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Pregnancy with Rheumatoid arthritis- anti- TNF agents

Are anti-TNF alpha medications (Remicade/ Enbrel) safe in pregnancy?
Presently, we do not have sufficient data to know the exact risk posed by anti-TNF alpha medications to the unborn child.

There is a database maintained by OTIS (Organization of Teratology Information Specialists) that follows pregnant women exposed to biologic agents. The database has followed up 32 pregnant women exposed to biologic agents (Anti-TNF alpha medications) during the first trimester. The follow up does not reveal any major risk of structural defects associated with Anti-TNF alpha medications.

Spanish registry for adverse events of biological therapies in rheumatic diseases (BIOADASER) has followed up 14 pregnancies in patients on anti TNF alpha agents.

British Society for Rheumatology Biologics Register has also reported 35 pregnancies. Both the reports have not shown any increased risk of structural defects in the fetus with these agents.

Though these studies have not found any major structural risks, it is very premature to consider these agents during pregnancy.

A recent study of 146 pregnancies (outcome data for 96) with exposure to infliximab did not reveal any increased risk of adverse events related to pregnancy/ fetal malformations(3).

  3. Katz JA, Antoni C, Keenan GF, et al. Outcome of pregnancy in women receiving infliximab for the treatment of Crohn's disease and rheumatoid arthritis. Am J Gastroenterol 2004; 99: 2385-2392

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Created on: April 2007
Last updated on: Feb 2015
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