Millie D Long, Sunanda Kane, Dawn Beaulieu, Bincy Abraham, Xian Zhang, Uma Mahadevan
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引用次数: 0
摘要
我们的目的是比较炎症性肠病患者使用生物仿制药和原药英夫利昔单抗(IFX)的妊娠结局。方法:在一组患有炎症性肠病的孕妇中,我们收集了她们的特征、药物、妊娠结局和发育里程碑。我们通过双变量统计比较了IFX生物类似药或原研者使用的结果。结果:共纳入100例原研IFX孕妇和20例生物仿制药IFX孕妇。两组妊娠并发症发生率无差异(48% vs 35%, P = 0.29)。婴儿发育里程碑在12个月时具有可比性。讨论:IFX生物仿制药与不良妊娠或婴儿结局无关。
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.
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.
期刊介绍:
Clinical and Translational Gastroenterology (CTG), published on behalf of the American College of Gastroenterology (ACG), is a peer-reviewed open access online journal dedicated to innovative clinical work in the field of gastroenterology and hepatology. CTG hopes to fulfill an unmet need for clinicians and scientists by welcoming novel cohort studies, early-phase clinical trials, qualitative and quantitative epidemiologic research, hypothesis-generating research, studies of novel mechanisms and methodologies including public health interventions, and integration of approaches across organs and disciplines. CTG also welcomes hypothesis-generating small studies, methods papers, and translational research with clear applications to human physiology or disease.
Colon and small bowel
Endoscopy and novel diagnostics
Esophagus
Functional GI disorders
Immunology of the GI tract
Microbiology of the GI tract
Inflammatory bowel disease
Pancreas and biliary tract
Liver
Pathology
Pediatrics
Preventative medicine
Nutrition/obesity
Stomach.