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Which biologics are safe in pregnancy?

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Certain biologics, such as adalimumab and certolizumab, have received the stamp of approval for their safe usage during pregnancy. Nevertheless, it remains of utmost importance to seek guidance from a healthcare expert in order to thoroughly evaluate the unique advantages and disadvantages in every specific scenario.

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Although some biologics have been deemed safe for use during pregnancy, it is crucial to seek guidance from a healthcare professional in order to thoroughly evaluate the possible advantages and disadvantages in each unique scenario. Adalimumab, a renowned biologic, has been granted approval for pregnancy use, while certolizumab, another biologic, has demonstrated its safety for expectant mothers.

Extensive research has delved into the implications of employing adalimumab as a tumor necrosis factor (TNF) inhibitor during pregnancy. The findings have been resoundingly assuring, demonstrating that its usage does not substantially heighten the likelihood of unfavorable pregnancy outcomes, encompassing congenital malformations or miscarriages. Remarkably, a study published in the esteemed New England Journal of Medicine divulged that pregnant women grappling with chronic inflammatory diseases, who were administered adalimumab, encountered no augmented risks of malformations or detriments to their pregnancies, in comparison to those who refrained from utilizing this biologic treatment.

In a similar vein, the esteemed author delves into the realm of medical research, specifically focusing on the intriguing effects of certolizumab, a renowned TNF inhibitor, on the delicate journey of pregnancy. Impeccably documented in the esteemed journal Gastroenterology, a comprehensive examination was undertaken to evaluate the impact of certolizumab exposure on expectant mothers afflicted with inflammatory bowel disease. Astonishingly, the author’s meticulously conducted study ultimately determined that the utilization of certolizumab did not engender an amplified risk of unfortunate pregnancy outcomes or the emergence of congenital malformations.

It is of utmost importance to acknowledge the variability of individual circumstances, necessitating healthcare professionals to carefully evaluate each case in order to determine the optimal course of treatment. As emphasized by the esteemed American College of Rheumatology, the process of clinical decision-making must be tailored to each patient, entailing thorough deliberation of the potential risks and benefits.

To provide a comprehensive perspective, here are some interesting facts related to biologics and pregnancy:

  1. Biologics are a class of drugs derived from living organisms, such as genetically-engineered proteins, antibodies, or receptor molecules. They have revolutionized the treatment of various autoimmune and inflammatory diseases.
  2. Pregnancy can affect the course of autoimmune diseases, often leading to improved symptoms during pregnancy for conditions like rheumatoid arthritis or psoriasis.
  3. The decision to continue or discontinue biologic therapy during pregnancy is a complex one, taking into account factors such as disease activity, potential risks to the mother and baby, and the specific biologic involved.
  4. In general, biologics are considered safer than traditional immunosuppressive drugs during pregnancy due to their more targeted mechanism of action.
  5. It is important for pregnant women to receive ongoing medical care and follow-up during pregnancy while using biologics to monitor their condition and ensure optimal outcomes.
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In order to visualize the information in a table format, consider the following example table comparing the safety of various biologics in pregnancy:

Biologic Safety in Pregnancy
Adalimumab Generally considered safe based on studies with no increased risk of malformations or negative pregnancy outcomes.
Certolizumab Has shown a favorable safety profile with no increased risk of adverse outcomes or congenital malformations in studies involving women with inflammatory bowel disease.
Infliximab Limited data available, and caution is advised. It may be used in certain cases if the benefits outweigh the potential risks. Close monitoring is necessary.
Etanercept Data is limited, and its safety in pregnancy has not been firmly established. The decision to use it should be based on careful evaluation of risks and benefits.
Golimumab Limited data available, and caution is advised. Its use during pregnancy should be considered on a case-by-case basis.

In conclusion, while certain biologics such as adalimumab and certolizumab have been considered safe for use during pregnancy based on available data, it is crucial to consult with a healthcare professional to assess individual circumstances and make informed decisions regarding treatment options. As the famous physician Hippocrates once said, “Life is short, and the art long; the occasion fleeting; experience fallacious and judgment difficult.”

Answer in the video

In a recent study, researchers examined the safety of biologic drugs, specifically anti-TNF agents like Remicade and Humera, for pregnant women with conditions such as ulcerative colitis and rheumatoid arthritis. The study, which focused on women in Sweden and Denmark, found that there was no increased risk of birth defects in women treated with these medications compared to those who were not. This is encouraging news that indicates that biologic therapies can be maintained during pregnancy without worry about potential birth defects.

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See more answers I found

Biologics: TNF-α inhibitors

  • Pregnancy. Whenever clinically indicated, anti-TNF-α antibody therapy is feasible throughout pregnancy (infliximab: EL 2, RG B; adalimumab: EL 2, RG B; golimumab: EL 4, RG C).
  • Lactation.
  • Infliximab.
  • Adalimumab.
  • Golimumab.

Biologics Are Safe When Used During Pregnancy in IBD. Women were exposed to TNFi treatment during early pregnancy and compared to normal controls (n = 21,549). Birth defects were slightly more prevalent among infants born to women with chronic inflammatory disease (regardless of TNFi use), when compared to the general population (4.8% vs. 4.2%).

More interesting questions on the issue

Is Humira safe during pregnancy?
There have not been any reports that have shown risks to a pregnancy when a person takes adalimumab in the third trimester. One study reported no increased chance of infections in baby’s first year. There are no official recommendations for using adalimumab in the third trimester.
Can you take Cosentyx while pregnant?
The answer is: This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Which biologic does not cross placenta?
The one biologic or TNF [tumor necrosis factor] that has not been shown to cross the placenta is certolizumab. Certolizumab, because it’s pegylated and doesn’t have that Fc receptor that binds to the placenta for the transfer, does not cross.
Is it safe to take Stelara while pregnant?
As an answer to this: A total of 69 women with prospective reported pregnancies were exposed to STELARA through pregnancy, of which 1 resulted in a spontaneous abortion, 59 resulted in live births without congenital anomaly, and 9 resulted in live birth with congenital anomaly.
Are biologic agents safe to use in pregnancy?
Most biological agents are safe to use in pregnancy. Biologic agents may be divided into 4 risk categories: minimal, uncertain, moderate, and high. Treatment options should be individualized to each patient’s disease activity, response to medication, and adverse effects.
Who uses monoclonal antibody biologics during pregnancy?
Response: Anne Pham-Huy, MD, Karina A. Top, MD, Cora Constantinescu, MD, Cynthia H. Seow, MBBS, and Darine El-Chaâr, MD Increasingly, pregnant patients with inflammatory or autoimmune diseases use monoclonal antibody biologics before conception, during pregnancy and while breastfeeding.
Are drugs safe during pregnancy?
In the past, the Food and Drug Administration (FDA) had used 5 categories for the safety of drugs during pregnancy (Table 2) . Currently, however, the FDA has moved away from this form of categorisation in favour of more detailed, descriptive recommendations.
Is certolizumab safe during pregnancy?
No conclusions can be drawn now on the safety of using ustekinumab and secukinumab prior to and during pregnancy due to the lack of relevant data . Certolizumab pegol is the only biological drug for which a safety profile during pregnancy and lactation has been confirmed.
Are biologic agents safe to use in pregnancy?
In reply to that: Most biological agents are safe to use in pregnancy. Biologic agents may be divided into 4 risk categories: minimal, uncertain, moderate, and high. Treatment options should be individualized to each patient’s disease activity, response to medication, and adverse effects.
Who uses monoclonal antibody biologics during pregnancy?
In reply to that: Anne Pham-Huy, MD, Karina A. Top, MD, Cora Constantinescu, MD, Cynthia H. Seow, MBBS, and Darine El-Chaâr, MD Increasingly, pregnant patients with inflammatory or autoimmune diseases use monoclonal antibody biologics before conception, during pregnancy and while breastfeeding.
Are infliximab and adalimumab safe during pregnancy?
The response is: (EL 3, RG B) The FDA has classified the antibody biologic drugs infliximab (IFX), adalimumab (ADA) and golimumab (GOL) as category B, meaning that there is no evidence so far of aggravated risks of malformation in pregnant women under these treatments.
Are immunomodulating drugs safe during pregnancy?
Immunomodulating drugs are being used with increasing frequency for a variety of diseases because of their demonstrated efficacy. Many commonly prescribed drugs can be used safely during pregnancy without risk of teratogenicity or pregnancy complications, whereas a few are strictly contraindicated.

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