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Biologicals in atopic disease in pregnancy: an EAACI position paper
Allergy ( IF 12.4 ) Pub Date : 2021-01-01 , DOI: 10.1111/all.14282
Birgit Pfaller 1 , Juan José Yepes‐Nuñez 2 , Ioana Agache 3 , Cezmi A. Akdis 4 , Mohammad Alsalamah 5, 6, 7 , Sevim Bavbek 8, 9 , Apostolos Bossios 10, 11 , Onur Boyman 12, 13 , Adam Chaker 14 , Susan Chan 15, 16 , Alexia Chatzipetrou 17, 18, 19, 20 , George Toit 21 , Marek Jutel 22, 23 , Paula Kauppi 24 , Antonios Kolios 12, 13 , Carmen Li 5 , Andrea Matucci 25 , Alanna Marson 5 , Sarah Bendien 26 , Oscar Palomares 27 , Barbara Rogala 28 , Zsolt Szepfalusi 29 , Eva Untersmayr 30 , Alessandra Vultaggio 24 , Thomas Eiwegger 5, 31, 32
Affiliation  

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.

中文翻译:

妊娠期特应性疾病中的生物制剂:EAACI 立场文件

生物制剂已经改变了哮喘、特应性皮炎和慢性自发性荨麻疹等严重疾病表型的管理。因此,批准用于治疗特应性疾病的生物制品的数量不断增加。尽管特应性疾病是育龄期最常见的疾病之一,但缺乏关于半衰期、定义新生儿 Fc 受体 (FcRn) 的药代动力学和妊娠期生物制品最重要安全性的研究和信息。鉴于调节受孕、胎儿发育以及宫内和出生后免疫系统成熟的免疫事件的复杂序列,这些信息至关重要。我们对妊娠期生物制品用于特应性疾病的适应症进行了系统评价。该领域的证据很少,主要用于报告奥马珠单抗的使用。由于缺乏证据,因此需要建立多学科方法来管理接受生物制剂和多中心注册进行长期随访的孕妇、适合育龄妇女的药物试验设计以及代表人类的更好的实验模型。情况。由于生物制品的半衰期很长,孕前咨询和医疗保健提供者教育对于为母亲和胎儿提供最佳护理至关重要。本立场文件通过系统评价整合了有关妊娠期间生物制品在特应性疾病中的安全性的现有数据,并详细审查了免疫学考虑因素如何抑制不同途径可能影响妊娠。
更新日期:2021-01-01
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