Objectives To assess the risk of preterm delivery and small-for-gestational-age (SGA) births in women with autoimmune diseases using biologics before or during pregnancy. Methods Using population-based administrative data in British Columbia, Canada, women with one or more autoimmune diseases who had pregnancies between 1 January 2002 and 31 December 2012 were included. Exposure to biologics was defined as having at least one biologic prescription 3 months before or during pregnancy. Each exposed pregnancy was matched with five unexposed pregnancies using high-dimensional propensity scores (HDPS). Logistic regression modelling was used to evaluate the association between biologics use and preterm delivery and SGA. Results There were 6218 women with 8607 pregnancies who had an autoimmune disease diagnosis; of which 109 women with 120 pregnancies were exposed to biologics 3 months before or during pregnancy. In unadjusted analyses, the ORs for the association of biologics exposure with preterm deliveries were 1.64 (95% CI 1.02 to 2.63) and 1.34 (95% CI 0.72 to 2.51) for SGA. After HDPS matching with 600 unexposed pregnancies, the ORs for the association of biologics exposure and preterm deliveries were 1.13 (95% CI 0.67 to 1.90) and 0.91 (95% CI 0.46 to 1.78) for SGA. Sensitivity analyses using HDPS deciles, continuous HDPS covariate or longer exposure window did not result in marked changes in point estimates and CIs. Conclusions These population-based data suggest that the use of biologics before and during pregnancy is not associated with an increased risk of preterm delivery or SGA births.

中文翻译：

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妊娠前或妊娠期间使用生物制剂的自身免疫性疾病女性早产和小于胎龄儿的风险：一项基于人群的队列研究

目的 旨在在怀孕前或怀孕期间使用生物制剂评估患有自身免疫性疾病的妇女的早产和小于胎龄 (SGA) 分娩的风险。方法 使用加拿大不列颠哥伦比亚省基于人口的行政数据，纳入了在 2002 年 1 月 1 日至 2012 年 12 月 31 日期间怀孕的患有一种或多种自身免疫性疾病的妇女。接触生物制剂的定义是在怀孕前 3 个月或怀孕期间至少服用过一种生物制剂。使用高维倾向评分 (HDPS) 将每个暴露的妊娠与五个未暴露的妊娠相匹配。Logistic 回归模型用于评估生物制剂使用与早产和 SGA 之间的关联。结果 诊断为自身免疫性疾病的妇女6218例，妊娠8607例；其中 109 名妇女有 120 次怀孕，在怀孕前 3 个月或怀孕期间接触过生物制剂。在未经调整的分析中，SGA 生物制剂暴露与早产相关的 OR 分别为 1.64（95% CI 1.02 至 2.63）和 1.34（95% CI 0.72 至 2.51）。在 HDPS 与 600 例未暴露妊娠匹配后，SGA 生物制剂暴露与早产关联的 OR 分别为 1.13（95% CI 0.67 至 1.90）和 0.91（95% CI 0.46 至 1.78）。使用 HDPS 十分位数、连续 HDPS 协变量或更长的暴露窗口进行的敏感性分析不会导致点估计和 CI 的显着变化。结论 这些基于人群的数据表明，在怀孕前和怀孕期间使用生物制剂与早产或 SGA 分娩风险的增加无关。