From the Guidelines
Yes, a pregnant woman can generally stay on Cimzia (certolizumab pegol) throughout pregnancy if needed for her medical condition. Cimzia is considered one of the safer TNF inhibitors to use during pregnancy because it has minimal placental transfer compared to other biologics in its class, as noted in the 2020 American College of Rheumatology guideline for the management of reproductive health in rheumatic and musculoskeletal diseases 1. This is due to its unique PEGylated structure that lacks an Fc portion, which prevents active transport across the placenta. The most recent guidance from the AGA clinical practice update on pregnancy-related gastrointestinal and liver disease: expert review, published in 2024, also supports the continuation of biologic agents like Cimzia throughout pregnancy and the postpartum period for patients with inflammatory bowel disease 1.
The medication can be continued at the standard dosing regimen (typically 400 mg initially and at weeks 2 and 4, followed by 200 mg every other week or 400 mg every 4 weeks) throughout all three trimesters. Women should discuss their specific situation with their rheumatologist or gastroenterologist and obstetrician to weigh the benefits of disease control against any potential risks. Maintaining disease control during pregnancy is important as active inflammatory disease (such as rheumatoid arthritis, psoriatic arthritis, or inflammatory bowel disease) can potentially lead to adverse pregnancy outcomes. Regular monitoring during pregnancy is recommended, and patients should inform all healthcare providers involved in their care about their medication regimen.
Key points to consider include:
- The importance of maintaining disease control during pregnancy to prevent adverse outcomes.
- The unique properties of Cimzia that make it safer for use during pregnancy compared to other TNF inhibitors.
- The need for regular monitoring and communication with all healthcare providers involved in the patient's care.
- The recommendation to continue biologic agents like Cimzia throughout pregnancy and the postpartum period, as per the latest clinical practice updates 1.
Overall, the decision to continue Cimzia during pregnancy should be made on a case-by-case basis, considering the individual patient's health status and the potential risks and benefits of the medication. However, based on the current evidence, continuing Cimzia throughout pregnancy is generally considered safe and recommended for maintaining disease control 1.
From the FDA Drug Label
Risk Summary Limited data from the ongoing pregnancy registry on use of CIMZIA in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes However, certolizumab pegol plasma concentrations obtained from two studies of CIMZIA use during the third trimester of pregnancy demonstrated that placental transfer of certolizumab pegol was negligible in most infants at birth, and low in other infants at birth
The FDA drug label does not provide sufficient information to determine if a pregnant woman can stay on Cimzia throughout pregnancy. Key points to consider include:
- Limited data from the ongoing pregnancy registry
- Negligible placental transfer of certolizumab pegol in most infants at birth
- Low certolizumab pegol plasma concentrations in some infants at birth However, due to the limited data, no conclusion can be drawn about the safety of staying on Cimzia throughout pregnancy 2.
From the Research
Pregnancy and Cimzia (Certolizumab Pegol) Use
- Cimzia, also known as certolizumab pegol, is an anti-tumor necrosis factor-alpha (anti-TNFα) agent used to treat various chronic inflammatory diseases.
- The safety of Cimzia during pregnancy has been evaluated in several studies, including those focused on its use in treating plaque psoriasis and other conditions 3, 4, 5.
Studies on Cimzia Use During Pregnancy
- A 2018 study published in the British medical bulletin discussed the management of hypertension in women planning for pregnancy, but did not provide direct information on Cimzia use during pregnancy 6.
- A 2021 review in Skin therapy letter discussed the safety considerations of certolizumab pegol in pregnancy, suggesting it offers a safe and effective treatment option for women during childbearing years based on pharmacokinetics and available safety data 3.
- Studies specifically examining pregnancy outcomes after exposure to certolizumab pegol found no significant harmful effects on pregnancy outcomes, including a low rate of major congenital malformations 4, 5.
Continuing Cimzia Throughout Pregnancy
- The available evidence suggests that certolizumab pegol can be continued throughout pregnancy, with studies indicating minimal to no active placental transfer and no increased risk of fetal death or major congenital malformations compared to the general population 4, 5.
- However, it is essential for pregnant women or those planning to become pregnant to discuss their treatment options with their healthcare provider, considering the individual's specific condition and the potential risks and benefits of continuing Cimzia therapy 3, 4, 5.