Exposure to biological therapies during conception and pregnancy: a systematic review

Summary Biologic therapies are effective treatments for psoriasis and are often used in women of childbearing age. Regulatory authorities state that there are no adequate studies to evaluate the safety of biologics at conception or during pregnancy and therefore advise against their use at these times. However, in practice these situations are challenging given the clinical need to treat on‐going psoriasis. To evaluate the safety of biologic therapy in conception and/or pregnancy, the authors of this study, from the U.K., performed a systematic review of studies of women exposed to biologic therapy for the treatment of psoriasis during conception and/or pregnancy. The authors identified four studies involving 1300 women exposed to biologics (called TNFi) 3 months prior to or during the first 3 months of pregnancy. These studies showed a trend towards drug‐specific harm with TNFi exposure in women with different inflammatory diseases (i.e. not just psoriasis), with an increased risk of congenital malformations in three of the studies, and pre‐term birth in one of the studies. However, the risk was low and there is uncertainty about the causal role of TNFi. The authors conclude that the potential effect of biologics on pregnancy outcomes specifically in women with psoriasis has not been adequately studied to quantify accurately. Data on use of biologics in other diseases is limited. Women of childbearing potential should be routinely advised to use regular contraception, however, when planning conception the risk and benefits of continuing versus stopping therapy should be discussed case‐by‐case. A large study is required, taking into account other factors that may influence pregnancy such as disease activity, other therapies and maternal demographics.