title: Safety of anti-tumor necrosis factor therapy during pregnancy in patients with inflammatory bowel disease.
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.
authors.affiliation: Ioannis Androulakis, Panagiotis Christopoulos, George Mastorakos, Endocrine Unit, Aretaieion Hospital, University of Athens Medical School, 11527 Athens, Greece.
authors.forename: Ioannis
authors.initials: I
authors.lastname: Androulakis
authors.affiliation: Ioannis Androulakis, Panagiotis Christopoulos, George Mastorakos, Endocrine Unit, Aretaieion Hospital, University of Athens Medical School, 11527 Athens, Greece.
authors.forename: Christos
authors.initials: C
authors.lastname: Zavos
authors.affiliation: Ioannis Androulakis, Panagiotis Christopoulos, George Mastorakos, Endocrine Unit, Aretaieion Hospital, University of Athens Medical School, 11527 Athens, Greece.
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Christopoulos
authors.affiliation: Ioannis Androulakis, Panagiotis Christopoulos, George Mastorakos, Endocrine Unit, Aretaieion Hospital, University of Athens Medical School, 11527 Athens, Greece.
authors.forename: George
authors.initials: G
authors.lastname: Mastorakos
authors.affiliation: Ioannis Androulakis, Panagiotis Christopoulos, George Mastorakos, Endocrine Unit, Aretaieion Hospital, University of Athens Medical School, 11527 Athens, Greece.
authors.forename: Maria
authors.initials: M
authors.lastname: Gazouli
mesh_terms: D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D003424:Crohn Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D005260:Female; D005333:Fetus / Q000187:drug effects / Q000276:immunology / Q000378:metabolism; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D006801:Humans; D010920:Placenta / Q000378:metabolism; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D011263:Pregnancy Trimester, Third; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors* / Q000276:immunology
chemical_list: D000893:Anti-Inflammatory Agents; D001688:Biological Products; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha
keywords: Adverse effects; Anti-tumor necrosis factor; Crohn’s disease; Inflammatory bowel disease; Pregnancy; Ulcerative colitis