Should Biological Therapies Be Used During Pregnancy by Inflammatory Bowel Disease Patients?

Should Biological Therapies Be Used During Pregnancy by Inflammatory Bowel Disease Patients?

A new article sheds light on whether pregnant women with inflammatory bowel disease (IBD) should continue using anti-tumor necrosis factor (TNF) therapy.

These therapies include the biological agents infliximab, adalimumab, certolizumab pegol, and golimumab, all of which block the naturally-occurring inflammatory molecule TNF.

Overall, the study authors suggest discontinuing these treatments during the third trimester of pregnancy. The recently released report, titled Safety of anti-tumor necrosis factor therapy during pregnancy in patients with inflammatory bowel disease, appeared in the World Journal of Gastroenterology.

IBD is characterized by an inflammation of part or all of the digestive tract. Different types include ulcerative colitis and Crohn’s disease. Symptoms can be extremely debilitating and include weight loss, severe diarrhea, pain and fatigue.

Treatment for IBD has improved with the introduction of biological agents, which the U.S. Food and Drug Administration classifies as category B, meaning they are safe to use in pregnancy and do not pose a risk to the developing fetus.

TNF, the target for IBD biological treatments, is a key molecule that mediates inflammation. It is one of the crucial triggers for what is known as the “acute phase reaction,” an inflammatory response to injury or infection that can be abnormally high in people with diseases such as IBD.

A new comprehensive review, led by first author Ioannis Androulakis from the University of Athens Medical School in Greece, noted that although biological therapies are classified as pregnancy category B, there is insufficient evidence available about their use during pregnancy.

Because biological therapies are antibodies, they may impact the immune system of the developing fetus, especially during the third trimester. This is particularly important because high levels of TNF are present in the plasma of babies at birth; this may mean that TNF is important for development, particularly of the immune system, and therapies designed to block TNF might impact normal fetal development.

In their study report, the authors concluded, “Each decision should be individualized, based on the distinct characteristics of the patient and her disease … There is a need for more clinical studies regarding the effect of anti-TNF therapeutic agents on pregnancy outcomes.”

The researchers propose that despite a lack of measured safety concerns so far, biological agents for IBD still need to be viewed with caution during pregnancy based on their known biological effects. The decision to use them should include weighing benefits to the mother in managing her IBD against any potential risks.