IBD Biologic Use During Pregnancy Does Not Impact Long-Term Infant Outcomes

New research is offering insight into the safety of biologic drug use during pregnancy in individuals with inflammatory bowel disease (IBD), with study findings suggesting in utero exposure to these medications does not lead to long-term adverse outcomes in their children.1

Long-term data from the Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes (PIANO) Study were presented at Digestive Disease Week (DDW) 2025 by Arushi Kohli, MD, an advanced IBD fellow at the University of California San Francisco, and support the use of biologics through pregnancy to support maternal health.1

In pregnant individuals with IBD, disease flares during pregnancy can increase complications like preterm birth, underscoring the importance of appropriate disease management to optimize outcomes. However, concerns also exist regarding the safety of taking certain IBD medications during pregnancy and their potential negative impact on neonatal outcomes.2

“Adverse events secondary to in utero drug exposure to biologics such as serious infection, congenital abnormalities, or developmental issues may be delayed in recognition,” Kohli and colleagues wrote.1

In PIANO, demographic and outcome data were collected at intake, during each trimester, and at completion of pregnancy. Outcomes for live offspring were assessed at 4, 9, and 12 months after birth and then annually thereafter.1

Infant outcomes included serious infections, congenital abnormalities, and developmental milestones measured by the Ages and Stages Questionnaire (ASQ). In the abstract presented at DDW, investigators described pregnancy and infant outcomes for those who had ≥ 4 years of data.1

Bivariate analyses were utilized to compare long-term outcomes by drug exposure classes including no exposure, anti-TNF, vedolizumab, ustekinumab, immunomodulator or combination therapy.1

In total, 438 live offspring with a median 4 years of follow up were included in the analysis. Among the cohort, 118 infants were not exposed to biologics, 56 were exposed to 6-MP/AZA monotherapy, 49 were exposed to anti-TNF combination therapy, 196 were exposed to anti-TNF monotherapy, 11 were exposed to vedolizumab, and 8 were exposed to ustekinumab.1

Investigators noted a greater percentage of mothers with ulcerative colitis had no biologic exposure (60%) and more steroid exposure (42%) as compared to those with Crohn’s disease. Additionally, those on anti-TNF and thiopurine combination therapy had significantly lower rates of active disease during pregnancy compared to those on no advanced therapy (2% vs 19% P = .003).1

The ratio between infant and maternal drug concentration was highest for infliximab (2.4), followed by ustekinumab (1.4), adalimumab (1.2) and lowest for vedolizumab (0.47). Overall, 71% of infants were breastfed.1

Results showed rates of serious infection by 4 years of age were comparable across drug classes. Investigators pointed out preterm birth was associated with significantly higher rates of serious infection (38% vs 13%; P <.001), but breastfeeding was not associated with any difference in serious infection (14% vs 18%; P = .345).1

Congenital malformations were present in 24 (5.5%) offspring, with no dominant pattern observed by investigators. They noted developmental milestones were comparable over 4 years between drug exposure groups and there was no signal for measured childhood chronic diseases by drug exposure class. Eczema was prevalent at the national average (n = 72; 16%) and a single child was diagnosed with ulcerative colitis at 3 years of age.1

“Childhood outcomes 4 to 16 years of age are comparable in biologic exposed and unexposed infants born to mothers with IBD, supporting the use of these medications through pregnancy to support maternal health,” investigators concluded.1

References

1. Kohli A, Long M, Beaulieu D, et al. LONG-TERM INFANT OUTCOMES IN THE PREGNANCY IN INFLAMMATORY BOWEL DISEASE AND NEONATAL OUTCOMES (PIANO) STUDY. Abstract presented at Digestive Disease Week (DDW) 2025 in San Diego, CA from May 3 - May 6, 2025.

2. Nielsen OH, Gubatan JM, Kolho KL, et al. Updates on the management of inflammatory bowel disease from periconception to pregnancy and lactation. The Lancet. doi:10.1016/S0140-6736(24)00052-7