Perinatal outcomes in pregnant women exposed to omalizumab: Interim results from a prospective, observational study
Namazy, J. A., Rahmaoui, A., Cabana, M. D., Scheuerle, A. E., Thorp, J. M., Carrigan, G., & Andrews, E. B. (2015). Perinatal outcomes in pregnant women exposed to omalizumab: Interim results from a prospective, observational study. In , p. AB1. .
Data regarding maternal and fetal outcomes for many asthma medications are insufficient.
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.
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 (
Given the small sample size and severity of maternal asthma, these pregnancy outcomes are not inconsistent with previous observations.