BACKGROUND The Observational Study of the Use and Safety of Xolair (omalizumab) during Pregnancy (EXPECT) pregnancy registry was a prospective observational study established in 2006 to evaluate perinatal outcomes in pregnant women exposed to omalizumab and their infants. OBJECTIVE This analysis compares EXPECT outcomes with those from a disease-matched population of pregnant women not treated with omalizumab. Data from a substudy of platelet counts among newborns are also presented. METHODS The EXPECT study enrolled 250 women with asthma exposed to omalizumab during pregnancy. The disease-matched external comparator cohort of women with moderate-to-severe asthma (n = 1153), termed the Quebec External Comparator Cohort (QECC), was created by using data from health care databases in Quebec, Canada. Outcome estimates were age adjusted based on the maternal age distribution of the EXPECT study. RESULTS Among singleton infants in the EXPECT study, the prevalence of major congenital anomalies was 8.1%, which was similar to the 8.9% seen in the QECC. In the EXPECT study 99.1% of pregnancies resulted in live births, which was similar to 99.3% in the QECC. Premature birth was identified in 15.0% of EXPECT infants and 11.3% in the QECC. Small for gestational age was identified in 9.7% of EXPECT infants and 15.8% in the QECC. CONCLUSION There was no evidence of an increased risk of major congenital anomalies among pregnant women exposed to omalizumab compared with a disease-matched unexposed cohort. Given the observational nature of this registry, however, an absence of increased risk with omalizumab cannot be definitively established.

中文翻译：

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omalizumab妊娠登记和疾病匹配的比较者队列中的妊娠结局。

背景技术Xolair（奥马珠单抗）孕期使用和安全性的观察研究（EXPECT）是一项前瞻性观察性研究，于2006年建立，旨在评估暴露于奥马珠单抗的孕妇及其婴儿的围产期结局。目的本分析将EXPECT结果与未接受奥马珠单抗治疗的疾病匹配孕妇群体的结果进行了比较。还提供了新生儿血小板计数子研究的数据。方法EXPECT研究招募了250名在妊娠期间暴露于奥马珠单抗的哮喘妇女。通过使用加拿大魁北克省医疗保健数据库中的数据，创建了与疾病匹配的患有中度至重度哮喘（n = 1153）的女性的外部比较者队列，称为魁北克外部比较者队列（QECC）。根据EXPECT研究的孕产妇年龄分布对结果估计值进行年龄调整。结果在EXPECT研究中，单胎婴儿的主要先天性异常患病率为8.1％，与QECC中的8.9％相似。在EXPECT研究中，有99.1％的怀孕是活产，这与QECC中的99.3％相似。在EXPECT婴儿中有15.0％的婴儿早产，而在QECC中则有11.3％的婴儿早产。9.7％的EXPECT婴儿和QECC的15.8％胎龄较小。结论没有证据表明与疾病匹配的未暴露人群相比，暴露于奥马珠单抗的孕妇发生重大先天性异常的风险增加。但是，鉴于该注册资料的观察性质，不能确切确定没有奥马珠单抗增加的风险。