创作:Epi汪 审核:Epi汪 2020年12月04日
  • 纳入队列研究中1490名炎症性肠炎(IBD)孕妇,其中孕期服用巯嘌呤类药物的有242人,服用生物制剂的有642人,二者都使用的有227人,而都不使用的有379人;
  • 无论使用何种药物,胎儿先天畸形、自然流产、早产、低出生体重、感染等不良妊娠结局发生率均未增高;
  • 反之,IBD症状更为严重者,其发生自然流产及早产的风险增高;
  • 本研究提示,IBD女性在孕期可继续使用生物制剂或巯嘌呤类药物缓解症状,或可减少不良妊娠事件。
Gastroenterology [IF:22.682]

Pregnancy and Neonatal Outcomes after Fetal Exposure To Biologics and Thiopurines among Women with Inflammatory Bowel Disease



2020-11-20, Article

Abstract & Authors:展开

Background: Pregnant women with inflammatory bowel disease (IBD) may require biologic or thiopurine therapy to control disease activity. Lack of safety data has led to therapy discontinuation during pregnancy with health repercussions to mother and child.
Methods: Between 2007 and 2019, pregnant women with IBD were enrolled in a prospective, observational, multicenter study across the United States. The primary analysis was a comparison of five outcomes (congenital malformations, spontaneous abortions, preterm birth, low birth weight (LBW) and infant infections) among pregnancies exposed versus unexposed in utero to biologics, thiopurines or a combination. Bivariate analyses followed by logistic regression models adjusted for relevant confounders were utilized to determine the independent effects of specific drug classes on outcomes of interest.
Results: Among 1490 completed pregnancies, there were 1431 live births. One-year infant outcomes were available in 1010. Exposure was to thiopurines (242), biologics (642) or both (227) versus unexposed (379). Drug exposure did not increase the rate of congenital malformations, spontaneous abortions, preterm birth, LBW, and infections over the first year of life. Higher disease activity was associated with risk of spontaneous abortion (HR 3.41, 95% CI 1.51-7.69) and preterm birth with increased infant infection (OR 1.73, 95% CI 1.19-2.51).
Conclusions: Biologic, thiopurine, or combination therapy exposure during pregnancy was not associated with increased adverse maternal or fetal outcomes at birth or within the first year of life. Therapy with these agents can be continued throughout pregnancy in women with IBD to maintain disease control and reduce pregnancy related adverse events

First Authors:
Uma Mahadevan

Correspondence Authors:
Uma Mahadevan

All Authors:
Uma Mahadevan,Millie D Long,Sunanda V Kane,Abhik Roy,Marla C Dubinsky,Bruce E Sands,Russell D Cohen,Christina D Chambers,William J Sandborn