Omalizumab therapy for children and adolescents with severe allergic asthma

References

• Jackson DJ, Hartert TV, Martinez FD, et al. Asthma: NHLBI workshop on the primary prevention of chronic lung diseases. Ann Am Thorac Soc 2014;11(Suppl 3):S139-45
   Google Scholar
• Fanta CH. Asthma. N Engl J Med 2009;360:1002-14
   PubMed Web of Science ®Google Scholar
• Global initiative for asthma (GINA). The global strategy for asthma management and prevention. 2011. Available from: www.ginasthma.org [Last accessed 19 June 2015]
   Google Scholar
• Novak N, Bieber T. Allergic and nonallergic forms of atopic diseases. J Allergy Clin Immunol 2003;112:252-62
   PubMed Web of Science ®Google Scholar
• Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014;43:343-73
   PubMed Web of Science ®Google Scholar
• National heart, Lung, and blood institute, National Institutes of Health. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. US. Department of Health and Human Services, Washington, DC; 2007. Accessible from www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines [Last accessed 19 June 2015]
   Google Scholar
• Dullaers M, De Bruyne R, Ramadani F, et al. The who, where, and when of IgE in allergic airway disease. J Allergy Clin Immunol 2012;129:635-45
   PubMed Web of Science ®Google Scholar
• Holgate ST. Innate and adaptive immune responses in asthma. Nat Med 2012;18:673-83
   PubMed Web of Science ®Google Scholar
• Licari A, Marseglia GL, Castagnoli R, et al. The discovery and development of omalizumab for the treatment of asthma. Expert Opin Drug Discov 2015. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• Incorvaia C, Mauro M, Russello M, et al. Omalizumab, an anti-immunoglobulin E antibody: state of the art. Drug Des Devel Ther 2014;8:197-207
   PubMed Web of Science ®Google Scholar
• Chang TW. The pharmacological basis of anti-IgE therapy. Nat Biotechnol 2000;18:157-62
   PubMed Web of Science ®Google Scholar
• Holgate S, Casale T, Wenzel S, et al. The anti-inflammatory effects of omalizumab confirm the central role of IgE in allergic inflammation. J Allergy Clin Immunol 2005;115:459-65
   PubMed Web of Science ®Google Scholar
• Beck LA, Marcotte GV, MacGlashan D, et al. Omalizumab-induced reductions in mast cell FcϵRI expression and function. J Allergy Clin Immunol 2004;114:527-30
   PubMed Web of Science ®Google Scholar
• Prussin C, Griffith DT, Boesel KM, et al. Omalizumab treatment downregulates dendritic cell FcϵRI expression. J Allergy Clin Immunol 2003;112:1147-54
   PubMed Web of Science ®Google Scholar
• Romano C, Sellitto A, De Fanis U, et al. Maintenance of remission with low-dose omalizumab in long-lasting, refractory chronic urticaria. Ann Allergy Asthma Immunol 2010;104:95-7
   PubMed Web of Science ®Google Scholar
• Romano C, Sellitto A, De Fanis U, et al. Omalizumab for difficult-to-treat dermatological conditions: clinical and immunological features from a retrospective real-life experience. Clin Drug Investig 2015;35:159-68
   PubMed Web of Science ®Google Scholar
• Chang TW, Chen C, Lin CJ, et al. The potential pharmacologic mechanisms of omalizumab in patients with chronic spontaneous urticaria. J Allergy Clin Immunol 2015;135:337-42
   PubMed Web of Science ®Google Scholar
• Fahy JV, Fleming HE, Wong HH, et al. The effect of an anti-IgE monoclonal antibody on the early- and late-phase responses to allergen inhalation in asthmatic subjects. Am J Respir Crit Care Med 1997;155:1828-34
   PubMed Web of Science ®Google Scholar
• Boulet LP, Chapman KR, Coté J, et al. Inhibitory effects of an anti-IgE antibody E25 on allergen-induced early asthmatic response. Am J Respir Crit Care Med 1997;155:1835-40
   PubMed Web of Science ®Google Scholar
• Xolair pharmacology review. Available from: www.fda.gov/downloads/Drugs/DevelopmentApprovalPrecess/DevelopmentResources/UCM202181.pdf [Last accessed 19 June 2015]
   Google Scholar
• Xolair Prescribing Information – Genentech. Available from: www.gene.com/download/pdf/xolair_prescribing.pdf [Last accessed 19 June 2015]
   Google Scholar
• Xolair. INN-omalizumab – European Medicines Agency – Europa. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000606/WC500057298.pdf [Last accessed 19 Jun 2015]
   Google Scholar
• Holgate ST, Chuchalin AG, Hebert J, et al. Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy 2004;34:632-8
   PubMed Web of Science ®Google Scholar
• Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol 2001;108:184-90
   PubMed Web of Science ®Google Scholar
• Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Resp J 2001;18:254-61
   PubMed Web of Science ®Google Scholar
• Ayres JG, Higgins B, Chilvers ER, et al. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma. Allergy 2004;59:701-8
   PubMed Web of Science ®Google Scholar
• Bousquet J, Cabrera P, Berkman N, et al. The effect of treatment with omalizumab, an anti-IgE antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent asthma. Allergy 2005;60:302-8
   PubMed Web of Science ®Google Scholar
• Humbert M, Beasley R, Ayres J, et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy 2005;60:309-16
   PubMed Web of Science ®Google Scholar
• Hanania NA, Alpan O, Hamilos DL, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy. Ann Intern Med 2011;154:573-82
   PubMed Web of Science ®Google Scholar
• Brusselle G, Michils A, Louis R, et al. ‘Real-life’ effectiveness of omalizumab in patients with severe persistent allergic asthma: the PERSIST study. Respir Med 2009;103:1633-42
   PubMed Web of Science ®Google Scholar
• Braunstahl GJ, Chen CW, Maykut R, et al. The eXpeRience registry: the ‘real-world’ effectiveness of omalizumab in allergic asthma. Respir Med 2013;107:1141-51
   PubMed Web of Science ®Google Scholar
• Grimaldi-Bensouda L, Zureik M, Aubier M, et al. Does omalizumab make a difference to the real-life treatment of asthma exacerbations?: results from a large cohort of patients with severe uncontrolled asthma. Chest 2013;143:398-405
   PubMed Web of Science ®Google Scholar
• Corren J, Casale TB, Lanier B, et al. Safety and tolerability of omalizumab. Clin Exp Allergy 2009;39:788-97
   PubMed Web of Science ®Google Scholar
• Cox L, Lieberman P, Wallace D, et al. American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma & Immunology omalizumab-associated anaphylaxis joint task force follow-up report. J Allergy Clin Immunol 2011;128:210-12
   PubMed Web of Science ®Google Scholar
• Long AA, Rahmaoui A, Rothman KJ, et al. Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab. J Allergy Clin Immunol 2014;134:560-7
   PubMed Web of Science ®Google Scholar
• Cooper PJ, Ayre G, Martin C, et al. Geohelminth infections: a review of the role of IgE and assessment of potential risks of anti-IgE treatment. Allergy 2008;63:409-17
   PubMed Web of Science ®Google Scholar
• Lai T, Wang S, Xu Z, et al. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis. Sci Rep 2015;5:8191
   PubMed Web of Science ®Google Scholar
• Chipps BE, Zeiger RS, Dorenbaum A, et al. Assessment of asthma control and asthma exacerbations in the epidemiology and natural history of asthma: outcomes and treatment regimens (TENOR) observational cohort. Curr Respir Care Rep 2012;1:259-69
   PubMedGoogle Scholar
• Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics 2001;108:E36
   PubMed Web of Science ®Google Scholar
• Berger W, Gupta N, McAlary M, Fowler-Taylor A. Evaluation of long-term safety of the anti-IgE antibody, omalizumab, in children with allergic asthma. Ann Allergy Asthma Immunol 2003;91:182-8
   PubMed Web of Science ®Google Scholar
• 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;124:1210-16
   PubMed Web of Science ®Google Scholar
• Kulus M, Hebert J, Garcia E, et al. Omalizumab in children with inadequately controlled severe allergic (IgE-mediated) asthma. Curr Med Res Opin 2010;26:1285-93
   PubMed Web of Science ®Google Scholar
• Busse WW, Morgan WJ, Gergen PJ, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med 2011;364:1005-15
   PubMed Web of Science ®Google Scholar
• Massanari M, Milgrom H, Pollard S, et al. Adding omalizumab to the therapy of adolescents with persistent uncontrolled moderate-severe allergic asthma. Clin Pediatr 2009;48:859-65
   PubMed Web of Science ®Google Scholar
• Vignola AM, Humbert M, Bousquet J, et al. Efficacy and tolerability of anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy 2004;34:632-8
   PubMed Web of Science ®Google Scholar
• Rodrigo GJ, Neffen H. Systematic review on the use of omalizumab for the treatment of asthmatic children and adolescents. Pediatr Allergy Immunol 2015; Epub ahead of print
   PubMed Web of Science ®Google Scholar
• 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;27:163-9
   PubMed Web of Science ®Google Scholar
• Deschildre A, Marguet C, Salleron J, et al. Add-on omalizumab in children with severe allergic asthma: a 1-year real life survey. Eur Respir J 2013;42:1224-33
   PubMed Web of Science ®Google Scholar
• Deschildre A, Marguet C, Langlois C, et al. Real-life long-term omalizumab therapy in children with severe allergic asthma. Eur Respir J 2015; Epub ahead of print
   PubMed Web of Science ®Google Scholar
• NICE. Technology appraisal guidance TA278. Omalizumab for treating severe persistent allergic asthma. National Institute for Health and Care Excellence, London; 2013. Available from: http://guidance.nice.org.uk/TA/Published [Last accessed 19 June 2015]
   Google Scholar
• Molimard M, Mala L, Bourdeix I, Le Gros V. Observational study in severe asthmatic patients after discontinuation of omalizumab for good asthma control. Respir Med 2014;108:571-6
   PubMed Web of Science ®Google Scholar
• Busse WW, Trzaskoma B, Omachi TA, et al. Evaluating Xolair persistency of response after long-term therapy (XPORT). Am J Respir Crit Care Med 2014;189:A6576
   Web of Science ®Google Scholar
• Janson SL, Solari PG, Trzaskoma B, et al. Omalizumab adherence in an observational study of patients with moderate to severe allergic asthma. Ann Allergy Asthma Immunol 2015;114:516-21
   PubMed Web of Science ®Google Scholar
• Oba Y, Salzman GA. Cost-effectiveness analysis of omalizumab in adults and adolescents with moderate to severe allergic asthma. J Allergy Clin Immunol 2004;114:265-9
   PubMed Web of Science ®Google Scholar
• Canadian Agency for Drugs and Technologies in Health. Omalizumab treatment for adults and children with allergic asthma: a review of the clinical effectiveness, cost-effectiveness, and guidelines. Available from: https://www.cadth.ca/media/pdf/htis/mar-2015/RC0638%20Omalizumab%20Allergic%20Asthma%20Final.pdf [Last accessed 19 June 2015]
   Google Scholar
• Faria R, McKenna C, Palmer S. Optimizing the position and use of omalizumab for severe persistent allergic asthma using cost-effectiveness analysis. Value Health 2014;17:772-82
   PubMed Web of Science ®Google Scholar
• Levy AN, Garcia a Ruiz A, Garcia-Agua Soler N, Sanjuan MV. Cost-effectiveness of omalizumab in severe persistent asthma in Spain: a real-life perspective. J Asthma 2014;1-6
   Google Scholar
• Van Nooten F, Stern S, Braunstahl GJ, et al. Cost-effectiveness of omalizumab for uncontrolled allergic asthma in the Netherlands. J Med Econ 2013;16:342-8
   PubMedGoogle Scholar
• Morishima T, Ikai H, Imanaka Y. Cost-effectiveness analysis of omalizumab for the treatment of severe asthma in Japan and the value of responder prediction methods based on a multinational trial. Value in Health Regional Issues 2013;2:29-36. Available from: www.sciencedirect.com/science/article/pii/S2212109913000083
   Google Scholar
• Bousquet J, Rabe K, Humbert M, et al. Predicting and evaluating response to omalizumab in patients with severe allergic asthma. Respir Med 2007;101:1483-92
   PubMed Web of Science ®Google Scholar
• Hanania NA, Wenzel S, Rosèn K, et al. Exploring the effects of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med 2013;187:804-11
   PubMed Web of Science ®Google Scholar
• Sorkness CA, Wildfire JJ, Calatroni A, et al. Reassessment of omalizumab-dosing strategies and pharmacodynamics in inner-city children and adolescents. J Allergy Clin Immunol Pract 2013;1:163-71
   PubMed Web of Science ®Google Scholar
• Garcia G, Magnan A, Chiron R, et al. A proof-of-concept, randomized, controlled trial of omalizumab in patients with severe, difficult-to-control, nonatopic asthma. Chest 2013;144:411-19
   PubMed Web of Science ®Google Scholar
• Gevaert P, Calus L, Van Zele T, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol 2013;131:110-16
   PubMed Web of Science ®Google Scholar
• Lommatzsch M, Korn S, Buhl R, Virchow JC. Against all odds: anti-IgE for intrinsic asthma? Thorax 2014;69:94-6
   PubMed Web of Science ®Google Scholar
• Lommatzsch M, Bratke K, Bier A, et al. Airway dendritic cell phenotypes in inflammatory diseases of the human lung. Eur Respir J 2007;30:878-86
   PubMed Web of Science ®Google Scholar
• Lynch JP, Mazzone SB, Rogers MJ, et al. The plasmacytoid dendritic cell: a cell at the cross-roads in asthma. Eur Respir J 2014;43:264-75
   PubMed Web of Science ®Google Scholar
• Tversky JR, Le TV, Bieneman AP, et al. Human blood dendritic cells from allergic subjects have impaired capacity to produce interferon-alpha via Toll-like receptor 9. Clin Exp Allergy 2008;38:781-8
   PubMed Web of Science ®Google Scholar
• Schroeder JT, Bieneman AP, Xiao H, et al. TLR9- and FcϵRI-mediated responses oppose one another in plasmacytoid dendritic cells by down-regulating receptor expression. J Immunol 2005;175:5724-31
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.gov, A service of the U.S. National Institutes of Health. Available from: www.clinicaltrials.gov/
   Google Scholar