TY - JOUR TI - Biologicals in atopic disease in pregnancy: An EAACI position paper AU - Pfaller, B. AU - José Yepes-Nuñez, J. AU - Agache, I. AU - Akdis, C.A. AU - Alsalamah, M. AU - Bavbek, S. AU - Bossios, A. AU - Boyman, O. AU - Chaker, A. AU - Chan, S. AU - Chatzipetrou, A. AU - du Toit, G. AU - Jutel, M. AU - Kauppi, P. AU - Kolios, A. AU - Li, C. AU - Matucci, A. AU - Marson, A. AU - Bendien, S. AU - Palomares, O. AU - Rogala, B. AU - Szepfalusi, Z. AU - Untersmayr, E. AU - Vultaggio, A. AU - Eiwegger, T. JO - Allergy: European Journal of Allergy and Clinical Immunology PY - 2021 VL - 76 TODO - 1 SP - 71-89 PB - Wiley-Blackwell Publishing Ltd SN - null TODO - 10.1111/all.14282 TODO - biological product; cytokine; omalizumab; rituximab; biological factor, allergic asthma; Article; atopic dermatitis; atopy; congenital malformation; data analysis software; drug absorption; drug approval; drug half life; drug safety; female; fertility; first trimester pregnancy; follow up; GRADE approach; health education; human; live birth; low birth weight; necrotizing enterocolitis; neonatal pneumonia; neonatal respiratory distress syndrome; neonatal thrombocytopenia; newborn sepsis; nonhuman; patient counseling; placenta; preeclampsia; pregnancy; pregnancy outcome; pregnant woman; premature labor; prepregnancy care; priority journal; respiratory failure; small for date infant; spontaneous abortion; stillbirth; study design; systematic review; twin pregnancy; urinary tract infection; urticaria; asthma; atopic dermatitis; multicenter study (topic); newborn; pregnancy, Asthma; Biological Factors; Biological Products; Dermatitis, Atopic; Female; Humans; Infant, Newborn; Multicenter Studies as Topic; Omalizumab; Pregnancy TODO - Biologicals have transformed the management of severe disease phenotypes in asthma, atopic dermatitis, and chronic spontaneous urticaria. As a result, the number of approved biologicals for the treatment of atopic diseases is continuously increasing. Although atopic diseases are among the most common diseases in the reproductive age, investigations, and information on half-life, pharmacokinetics defining the neonatal Fc receptors (FcRn) and most important safety of biologicals in pregnancy are lacking. Given the complex sequence of immunological events that regulate conception, fetal development, and the intrauterine and postnatal maturation of the immune system, this information is of utmost importance. We conducted a systematic review on biologicals in pregnancy for indications of atopic diseases. Evidence in this field is scarce and mainly reserved to reports on the usage of omalizumab. This lack of evidence demands the establishment of a multidisciplinary approach for the management of pregnant women who receive biologicals and multicenter registries for long-term follow-up, drug trial designs suitable for women in the reproductive age, and better experimental models that represent the human situation. Due to the very long half-life of biologicals, preconception counseling and healthcare provider education are crucial to offer the best care for mother and fetus. This position paper integrates available data on safety of biologicals during pregnancy in atopic diseases via a systematic review with a detailed review on immunological considerations how inhibition of different pathways may impact pregnancy. © 2020 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd. ER -