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Pediatric Drugs
Published in: Pediatric Drugs 6/2014

Open Access 01-12-2014 | Review Article

Omalizumab in Children

Authors: Amelia Licari, Alessia Marseglia, Silvia Caimmi, Riccardo Castagnoli, Thomas Foiadelli, Salvatore Barberi, Gian Luigi Marseglia

Published in: Pediatric Drugs | Issue 6/2014

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Abstract

Omalizumab is a recombinant humanized monoclonal antibody that reduces levels of circulating immunoglobulin E (IgE) and expression of IgE high-affinity receptors on mast cells and basophils, interrupting the subsequent allergic inflammatory cascade. Current indications for treatment with omalizumab in pediatric patients are clearly defined and are confined to moderate-to-severe uncontrolled allergic asthma and chronic spontaneous urticaria (CSU). Any other prescription can only be off label. Data available from clinical trials conducted in children suggest that omalizumab is clinically effective and generally well tolerated. Given its mechanism of action, recent reports have suggested its possible clinical use in other IgE-mediated disorders, such as allergic rhinitis, food allergy, and anaphylaxis. In recent years, several studies have also investigated the possible applications of omalizumab in a number of non IgE-mediated diseases. The aim of the present review is to assess all applications of omalizumab as therapy in the pediatric population. The approved indications—allergic asthma and CSU—are reviewed. Moreover, further potential applications of omalizumab are discussed in both IgE-mediated and non-IgE-mediated diseases.
Literature
1.
Holgate S, Casale T, Wenzel S, Bousquet J, Deniz Y, Reisner C. The anti-inflammatory effects of omalizumab confirm the central role of IgE in allergic inflammation. J Allergy Clin Immunol. 2005;115:459–65.PubMedCrossRef
2.
3.
Prussin C, Griffith DT, Boesel KM, Lin H, Foster B, Casale TB. Omalizumab treatment downregulates dendritic cell FcepsilonRI expression. J Allergy Clin Immunol. 2003;112(6):1147–54.PubMedCrossRef
4.
Holgate S, Smith N, Massanari M, Jimenez P. Effects of omalizumab on markers of inflammation in patients with allergic asthma. Allergy. 2009;64(12):1728–36.PubMedCrossRef
5.
Djukanović R, Wilson SJ, Kraft M, Jarjour NN, Steel M, Chung KF, et al. Effects of treatment with anti-immunoglobulin E antibody omalizumab on airway inflammation in allergic asthma. Am J Respir Crit Care Med. 2004;170(6):583–93.PubMedCrossRef
6.
7.
8.
Burch J, Griffin S, McKenna C, Walker S, Paton J, Wright K, Woolacott N. Omalizumab for the treatment of severe persistent allergic asthma in children aged 6–11 years: a NICE single technology appraisal. Pharmacoeconomics. 2012;30(11):991–1004.PubMedCrossRef
9.
Baena-Cagnani CE, Gómez RM. Current status of therapy with omalizumab in children. Curr Opin Allergy Clin Immunol. 2014;14(2):149–54.PubMedCrossRef
10.
Incorvaia C, Mauro M, Russello M, Formigoni C, Riario-Sforza GG, Ridolo E. Omalizumab, an anti immunoglobulin E antibody: state of the art. Drug Des Devel Ther. 2014;7(8):197–207.CrossRef
11.
Babu KS, Polosa R, Morjaria JB. Anti-IgE–emerging opportunities for Omalizumab. Expert Opin Biol Ther. 2013;13(5):765–77.PubMedCrossRef
12.
Normansell R, Walker S, Milan SJ, Walters EH, Nair P. Omalizumab for asthma in adults and children. Cochrane Database Syst Rev. 2014;1:CD003559.
13.
Corren J, Casale TB, Lanier B, Buhl R, Holgate S, Jimenez P. Safety and tolerability of omalizumab. Clin Exp Allergy. 2009;39(6):788–97.PubMedCrossRef
14.
Cox L, Platts-Mills TA, Finegold I, Schwartz LB, Simons FE, Wallace DV, American Academy of Allergy, Asthma & Immunology; American College of Allergy, Asthma and Immunology. American Academy of Allergy, Asthma & Immunology/American College of Allergy, Asthma and Immunology Joint Task Force Report on omalizumab-associated anaphylaxis. J Allergy Clin Immunol. 2007;120(6):1373–7.PubMedCrossRef
15.
Cox L, Lieberman P, Wallace D, Simons FE, Finegold I, Platts-Mills T, Schwartz L. 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(1):210–2.PubMedCrossRef
16.
17.
18.
19.
Papadopoulos NG, Arakawa H, Carlsen KH, Custovic A, Gern J, Lemanske R, et al. International consensus on (ICON) pediatric asthma. Allergy. 2012;67:976–97.PubMedCrossRef
20.
Hanania NA, Alpan O, Hamilos DL, Condemi JJ, Reyes-Rivera I, Zhu J, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011;154(9):573–82.PubMedCrossRef
21.
Busse W, Corren J, Lanier BQ, McAlary M, Fowler-Taylor A, Cioppa GD, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001;108(2):184–90.PubMedCrossRef
22.
Humbert M, Beasley R, Ayres J, Slavin R, Hébert J, Bousquet 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(3):309–16.PubMedCrossRef
23.
Bousquet J, Siergiejko Z, Swiebocka E, Humbert M, Rabe KF, Smith N, et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy. 2011;66(5):671–8.PubMedCrossRef
24.
Holgate ST, Chuchalin AG, Hebert J, Lötvall J, Persson GB, Chung KF, et al. Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy. 2004;34(4):632–8.PubMedCrossRef
25.
Milgrom H, Berger W, Nayak A, Gupta N, Pollard S, McAlary M, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics. 2001;108(2):E36.PubMedCrossRef
26.
Lemanske RF Jr, Nayak A, McAlary M, Everhard F, Fowler-Taylor A, Gupta N. Omalizumab improves asthma-related quality of life in children with allergic asthma. Pediatrics. 2002;110(5):e55.PubMedCrossRef
27.
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(2):182–8.PubMedCrossRef
28.
Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124(6):1210–6.PubMedCrossRef
29.
Kulus M, Hébert J, Garcia E, Fowler Taylor A, Fernandez Vidaurre C, Blogg M. Omalizumab in children with inadequately controlled severe allergic (IgE-mediated) asthma. Curr Med Res Opin. 2010;26(6):1285–93.PubMedCrossRef
30.
Busse WW, Morgan WJ, Gergen PJ, Mitchell HE, Gern JE, Liu AH, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. N Engl J Med. 2011;364:1005–15.PubMedCentralPubMedCrossRef
31.
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):163–9.PubMedCrossRef
32.
Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Efficacy and safety of subcutaneous omalizumab vs placebo as add-on therapy to corticosteroids for children and adults with asthma: a systematic review. Chest. 2011;139(1):28–35.PubMedCrossRef
33.
Brodlie M, McKean MC, Moss S, Spencer DA. The oral corticosteroid-sparing effect of omalizumab in children with severe asthma. Arch Dis Child. 2012;97(7):604–9.PubMedCrossRef
34.
Deschildre A, Marguet C, Salleron J, Pin I, Rittié JL, Derelle J, et al. Add-on omalizumab in children with severe allergic asthma: a 1-year real life survey. Eur Respir J. 2013;42(5):1224–33.PubMedCrossRef
35.
Braunstahl GJ, Chen CW, Maykut R, Georgiou P, Peachey G, Bruce J. The eXpeRience registry: the ‘real-world’ effectiveness of omalizumab in allergic asthma. Respir Med. 2013;107(8):1141–51.PubMedCrossRef
36.
Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, Brzoza Z, Canonica GW, et al. The EAACI/GAL2EN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy. 2014;69(7):868–87.PubMedCrossRef
37.
Maurer M, Weller K, Bindslev-Jensen C, Giménez-Arnau A, Bousquet PJ, Bousquet J, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy. 2011;66(3):317–30.PubMedCrossRef
38.
Kulthanan K, Jiamton S, Thumpimukvatana N, Pinkaew S. Chronic idiopathic urticaria: prevalence and clinical course. J Dermatol. 2007;34:294–301.PubMedCrossRef
39.
Chang TW, Chen C, Lin CJ, Metz M, Church MK, Maurer M. The potential pharmacologic mechanisms of omalizumab in patients with chronic spontaneous urticaria. J Allergy Clin Immunol. 2014. pii: S0091-6749(14)00657-5.
40.
Sánchez-Borges M, Asero R, Ansotegui IJ, Baiardini I, Bernstein JA, Canonica GW, WAO Scientific and Clinical Issues Council, et al. Diagnosis and treatment of urticaria and angioedema: a worldwide perspective. World Allergy Organ J. 2012;5(11):125–47.PubMedCentralPubMedCrossRef
41.
Bernstein JA, Sarbjit SS, Maurer R, Hsin-JU H, Chen H, Canvin J, et al. Efficacy of omalizumab in patients with chronic idiopathic/spontaneous urticaria with different background therapy: post hoc analysis of Asteria I, Asteria II, and Glacial studies. J Allergy Clin Immunol. 2014;133(2 Suppl):AB117.CrossRef
42.
Maurer M, Rosén K, Hsieh HJ, Saini S, Grattan C, Gimenéz-Arnau A, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013;368(10):924–35.PubMedCrossRef
43.
Kaplan A, Ledford D, Ashby M, Canvin J, Zazzali JL, Conner E, et al. Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. J Allergy Clin Immunol. 2013;132(1):101–9.PubMedCrossRef
44.
Saini SS, Bindslev-Jensen C, Maurer M, Grob JJ, Bülbül Baskan E, Bradley MS, Canvin J, Rahmaoui A, Georgiou P, Alpan O, Spector S, Rosén K. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. Epub 2014 Jul 21.
45.
Church MK, Weller K, Stock P, Maurer M. Chronic spontaneous urticaria in children: itching for insight. Pediatr Allergy Immunol. 2011;22(1 Pt 1):1–8.PubMedCrossRef
46.
McCormack PL. Omalizumab: a review of its use in patients with chronic spontaneous urticaria. Drugs. 2014;74(14):1693–9.PubMedCrossRef
47.
Casale TB, Condemi J, LaForce C, Nayak A, Rowe M, Watrous M, Omalizumab Seasonal Allergic Rhinitis Trial Group, et al. Effect of omalizumab on symptoms of seasonal allergic rhinitis: a randomized controlled trial. JAMA. 2001;286(23):2956–67.PubMedCrossRef
48.
Adelroth E, Rak S, Haahtela T, Aasand G, Rosenhall L, Zetterstrom O, et al. Recombinant humanized mAb-E25, an anti-IgE mAb, in birch pollen-induced seasonal allergic rhinitis. J Allergy Clin Immunol. 2000;106(2):253–9.PubMedCrossRef
49.
Chervinsky P, Casale T, Townley R, Tripathy I, Hedgecock S, Fowler-Taylor A, et al. Omalizumab, an anti-IgE antibody, in the treatment of adults and adolescents with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2003;91(2):160–7.PubMedCrossRef
50.
Vignola AM, Humbert M, Bousquet J, Boulet LP, Hedgecock S, Blogg M, et al. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with concomitant allergic asthma and persistent allergic rhinitis: SOLAR. Allergy. 2004;59(7):709–17.PubMedCrossRef
51.
Nayak A, Casale T, Miller SD, Condemi J, McAlary M, Fowler-Taylor A, et al. Tolerability of retreatment with omalizumab, a recombinant humanized monoclonal anti-IgE antibody, during a second ragweed pollen season in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2003;24(5):323–9.PubMed
52.
Tsabouri S, Tseretopoulou X, Priftis K, Ntzani EE. Omalizumab for the treatment of inadequately controlled allergic rhinitis: a systematic review and meta-analysis of randomized clinical trials. J Allergy Clin Immunol Pract. 2014;2(3):332–40.PubMedCrossRef
53.
Verbruggen K, Van Cauwenberge P, Bachert C. Anti-IgE for the treatment of allergic rhinitis—and eventually nasal polyps? Int Arch Allergy Immunol. 2009;148(2):87–98.PubMedCrossRef
54.
Roberts G, Xatzipsalti M, Borrego LM, Custovic A, Halken S, Hellings PW, et al. Paediatric rhinitis: position paper of the European Academy of Allergy and Clinical Immunology. Allergy. 2013;68(9):1102–16.PubMed
55.
Vashisht P, Casale T. Omalizumab for treatment of allergic rhinitis. Expert Opin Biol Ther. 2013;13(6):933–45.PubMedCrossRef
56.
Kopp MV, Stenglein S, Kamin W, Friedrichs F, von Berg A, Zielen S, Hamelmann E, Wahn U, Kuehr J. Omalizumab (Xolair) in children with seasonal allergic rhinitis: leukotriene release as a potential in vitro parameter to monitor therapeutic effects. Pediatr Allergy Immunol. 2007;18(6):523–7.PubMedCrossRef
57.
Kopp MV, Hamelmann E, Bendiks M, Zielen S, Kamin W, Bergmann KC, Klein C. Wahn U; DUAL study group. Transient impact of omalizumab in pollen allergic patients undergoing specific immunotherapy. Pediatr Allergy Immunol. 2013;24(5):427–33.PubMedCrossRef
58.
Rolinck-Werninghaus C, Hamelmann E, Keil T, Kulig M, Koetz K, Gerstner B, Kuehr J, Zielen S, Schauer U, Kamin W, Von Berg A, Hammermann J, Weinkauf B, Weidinger G, Stenglein S, Wahn U, Omalizumab Rhinitis Study Group. The co-seasonal application of anti-IgE after preseasonal specific immunotherapy decreases ocular and nasal symptom scores and rescue medication use in grass pollen allergic children. Allergy. 2004;59(9):973–9.PubMedCrossRef
59.
Kamin W, Kopp MV, Erdnuess F, Schauer U, Zielen S, Wahn U. Safety of anti-IgE treatment with omalizumab in children with seasonal allergic rhinitis undergoing specific immunotherapy simultaneously. Pediatr Allergy Immunol. 2010;21(1 Pt 2):e160–5.PubMedCrossRef
60.
Agarwal R, Chakrabarti A, Shah A, Gupta D, Meis JF, Guleria R, Moss R, Denning DW, ABPA complicating asthma ISHAM working group. Allergic bronchopulmonary aspergillosis: review of literature and proposal of new diagnostic and classification criteria. Clin Exp Allergy. 2013;43(8):850–73.PubMedCrossRef
61.
Tanou K, Zintzaras E, Kaditis AG. Omalizumab therapy for allergic bronchopulmonary aspergillosis in children with cystic fibrosis: a synthesis of published evidence. Pediatr Pulmonol. 2014;49(5):503–7.PubMedCrossRef
62.
Jat KR, Walia DK, Khairwa A. Anti-IgE therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis. Cochrane Database Syst Rev. 2013;9:CD010288.
63.
Gevaert P, Calus L, Van Zele T, Blomme K, De Ruyck N, Bauters W, et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 2013;131(1):110–116.e1.PubMedCrossRef
64.
Ring J, Alomar A, Bieber T, Deleuran M, Fink-Wagner A, Gelmetti C, Gieler U, Lipozencic J, Luger T, Oranje AP, Schäfer T, Schwennesen T, Seidenari S, Simon D, Ständer S, Stingl G, Szalai S, Szepietowski JC, Taïeb A, Werfel T, Wollenberg A, Darsow U, European Dermatology Forum; European Academy of Dermatology and Venereology; European Task Force on Atopic Dermatitis; European Federation of Allergy; European Society of Pediatric Dermatology; Global Allergy and Asthma European Network. Guidelines for treatment of atopic eczema (atopic dermatitis) Part II. J Eur Acad Dermatol Venereol. 2012;26(9):1176–93.PubMedCrossRef
65.
Lane JE, Cheyney JM, Lane TN, Kent DE, Cohen DJ. Treatment of recalcitrant atopic dermatitis with omalizumab. J Am Acad Dermatol. 2006;54:68–72.PubMedCrossRef
66.
Vigo PG, Girgis KR, Pfuetze PL, Critchlow ME, Fisher J, Hussain I. Efficacy of anti-IgE therapy in patients with atopic dermatitis. J Am Acad Dermatol. 2006;55:168–70.PubMedCrossRef
67.
Sheinkopf LE, Rafi AW, Do LT, Katz RM, Klaustermeyer WB. Efficacy of omalizumab in the treatment of atopic dermatitis: a pilot study. Allergy Asthma Proc. 2008;29(5):530–7.PubMedCrossRef
68.
Iyengar SR, Hoyte EG, Loza A, Bonaccorso S, Chiang D, Umetsu DT, et al. Immunologic effects of omalizumab in children with severe refractory atopic dermatitis: a randomized, placebo-controlled clinical trial. Int Arch Allergy Immunol. 2013;162(1):89–93.PubMedCentralPubMedCrossRef
69.
Ramírez del Pozo ME. Contreras Contreras E, López Tiro J, Gómez Vera J. Omalizumab (an anti-IgE antibody) in the treatment of severe atopic eczema. J Investig Allergol Clin Immunol. 2011;21(5):416–7.PubMed
70.
Lacombe Barrios J, Bégin P, Paradis L, Hatami A, Paradis J, Des Roches A. Anti-IgE therapy and severe atopic dermatitis: a pediatric perspective. J Am Acad Dermatol. 2013;69(5):832–4.PubMedCrossRef
71.
Sicherer SH, Sampson HA. Food allergy: Epidemiology, pathogenesis, diagnosis, and treatment. J Allergy Clin Immunol. 2014;133(2):291–307 (quiz 308).PubMedCrossRef
72.
Muraro A, Roberts G, Worm M, Bilò MB, Brockow K, Fernández Rivas M, Santos AF, Zolkipli ZQ, Bellou A, Beyer K, Bindslev-Jensen C, Cardona V, Clark AT, Demoly P, Dubois AE, DunnGalvin A, Eigenmann P, Halken S, Harada L, Lack G, Jutel M, Niggemann B, Ruëff F, Timmermans F, Vlieg-Boerstra BJ, Werfel T, Dhami S, Panesar S, Akdis CA, Sheikh A, EAACI Food Allergy and Anaphylaxis Guidelines Group. Anaphylaxis: guidelines from the European Academy of Allergy and Clinical Immunology. Allergy. 2014;69(8):1026–45.PubMedCrossRef
73.
Lieberman JA, Chehade M. Use of omalizumab in the treatment of food allergy and anaphylaxis. Curr Allergy Asthma Rep. 2013;13(1):78–84.PubMedCrossRef
74.
Leung DY, Sampson HA, Yunginger JW, Burks AW Jr, Schneider LC, Wortel CH, Avon Longitudinal Study of Parents and Children Study Team, et al. Effect of anti-IgE therapy in patients with peanut allergy. N Engl J Med. 2003;348(11):986–93.PubMedCrossRef
75.
Sampson HA, Leung DY, Burks AW, Lack G, Bahna SL, Jones SM, et al. A phase II, randomized, double-blind, parallel-group, placebo-controlled oral food challenge trial of Xolair (omalizumab) in peanut allergy. J Allergy Clin Immunol. 2011;127(5):1309–1310.e1.PubMedCrossRef
76.
Nadeau KC, Schneider LC, Hoyte L, Borras I, Umetsu DT. Rapid oral desensitization in combination with omalizumab therapy in patients with cow’s milk allergy. J Allergy Clin Immunol. 2011;127(6):1622–4.PubMedCentralPubMedCrossRef
Metadata
Title
Omalizumab in Children
Authors
Amelia Licari
Alessia Marseglia
Silvia Caimmi
Riccardo Castagnoli
Thomas Foiadelli
Salvatore Barberi
Gian Luigi Marseglia
Publication date
01-12-2014
Publisher
Springer International Publishing
Published in
Pediatric Drugs / Issue 6/2014
Print ISSN: 1174-5878
Electronic ISSN: 1179-2019
DOI
https://doi.org/10.1007/s40272-014-0107-z

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