The Xolair Pregnancy Registry (EXPECT): The safety of omalizumab use during pregnancy
The Xolair Pregnancy Registry (EXPECT): The safety of omalizumab use during pregnancy
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DOI：
10.1016/j.jaci.2014.08.025
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发表时间：
2015-02-01
影响因子：
14.2
通讯作者：
Andrews, Elizabeth B.
中科院分区：
文献类型：
--
作者：
Namazy, Jennifer;Cabana, Michael D.;Andrews, Elizabeth B.
背景：对于许多哮喘药物，妊娠安全性数据仍然不足。目的：奥马珠单抗妊娠登记处 EXPECT 评估接触奥马珠单抗后的孕产妇、妊娠和婴儿结局，包括先天性异常的发生率。方法：EXPECT 是一项前瞻性观察性研究，对象是在受孕前 8 周内或妊娠期间任何时间接触 >= 1 剂奥马珠单抗的孕妇。主要结局指标包括活产率、选择性终止妊娠、死产率和先天性异常率。在入组、每个妊娠期、出生以及产后每 6 个月直至 18 个月收集数据。 结果：截至 2012 年 11 月，191 名孕妇中有 188 名在妊娠前三个月接触过奥马珠单抗。在 169 例已知结局的妊娠中（妊娠期间中位暴露时间为 8.8 个月），有 160 名婴儿（4 对双胞胎）中的 156 名活产婴儿、1 名胎儿死亡/死产、11 名自然流产和 1 名选择性终止妊娠。 152 名单胎婴儿中，22 名（14.5%）早产。在 147 名有体重数据的单胎婴儿中，16 名（10.9%）小于胎龄。 125 名单胎足月儿中，4 名（3.2%）出生体重过低。总体而言，20 名婴儿被确诊患有先天性异常，其中 7 名（4.4%）有 1 项重大缺陷。未观察到任何异常模式。结论：迄今为止，在 EXPECT 登记中观察到的主要先天性异常、早产、低出生体重和小于胎龄的比例与该哮喘人群的其他研究结果并不不一致。考虑到可用样本量较小，尚未观察到主要异常或主要异常模式的出生率明显增加。
Background: For many asthma medications, pregnancy safety data remains insufficient.Objective: The omalizumab pregnancy registry, EXPECT, evaluates maternal, pregnancy, and infant outcomes after exposure to omalizumab, including incidence of congenital anomalies.Methods: EXPECT is a prospective, observational study of pregnant women exposed to >= 1 dose of omalizumab within 8 weeks prior to conception or at any time during pregnancy. Primary outcome measures include rates of live births, elective terminations, stillbirths, and congenital anomalies. Data were collected at enrollment, each trimester, birth, and every 6 months up to 18 months post-delivery.Results: As of November 2012, 188 of 191 pregnant women were exposed to omalizumab during their first trimester. Of 169 pregnancies with known outcomes (median exposure during pregnancy, 8.8 months), there were 156 live births of 160 infants (4 twin pairs), 1 fetal death/stillbirth, 11 spontaneous abortions, and 1 elective termination. Among 152 singleton infants, 22 (14.5%) were born prematurely. Of 147 singleton infants with weight data, 16 (10.9%) were small for gestational age. Among 125 singleton full-term infants, 4 (3.2%) had low birth weights. Overall, 20 infants had congenital anomalies confirmed, 7 (4.4%) of whom had 1 major defect. No pattern of anomalies was observed.Conclusions: To date, proportions of major congenital anomalies, prematurity, low birth weight, and small size for gestational age observed in the EXPECT registry are not inconsistent with findings from other studies in this asthma population. Recognizing the small sample size available, no apparent increased birth prevalence of major anomalies or patterns of major anomalies has been observed.