Scott R, Parker H, Mccartney S, Harrow P, Williams D, Giles I
Department of Obstetrics, University College London Hospital NHS Foundation Trust, London, UK.
Department of Gastroenterology, University College London Hospital NHS Foundation Trust, London, UK.
Obstet Med. 2022 Jun;15(2):104-107. doi: 10.1177/1753495X211028779. Epub 2021 Sep 2.
Biosimilar tumour necrosis factor inhibitors (TNFi) are increasingly used to treat inflammatory immune-mediated disorders as they cost less than the originator biologic drug. More women are therefore becoming pregnant on biosimilar TNFi. This is the first paper to explore the safety and efficacy of biosimilar therapies in pregnancy.
A retrospective review of clinical data reviewed pregnancy outcomes and inflammatory disease activity in 18 pregnancies where the mother was using a biosimilar TNFi at conception.
Biosimilar therapy was not associated with congenital abnormalities, preterm birth or other adverse pregnancy outcomes. Stopping biosimilar TNFi in pregnancy was associated with childbirth at an earlier gestation, as well as a flare of inflammatory disease in pregnancy or post-partum.
Women and clinicians should feel confident in using biosimilar TNFi in early pregnancy, and continuing them through pregnancy to prevent flares in late pregnancy or the early post-partum.
生物类似药肿瘤坏死因子抑制剂(TNFi)因其成本低于原研生物药,越来越多地用于治疗炎症性免疫介导疾病。因此,越来越多使用生物类似药TNFi的女性怀孕。本文首次探讨生物类似药疗法在孕期的安全性和有效性。
对临床数据进行回顾性分析,评估18例母亲在受孕时使用生物类似药TNFi的妊娠结局和炎症性疾病活动情况。
生物类似药治疗与先天性异常、早产或其他不良妊娠结局无关。孕期停用生物类似药TNFi与更早孕周分娩以及孕期或产后炎症性疾病复发有关。
女性和临床医生在孕早期使用生物类似药TNFi时应充满信心,并在整个孕期持续使用以预防孕晚期或产后早期炎症复发。