Colon to Rectum
Am J Gastroenterol. 2024;119(3):468–76
Maternal and neonatal outcomes in vedolizumab- and ustekinumab-exposed pregnancies: Results from the PIANO registry
Background: Pregnancy outcomes in inflammatory bowel disease (IBD) patients with quiescent disease are similar to those in the general population. Data from the Pregnancy Inflammatory bowel disease And Neonatal Outcomes (PIANO) registry have demonstrated the safety of anti-tumor necrosis factor (TNF) α 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, the authors 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-TNF, immunomodulators, and combination with anti-TNF and immunomodulators. All were compared to no exposure and to biologics/immunomodulators.
Results: There were 1669 completed pregnancies with 1610 live births. The maternal mean age was 32.1 years (standard deviation 4.6) 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 the UST-exposed cohort when compared with other cohorts including VDZ (13.8%), anti-TNF (8.2%), combination therapy (14.2%), immunomodulators (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 cohorts. Non-serious 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 with maternal serum drug concentration.
Conclusion: This analysis of ustekinumab (UST) and vedolizumab (VDZ) exposure during pregnancy suggests no increase in complications compared with anti-tumor necrosis factor (TNF), immunomodulators and combination TNF/immunomodulators. No signal was found for increased placental events with either therapy. Continuation of UST and VDZ throughout pregnancy is recommended.