Pregnancy brings unique health challenges, even for women without chronic illness. Conditions like preeclampsia, gestational diabetes, and placental disorders not only affect maternal health during pregnancy but can also raise long-term risks of heart disease and metabolic disorders. Despite this, a 2024 survey revealed that more than 70% of mothers were unaware of these risks—highlighting the need for clearer education and ongoing care.
For women living with chronic inflammatory conditions, pregnancy can feel even more complex. The body’s immune changes, combined with the need to keep disease under control, often raise difficult questions about the safety of continuing treatment. One therapy frequently discussed in this context is Cimzia (certolizumab pegol), a TNF inhibitor with a distinctive Fc-free structure. This design limits how much of the drug crosses the placenta, which may lower fetal exposure compared with other biologics in its class.
In this article, we’ll explore what is known about Cimzia and pregnancy, including findings from clinical trials and registry studies. We’ll also review key considerations for women of childbearing age, while emphasizing that all treatment decisions should be made in partnership with a qualified healthcare professional.
Key Takeaways
- The CRIB study found almost no Cimzia crossing the placenta, and the CRADLE study showed very low or undetectable levels in breast milk.
- Large pregnancy registries report no higher rates of miscarriage, birth defects, or stillbirth compared to the general population.
- Stable disease control with Cimzia can lower risks of pregnancy complications like preterm birth and poor fetal growth.
- Decisions about Cimzia use during pregnancy and lactation should be made jointly between the patient and the provider.
- Regular prenatal visits, infant observation, and follow-up support help ensure safety for both mother and child.
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Placental and Breast Milk Transfer of Cimzia: CRIB and CRADLE Studies
The Cimzia CRIB study, which followed 16 pregnant women, was designed to measure placental transfer during pregnancy. Results showed that almost no Cimzia was detectable in the infant’s blood at birth, indicating that the drug does not cross the placenta in clinically significant amounts. This finding is significant for women of childbearing age, as it lowers concerns about fetal exposure.
The Cimzia CRADLE study, involving 17 breastfeeding mothers, looked at whether the drug appeared in breast milk. Researchers found that Cimzia levels were extremely low or undetectable, suggesting minimal risk of transfer to nursing infants.
Together, these two studies provide reassuring, though limited, evidence that Cimzia poses little risk of neonatal exposure during pregnancy and lactation. While ongoing monitoring remains important, the CRIB and CRADLE results help guide physicians in considering Cimzia as an option for women who need consistent disease control during these stages of life.
Safety Data: Registry Evidence and Clinical Experience with Cimzia in Pregnancy
Beyond controlled studies, real-world registry data offer valuable insight into Cimzia use during pregnancy. Large pregnancy exposure registries and observational studies have found no increased risk of miscarriage, stillbirth, or congenital anomalies among women treated with Cimzia compared with population averages. These findings suggest Cimzia may be a reasonable choice when treatment is needed to stabilize disease activity.
Clinical experience supports these results. For years, rheumatologists and gastroenterologists have prescribed Cimzia to help pregnant patients manage inflammatory conditions. In many cases, keeping maternal disease under control has proven to reduce complications such as preterm birth or poor fetal growth.
Although neonatal exposure is considered minimal due to Cimzia’s molecular structure, vigilance is still required. Providers often discuss not only safety but also how Cimzia is administered to ensure patients feel comfortable with both the injection technique and long-term management. Registries and post-marketing surveillance continue to track outcomes, reinforcing confidence in Cimzia as part of individualized reproductive care.
Risk-Benefit Considerations for Pregnant Patients Requiring Cimzia
When evaluating Cimzia during pregnancy, providers must balance the risks of active disease against the drug’s limited transfer to infants. Conditions such as rheumatoid arthritis, psoriatic arthritis, or Crohn’s disease can increase the chances of preterm birth or growth restriction if left uncontrolled. For many women, maintaining stable maternal health becomes the higher priority, making Cimzia a viable option when clinically indicated.
Key Factors that Influence Treatment Decisions
- Disease Severity and Stability: Active disease may require Cimzia to reduce flares and complications.
- Placental Transfer Evidence: CRIB study data suggest minimal passage of Cimzia to the fetus.
- Registry Safety Data: Large databases report no higher rates of miscarriage or birth defects.
- Maternal Quality of Life: Ongoing treatment supports mobility, independence, and emotional well-being.
- Disease Control Benefits: Consistent therapy reduces pregnancy complications linked to inflammation.
In most cases, continuing Cimzia offers more benefits than stopping therapy. Open discussions between patients and providers about reproductive health, ideally before conception, help align treatment with both maternal and fetal safety.
Clinical Guidance: Monitoring and Counseling for Cimzia During Pregnancy and Lactation
Ongoing monitoring is an essential part of using Cimzia during pregnancy. Providers typically recommend standard prenatal care along with closer follow-up to track maternal disease activity and fetal growth. This helps detect and address any concerns early. Clinical guidance often includes:
- Preconception Counseling: Providers review disease history, treatment requirements, and pregnancy planning to ensure women understand the role of Cimzia and optimize maternal and fetal outcomes.
- Regular Prenatal Monitoring: Ongoing assessments track maternal well-being, disease activity, and infant growth, helping healthcare teams identify potential concerns early and adjust treatment if necessary.
- Cimzia Breastfeeding Counseling: Physicians educate mothers about minimal drug transfer into breast milk, reassuring them about safety while emphasizing the importance of continued infant observation.
- Shared Decision-Making: Patients and providers work together to align Cimzia treatment with individual health goals, ensuring therapy supports maternal stability and safe pregnancy management.
- Postpartum Follow-Up: After delivery, providers assess maternal disease stability and infant development, adjusting treatment plans as needed to maintain health during the lactation period.
This structured, evidence-based approach helps women feel supported while maintaining disease control through pregnancy and lactation.
Conclusion
Current evidence, including the CRIB and CRADLE studies, suggests that Cimzia may be considered safe when used during pregnancy and breastfeeding, as it shows minimal transfer to infants. Registry findings and physician experience further support its use, particularly when maternal disease control is vital to preventing complications.
For women requiring biologic therapy, Cimzia remains a trusted option when guided by shared decision-making, individualized counseling, and careful monitoring.
FAQs
1. Is Cimzia safe during pregnancy?
Current evidence suggests Cimzia may be considered safe when clinically indicated, as studies show minimal placental transfer and no increased risk of birth defects.
2. What did the Cimzia CRIB study find?
The CRIB study found negligible placental transfer, meaning newborns had almost no Cimzia exposure at birth.
3. Can I breastfeed while using Cimzia?
Yes. The CRADLE study reported very low or undetectable levels of Cimzia in breast milk, supporting its use during breastfeeding.
4. What are the risks of Cimzia neonatal exposure?
Risks appear limited. Both CRIB and CRADLE showed minimal transfer, but providers still recommend ongoing monitoring.
5. Should I stop Cimzia if planning a pregnancy?
Not necessarily. Many women continue treatment after discussing risks and benefits with their healthcare provider to ensure stable maternal health.
References
Böhm M, Von Kaisenberg C, Schippert C, Von Versen-Höynck F. Maternal knowledge about long-term consequences of pregnancy complications – a cross-sectional study. BMC Pregnancy and Childbirth. 2025;25(1). doi:10.1186/s12884-025-08156-0
O’Byrne LJ, Alqatari SG, Maher GM, et al. Fetal and maternal outcomes after maternal biologic use during conception and pregnancy: A systematic review and meta‐analysis. BJOG an International Journal of Obstetrics & Gynaecology. 2022;129(8):1236-1246. doi:10.1111/1471-0528.17093
