Safety of anti-tumor necrosis factor therapy during pregnancy in patients with inflammatory bowel disease

World J Gastroenterol. 2015 Dec 21;21(47):13205-11. doi: 10.3748/wjg.v21.i47.13205.

Abstract

Treatment of inflammatory bowel disease has significantly improved since the introduction of biological agents, such as infliximab, adalimumab, certolizumab pegol, and golimumab. The Food and Drug Administration has classified these factors in category B, which means that they do not demonstrate a fetal risk. However, during pregnancy fetuses are exposed to high anti-tumor necrosis factor (TNF) levels that are measurable in their plasma after birth. Since antibodies can transfer through the placenta at the end of the second and during the third trimesters, it is important to know the safety profile of these drugs, particularly for the fetus, and whether maintaining relapse of the disease compensates for the potential risks of fetal exposure. The limited data available for the anti-TNF drugs to date have not demonstrated any significant adverse outcomes in the pregnant women who continued their therapy from conception to the first trimester of gestation. However, data suggest that anti-TNFs should be discontinued during the third trimester, as they may affect the immunological system of the newborn baby. Each decision should be individualized, based on the distinct characteristics of the patient and her disease. Considering all the above, there is a need for more clinical studies regarding the effect of anti-TNF therapeutic agents on pregnancy outcomes.

Keywords: Adverse effects; Anti-tumor necrosis factor; Crohn’s disease; Inflammatory bowel disease; Pregnancy; Ulcerative colitis.

Publication types

  • Editorial
  • Review

MeSH terms

  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / metabolism
  • Anti-Inflammatory Agents / therapeutic use*
  • Biological Products / adverse effects
  • Biological Products / therapeutic use*
  • Colitis, Ulcerative / diagnosis
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / immunology
  • Crohn Disease / diagnosis
  • Crohn Disease / drug therapy*
  • Crohn Disease / immunology
  • Female
  • Fetus / drug effects
  • Fetus / immunology
  • Fetus / metabolism
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / metabolism
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Placenta / metabolism
  • Pregnancy
  • Pregnancy Complications / diagnosis
  • Pregnancy Complications / drug therapy*
  • Pregnancy Complications / immunology
  • Pregnancy Trimester, Third
  • Risk Assessment
  • Risk Factors
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*
  • Tumor Necrosis Factor-alpha / immunology

Substances

  • Anti-Inflammatory Agents
  • Biological Products
  • Gastrointestinal Agents
  • Tumor Necrosis Factor-alpha