Perinatal outcomes in pregnant women exposed to omalizumab Interim results from a prospective, observational study
Rationale<br>Data regarding maternal and fetal outcomes for many asthma medications are insufficient.<br><br>Methods<br>EXPECT is an ongoing prospective, observational study of pregnant women exposed to ?1 dose of omalizumab within 8 weeks prior to conception or at any time during pregnancy. Data on mother and pregnancy/infant are collected at enrollment, each trimester of pregnancy, pregnancy outcome, and up to 18 months post-delivery. Maternal asthma severity is assessed by mother’s health provider. Data collected: rates of live births, spontaneous abortions, elective terminations, stillbirths, birth weight, gestational age, and congenital anomalies. Data are from an annual cumulative summary including September 29, 2006 -November 30, 2013.<br><br>Results<br>Of 207 prospectively enrolled pregnancies, outcomes from 186 pregnancies were reported. Asthma severity was available for 164 women: mild (4/164, 2.4%), moderate (55/164, 33.5%), severe (105/164, 64.0%). There were 174 live births of 178 infants (4 twin pairs), 8 spontaneous abortions, 2 fetal deaths/stillbirths and 2 elective terminations. Of 170 singleton infants, 24 (14.1%) were born prematurely (<37 weeks) and of these 3 (12.5%) were considered small for gestational age (SGA, weight <10thpercentile for gestational age). Of 140 singleton full-term infants with weight data, 4 (2.9%) had low birthweight (<2500 g) and 16 (11.4%) were considered SGA. Overall, 27 (15.2%) infants had confirmed congenital anomalies. Eleven (6.2%) infants had a major birth defect; omalizumab exposure occurred in the first trimester in all cases. No pattern of anomalies was observed.<br><br>Conclusions<br>Given the small sample size and severity of maternal asthma, these pregnancy outcomes are not inconsistent with previous observations.
Namazy, J. A., Rahmaoui, A., Cabana, M. D., Scheuerle, A. E., Thorp, J. M., Carrigan, G., & Andrews, E. (2015). Perinatal outcomes in pregnant women exposed to omalizumab: Interim results from a prospective, observational study. Journal of Allergy and Clinical Immunology, 135(2, Suppl), AB1. DOI: 10.1016/j.jaci.2014.12.936