奥马珠单抗妊娠登记和疾病匹配的对照队列中的妊娠结局
2021/04/23
摘要
背景：EXPECT妊娠登记是建立于2006年的怀孕期间使用奥马珠单抗（茁乐）的前瞻性观察性研究，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：该分析比较了预期结果与疾病匹配人群中未接受奥马珠单抗治疗孕妇的预期结果。还提供了来自新生儿血小板计数的子研究数据。
方法：EXPECT研究纳入了250例妊娠期暴露于奥马珠单抗的哮喘女性。使用来自加拿大魁北克省医疗保健数据库的数据创建了疾病匹配的中度至重度哮喘女性外部比较队列（n=1153），称为魁北克外部比较队列（QECC）。结果估计是根据EXPECT研究中产妇年龄分布进行年龄调整的。
结果：在EXPECT研究中的单胎婴儿中，主要先天性异常的患病率为8.1%，与QECC中的8.9%相似。在EXPECT研究中，99.1%的妊娠结果是活胎，这与QECC中的99.3%相似。15%的预期婴儿和11.3%的QECC中发现了早产。在9.7%的预期婴儿和15.8%的QECC中发现了小于胎龄儿。
结论：与疾病匹配的未暴露队列相比，没有证据表明暴露于奥马珠单抗的孕妇发生主要先天性异常的风险增加。然而，考虑到本注册研究的观察性质，无法确定奥马珠单抗的风险没有增加。
Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort
Jennifer A Namazy , Lucie Blais , Elizabeth B Andrews, Angela E Scheuerle , Michael D Cabana, John M Thorp , Dale T Umetsu, Joachim H Veith, Diana Sun, Derrick G Kaufman, Deborah L Covington, Santanu Mukhopadhyay, Robert B Fogel , Sandra Lopez-Leon , C Victor Spain
Abstract
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.
背景：EXPECT妊娠登记是建立于2006年的怀孕期间使用奥马珠单抗（茁乐）的前瞻性观察性研究，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：该分析比较了预期结果与疾病匹配人群中未接受奥马珠单抗治疗孕妇的预期结果。还提供了来自新生儿血小板计数的子研究数据。
方法：EXPECT研究纳入了250例妊娠期暴露于奥马珠单抗的哮喘女性。使用来自加拿大魁北克省医疗保健数据库的数据创建了疾病匹配的中度至重度哮喘女性外部比较队列（n=1153），称为魁北克外部比较队列（QECC）。结果估计是根据EXPECT研究中产妇年龄分布进行年龄调整的。
结果：在EXPECT研究中的单胎婴儿中，主要先天性异常的患病率为8.1%，与QECC中的8.9%相似。在EXPECT研究中，99.1%的妊娠结果是活胎，这与QECC中的99.3%相似。15%的预期婴儿和11.3%的QECC中发现了早产。在9.7%的预期婴儿和15.8%的QECC中发现了小于胎龄儿。
结论：与疾病匹配的未暴露队列相比，没有证据表明暴露于奥马珠单抗的孕妇发生主要先天性异常的风险增加。然而，考虑到本注册研究的观察性质，无法确定奥马珠单抗的风险没有增加。
(中日友好医院呼吸与危重症医学科 张清 摘译 林江涛 审校)
(J Allergy Clin Immunol . 2020 Feb;145(2):528-536.e1. doi: 10.1016/j.jaci.2019.05.019 .)
(J Allergy Clin Immunol . 2020 Feb;145(2):528-536.e1. doi: 10.1016/j.jaci.2019.05.019 .)
Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort
Jennifer A Namazy , Lucie Blais , Elizabeth B Andrews, Angela E Scheuerle , Michael D Cabana, John M Thorp , Dale T Umetsu, Joachim H Veith, Diana Sun, Derrick G Kaufman, Deborah L Covington, Santanu Mukhopadhyay, Robert B Fogel , Sandra Lopez-Leon , C Victor Spain
Abstract
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.
