Leflunomide is contraindicated in pregnant women, yet human data from leflunomide-exposed pregnancies do not indicate an embryofetal toxicity signal. The objective of the present analysis was to report pregnancy outcomes for leflunomide-exposed pregnancies in clinical trials and in the post-marketing setting. Pregnancy outcomes are summarized from leflunomide clinical trials and the post-marketing setting. The data cut-off was 31 December 2017. Of 1167 pregnancies reported in female patients exposed to leflunomide, 587 had a known outcome. Of these, 337 (57.4%) were reported prospectively and 250 (42.6%) were reported retrospectively. Of the 587 pregnancies with a known outcome (which involved 15 sets of twins), there were 333 (56.7%) live births, with 285 (48.6%) full-term births and 48 (8.2%) pre-term births. Birth defects were reported in 44 babies/fetuses/embryos from 587 pregnancies, with 2 reporting at least 3 minor defects and 20 reporting major defects. Major defects were reported in 3 of 337 (0.9%) prospectively-reported pregnancies; 1 major birth defect occurred in a live birth, and 2 were electively terminated due to a detected fetal anomaly. Two of the babies/fetuses/embryos, a live birth and an electively aborted baby/fetus/embryo, from 206 prospectively-reported pregnancies exposed to leflunomide during the first trimester experienced major defects. Birth defects showed no specific patterns and were distributed evenly across organ systems. Outcomes were consistent with the general population. These findings do not suggest an embryofetal toxicity signal for leflunomide, which is consistent with previous findings from leflunomide-exposed pregnancies.

中文翻译：

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来氟米特是多发性硬化症药物特氟米特的母体化合物来氟米特治疗的患者的妊娠结局。

来氟米特是孕妇的禁忌症，但是来自来氟米特暴露的孕妇的人体数据并未显示出胚胎胎儿毒性信号。本分析的目的是在临床试验和上市后的报告中报告来氟米特暴露的孕妇的妊娠结局。来氟米特的临床试验和上市后的结果总结了妊娠结局。数据截止日期为2017年12月31日。在暴露于来氟米特的女性患者中报告的1167例妊娠中，有587例有已知结局。其中，前瞻性报道了337（57.4％），回顾性报道了250（42.6％）。在587例结果已知的怀孕中（涉及15对双胞胎），有333例（56.7％）活产，其中285例（48.6％）足月产和48例（8.2％）早产。在587例孕妇中，有44例婴儿/胎儿/胚胎报告了出生缺陷，其中2例报告了至少3例次要缺陷，20例报告了重大缺陷。在337例预期报告的妊娠中，有3例（0.9％）报告了严重缺陷；有1例主要的出生缺陷发生在活产中，有2例由于发现胎儿异常而被选择性终止。在前三个月中，从206例前期报告的暴露于来氟米特的孕妇中，有两个婴儿/胎儿/胚胎，活产婴儿和选择性流产的婴儿/胎儿/胚胎。出生缺陷没有特定的模式，并且在器官系统中均匀分布。结果与一般人群一致。这些发现并未暗示来氟米特的胚胎胎儿毒性信号，