TY - JOUR
T1 - Biologicals in atopic disease in pregnancy
T2 - An EAACI position paper
AU - Pfaller, Birgit
AU - José Yepes-Nuñez, Juan
AU - Agache, Ioana
AU - Akdis, Cezmi A.
AU - Alsalamah, Mohammad
AU - Bavbek, Sevim
AU - Bossios, Apostolos
AU - Boyman, Onur
AU - Chaker, Adam
AU - Chan, Susan
AU - Chatzipetrou, Alexia
AU - du Toit, George
AU - Jutel, Marek
AU - Kauppi, Paula
AU - Kolios, Antonios
AU - Li, Carmen
AU - Matucci, Andrea
AU - Marson, Alanna
AU - Bendien, Sarah
AU - Palomares, Oscar
AU - Rogala, Barbara
AU - Szepfalusi, Zsolt
AU - Untersmayr, Eva
AU - Vultaggio, Alessandra
AU - Eiwegger, Thomas
N1 - Funding Information:
Dr Agache reports and Associate Editor Allergy. Dr Yepes‐Nuñez has nothing to disclose. Dr Bendien reports personal fees from ALK, personal fees from Genzyme, personal fees from GSK, personal fees from Astra‐Zeneca, outside the submitted work. Dr Untersmayr has nothing to disclose. Dr Szepfalusi has nothing to disclose. Dr Rogala has nothing to disclose. Dr Pfaller has nothing to disclose. Dr Oscar Palomares received research grants from Inmunotek SL and Novartis Oscar Palomares has received fees for giving scientific lectures from Allergy Therapeutics, Amgen, AstraZeneca, Diater, GlaxoSmithKline, S.A, Inmunotek S.L, Novartis, Sanofi‐Genzyme, and Stallergenes Oscar Palomares has participated in advisory boards from Novartis and Sanofi‐Genezyme. Alanna Marson has nothing to disclose. Dr Kolios has nothing to disclose. Dr Kauppi reports personal fees from TEVA, Novartis, GSK, Sanofi, Fimea, outside the submitted work. Dr Jutel reports personal fees from ALK‐Abello, personal fees from Allergopharma, personal fees from Stallergenes, personal fees from Anergis, personal fees from Allergy Therapeutics, personal fees from Circassia, personal fees from Leti, personal fees from Biomay, personal fees from HAL, during the conduct of the study, personal fees from Astra‐Zeneka, personal fees from GSK, personal fees from Novartis, personal fees from Teva, personal fees from Vectura, personal fees from UCB, personal fees from Takeda, personal fees from Roche, personal fees from Janssen, personal fees from Medimmune, personal fees from Chiesi, outside the submitted work. Dr Eiwegger reports other from DBV, grants from Innovation fund Denmark, other from Regeneron, outside the submitted work; and I am the Co‐I or scientific lead in three investigator‐initiated oral immunotherapy trials supported by the Allergy and Anaphylaxis Program Sickkids and serve as associate editor for Allergy. Local advisory board ALK. Dr Du Toit reports income from grants from National Institute of Allergy and Infectious Diseases (NIAID, NIH), Food Allergy & Research Education (FARE), MRC & Asthma UK Centre, UK Dept of Health through NIHR, National Peanut Board (NPB), and grants from UK Food Standards Agency (FSA); these grants part funded salary over period of this submitted work. Dr Chatzipetrou reports nonfinancial support from Novartis, outside the submitted work. Dr Chan was PI on the ADAPTrial; Novartis supported the active and placebo drug for the study. Dr Chaker reports grants for clinical studies and research and other from Allergopharma, ALK‐Abello, AstraZeneca, Bencard/Allergen Therapeutics, ASIT Biotech, Lofarma, GSK, Novartis, LETI, Roche, Sanofi Genzyme, Zeller and from the European Institute of Technology (EIT) and has received travel support from the European Academy of Allergy and Clinical Immunology (EAACI), DGAKI, all outside the submitted work. Dr Akdis reports grants from Allergopharma, grants from Idorsia, grants from Swiss National Science Foundation, grants from Christine Kühne‐Center for Allergy Research and Education, grants from European Commission's Horison's 2020 Framework Programme, Cure, grants from Novartis Research Institutes, grants from Astra Zeneca, grants from Scibase, advisory board membership in Sanofi/Regeneron. Dr Bossios reports personal fees from Novartis (advisory and/or lecture honorarium), personal fees from AstraZeneca (advisory and/or lecture honorarium), personal fees from GSK (advisory and/or lecture honorarium), and personal fees from TEVA for (advisory and/or lecture honorarium), outside the submitted work.
Publisher Copyright:
© 2020 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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.
KW - allergy
KW - asthma
KW - atopic dermatitis
KW - biologicals
KW - pregnancy
UR - http://www.scopus.com/inward/record.url?scp=85098847060&partnerID=8YFLogxK
U2 - 10.1111/all.14282
DO - 10.1111/all.14282
M3 - Article
C2 - 32189356
AN - SCOPUS:85098847060
SN - 0105-4538
VL - 76
SP - 71
EP - 89
JO - Allergy: European Journal of Allergy and Clinical Immunology
JF - Allergy: European Journal of Allergy and Clinical Immunology
IS - 1
ER -