Risk Summary1
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.1,29
The Quebec External Comparator Cohort (QECC)1,29
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.
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 Considerations1
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.
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.1,29
XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation; 2021.
XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation; 2021.
Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016;116(1):37-42.
Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016;116(1):37-42.
Allergens and allergic asthma. Asthma and Allergy Foundation of America. Accessed August 11, 2021. https://www.aafa.org/allergic-asthma/
Allergens and allergic asthma. Asthma and Allergy Foundation of America. Accessed August 11, 2021. https://www.aafa.org/allergic-asthma/
World Health Organization. Prevention of allergy and allergic asthma. Based on the WHO/WAO meeting on the prevention of allergy and allergic asthma; January 8-9, 2002; Geneva, Switzerland.
World Health Organization. Prevention of allergy and allergic asthma. Based on the WHO/WAO meeting on the prevention of allergy and allergic asthma; January 8-9, 2002; Geneva, Switzerland.
Data on file. Genentech USA, Inc. South San Francisco, CA.
Data on file. Genentech USA, Inc. South San Francisco, CA.
Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-lgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184-190.
Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-lgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184-190.
Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001;18(2):254-261.
Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001;18(2):254-261.
Chipps BE, Zeiger RS, Luskin AT, et al. Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO. Ann Allergy Asthma Immunol. 2017;119(6):524-532.e2.
Chipps BE, Zeiger RS, Luskin AT, et al. Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO. Ann Allergy Asthma Immunol. 2017;119(6):524-532.e2.
Ledford DK, Lockey RF. Asthma and comorbidities. Curr Opin Allergy Clin Immunol. 2013;13(1):78-86.
Ledford DK, Lockey RF. Asthma and comorbidities. Curr Opin Allergy Clin Immunol. 2013;13(1):78-86.
Comberiati P, McCormack K, Malka-Rais J, Spahn JD. Proportion of severe asthma patients eligible for mepolizumab therapy by age and age of onset of asthma. J Allergy Clin Immunol Pract. 2019;7(8):2689-2696.e2.
Comberiati P, McCormack K, Malka-Rais J, Spahn JD. Proportion of severe asthma patients eligible for mepolizumab therapy by age and age of onset of asthma. J Allergy Clin Immunol Pract. 2019;7(8):2689-2696.e2.
Castillo JR, Peters SP, Busse WW. Asthma exacerbations: pathogenesis, prevention, and treatment. J Allergy Clin Immunol Pract. 2017;5(4):918-927.
Castillo JR, Peters SP, Busse WW. Asthma exacerbations: pathogenesis, prevention, and treatment. J Allergy Clin Immunol Pract. 2017;5(4):918-927.
Eguiluz-Gracia I, Layhadi JA, Rondon C, Shamji MH. Mucosal IgE immune responses in respiratory diseases. Curr Opin Pharmacol. 2019;46:100-107.
Eguiluz-Gracia I, Layhadi JA, Rondon C, Shamji MH. Mucosal IgE immune responses in respiratory diseases. Curr Opin Pharmacol. 2019;46:100-107.
Gould HJ, Sutton BJ. IgE in allergy and asthma today. Nat Rev Immunol. 2008;8(3):205-217.
Gould HJ, Sutton BJ. IgE in allergy and asthma today. Nat Rev Immunol. 2008;8(3):205-217.
Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med. 2012;18(5):693-704.
Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med. 2012;18(5):693-704.
Akdis CA, Arkwright PD, Brüggen M-C, et al. Type 2 immunity in the skin and lungs. Allergy. 2020;75(7):1582-1605.
Akdis CA, Arkwright PD, Brüggen M-C, et al. Type 2 immunity in the skin and lungs. Allergy. 2020;75(7):1582-1605.
Siles RI, Hsieh FH. Allergy blood testing: a practical guide for clinicians. Cleve Clin J Med. 2011;78(9):585-592. doi:10.3949/ccjm.78a.11023.
Siles RI, Hsieh FH. Allergy blood testing: a practical guide for clinicians. Cleve Clin J Med. 2011;78(9):585-592. doi:10.3949/ccjm.78a.11023.
National Heart, Lung, and Blood Institute of Health; 2007. NIG publication 07-4051.
National Heart, Lung, and Blood Institute of Health; 2007. NIG publication 07-4051.
Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008;100(3)(Suppl 3):S1-S148.
Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008;100(3)(Suppl 3):S1-S148.
Akar-Ghibril N, Casale T, Custovic A, Phipatanakul W. Clinical management review: allergic endotypes and phenotypes of asthma. J Allergy Clin Immunol Pract. 2020;8:429-440.
Akar-Ghibril N, Casale T, Custovic A, Phipatanakul W. Clinical management review: allergic endotypes and phenotypes of asthma. J Allergy Clin Immunol Pract. 2020;8:429-440.
Sonora Quest Laboratories. Test Interpretation and Management Options—Utilizing ImmunoCAP®’ KU/L Results. https://www.sonoraquest.com/media/2315/immunocap-ref-range_test-menu_0318.pdf. Accessed March 19, 2020.
Sonora Quest Laboratories. Test Interpretation and Management Options—Utilizing ImmunoCAP®’ KU/L Results. https://www.sonoraquest.com/media/2315/immunocap-ref-range_test-menu_0318.pdf. Accessed March 19, 2020.
Kerkhof M, Dubois AE, Postma DS, et al. Role and interpretation of total serum IgE measurements in the diagnosis of allergic airway disease in adults. Allergy. 2003;58(9):905-911.
Kerkhof M, Dubois AE, Postma DS, et al. Role and interpretation of total serum IgE measurements in the diagnosis of allergic airway disease in adults. Allergy. 2003;58(9):905-911.
Casale TB, Chipps BE, Rosén K, et al. Response to omalizumab using patient enrichment criteria from trials of novel biologics in asthma. Allergy. 2018;73(2):490-497.
Casale TB, Chipps BE, Rosén K, et al. Response to omalizumab using patient enrichment criteria from trials of novel biologics in asthma. Allergy. 2018;73(2):490-497.
Arbes SJ Jr, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to atopy: results from the Third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2007;120(5):1139-1145.
Arbes SJ Jr, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to atopy: results from the Third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2007;120(5):1139-1145.
Reddel HK, Taylor DR, Bateman ED, et al; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59-99.
Reddel HK, Taylor DR, Bateman ED, et al; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59-99.
Lanier B, Bridges T, Kulus M, et al. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.
Lanier B, Bridges T, Kulus M, et al. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.
Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2011;27(1):163-169.
Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2011;27(1):163-169.
Global Initiative for Asthma (GINA). What’s new in GINA 2021? GINA global strategy for asthma management and prevention.
Global Initiative for Asthma (GINA). What’s new in GINA 2021? GINA global strategy for asthma management and prevention.
Global Initiative for Asthma. Global strategy for asthma management and prevention, 2021.
Global Initiative for Asthma. Global strategy for asthma management and prevention, 2021.
Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. J All Clin Immunol. 2020;145(2):528-536.e1.
Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. J All Clin Immunol. 2020;145(2):528-536.e1.
Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day [press release]. Washington, DC: U.S. Census Bureau; December 30, 2013.
Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day [press release]. Washington, DC: U.S. Census Bureau; December 30, 2013.
Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report [published online November 17, 2010]. Allergy. 2011;66(3):317-330. doi:10.1111/j.1398-9995.2010.02496.x.
Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report [published online November 17, 2010]. Allergy. 2011;66(3):317-330. doi:10.1111/j.1398-9995.2010.02496.x.
Grattan CEH. Urticaria and angioedema. In: Bolognia JL, Jorizzo JL, Schaffer JV, eds. Dermatology. 3rd ed. Philadelphia, PA: Elsevier Saunders; 2012:291-306.
Grattan CEH. Urticaria and angioedema. In: Bolognia JL, Jorizzo JL, Schaffer JV, eds. Dermatology. 3rd ed. Philadelphia, PA: Elsevier Saunders; 2012:291-306.
Hoskin B, Ortiz B, Paknis B, Kavati A. Exploring the real-world profile of refractory and non-refractory chronic idiopathic urticaria in the USA: clinical burden and healthcare resource use. Curr Med Res Opin. 2019;35(8):1387-1395.
Hoskin B, Ortiz B, Paknis B, Kavati A. Exploring the real-world profile of refractory and non-refractory chronic idiopathic urticaria in the USA: clinical burden and healthcare resource use. Curr Med Res Opin. 2019;35(8):1387-1395.
Roche. FDA approves Xolair (omalizumab) for people with chronic idiopathic urticaria, a form of chronic hives. https://www.roche.com/media/releases/med-cor-2014-03-24.htm. March 2014. Accessed January 14, 2021.
Roche. FDA approves Xolair (omalizumab) for people with chronic idiopathic urticaria, a form of chronic hives. https://www.roche.com/media/releases/med-cor-2014-03-24.htm. March 2014. Accessed January 14, 2021.
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. doi:10.1038/jid.2014.512]. J Invest Dermatol. 2015;135(1):67-75. doi:10.1038/jid.2014.306.
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. doi:10.1038/jid.2014.512]. J Invest Dermatol. 2015;135(1):67-75. doi:10.1038/jid.2014.306.
US Department of Health and Human Services. Determination that astemizole 10-milligram tablets were withdrawn from sale for safety reasons. Federal Register. 1999;64(162):45973-45974.
US Department of Health and Human Services. Determination that astemizole 10-milligram tablets were withdrawn from sale for safety reasons. Federal Register. 1999;64(162):45973-45974.
XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation; 2021.
XOLAIR [prescribing information]. Genentech USA, Inc. and Novartis Pharmaceuticals Corporation; 2021.
Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016;116(1):37-42.
Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016;116(1):37-42.
Allergens and allergic asthma. Asthma and Allergy Foundation of America. Accessed August 11, 2021. https://www.aafa.org/allergic-asthma/
Allergens and allergic asthma. Asthma and Allergy Foundation of America. Accessed August 11, 2021. https://www.aafa.org/allergic-asthma/
World Health Organization. Prevention of allergy and allergic asthma. Based on the WHO/WAO meeting on the prevention of allergy and allergic asthma; January 8-9, 2002; Geneva, Switzerland.
World Health Organization. Prevention of allergy and allergic asthma. Based on the WHO/WAO meeting on the prevention of allergy and allergic asthma; January 8-9, 2002; Geneva, Switzerland.
Data on file. Genentech USA, Inc. South San Francisco, CA.
Data on file. Genentech USA, Inc. South San Francisco, CA.
Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-lgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184-190.
Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-lgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184-190.
Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001;18(2):254-261.
Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001;18(2):254-261.
Chipps BE, Zeiger RS, Luskin AT, et al. Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO. Ann Allergy Asthma Immunol. 2017;119(6):524-532.e2.
Chipps BE, Zeiger RS, Luskin AT, et al. Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO. Ann Allergy Asthma Immunol. 2017;119(6):524-532.e2.
Ledford DK, Lockey RF. Asthma and comorbidities. Curr Opin Allergy Clin Immunol. 2013;13(1):78-86.
Ledford DK, Lockey RF. Asthma and comorbidities. Curr Opin Allergy Clin Immunol. 2013;13(1):78-86.
Comberiati P, McCormack K, Malka-Rais J, Spahn JD. Proportion of severe asthma patients eligible for mepolizumab therapy by age and age of onset of asthma. J Allergy Clin Immunol Pract. 2019;7(8):2689-2696.e2.
Comberiati P, McCormack K, Malka-Rais J, Spahn JD. Proportion of severe asthma patients eligible for mepolizumab therapy by age and age of onset of asthma. J Allergy Clin Immunol Pract. 2019;7(8):2689-2696.e2.
Castillo JR, Peters SP, Busse WW. Asthma exacerbations: pathogenesis, prevention, and treatment. J Allergy Clin Immunol Pract. 2017;5(4):918-927.
Castillo JR, Peters SP, Busse WW. Asthma exacerbations: pathogenesis, prevention, and treatment. J Allergy Clin Immunol Pract. 2017;5(4):918-927.
Eguiluz-Gracia I, Layhadi JA, Rondon C, Shamji MH. Mucosal IgE immune responses in respiratory diseases. Curr Opin Pharmacol. 2019;46:100-107.
Eguiluz-Gracia I, Layhadi JA, Rondon C, Shamji MH. Mucosal IgE immune responses in respiratory diseases. Curr Opin Pharmacol. 2019;46:100-107.
Gould HJ, Sutton BJ. IgE in allergy and asthma today. Nat Rev Immunol. 2008;8(3):205-217.
Gould HJ, Sutton BJ. IgE in allergy and asthma today. Nat Rev Immunol. 2008;8(3):205-217.
Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med. 2012;18(5):693-704.
Galli SJ, Tsai M. IgE and mast cells in allergic disease. Nat Med. 2012;18(5):693-704.
Akdis CA, Arkwright PD, Brüggen M-C, et al. Type 2 immunity in the skin and lungs. Allergy. 2020;75(7):1582-1605.
Akdis CA, Arkwright PD, Brüggen M-C, et al. Type 2 immunity in the skin and lungs. Allergy. 2020;75(7):1582-1605.
Siles RI, Hsieh FH. Allergy blood testing: a practical guide for clinicians. Cleve Clin J Med. 2011;78(9):585-592. doi:10.3949/ccjm.78a.11023.
Siles RI, Hsieh FH. Allergy blood testing: a practical guide for clinicians. Cleve Clin J Med. 2011;78(9):585-592. doi:10.3949/ccjm.78a.11023.
National Heart, Lung, and Blood Institute of Health; 2007. NIG publication 07-4051.
National Heart, Lung, and Blood Institute of Health; 2007. NIG publication 07-4051.
Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008;100(3)(Suppl 3):S1-S148.
Bernstein IL, Li JT, Bernstein DI, et al. Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008;100(3)(Suppl 3):S1-S148.
Akar-Ghibril N, Casale T, Custovic A, Phipatanakul W. Clinical management review: allergic endotypes and phenotypes of asthma. J Allergy Clin Immunol Pract. 2020;8:429-440.
Akar-Ghibril N, Casale T, Custovic A, Phipatanakul W. Clinical management review: allergic endotypes and phenotypes of asthma. J Allergy Clin Immunol Pract. 2020;8:429-440.
Sonora Quest Laboratories. Test Interpretation and Management Options—Utilizing ImmunoCAP®’ KU/L Results. https://www.sonoraquest.com/media/
2315/immunocap-ref-range_test-menu_0318.pdf.
Accessed March 19, 2020.
Sonora Quest Laboratories. Test Interpretation and Management Options—Utilizing ImmunoCAP®’ KU/L Results. https://www.sonoraquest.com/media/
2315/immunocap-ref-range_test-menu_0318.pdf.
Accessed March 19, 2020.
Kerkhof M, Dubois AE, Postma DS, et al. Role and interpretation of total serum IgE measurements in the diagnosis of allergic airway disease in adults. Allergy. 2003;58(9):905-911.
Kerkhof M, Dubois AE, Postma DS, et al. Role and interpretation of total serum IgE measurements in the diagnosis of allergic airway disease in adults. Allergy. 2003;58(9):905-911.
Casale TB, Chipps BE, Rosén K, et al. Response to omalizumab using patient enrichment criteria from trials of novel biologics in asthma. Allergy. 2018;73(2):490-497.
Casale TB, Chipps BE, Rosén K, et al. Response to omalizumab using patient enrichment criteria from trials of novel biologics in asthma. Allergy. 2018;73(2):490-497.
Arbes SJ Jr, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to atopy: results from the Third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2007;120(5):1139-1145.
Arbes SJ Jr, Gergen PJ, Vaughn B, Zeldin DC. Asthma cases attributable to atopy: results from the Third National Health and Nutrition Examination Survey. J Allergy Clin Immunol. 2007;120(5):1139-1145.
Reddel HK, Taylor DR, Bateman ED, et al; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59-99.
Reddel HK, Taylor DR, Bateman ED, et al; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009;180(1):59-99.
Lanier B, Bridges T, Kulus M, et al. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.
Lanier B, Bridges T, Kulus M, et al. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210-1216.
Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2011;27(1):163-169.
Milgrom H, Fowler-Taylor A, Vidaurre CF, Jayawardene S. Safety and tolerability of omalizumab in children with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2011;27(1):163-169.
Global Initiative for Asthma (GINA). What’s new in GINA 2021? GINA global strategy for asthma management and prevention.
Global Initiative for Asthma (GINA). What’s new in GINA 2021? GINA global strategy for asthma management and prevention.
Global Initiative for Asthma. Global strategy for asthma management and prevention, 2021.
Global Initiative for Asthma. Global strategy for asthma management and prevention, 2021.
Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. J All Clin Immunol. 2020;145(2):528-536.e1.
Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. J All Clin Immunol. 2020;145(2):528-536.e1.
Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day [press release]. Washington, DC: U.S. Census Bureau; December 30, 2013.
Census Bureau Projects U.S. Population of 317.3 Million on New Year's Day [press release]. Washington, DC: U.S. Census Bureau; December 30, 2013.
Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report [published online November 17, 2010]. Allergy. 2011;66(3):317-330. doi:10.1111/j.1398-9995.2010.02496.x.
Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report [published online November 17, 2010]. Allergy. 2011;66(3):317-330. doi:10.1111/j.1398-9995.2010.02496.x.
Grattan CEH. Urticaria and angioedema. In: Bolognia JL, Jorizzo JL, Schaffer JV, eds. Dermatology. 3rd ed. Philadelphia, PA: Elsevier Saunders; 2012:291-306.
Grattan CEH. Urticaria and angioedema. In: Bolognia JL, Jorizzo JL, Schaffer JV, eds. Dermatology. 3rd ed. Philadelphia, PA: Elsevier Saunders; 2012:291-306.
Hoskin B, Ortiz B, Paknis B, Kavati A. Exploring the real-world profile of refractory and non-refractory chronic idiopathic urticaria in the USA: clinical burden and healthcare resource use. Curr Med Res Opin. 2019;35(8):1387-1395.
Hoskin B, Ortiz B, Paknis B, Kavati A. Exploring the real-world profile of refractory and non-refractory chronic idiopathic urticaria in the USA: clinical burden and healthcare resource use. Curr Med Res Opin. 2019;35(8):1387-1395.
Roche. FDA approves Xolair (omalizumab) for people with chronic idiopathic urticaria, a form of chronic hives. https://www.roche.com/media/releases/med-cor-2014-03-24.htm. March 2014. Accessed January 14, 2021.
Roche. FDA approves Xolair (omalizumab) for people with chronic idiopathic urticaria, a form of chronic hives. https://www.roche.com/media/releases/med-cor-2014-03-24.htm. March 2014. Accessed January 14, 2021.
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. doi:10.1038/jid.2014.512]. J Invest Dermatol. 2015;135(1):67-75. doi:10.1038/jid.2014.306.
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. doi:10.1038/jid.2014.512]. J Invest Dermatol. 2015;135(1):67-75. doi:10.1038/jid.2014.306.
US Department of Health and Human Services. Determination that astemizole 10-milligram tablets were withdrawn from sale for safety reasons. Federal Register. 1999;64(162):45973-45974.
US Department of Health and Human Services. Determination that astemizole 10-milligram tablets were withdrawn from sale for safety reasons. Federal Register. 1999;64(162):45973-45974.
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