Maternal and Neonatal Outcomes in Pregnancies Involving Exposure to Vedolizumab and Ustekinumab
abstract
This abstract is available on the publisher's site.
Access this abstract nowBACKGROUND
Pregnancy outcomes in inflammatory bowel disease (IBD) patients with quiescent disease are similar to the general population. Data from the Pregnancy Inflammatory bowel disease And Neonatal Outcomes (PIANO) registry have demonstrated the safety of anti-tumor necrosis factor alpha (TNFs) agents and thiopurines in pregnancy. The objective of this study was to provide information from the PIANO registry on maternal and fetal outcomes in patients exposed to the newer biologics ustekinumab (UST) and vedolizumab (VDZ).
METHODS
In this multicenter prospective observational study, we included pregnant women with singleton pregnancies and a diagnosis of IBD. Questionnaires were administered to women at study intake, each subsequent trimester, delivery, and at 4, 9, and 12 months after birth. Bivariate analyses were utilized to determine the independent effects of specific drug classes on outcomes. The exposure cohorts were VDZ, UST, anti-TNFs, immunomodulators, and combination with anti-TNFs and immunomodulators. All were compared to no exposure and to biologics/immunomodulators.
RESULTS
There were 1669 completed pregnancies with 1610 live births. Maternal mean age was 32.1 (SD 4.6) years at delivery with 66 VDZ and 47 UST exposed. Women on UST were more likely to have Crohn's disease. There was no increased risk of spontaneous abortion, small for gestational age, low birth weight, neonatal intensive care unit stay, congenital malformations, or intrauterine growth restriction with in utero VDZ or UST exposure. The rate of preterm birth was lower (0.0%) for UST-exposed as compared to other groups including VDZ (13.8%), anti-TNF (8.2%), combination therapy (14.2%), immunomodulator (12.3%), and unexposed (9.7%)(p = 0.03). Rates of serious infections at birth, 4 months, and within the first 12 months of life were comparable among all groups. Nonserious infections were lower at 12 months in UST exposed pregnancies. There was no increased risk signal for placental complications in the VDZ cohort. UST infant concentrations at birth were increased whereas VDZ concentrations were overall decreased compared to maternal serum drug concentration.
CONCLUSION
This analysis of UST and VDZ exposure during pregnancy suggests no increase in complications compared to TNFs, immunomodulators and combination TNFs/immunomodulators. No signal was found for increased placental events with either therapy. Continuation of UST and VDZ throughout pregnancy is recommended.
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Additional Info
Disclosure statements are available on the authors' profiles:
Maternal and Neonatal Outcomes in Vedolizumab and Ustekinumab Exposed Pregnancies: Results from the PIANO registry
Am. J. Gastroenterol 2024 Mar 01;119(3)468-476, R Chugh, MD Long, Y Jiang, KN Weaver, DB Beaulieu, EJ Scherl, U MahadevanFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
For women with inflammatory bowel disease, we know that pregnancy outcomes are different just from the nature of the disease. They are more at risk for preterm birth, small for gestational age infants, and having a C-section. We also know that anti-TNF agents as well as other biologics cross the placenta. We have over a decade of data to show that, despite placental transfer and measurable infant drug levels, children with in utero exposure are not at increased risk for adverse outcomes. As more mechanisms of action are understood, it is important that we understand outcomes based on maternal exposure as well as infant in utero exposure.
Recently more results from PIANO, a nationwide prospective registry to study pregnancy outcomes, have been reported. The study followed 66 patients on vedolizumab and 47 on ustekinumab through pregnancy. When compared with pregnant women treated with anti-TNF agents or those on non-biologics, there was no difference in spontaneous abortion, congenital anomalies, preterm birth, small for gestational age infants, or neonatal ICU admissions. It was interesting that babies born of mothers on ustekinumab had a lower risk for preterm birth compared with those of mothers taking other medications. It is unclear whether this is a true signal for a difference or just a statistical finding at this point.
Continued reporting of data like these are extremely important for clinicians and patients alike. The patients in PIANO are from both academic as well as community practices and thus representative of the IBD population. In addition, these data are prospective in nature and thus less likely to be subject to bias. Certainly these results have helped me as well as other IBD providers have discussions with women of childbearing age with regard to the safety of starting and then continuing medications in the preconception and pregnancy timeframes.