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Expert Rev Clin Pharmacol. 2018 Oct;11(10):987-998. doi: 10.1080/17512433.2018.1525293. Epub 2018 Sep 29.

The use of biologics and small molecules in pregnant patients with rheumatic diseases.

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a Department of Clinical Sciences and Community Health , University of Milan, Division of Clinical Rheumatology, ASST Istituto Gaetano Pini - CTO , Milan , Italy.
b Division of Clinical Rheumatology , ASST Istituto Gaetano Pini - CTO , Milan , Italy.
c Department of Clinical Sciences and Community Health , University of Milan, Milan, Italy; Experimental Laboratory of Immunorheumatological Researches, Istituto Auxologico Italiano , Milan , Italy.


Biological agents have radically changed the prognosis of rheumatic patients. Current evidence demonstrates that tight disease control during pregnancy is mandatory to minimize adverse outcome risk. As the new therapeutic tools are pivotal to maintain appropriate disease activity, it is timely to review available evidence about the safety of biologics and small molecules in pregnancy. Areas covered: A comprehensive literature review has been performed, reporting available data about the passage into breast milk, rate of pregnancy loss and fetal malformations, and long-term complications due to in utero exposure to biological agents and small molecules. Expert commentary: Data about the safety of agents against tumor necrosis factor in pregnancy are reassuring. Even rituximab, tocilizumab, belimumab, ustekinumab, secukinumab, and abatacept have not been associated with an increased rate of fetal abnormalities or adverse pregnancy outcome. Experience with small molecules is too small to draw any conclusion. Even if further data are warranted to define the possible long-term effects of in utero biologic exposure on the infant immune system development, it is reasonable to speculate that in the next future the use of biologics during pregnancy will continue to expand, at least when maternal benefit justifies the potential risk to the fetus.


Abatacept; abortion; anakinra; anti-TNF agents; apremilast; baricitinib; belimumab; foetal malformation; pregnancy; rituximab; secukinumab; tocilizumab; tofacitinib; ustekinumab

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