title: The Xolair Pregnancy Registry (EXPECT): the safety of omalizumab use during pregnancy.
abstract: 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.
authors.affiliation: Scripps Clinic, La Jolla, Calif. Electronic address: janamazy@me.com.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Namazy
authors.affiliation: Department of Pediatrics, University of California, San Francisco, Calif.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Cabana
authors.affiliation: Tesserae Genetics, Dallas, Tex.
authors.forename: Angela E
authors.initials: AE
authors.lastname: Scheuerle
authors.affiliation: School of Medicine, University of North Carolina, Chapel Hill, NC.
authors.forename: John M
authors.initials: JM
authors.lastname: Thorp
authors.affiliation: Genentech, Inc, South San Francisco, Calif.
authors.forename: Hubert
authors.initials: H
authors.lastname: Chen
authors.affiliation: Genentech, Inc, South San Francisco, Calif.
authors.forename: Gillis
authors.initials: G
authors.lastname: Carrigan
authors.affiliation: Genentech, Inc, South San Francisco, Calif.
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Genentech, Inc, South San Francisco, Calif.
authors.forename: Joachim
authors.initials: J
authors.lastname: Veith
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC.
authors.forename: Elizabeth B
authors.initials: EB
authors.lastname: Andrews
mesh_terms: D000293:Adolescent; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000888:Antibodies, Anti-Idiotypic / Q000008:administration & dosage / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects*; D000013:Congenital Abnormalities / Q000453:epidemiology; D005260:Female; D005865:Gestational Age; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018811:Maternal Exposure; D008875:Middle Aged; D000069444:Omalizumab; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000453:epidemiology*; D011297:Prenatal Exposure Delayed Effects / Q000453:epidemiology*; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab
keywords: Omalizumab; moderate-to-severe persistent allergic asthma; pregnancy