Cimzia for Pregnancy – Safety Considerations and Risks

Managing medication during pregnancy requires careful consideration, as some drugs may pose risks to both the mother and the developing baby. Research on biologic medications, particularly anti-TNF agents, has shown varying safety profiles during pregnancy, making it essential for patients and healthcare providers to weigh potential benefits and risks.

Cimzia (certolizumab pegol) is an anti-TNF biologic commonly prescribed for autoimmune conditions like rheumatoid arthritis and Crohn’s disease. Unlike other biologics, its unique molecular structure may limit placental transfer, potentially making it a safer option during pregnancy. However, further evaluation is necessary to ensure its safety for both mother and child.

In this article, we will explore Cimzia’s safety during pregnancy, its potential risks, and expert recommendations based on the latest research.

Key Takeaways

• Cimzia’s unique pegylated structure minimizes placental transfer, significantly reducing fetal exposure compared to other TNF inhibitors.
• Studies show no increased risk of congenital disabilities, miscarriage, stillbirth, or preterm birth in pregnant women using Cimzia.
• Compared to biologics like Humira, Enbrel, and Remicade, Cimzia is preferred during pregnancy due to its minimal placental transfer and strong safety profile.
• Maintaining Cimzia during pregnancy helps control disease activity, which often poses greater risks to maternal and fetal health than the medication itself.
• Treatment decisions should be individualized, but Cimzia’s safety profile allows continued use, including during the third trimester.
• Cimzia is also considered safe for breastfeeding, with low transfer into breast milk and no reported adverse effects in infants.

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Understanding Cimzia’s Pharmacokinetics During Pregnancy

Cimzia is a tumor necrosis factor (TNF) inhibitor designed to reduce inflammation by blocking TNF-alpha, a protein in immune system responses. Unlike other biologics, its unique pegylated structure minimizes its transfer across the placenta.

• Most monoclonal antibodies cross the placenta significantly during the third trimester.
• Cimzia has minimal placental transfer, reducing the risk of fetal exposure.
• Studies indicate that Cimzia levels in umbilical cord blood are low to undetectable.

This pharmacokinetic profile makes Cimzia a preferred option for pregnant patients requiring TNF inhibitors.

Clinical Research Findings on Cimzia Use in Pregnant Patients

Clinical trials and observational studies provide reassuring data regarding Cimzia for pregnancy safety:

• The CRIB study analyzed the placental transfer of Cimzia and found minimal drug levels in newborns.
• The CERTAIN (CertiTaliban Registry of Adverse Events in Rheumatology) registry, along with other studies like the OTIS (Organization of Teratology Information Specialists) Autoimmune Diseases in Pregnancy Project, has monitored pregnant women using Cimzia. These studies have shown no increased risk of congenital disabilities or pregnancy complications associated with Cimzia use during pregnancy
• Observational data suggests that Cimzia does not elevate the risk of miscarriage, stillbirth, or preterm birth compared to the general population.

These findings support the continued use of Cimzia in pregnancy for patients needing disease control.

Comparative Safety of Cimzia Versus Other Biologics in Pregnancy

When considering Cimzia vs. other TNF inhibitors, key differences emerge:

Biologic	Placental Transfer	Pregnancy Safety	Discontinuation Consideration
Cimzia	Minimal	Generally safe	Often continued
Humira (adalimumab)	High in the third trimester	Safe but crosses the placenta	It may require stopping before the third trimester
Enbrel (etanercept)	Moderate	Considered safe	Stopping varies by case
Remicade (infliximab)	High	Safe but with higher placental transfer	Stopped before the third trimester

Given its low placental transfer, Cimzia is a preferred choice over other TNF inhibitors for pregnant patients requiring continued biologic therapy.

Risk-Benefit Analysis of Continuing Cimzia During Pregnancy

Deciding whether to continue Cimzia during pregnancy requires weighing its risks and benefits. One significant advantage is its ability to control disease activity, reducing complications like preterm birth and low birth weight. Cimzia’s minimal placental transfer also limits fetal drug exposure. Additionally, uncontrolled inflammation poses more significant risks than medication use, making Cimzia a preferred option for pregnant patients with active autoimmune conditions.

However, some risks remain under study. Long-term fetal effects and developmental outcomes in children exposed to Cimzia in utero are not yet fully understood.  While Cimzia side effects are possible, they are generally similar to those experienced by non-pregnant patients. Given the risks of untreated disease, most experts recommend continuing Cimzia when necessary to support both maternal and fetal health.

Guidelines for Discontinuation or Continuation of Cimzia in Expectant Mothers

The decision to continue or discontinue Cimzia during pregnancy depends on individual health factors. If disease activity is high, continuation is recommended to protect maternal and fetal health. For patients in stable remission before pregnancy, stopping Cimzia may be an option under medical supervision. Since Cimzia has minimal placental transfer, many experts prefer continuation in the third trimester. 

Lactation Considerations for Patients on Cimzia

For breastfeeding mothers, studies suggest that Cimzia is safe during lactation:

• Cimzia has low transfer into breast milk, with minimal to undetectable drug levels found.
• No adverse effects have been reported in breastfed infants.
• Unlike some biologics, Cimzia’s large molecular size prevents significant passage into milk.

Professional Organization Recommendations on Cimzia Use in Pregnancy

Leading medical organizations guide Cimzia use during pregnancy and breastfeeding:

• American College of Rheumatology (ACR): Cimzia is a safe option for pregnant patients needing TNF inhibitors.
• European League Against Rheumatism (EULAR): Supports Cimzia continuation in pregnancy due to minimal placental transfer.
• American Gastroenterological Association (AGA): Recommends maintaining Cimzia in pregnant patients with inflammatory bowel disease.
• FDA Classification: Cimzia is not classified as high-risk in pregnancy.

These endorsements further reinforce Cimzia’s safety profile for expectant mothers.

Conclusion

For women managing autoimmune diseases, Cimzia for pregnancy offers a safe and effective treatment option with minimal fetal exposure. Clinical studies and expert recommendations support its continued use during pregnancy and breastfeeding, helping to maintain disease control while reducing risks to both mother and baby. 

However, every patient’s situation is unique, and treatment decisions should be made in close collaboration with a healthcare provider to ensure the best possible outcomes for both maternal and fetal health.

FAQs

1. Can Cimzia be used safely during pregnancy?

Cimzia is considered one of the safest TNF inhibitors during pregnancy due to its low placental transfer. Studies show no increased risk of congenital disabilities or complications when used as prescribed.

2. Do I need to stop Cimzia before the third trimester?

Unlike other biologics, Cimzia does not require discontinuation before the third treatment or second placental passage. Your doctor will determine whether use is necessary based on disease activity.

3. Does Cimzia affect breastfeeding?

No, Cimzia has low transfer into breast milk and is generally safe for breastfeeding mothers. Most professional organizations support its use during lactation.

4. What are the possible side effects of Cimzia during pregnancy?

While Cimzia is well-tolerated, potential Cimzia side effects include injection site reactions, infections, and fatigue. These risks should be weighed against the dangers of untreated autoimmune disease during pregnancy.

References

Yaghi M, Murase EM, Murase JE. Considerations for the use of biologics in Pregnancy | MDEDge. https://community.the-hospitalist.org/content/considerations-use-biologics-pregnancy

Ali YM, Kuriya B, Orozco C, Cush JJ, Keystone EC. Can tumor necrosis factor inhibitors be safely used in pregnancy? The Journal of Rheumatology. 2009;37(1):9-17. doi:10.3899/jrheum.090563