PREGNANCY REGISTRY DATA
PREGNANCY REGISTRY DATA
PREGNANCY REGISTRY DATA
See the breadth of efficacy data, click here.
Risk Summary4
The EXPECT study assessed perinatal outcomes in pregnant women and their infants who were exposed to XOLAIR. The analysis showed no increase in the rate of major birth defects or miscarriage with XOLAIR exposure during pregnancy.
There was an increased rate of low birth weight among registry infants compared to infants in the Quebec External Comparator Cohort (QECC), despite average gestational age at birth; however, women taking XOLAIR during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight was due to the drug or the disease severity.
Study design: EXPECT was a prospective cohort pregnancy exposure registry study conducted from 2006-2018 that included 250 women with asthma who were treated with XOLAIR. Of these, 246 patients were exposed to XOLAIR during the first trimester of pregnancy, and the median exposure duration was 8.7 months.
This analysis compares the final data from the EXPECT registry with findings from the QECC, a disease-matched population of pregnant women with moderate to severe asthma who were not treated with XOLAIR.4,34
The Quebec External Comparator Cohort (QECC)4,33
The registry findings for applicable mother and infant subgroups were compared to age-adjusted frequencies in a disease-matched external cohort. This cohort consisted of 1153 pregnant women with asthma (with no exposure to XOLAIR), who were identified from healthcare databases of residents in the Canadian province of Quebec, and referred to as the Quebec External Comparator Cohort.
246 women received XOLAIR in the
first trimester with a median
exposure of 8.7 months4
246 women received
XOLAIR in the
first trimester with a
median exposure of 8.7 months4
Study limitations
The registry study could not definitively establish the absence of any risk because of methodological limitations, including the observational nature of the registry, the small sample size, and potential differences between the registry population and the comparator cohort.
Clinical Considerations4
Disease-associated maternal and/or embryo-fetal risk
In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother. Neonates have an increased risk of prematurity, low birth weight, and being small for gestational age. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.
There are risks associated with poorly or moderately
controlled asthma in pregnancy4
The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.4,33
The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.4,34
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Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study [published correction appears in J Invest Dermatol. 2015;135(3):925]. J Invest Dermatol. 2015;135(1):67-75.
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XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation.
XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation.
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Data on file. Genentech USA, Inc. South San Francisco, CA.
Data on file. Genentech USA, Inc. South San Francisco, CA.
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