D'Gama Jonathan D, Bermas Bonnie L
Division of Rheumatic Diseases, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Curr Opin Rheumatol. 2024 May 1;36(3):184-190. doi: 10.1097/BOR.0000000000001014. Epub 2024 Mar 8.
To discuss the current understanding regarding the use of biologic therapeutics in pregnancy.
Our understanding of the mechanisms underlying the potential fetal and infant exposure to biologics as well as a growing body of empirical evidence from real world use of biologics in pregnancy have demonstrated that biologics are generally compatible preconception and during pregnancy. Long-term effects of exposure to biologic agents in utero are not known, but will be uncovered in time. Biosimilars, which are becoming more popular, may not always share the same safety profiles as their originators.
Biologics have revolutionized the management of rheumatologic disease and ushered in a new era of clinical remission among patients. These agents, developed and introduced into clinical use at the beginning of the new millennium, are very potent, yet their efficacy in treating disease often in reproductive aged women, raises questions regarding their safety during pregnancy. These therapeutics can cause immunosuppression and can inhibit immunologic circuits that are not only involved in disease pathophysiology but hypothetically could impact the development of the fetal immune system. Reassuringly, biologics, typically antibodies or antibody-based proteins, are introduced to the fetus via the typical route of transplacental antibody transfer, and thus only begin to be transferred in appreciable amounts in the second trimester (after organogenesis). From theoretic and empirical standpoints, biologic use during pregnancy appears well tolerated for fetal development and to not substantially affect infant immune development.
综述目的：探讨目前关于生物治疗药物在孕期应用的认识。
最新发现：我们对胎儿和婴儿接触生物制剂潜在机制的理解，以及越来越多来自生物制剂在孕期实际应用的经验证据表明，生物制剂在孕前和孕期通常是相容的。子宫内接触生物制剂的长期影响尚不清楚，但迟早会被揭示。越来越受欢迎的生物类似药，其安全性可能并不总是与其原研药相同。
总结：生物制剂彻底改变了风湿病的治疗方式，开创了患者临床缓解的新时代。这些药物在新千年伊始研发并引入临床使用，效力很强，然而它们在治疗处于生育年龄女性疾病方面的疗效，引发了关于其在孕期安全性的问题。这些治疗方法可导致免疫抑制，并能抑制不仅参与疾病病理生理过程，而且理论上可能影响胎儿免疫系统发育的免疫通路。令人安心的是，生物制剂，通常是抗体或基于抗体的蛋白质，通过胎盘抗体转移的典型途径进入胎儿体内，因此在孕中期（器官形成之后）才开始大量转移。从理论和经验角度来看，孕期使用生物制剂似乎对胎儿发育耐受性良好，并且不会对婴儿免疫发育产生实质性影响。
