Anti-ige therapy with omalizumab for severe asthma: Current concepts and potential developments

Current Drug Targets

Volumn 16, Issue 2, 2015, Pages 171-178

  Pelaia, Girolamo ^a   Vatrella, Alessandro ^b   Busceti, Mariateresa ^a   Gallelli, Luca ^a   Terracciano, Rosa ^a   Maselli, Rosario ^a  

^a UNIVERSITY MAGNA GRAECIA OF CATANZARO   (Italy)

^b UNIVERSITY OF SALERNO   (Italy)

Author keywords

Anti IgE; Omalizumab; Severe asthma

Indexed keywords

GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; IMMUNOGLOBULIN E; IMMUNOGLOBULIN E RECEPTOR; INTERLEUKIN 13; INTERLEUKIN 4; INTERLEUKIN 6; OMALIZUMAB; TUMOR NECROSIS FACTOR; ANTIASTHMATIC AGENT; ANTIIDIOTYPIC ANTIBODY; MONOCLONAL ANTIBODY;

ANTIGEN ANTIBODY COMPLEX; ARTICLE; ASTHMA; CARDIOVASCULAR RISK; CHURG STRAUSS SYNDROME; COMPUTER ASSISTED TOMOGRAPHY; DOWN REGULATION; DRUG BIOAVAILABILITY; DRUG SAFETY; DRUG TOLERABILITY; HOSPITALIZATION; HUMAN; PEAK EXPIRATORY FLOW; PHENOTYPE; PROTEIN EXPRESSION; QUALITY OF LIFE; UPREGULATION; ANTAGONISTS AND INHIBITORS; BLOOD; CLINICAL TRIAL (TOPIC); IMMUNOLOGY; SEVERITY OF ILLNESS INDEX;

ANTI-ASTHMATIC AGENTS; ANTIBODIES, ANTI-IDIOTYPIC; ANTIBODIES, MONOCLONAL, HUMANIZED; ASTHMA; CLINICAL TRIALS AS TOPIC; HUMANS; IMMUNOGLOBULIN E; RECEPTORS, IGE; SEVERITY OF ILLNESS INDEX;

EID: 84946235631     PISSN: 13894501     EISSN: 18735592     Source Type: Journal    
DOI: 10.2174/1389450116666141219122157     Document Type: Article

References (91)

1. Hentges F, Leonard C, Arumugam K, Hilger C. Immune responses to inhalant mammalian allergens. Front Immunol 2014; 5: 234.
2. Dullaers M, De Bruyne R, Ramadani F, Gould HJ, Gevaert P, Lambrecht BN. The who, where and when of IgE in allergic airway disease. J Allergy Clin Immunol 2012; 129: 635-645.
3. Gould HJ, Sutton BJ. IgE in allergy and asthma today. Nat Rev Immunol 2008; 8: 205-17.
4. Holgate ST. Mechanisms of asthma and implications for its prevention and treatment: a personal journey. Allergy Asthma Immunol Res 2013; 5: 343-7.
5. Ishizaka K, Ishizaka T. Identification of γE antibodies as a carrier of reaginic activity. J Immunol 1967; 6: 1187-98.
6. Pelaia G, Vatrella A, Calabrese C, Mazzarella G, Marsico SA. New perspectives in asthma treatment. Allergy 2000; 55 (suppl 61): 60-66.
7. Global Initiative for Asthma (GINA) - Global strategy for asthma management and prevention. Available from: http://www.ginasthma.org, accessed: October 15, 2014..
8. European Public Assessment Report (Xolair). Available from: http://www.ema.europa.eu/humandocs/PDFs/EPAR/Xolair/emeacombined- h606en.pdf accessed: October 15, 2014..
9. Anandan C, Nurmatov U, van Schayck OCP, Skeih A. Is the prevalence of asthma declining? Systematic review of epidemiological studies. Allergy 2010; 65: 152-67.
10. Fanta CH. Drug therapy: asthma. N Engl J Med 2009; 360: 1002-14.
11. 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.
12. Dolan CM, Fraher KE, Bleecker ER, et al. Design of baseline characteristics of the epidemiology and natural history of asthma: outcomes and treatment regimens (TENOR) study: a large cohort of patients with severe or difficult-to-treat asthma. Ann Allergy Asthma Immunol 2004; 92: 32-9.
13. ENFUMOSA (European network for understanding mechanisms of severe asthma) Study Group. The ENFUMOSA cross-sectional European multicentre study of the clinical phenotype of chronic severe asthma. Eur Respir J 2003; 22: 470-7.
14. Haselkorn T, Borish L, Miller DP, Weiss ST, Wong DA. High prevalence of skin test positivity in severe or difficult-to-treat asthma. J Asthma 2006; 43: 745-52.
15. Presta LG, Lahr SJ, Shields RL, et al. Humanization of an antibody directed against IgE. J Immunol 1993; 151: 2623-32.
16. Spector S. Omalizumab efficacy in allergic disease. Panminerva Med 2004; 46: 141-8.
17. Hochhaus G, Brookman L, Fox H, et al. Pharmacodynamics of omalizumab: implications for optimised dosing strategy and clinical efficacy in the treatment of allergic asthma. Curr Med Res Opin 2003; 19: 491-8.
18. Fox JA, Hotaling TE, Struble C, Ruppel J, Bates DJ, Schoenhoff MB. Tissue distribution and complex generation with IgE of an anti-IgE antibody after intravenous administration in cynomolgus monkeys. J Pharmacol Exp Ther 1996; 279: 1000-8.
19. Chang TW, Wu PC, Hsu CL, Hung AF. Anti-IgE antibodies for the treatment of IgE-mediated allergic diseases. Adv Immunol 2007; 93: 63-119.
20. Presta L, Shields R, O’ Connell L, et al. The binding site of a human immunoglobulin E for its high affinity receptor. J Biol Chem 1994; 269: 26368-73.
21. Kalesnikoff J, Huber M, Lam V, et al. Monomeric IgE stimulates signaling pathways in mast cells that lead to cytokine production and cell survival. Immunity 2001; 14: 801-11.
22. Domingo C. Omalizumab for severe asthma: efficacy beyond the atopic patient? Drugs 2014; 74: 521-33.
23. Noga O, Hanf G, Brachmann I, et al. Effect of omalizumab treatment on peripheral eosinophil and T-lymphocyte function in patients with allergic asthma. J Allergy Clin Immunol 2006; 117: 1493-9.
24. 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.
25. Marcus P. Incorporating anti-IgE (omalizumab) therapy in clinical practice: practice management implications. Chest 2006; 129: 466-74.
26. Miller CWT, Krishnaswamy N, Johnston C, Krishnaswamy G. Severe asthma and the omalizumab option. Clin Mol Allergy 2008; 6: 4.
27. Domingo C, Pacheco A, Hinojosa M, Bosque M. The relevance of IgE in the pathogenesis of allergy: the effect of an anti-IgE drug in asthma and other diseases. Recent Pat Inflamm Allergy Drug Discov 2007; 1: 151-64.
28. Buhl R, Marco AG, Cohen D, Canonica GW. Eligibility for treatment with omalizumab in Italy and Germany. Respir Med 2014; 108: 50-6.
29. Hendeles L, Sorkness CA. Anti-immunoglobulin E therapy with omalizumab for asthma. Ann Pharmacother 2007; 41: 1397-410.
30. 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.
31. 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.
32. Solèr 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: 254-61.
33. Holgate ST, Chuchalin AG, Hebert J, et al. Efficacy and tolerability of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy 2004; 34: 632-8.
34. Vignola AM, Humbert M, Bousquet J, 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: 709-17.
35. Ayres JG, Higgins B, Chilvers ER, Ayre G, Blogg M, Fox H. 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.
36. 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.
37. Price D. The use of omalizumab in asthma. Prim Care Respir J 2008; 17: 62-72.
38. Pelaia G, Renda T, Romeo P, Busceti MT, Maselli R. Omalizumab in the treatment of severe asthma: efficacy and current problems. Ther Adv Respir Res 2008; 2: 409-21.
39. Pelaia G, Gallelli L, Renda T, et al. Update on optimal use of omalizumab in management of asthma. J Asthma Allergy 2011; 4: 49-59.
40. D’Amato G, Stanziola A, Sanduzzi A, et al. Treating severe allergic asthma with anti-IgE monoclonal antibody (omalizumab): a review. Multidiscip Respir Med 2014; 9: 23.
41. 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: 28-35.
42. Allen DB, Mullen M, Mullen B. A meta-analysis of the effect of oral and inhaled corticosteroids on growth. J Allergy Clin Immunol 1994; 93: 967-76.
43. van Staa TP, Cooper C, Leufkens HG, et al. Children and the risk of fractures caused by oral corticosteroids. J Bone Miner Res 2003; 18: 913-18.
44. Hanania NA, Alpan O, Hamilos DL, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med 2011; 154: 573-82.
45. Busse WW, Morgan WJ, Gergen PJ, et al. Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children. New Engl J Med 2011; 364: 1005-15.
46. Molimard M, de Blay F, Didier A, Le Gros V. Effectiveness of omalizumab (Xolair) in the first patients treated in real-life practice in France. Respir Med 2008; 102: 71-6.
47. Korn S, Thielen A, Seyfried S, Taube C, Kornmann O, Buhl R. Omalizumab in patients with severe persistent allergic asthma in a real-life setting in Germany. Respir Med 2009; 103: 1725-31.
48. 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.
49. Cazzola M, Camiciottoli G, Bonavia M, et al. Italian real-life experience of omalizumab. Respir Med 2010; 104: 1410-6.
50. Molimard M, Buhl R, Niven R, et al. Omalizumab reduces oral corticosteroid use in patients with severe allergic asthma; Real-life data. Respir Med 2010; 104: 1381-5.
51. Storms W, Bowdish MS, Farrar JR. Omalizumab and asthma control in patients with moderate-to-severe allergic asthma: a 6-year pragmatic data review. Allergy Asthma Proc 2012; 33: 172-7.
52. Tzortzaki EG, Georgiou A, Kampas D, et al. Long-term omalizumab treatment in severe allergic asthma: the South-Eastern Mediterranean “real-life” experience. Pulm Pharmacol Ther 2012; 25: 77-82.
53. 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.
54. Levy AN, Garcia AR, Garcia-Agua NS, Hidalgo MV. Costeffectiveness of omalizumab in severe persistent asthma in Spain: a real-life perspective. J Asthma 2014, in press.
55. Lopez Tiro JJ, Contreras EA, Del Pozo ME, Gomez Vera J, Larenas Linnemann D. Real life study of three years omalizumab in patients with difficult-to-control asthma. Allergol Immunopathol 2014, in press.
56. Pelaia G, Gallelli L, Romeo P, et al. Omalizumab decreases exacerbation frequency, oral intake of corticosteroids and peripheral blood eosinophils in atopic patients with uncontrolled asthma. Int J Clin Pharmacol Ther 2011; 49: 713-21.
57. Hanania NA, Wenzel S, Rosén 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.
58. 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.
59. Bousquet J, Siergiejko Z, Swiebocka E, et al. Persistence of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy 2011; 66: 671-8.
60. Campbell AM, Vachier I, Chanez P, et al. Expression of the highaffinity receptor for IgE on bronchial epithelial cells of asthmatics. Am J Respir Cell Mol Biol 1998; 19: 92-7.
61. Redhu NS, Gounni AS. The high affinity IgE receptor (FcεRI) expression and function in airway smooth muscle. Pulm Pharmacol Ther 2013; 26: 86-94.
62. Huang YC, Leyko B, Frier M. Effects of omalizumab and budesonide on markers of inflammation in human bronchial epithelial cells. Ann Allergy Asthma Immunol 2005; 95: 443-51.
63. Zietkowski Z, Skiepko R, Tomasiak-Lozowska MM, Bodzenta- Lukaszyk A. Anti-IgE therapy with omalizumab decreases endothelin- 1 in exhaled breath condensate of patients with severe persistent allergic asthma. Respiration 2010; 80: 534-42.
64. Roth M, Zhong J, Zumkeller C, S’ng CT, Goulet S, Tamm M. The role of IgE-receptors in IgE-dependent airway smooth muscle cell remodelling. PLoS One 2013; 8: e56015.
65. Hoshino M, Ohtawa J. Effects of adding omalizumab, an antiimmunoglobulin E antibody, on airway wall thickening in asthma. Respiration 2012; 83: 520-8.
66. Tajiri T, Niimi A, Matsumoto H, et al. Comprehensive efficacy of omalizumab for severe refractory asthma: a time-series observational study. Ann Allergy Asthma Immunol 2014; 113: 470-5.
67. Riccio AM, Dal Negro RW, Micheletto C, et al. Omalizumab modulates bronchial reticular basement membrane thickness and eosinophil infiltration in severe persistent allergic asthma patients. Int J Immunopathol Pharmacol 2012; 25: 475-84.
68. de Llano LP, Vennera Mdel C, Alvarez FJ, et al. Effects of omalizumab in non-atopic asthma: results from a Spanish multicenter registry. J Asthma 2013; 50; 296-301.
69. Grimaldi-Bensouda L, Zureik M, Aubier M, et al. Does omalizumab make a difference to the real-life treatment of asthma exacer bations? Results from a large cohort of patients with severe uncontrolled asthma. Chest 2013; 143: 398-405.
70. 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: 411-9.
71. Lommatzsch M, Korn S, Buhl R, Virchow JC. Against all odds: anti-IgE for intrinsic asthma? Thorax 2014; 69: 94-6.
72. Saini SS, MacGlashan DW, Sterbinsky SA, et al. Down-regulation of human basophil IgE and FcεRIα surface densities and mediator release by anti-IgE infusions is reversible in vitro and in vivo. J Immunol 1999; 162: 5624-39.
73. Corren J, Shapiro G, Reimann J, et al. Allergen skin tests and free IgE levels during reduction and cessation of omalizumab therapy. J Allergy Clin Immunol 2008; 121: 506-11.
74. Nopp A, Johansson SGO, Ankerst J, Palmqvist M, Oman H. CDsens and clinical changes during withdrawal of Xolair after 6 years of treatment. Allergy 2007; 62: 1175-81.
75. Solèr M. Omalizumab for severe allergic asthma: 7 years and open questions. Respiration 2014; 88: 158-161.
76. Holgate ST, Djukanovich R, Casale T, Bousquet J. Antiimmunoglobulin E treatment with omalizumab in allergic diseases: an update on anti-inflammatory activity and clinical efficacy. Clin Exp Allergy 2005; 35: 408-16.
77. Cox L, Platts-Mills TAE, Finegold I, Schwartz LB, Simons FER, Wallace DV. American Academy of Allergy, Asthma and Immunology/ American College of Allergy, Asthma and Immunology Joint Task Force report on omalizumab-associated anaphylaxis. J Allergy Clin Immunol 2007; 120: 1373-7.
78. Busse W, Buhl R, Fernandez Vidaurre C, et al. Omalizumab and the risk of malignancy: results from a pooled analysis. J Allergy Clin Immunol 2012; 129: 983-9.
79. Winchester DE, Jacob A, Murphy T. Omalizumab for asthma. N Engl J Med 2006; 355: 1281-2.
80. Puéchal X, Rivereau P, Vinchon F. Churg-Strauss syndrome associated with omalizumab. Eur J Intern Med 2008; 19: 364-6.
81. Bargagli E, Madioni C, Olivieri C, Penza F, Rottoli P. Churg- Strauss vasculitis in a patient treated with omalizumab. J Asthma 2008; 45: 115-6.
82. Vaglio A, Moosig F, Zwerina J. Churg-Strauss syndrome: update on pathophysiology and treatment. Curr Opin Rheumatol 2012; 24: 24-30.
83. Cruz AA, Lima F, Sarinho E, et al. Safety of anti-immunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infections. Clin Exp Allergy 2007; 37: 197-207.
84. Corren J, Casale TB, Lanier B, Buhl R, Holgate S, Jimenez P. Safety and tolerability of omalizumab. Clin Exp Allergy 2009; 39: 788-97.
85. Tan RA, Corren J. Safety of omalizumab in asthma. Expert Opin Drug Saf 2011; 10: 463-71.
86. Brown R, Turk F, Dale P, Bousquet J. Cost-effectiveness of omalizumab in patients with severe persistent allergic asthma. Allergy 2007; 62: 149-53.
87. Dewilde S, Turk F, Tambour M, Sandstrom T. The economic value of anti-IgE in severe persistent, IgE-mediated (allergic) asthma patients: adaptation of INNOVATE to Sweden. Curr Med Res Opin 2006; 22: 1765-76.
88. Bahadori K, Quon BS, Doyle-Waters MM, Marra C, Fitzgerald JM. A systematic review of economic evaluations of therapy in asthma. J Asthma Allergy 2010; 3: 33-42.
89. Sullivan SD, Turk F. An evaluation of the cost-effectiveness of omalizumab for the treatment of severe allergic asthma. Allergy 2008; 63: 670-84.
90. Campbell JD, Spackman DE, Sullivan SD. The costs and consequences of omalizumab in uncontrolled asthma from a USA payer perspective. Allergy 2010; 65: 1141-8.
91. Pelaia G, Vatrella A, Maselli R. The potential of biologics for the treatment of asthma. Nat Rev Drug Discov 2012; 11: 958-72.