The Xolair Pregnancy Registry (EXPECT): The safety of omalizumab use during pregnancy - 05/02/15
, Michael D. Cabana, MD, MPH b, Angela E. Scheuerle, MD c, John M. Thorp, MD d, Hubert Chen, MD e, Gillis Carrigan, PhD e, Yan Wang, PhD e, Joachim Veith, MD e, Elizabeth B. Andrews, PhD fAbstract |
Background |
For many asthma medications, pregnancy safety data remains insufficient.
Objective |
The omalizumab pregnancy registry, EXPECT, evaluates maternal, pregnancy, and infant outcomes after exposure to omalizumab, including incidence of congenital anomalies.
Methods |
EXPECT is a prospective, observational study of pregnant women exposed to ≥1 dose of omalizumab within 8 weeks prior to conception or at any time during pregnancy. Primary outcome measures include rates of live births, elective terminations, stillbirths, and congenital anomalies. Data were collected at enrollment, each trimester, birth, and every 6 months up to 18 months post-delivery.
Results |
As of November 2012, 188 of 191 pregnant women were exposed to omalizumab during their first trimester. Of 169 pregnancies with known outcomes (median exposure during pregnancy, 8.8 months), there were 156 live births of 160 infants (4 twin pairs), 1 fetal death/stillbirth, 11 spontaneous abortions, and 1 elective termination. Among 152 singleton infants, 22 (14.5%) were born prematurely. Of 147 singleton infants with weight data, 16 (10.9%) were small for gestational age. Among 125 singleton full-term infants, 4 (3.2%) had low birth weights. Overall, 20 infants had congenital anomalies confirmed, 7 (4.4%) of whom had 1 major defect. No pattern of anomalies was observed.
Conclusions |
To date, proportions of major congenital anomalies, prematurity, low birth weight, and small size for gestational age observed in the EXPECT registry are not inconsistent with findings from other studies in this asthma population. Recognizing the small sample size available, no apparent increased birth prevalence of major anomalies or patterns of major anomalies has been observed.
Le texte complet de cet article est disponible en PDF.Key words : Omalizumab, pregnancy, moderate-to-severe persistent allergic asthma
Abbreviations used : HCP, ICS, LABA, MACDP, SGA, US, FDA
Plan
| This study was funded by Genentech, Inc. |
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| Disclosure of potential conflict of interest: J. Namazy has received travel support, fees for participation in review activities, consulting fees, and payment for writing the manuscript from Genentech. M. Cabana has received fees for participation in review activities from Genentech. A. Scheurle has received fees as a paid consultant to the EXPECT pregnancy registry from Genentech. H. Chen is employed by Genentech and has stock options with Roche. G. Carrigan is employed by and holds stock options with Roche/Genentech. Y. Wang is employed by Genentech. J. Veith has received travel support from, is employed by, and has stock options with Genentech. E. Andrews has received travel support, fees for participation in review activities, and consulting fees from Genentech. J. Thorp declares that he has no relevant conflicts of interest. |
Vol 135 - N° 2
P. 407-412 - février 2015 Retour au numéro
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