炎症性肠病女性孕期使用英夫利昔单抗生物类似药：炎症性肠病妊娠与新生儿结局研究结果
Use of Biosimilars to Infliximab During Pregnancy in Women With Inflammatory Bowel Disease: Results From the Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes Study.
作者信息
Long Millie D, Kane Sunanda, Beaulieu Dawn, Abraham Bincy, Zhang Xian, Mahadevan Uma
机构信息
University of North Carolina, Chapel Hill, North Carolina, USA.
Mayo Clinic, Rochester, Minnesota, USA.
出版信息
Clin Transl Gastroenterol. 2024 Dec 1;15(12):e00795. doi: 10.14309/ctg.0000000000000795.
Abstract
INTRODUCTION
We aimed to compare pregnancy outcomes of women with inflammatory bowel disease using biosimilar vs originator infliximab (IFX).
METHODS
In a prospective cohort of pregnant women with inflammatory bowel disease, we collected characteristics, medications, pregnancy outcomes, and developmental milestones. We compared outcomes by IFX biosimilar or originator use via bivariate statistics.
RESULTS
A total of 100 pregnant women on originator IFX and 20 on biosimilar IFX were included. There were no differences in pregnancy complications between groups (48% vs 35%, P = 0.29). Infant developmental milestones were comparable at 12 months.
DISCUSSION
Biosimilar IFX is not associated with adverse pregnancy or infant outcomes.
摘要
引言
我们旨在比较使用生物类似药与原研英夫利昔单抗（IFX）的炎症性肠病女性的妊娠结局。
方法
在一个炎症性肠病孕妇的前瞻性队列中，我们收集了特征、用药情况、妊娠结局和发育里程碑。我们通过双变量统计比较了使用生物类似药或原研IFX的结局。
结果
共纳入100名使用原研IFX的孕妇和20名使用生物类似药IFX的孕妇。两组之间的妊娠并发症无差异（48%对35%，P = 0.29）。婴儿在12个月时的发育里程碑相当。
讨论
生物类似药IFX与不良妊娠或婴儿结局无关。
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