XOLAIR has been shown to significantly reduce exacerbations in appropriate allergic asthma patients uncontrolled on inhaled corticosteroids (ICS).1
Multiple clinical studies were done to analyze the efficacy and safety of XOLAIR in 2 patient populations:
See additional information for patient baseline characteristics. Please see full safety information.
Study design for Studies 1 and 2: Identical 28-week, randomized, double-blind, placebo-controlled studies evaluating the number of exacerbations in a total of 1071 patients aged 12 to 76 years with moderate to severe persistent allergic asthma who were symptomatic despite ICS treatment.1,6,7
Patients received XOLAIR or placebo every 2 or 4 weeks for 16 weeks with an unchanged BDP dose unless an acute exacerbation necessitated an increase. Patients then entered a 12-week ICS-reduction phase during which ICS dose reduction was attempted in a stepwise manner.1,6
Primary endpoint: number of exacerbations.1,6
Study design for Study 3: A 32-week, randomized, double-blind, placebo-controlled study designed to evaluate ICS reduction in 341 patients aged 12 to 76 years with severe allergic asthma. Exacerbation reduction was also evaluated as a secondary endpoint; however, this study was not powered to show statistical differences in exacerbation reduction.1
Exacerbation was defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of the patient’s baseline ICS dose.
Patients were stratified by use of ICS only or ICS with concomitant OCS. Patients received XOLAIR for 16 weeks with an unchanged corticosteroid dose unless an acute exacerbation necessitated an increase. Patients then entered a 16-week ICS-reduction phase during which ICS dose reduction was attempted in a stepwise manner.1,5
In the ICS-stable phase:
In the ICS-reduction phase:
CI=confidence interval; FEV1=forced expiratory volume in 1 second; LABA=long-acting beta2-agonist; OCS=oral corticosteroids.
There were no differences in the incidence of adverse reactions based on age (among patients under 65), gender or race.
Limitations of these analyses of pooled data from Studies 1 and 2 include that they are post hoc (ie, not prespecified) and that the 95% confidence intervals were calculated within each investigated range of IgE levels, number of positive allergens, or eosinophil counts, which does not afford the ability to compare the subgroups to each other directly. These analyses do not allow the inference of any sort of trend with increasing IgE levels, number of positive allergens, or eosinophil counts, as no trend tests were performed.5,22
In these post hoc analyses, an asthma exacerbation was defined as the worsening of asthma requiring treatment with oral or intravenous corticosteroids for at least 3 days (adapted from 2009 American Thoracic Society/European Respiratory Society).24
BDP=beclomethasone dipropionate; SD=standard deviation; SE=standard error.
Study design: A 52-week, multicenter, randomized, double-blind, placebo-controlled study of 628 patients aged 6 to <12 years with moderate to severe allergic asthma evaluated XOLAIR as add-on therapy to ICS with or without additional controller medications. Patients received XOLAIR or placebo every 2 or 4 weeks for 24 weeks during the fixed-steroid treatment phase. Steroid doses remained constant from baseline unless an acute exacerbation necessitated an increase. Patients then entered a 28-week period during which steroid adjustment was allowed.1,25,26
Throughout the study, both groups were allowed to use additional controller medications, including inhaled and nebulized beta2-agonists and LTRA.25
Primary measure: rate of asthma exacerbations during the 24-week period.1
Exacerbation was defined as a worsening of asthma symptoms requiring doubling of baseline ICS dose for at least 3 days and/or treatment with rescue systemic corticosteroids for at least 3 days.1
—Global Initiative for Asthma (GINA), 2021 Guideline Update
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.
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