A 2023 narrative review in Reproductive Medicine revealed that pregnant individuals with active inflammatory bowel disease (IBD) face significantly higher risks of complications such as preterm delivery, low birth weight, and neonatal intensive care admissions, compared to those in remission. These findings highlight the urgent need for stable, effective disease control throughout pregnancy.
Amid evolving treatment landscapes, Entyvio (vedolizumab) has gained recognition as a gut-selective biologic used in managing moderate to severe IBD. Unlike traditional immunosuppressants, its targeted mechanism minimizes systemic exposure—an appealing trait during pregnancy. While formal clinical trials in pregnant populations remain limited, early registry data suggest an encouraging safety profile, prompting interest among clinicians and patients alike.
In this article, we’ll explore the latest research on Entyvio and pregnancy, reviewing safety data, expert recommendations, and practical considerations for managing IBD in expectant individuals.
Key Takeaways
- Vedolizumab, sold under the brand name Entyvio, is a gut-selective biologic therapy used to treat moderate to severe inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis.
- Early safety data suggests Entyvio may be safe during pregnancy, with no consistent evidence linking it to serious birth defects or adverse neonatal outcomes.
- Placental transfer of vedolizumab is limited, and cord blood levels are typically lower than maternal levels, suggesting minimal fetal exposure.
- Real-world registry studies, including PIANO, show comparable rates of preterm birth and congenital anomalies in Entyvio-treated pregnancies versus the general population.
- While the research is promising, the limited number of studied cases means ongoing data collection and long-term monitoring remain critical.
- Shared decision-making between patient and provider—based on individual disease severity, risks, and treatment goals—is essential for managing IBD during pregnancy safely.
- Entyvio should only be used when the benefit of disease control outweighs potential risks, and clinical guidelines recommend personalized risk assessment and continuous maternal-fetal monitoring.
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Review of Safety Data on Vedolizumab Use During Pregnancy
According to the prescribing information, vedolizumab (Entyvio’s generic name) has not consistently demonstrated a risk of significant birth defects, miscarriage, or other serious pregnancy-related outcomes. This has positioned it as a potentially reassuring option for maintaining inflammatory bowel disease (IBD) control during pregnancy.
A targeted literature review indicates that current research does not link vedolizumab to elevated risks. However, because existing studies involve relatively small sample sizes, more robust data is needed to confirm its long-term safety in pregnancy.
Another systematic review has raised concerns regarding possible risks, reporting a slight increase in unfavorable pregnancy outcomes among women treated with vedolizumab. These included premature births and early pregnancy losses. Importantly, researchers noted that such outcomes may be attributed more to the underlying disease activity than to the medication itself, highlighting the complex nature of risk assessment in this population.
Placental Transfer and Potential Neonatal Effects
Vedolizumab, a gut-selective monoclonal antibody used in Entyvio, is specifically designed to reduce intestinal inflammation in ulcerative colitis and Crohn’s disease. During pregnancy, one of the key concerns is how much of the drug crosses the placenta and its potential effects on the newborn.
A 2021 study revealed that Entyvio exhibits lower placental transfer compared to other biologics, with significantly lower drug concentrations detected in cord blood than in maternal blood. This suggests a limited direct exposure for the fetus.
Current registry data and observational studies have not revealed any consistent neonatal adverse effects from in utero exposure to Entyvio. Parameters such as birth weight, APGAR scores, and early immune development have remained within normal ranges, although researchers continue to observe these children in long-term follow-ups. These findings support a cautiously optimistic view but underscore the importance of continued surveillance.
Clinical Guidelines and Recommendations
Guidelines from gastroenterological societies recommend a case-by-case approach to using Entyvio during pregnancy. Since uncontrolled IBD poses its own serious risks—including miscarriage, preterm birth, and low birth weight—continuing treatment may be necessary for maternal and fetal health.
Current clinical guidance advises that Entyvio be considered when the benefits of disease control outweigh potential risks. Key recommendations include:
- Prioritize Entyvio when maintaining remission is essential for maternal health.
- Monitor both maternal disease activity and fetal development throughout the pregnancy.
- Engage patients in comprehensive discussions about potential risks, benefits, and uncertainties based on the latest research.
By staying updated with ongoing registry findings, providers can make informed prescribing decisions that align with evolving safety data.
Case Studies and Registry Data Insights
Real-world evidence, including findings from the PIANO (Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes) registry, provides important insights into the use of vedolizumab during pregnancy.
Multiple registry analyses show that key pregnancy outcomes—including spontaneous abortion, congenital anomalies, and preterm birth—remain comparable to baseline population risks. In some studies, vedolizumab helped sustain disease remission throughout pregnancy, further reinforcing its role as a supportive treatment in high-risk cases.
Importantly, these studies reaffirm that vedolizumab does not appear to negatively impact long-term infant health. However, given the relatively small cohorts and the novelty of long-term follow-up, more data is still needed to establish definitive conclusions.
Counseling Patients: Risks, Benefits, and Shared Decision-Making
Open, empathetic communication is essential when counseling pregnant patients about biologic therapies. Physicians must clearly explain the potential risks and benefits, tailoring the conversation to each patient’s medical history, pregnancy goals, and preferences.
Key steps include:
- Explaining all treatment options, including the risks of active disease versus biologic therapy.
- Encouraging patient involvement in each decision, validating their concerns and questions.
- Using visual or written decision aids to simplify complex medical concepts.
- Promoting shared decision-making, where both patient and provider agree on a personalized care plan.
Such discussions help patients feel more empowered, reduce anxiety, and improve long-term adherence to treatment strategies.
Conclusion
Managing inflammatory bowel disease during pregnancy presents a unique challenge. Active disease increases the risk of complications for both mother and baby, making consistent disease control essential. Thanks to its gut-selective mechanism and favorable early safety data, Entyvio offers a promising option for many expectant individuals.
Current findings are encouraging despite needing larger and longer-term studies for Entyvio’s influence on pregnancy. With careful patient selection, close monitoring, and open dialogue, Entyvio can be part of a well-considered treatment strategy for managing IBD during pregnancy.
FAQs
1. Is Entyvio safe to use during pregnancy?
Current research suggests that Entyvio (vedolizumab) has an encouraging safety profile during pregnancy, with no consistent evidence linking it to significant congenital disabilities or adverse outcomes. However, more studies are needed to fully assess its safety.
2. What should healthcare providers consider when prescribing Entyvio to pregnant patients?
Providers should carefully evaluate the balance of risks and benefits, ensuring that maintaining disease control is essential for the health of the mother and fetus. Close monitoring throughout the pregnancy is also critical.
3. What are the potential risks of using Entyvio during pregnancy?
While studies indicate a favorable safety profile, underlying disease activity could influence potential risks, including premature birth and early pregnancy loss. It is essential to have ongoing discussions about these risks with patients.
References
- Hossein-Javaheri, N., Youssef, M., Jeyakumar, Y., Huang, V., & Tandon, P. (2023). The Management of Inflammatory Bowel Disease during Reproductive Years: An Updated Narrative Review. Reproductive Medicine, 4(3), 180–197. https://doi.org/10.3390/reprodmed4030017
- Terjung, B., Schmelz, R., Ehehalt, R., Klaus, J., Knop, J., Schwind, S., Wilke, T., & Stallmach, A. (2020). Safety of vedolizumab in the treatment of pregnant women with inflammatory bowel disease: a targeted literature review. Therapeutic Advances in Gastroenterology, 13. https://doi.org/10.1177/1756284820952592
- Chugh, R., Long, M. D., Jiang, Y., Weaver, K. N., Beaulieu, D. B., Scherl, E. J., & Mahadevan, U. (2024). Maternal and Neonatal Outcomes in Vedolizumab- and Ustekinumab-Exposed Pregnancies: Results From the PIANO Registry. The American journal of gastroenterology, 119(3), 468–476. https://doi.org/10.14309/ajg.0000000000002553
