Pfaller Birgit, José Yepes-Nuñez Juan, Agache Ioana, Akdis Cezmi A, Alsalamah Mohammad, Bavbek Sevim, Bossios Apostolos, Boyman Onur, Chaker Adam, Chan Susan, Chatzipetrou Alexia, du Toit George, Jutel Marek, Kauppi Paula, Kolios Antonios, Li Carmen, Matucci Andrea, Marson Alanna, Bendien Sarah, Palomares Oscar, Rogala Barbara, Szepfalusi Zsolt, Untersmayr Eva, Vultaggio Alessandra, Eiwegger Thomas
Division of Cardiology, Department of Medicine, University of Toronto Pregnancy and Heart Disease Research Program, Mount Sinai and Toronto General Hospitals, Toronto, ON, Canada.
School of Medicine, Universidad de los Andes, Bogotá, D.C., Colombia.
Allergy. 2021 Jan;76(1):71-89. doi: 10.1111/all.14282.
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.
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方式。因此，获批用于治疗特应性疾病的生物制剂数量在不断增加。尽管特应性疾病是育龄期最常见的疾病之一，但关于生物制剂的半衰期、定义新生儿Fc受体（FcRn）的药代动力学以及孕期最重要的安全性方面的研究和信息却很匮乏。鉴于调节受孕、胎儿发育以及免疫系统在子宫内和出生后成熟的免疫事件序列复杂，这些信息至关重要。我们对孕期用于特应性疾病适应症的生物制剂进行了系统评价。该领域的证据稀少，主要局限于有关奥马珠单抗使用情况的报告。这种证据的缺乏要求建立一种多学科方法来管理接受生物制剂治疗的孕妇，并建立多中心登记处进行长期随访，设计适合育龄期女性的药物试验，以及建立更能代表人类情况的更好的实验模型。由于生物制剂的半衰期很长，孕前咨询和医疗服务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孕期用于特应性疾病的生物制剂安全性的现有数据，并对不同途径的抑制如何影响妊娠的免疫学考虑因素进行了详细综述。
