The Xolair Pregnancy Registry (EXPECT): The safety of omalizumab use during pregnancy

Jennifer Namazy, Michael D. Cabana, Angela E. Scheuerle, John M. Thorp, Hubert Chen, Gillis Carrigan, Yan Wang, Joachim Veith, Elizabeth B. Andrews

Research output: Contribution to journalArticle

78 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)407-412
Number of pages6
JournalJournal of Allergy and Clinical Immunology
Volume135
Issue number2
DOIs
StatePublished - Feb 1 2015

Fingerprint

Registries
Safety
Pregnancy
Stillbirth
Live Birth
Low Birth Weight Infant
Gestational Age
Pregnant Women
Asthma
Parturition
Fetal Death
Spontaneous Abortion
First Pregnancy Trimester
Pregnancy Outcome
Sample Size
Observational Studies
Omalizumab
Mothers
Outcome Assessment (Health Care)
Prospective Studies

Keywords

  • moderate-to-severe persistent allergic asthma
  • Omalizumab
  • pregnancy

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Medicine(all)

Cite this

The Xolair Pregnancy Registry (EXPECT) : The safety of omalizumab use during pregnancy. / Namazy, Jennifer; Cabana, Michael D.; Scheuerle, Angela E.; Thorp, John M.; Chen, Hubert; Carrigan, Gillis; Wang, Yan; Veith, Joachim; Andrews, Elizabeth B.

In: Journal of Allergy and Clinical Immunology, Vol. 135, No. 2, 01.02.2015, p. 407-412.

Research output: Contribution to journalArticle

Namazy, J, Cabana, MD, Scheuerle, AE, Thorp, JM, Chen, H, Carrigan, G, Wang, Y, Veith, J & Andrews, EB 2015, 'The Xolair Pregnancy Registry (EXPECT): The safety of omalizumab use during pregnancy', Journal of Allergy and Clinical Immunology, vol. 135, no. 2, pp. 407-412. https://doi.org/10.1016/j.jaci.2014.08.025
Namazy, Jennifer ; Cabana, Michael D. ; Scheuerle, Angela E. ; Thorp, John M. ; Chen, Hubert ; Carrigan, Gillis ; Wang, Yan ; Veith, Joachim ; Andrews, Elizabeth B. / The Xolair Pregnancy Registry (EXPECT) : The safety of omalizumab use during pregnancy. In: Journal of Allergy and Clinical Immunology. 2015 ; Vol. 135, No. 2. pp. 407-412.
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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.",
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N2 - 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.

AB - 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.

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