To review available data regarding the safety of biological therapies during pregnancy, focusing on agents used in rheumatology.
A systematic literature search was carried out to identify all studies with human data on fetal and/or child outcomes following exposure to biologic agents during pregnancy.
A total of 65 publications out of 745 identified references were included in the review.
Experience with pregnancy exposure to anti-TNF agents has been slowly accumulating. Although the numbers are small and with few controlled studies the reviewed data suggest that the overall risk of TNF antagonists is relatively low and benefits may outweigh the risks of drug exposure to the fetus. Information on other biologic agents is still very limited. Large controlled studies with longer follow-up periods will be necessary before firm conclusions about the safety of biologics du-ring conception and pregnancy can be drawn.