birth was reportedly highest in the vedolizumab-exposed cohort (12.7%), followed by the unexposed cohort (9.7%), the TNF-inhibitor-exposed cohort (8.2%) and the ustekinumab-exposed cohort (0%; P = .037).

All cohorts showed similar rates of both serious and non-serious infections for infants in the first year of life, Chugh and colleagues wrote. Although there was an increase in non-serious infections among infants whose mothers were exposed to ustekinumab at 4 months, this did not persist by the 1-year mark, according to the researchers. Patients exposed to vedolizumab were not reported to face an increased risk for placental complications compared to patients not exposed to any of the therapies included in the study. Infants whose mothers were exposed to ustekinumab had elevated concentrations of the drug compared to maternal serum concentrations, whereas vedolizumab concentrations were decreased compared to maternal serum levels, according to Chugh and colleagues.

“An updated analysis of ustekinumab and vedolizumab exposure during pregnancy suggests no increase in complications compared to TNF inhibitors, immunomodulators and combination of biologics with immunomodulators,” the researchers wrote in their abstract. “Ustekinumab was associated with lower rates of preterm birth and Cesarean section. No signal was found for increased placental events with either therapy. Continuation of ustekinumab and vedolizumab during pregnancy is recommended.”

Disclosures: Chugh declared no financial ties to drugmakers. Some authors declared financial ties to drugmakers. See abstract for details.

Photo Credit: Getty Images

 

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