TY - JOUR
T1 - Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort
AU - Namazy, Jennifer A.
AU - Blais, Lucie
AU - Andrews, Elizabeth B.
AU - Scheuerle, Angela E.
AU - Cabana, Michael D.
AU - Thorp, John M.
AU - Umetsu, Dale T.
AU - Veith, Joachim H.
AU - Sun, Diana
AU - Kaufman, Derrick G.
AU - Covington, Deborah L.
AU - Mukhopadhyay, Santanu
AU - Fogel, Robert B.
AU - Lopez-Leon, Sandra
AU - Spain, C. Victor
N1 - Funding Information:
Supported by Genentech.Disclosure of potential conflict of interest: J. A. Namazy has received travel support, fees for participation in review activities, consulting fees, and payment for writing the manuscript from Genentech. L. Blais received a research contract and personal fees from Genentech for this study and research grants, contracts, or personal fees from AstraZeneca and TEVA outside the submitted work. E. B. Andrews' employer, RTI Health Solutions, received consulting fees from Gententech for her consultation. A. E. Scheurle has received fees as a paid consultant to the EXPECT pregnancy registry from Genentech. M. D. Cabana has received fees for participation in review activities from Genentech and Novartis and is a member of the US Preventive Services Task Force (USPSTF). D. T. Umetsu was previously employed by Genentech and owns stock and stock options in Roche/Genentech. J. H. Veith was previously employed by Genentech and owns stock and stock options in Roche/Genentech. D. Sun is employed by Genentech and owns stock and stock options in Roche/Genentech. D. G. Kaufman is employed by Genentech and owns stock and stock options in Roche/Genentech. D. L. Covington is an employee of Evidera, a PPD Company, which was contracted by Genentech to conduct the EXPECT pregnancy registry and write the manuscript. S. Mukhopadhyay is an employee of and owns stock in Novartis Pharmaceuticals Corporation. R. B. Fogel is an employee of and owns stock in Novartis Pharmaceuticals. S. Lopez-Leon is an employee of and owns stock in Novartis Pharmaceuticals. C. V. Spain is employed by Genentech and owns stock and stock options in Roche/Genentech. J. M. Thorp declares that he has no relevant conflicts of interest.
Publisher Copyright:
© 2019 The Authors
PY - 2020/2
Y1 - 2020/2
N2 - 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.
AB - 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.
KW - Omalizumab
KW - congenital anomalies
KW - moderate to severe asthma
KW - pregnancy
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U2 - 10.1016/j.jaci.2019.05.019
DO - 10.1016/j.jaci.2019.05.019
M3 - Article
C2 - 31145939
AN - SCOPUS:85067703052
SN - 0091-6749
VL - 145
SP - 528-536.e1
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 2
ER -