Review: Omalizumab in the treatment of severe asthma: Efficacy and current problems

Therapeutic Advances in Respiratory Disease

Volumn 2, Issue 6, 2008, Pages 409-421

  Pelaia, Girolamo ^a   Renda, Teresa ^a   Romeo, Pasquale ^a   Busceti, Maria Teresa ^a   Maselli, Rosario ^a  

^a UNIVERSITY MAGNA GRAECIA OF CATANZARO   (Italy)

Author keywords

anti IgE; omalizumab; severe asthma

Indexed keywords

ANTIASTHMATIC AGENT; AZATHIOPRINE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BRONCHODILATING AGENT; CORTICOSTEROID; IMMUNOGLOBULIN E; IMMUNOGLOBULIN E RECEPTOR; OMALIZUMAB; PLACEBO;

ADD ON THERAPY; ALLERGIC ASTHMA; ALLERGIC RHINITIS; ANAPHYLAXIS; ANTIINFLAMMATORY ACTIVITY; ASTHMA; BLOOD TOXICITY; CHURG STRAUSS SYNDROME; CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; DISEASE CONTROL; DISEASE EXACERBATION; DISEASE SEVERITY; DRUG BIOAVAILABILITY; DRUG COST; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG INDUCED CANCER; DRUG MECHANISM; DRUG MEGADOSE; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; EMERGENCY WARD; EOSINOPHILIA; EYE IRRITATION; HUMAN; IMMUNOGLOBULIN BLOOD LEVEL; IMMUNOPATHOGENESIS; INJECTION SITE CONTUSION; INJECTION SITE ERYTHEMA; INJECTION SITE SWELLING; INJECTION SITE URTICARIA; INJECTION SITE WARMTH; NONHUMAN; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; QUALITY OF LIFE; REVIEW; THROAT DISEASE; THROMBOCYTOPENIA; TONGUE EDEMA; TREATMENT DURATION;

ANTI-ASTHMATIC AGENTS; ANTIBODIES, MONOCLONAL; ASTHMA; CLINICAL TRIALS AS TOPIC; DRUG THERAPY, COMBINATION; HUMANS; IMMUNOGLOBULIN E; SEVERITY OF ILLNESS INDEX;

EID: 67049095114     PISSN: 17534658     EISSN: None     Source Type: Journal    
DOI: 10.1177/1753465808100431     Document Type: Review

References (78)

1. Ayres, J.G., Higgins, B., Chilvers, E.R., Ayre, G., Blogg, M. and Fox, H. (2004) Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma. Allergy 59: 701-708.
2. Bargagli, E., Madioni, C., Olivieri, C., Penza, F. and Rottoli, P. (2008) Churg-Strauss vasculitis in a patient treated with omalizumab. J Asthma 45: 115-116.
3. Barnes, P.J. (2008) Immunology of asthma and chronic obstructive pulmonary disease. Nat Rev Immunol 8: 183-192.
4. Bateman, E.D., Boushey, H.A., Bousquet, J., Busse, W.W., Clark, T.J., Pauwels, R.A. et al. (2004) Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL (GOAL) study. Am J Respir Crit Care Med 170: 836-844.
5. Bousquet, J., Rabe, K., Humbert, M., Chung, K.F., Berger, W., Fox, H. et al. (2007) Predicting and evaluating response to omalizumab in patients with severe allergic asthma. Respir Med 101: 1483-1492.
6. Brown, R., Turk, F., Dale, P. and Bousquet, J. (2007) Cost-effectiveness of omalizumab in patients with severe persistent allergic asthma. Allergy 62: 149-153.
7. Busse, W., Corren, J., Lanier, B.Q., McAlary, M., Fowler-Taylor, A., Cioppa, G.D. et al. (2001) Omalizumab, anti-IgE recombinant humanized monoclonal antibody for the treatment of severe allergic asthma. J Allergy Clin Immunol 108: 184-190.
8. Carlsson, F., Hjelm, F., Conrad, D.H. and Heyman, B. (2007) IgE enhances specific antibody and T cell responses in mice over-expressing CD23. Scand J Immunol 66: 261-270.
9. Casale, T.B., Condemi, J., LaForce, C., Nayak, A., Rowe, M., Watrous, M. et al. (2001) Effect of omalizumab on symptoms of seasonal allergic rhinitis. A randomised controlled trial. JAMA 286: 2956-2967.
10. Chang, T.W. (2000) The pharmacological basis of anti-IgE therapy. Nat Biotechnol 18: 157-162.
11. Chang, T.W., Wu, P.C., Hsu, C.L. and Hung, A.F. (2007) Anti-IgE antibodies for the treatment of IgE-mediated allergic diseases. Adv Immunol 93: 63-119.
12. Cooper, P.J., Ayre, G., Martin, C., Rizzo, J.A., Ponte, E.V. and Cruz, A.A. (2008) Geohelminth infections: a review of the role of IgE and assessment of potential risks of anti-IgE treatment. Allergy 63: 409-418.
13. Corren, J., Shapiro, G., Reimann, J., Deniz, Y., Wong, D., Adelman, D. et al. (2008) Allergen skin tests and free IgE levels during reduction and cessation of omalizumab therapy. J Allergy Clin Immunol 121: 506-511.
14. Cox, L., Platts-Mills, T.A.E., Finegold, I., Schwartz, L.B., Simons, F.E.R. and Wallace, D.V. (2007) 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 120: 1373-1377.
15. Cruz, A.A., Lima, F., Sarinho, E., Ayre, G., Martin, C., Fox, H. et al. (2007) Safety on anti-immunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infections. Clin Exp Allergy 37: 197-207.
16. D'Amato, G. (2006) Role of anti-IgE monoclonal antibody (omalizumab) in the treatment of bronchial asthma and allergic respiratory diseases. Eur J Pharmacol 533: 302-307.
17. D'Amato, G., Salzillo, A., Piccolo, A., D'Amato, M. and Liccardi, G. (2007) A review of anti-IgE monoclonal antibody (omalizumab) as add on therapy for severe allergic (IgE-mediated) asthma. Ther Clin Risk Managem 3: 613-619.
18. Djukanovic, R., Wilson, S.J., Kraft, M., Jarjour, N.N., Steel, M., Chung, K.F. et al. (2004) Effects of treatment with anti-immunoglobulin E antibody omalizumab on airway inflammation in allergic asthma. Am J Respir Crit Care Med 170: 583-593.
19. Dolan, C.M., Fraher, K.E., Bleecker, E.R., Borish, L., Chipps, B., Hayden, M.L. et al. (2004) 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 92: 32-39.
20. ENFUMOSA (European Network for Understanding Mechanisms of Severe Asthma) Study Group) (2003) The ENFUMOSA cross-sectional European multicentre study of the clinical phenotype of chronic severe asthma. Eur Respir J 22: 470-477.
21. Fahy, J.V., Fleming, H.E., Wong, H.H., Liu, J.T., Su, J.Q., Reimann, J. et al. (1997) 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 155: 1828-1834.
22. Fox, J.A., Hotaling, T.E., Struble, C., Ruppel, J., Bates, D.J. and Schoenhoff, M.B. (1996) Tissue distribution and complex generation with IgE of an anti-IgE antibody after intravenous administration in cynomolgus monkeys. J Pharmacol Exp Ther 279: 1000-1008.
23. Giavina-Bianchi, P., Gravina-Bianchi, M., Agoni, R. and Kalil, J. (2008) Omalizumab and Churg-Strauss syndrome. J Allergy Clin Immunol 122: 217.
24. Global Initiative for Asthma (GINA) (2006) Global strategy for asthma management and prevention. Available at: http://www.ginasthma.org.
25. Gould, H.J. and Sutton, B.J. (2008) IgE in allergy and asthma today. Nat Rev Immunol 8: 205-217.
26. Hanania, A. (2008) Targeting airway inflammation in asthma: current and future therapies. Chest 133: 989-998.
27. Hartert, T.V. and Peebles Jr., R.S. (2000) Epidemiology of asthma: the year in review. Curr Opin Pulm Med 6: 4-9.
28. Haselkorn, T., Borish, L., Miller, D.P., Weiss, S.T. and Wong, D.A. (2006) High prevalence of skin test positivity in severe or difficult-to-treat asthma. J Asthma 43: 745-752.
29. Hendeles, L. and Sorkness, C.A. (2007) Anti-immunoglobulin E therapy with omalizumab for asthma. Ann Pharmacother 41: 1397-1410.
30. Hochhaus, G., Brookman, L., Fox, H., Johnson, C., Matthews, J., Ren, S. et al. (2003) Pharmacodynamics of omalizumab: implications for optimised dosing strategy and clinical efficacy in the treatment of allergic asthma. Curr Med Res Opin 19: 491-498.
31. Holgate, S.T. (2008) Pathogenesis of asthma. Clin Exp Allergy 38: 872-897.
32. Holgate, S.T., Chuchalin, A.G., Hebert, J., Lotvall, J., Persson, G.B., Chung, K.F. et al. (2004) Efficacy and tolerability of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy 36: 632-638.
33. Holgate, S., Casale, T., Wenzel, S., Bousquet, J., Deniz, Y. and Reisner, C. (2005a) The anti-inflammatory effects of omalizumab confirm the central role of IgE in allergic inflammation. J Allergy Clin Immunol 115: 459-465.
34. Holgate, S.T., Djukanovic, R., Casale, T. and Bousquet, J. (2005b) Anti-immunoglobulin E treatment with omalizumab in allergic diseases: an update on anti-inflammatory activity and clinical efficacy. Clin Exp Allergy 35: 408-416.
35. Holgate, S.T. and Polosa, R. (2008) Treatment strategies for allergy and asthma. Nat Rev Immunol 8: 218-230.
36. Humbert, M., Beasley, R., Ayres, J., Slavin, R., Hebert, J., Bousquet, J. et al. (2005) 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 60: 309-316.
37. Humbert, M., Berger, W., Rapatz, G. and Turk, F. (2008) Add-on omalizumab improves day-to-day symptoms in inadequately controlled severe persistent asthma. Allergy 63: 592-596.
38. Kitamura, K., Takeda, K., Koya, T., Miyahara, N., Kodama, T., Dakhama, A. et al. (2007) Critical role of the Fc receptor [gamma]-chain on APCs in the development of allergen-induced airway hyper-responsiveness and inflammation. J Immunol 178: 480-488.
39. Kitaura, J., Song, J., Tsai, M., Asai, K., Maeda-Yamamoto, M., Mocsai, A. et al. (2003) Evidence that IgE molecules mediate a spectrum of effects on mast cell survival and activation via aggregation of the FcepsilonRI. Proc Natl Acad Sci USA 100: 12911-12916.
40. Lang, D.M. (2007) An overview of EPR3 asthma guidelines: what's different?. Allergy Asthma Proc 28: 620-627.
41. Lanier, B.Q. (2003) Newer aspects in the treatment of pediatric and adult asthma: monoclonal anti-IgE. Ann Allergy Asthma Immunol 90: 13-15.
42. Lanier, B.Q., Corren, J., Lumry, W., Liu, J., Fowler-Taylor, A. and Gupta, N. (2003) Omalizumab is effective in the long-term control of severe allergic asthma. Ann Allergy Asthma Immunol 91: 154-159.
43. Lanier, B.Q. and Chang, T.W. (2004) Will anti-IgE therapy compromise normal immune functions?. Allergy Clin Immunol Int: J World Allergy Org 16: 237-240.
44. Larché, M., Robinson, D.S. and Kay, A.B. (2003) The role of T lymphocytes in the pathogenesis of asthma. J Allergy Clin Immunol 111: 450-463.
45. Marcus, P. (2006) Incorporating anti-IgE (omalizumab) therapy in clinical practice: practice management implications. Chest 129: 466-474.
46. Masoli, M., Fabian, D., Holt, S. and Beasley, R. (2004) The global burden of asthma: executive summary of the GINA dissemination committee report. Allergy 59: 469-478.
47. McDanel, D.L. and Muller, B.A. (2005) The linkage between Churg-Strauss syndrome and leukotriene receptor antagonists: fact or fiction? Ther Clin Risk Manag 1: 125-140.
48. Miller, C.W.T., Krishnaswamy, N., Johnston, C. and Krishnaswamy, G. (2008) Severe asthma and the omalizumab option. Clin Mol Allergy 6: 4.
49. Molimard, M., de Blay, F., Didier, A. and Le Gros, V. (2008) Effectiveness of omalizumab (Xolair) in the first patients treated in real-life practice in France. Respir Med 102: 71-76.
50. National Health Interview Survey (2003- 2005) Asthma prevalence, health care use, and mortality: United States, 2003-05. National Center for Health Statistics. Available at: http://www.cdc.gov/nhcs/products/pubs/pubd/hestats/asthma03-05/asthma03-05.htm
51. Niven, R., Chung, K.F., Panahloo, Z., Blogg, M. and Ayre, G. (2008) Effectiveness of omalizumab in patients with inadequately controlled severe persistent allergic asthma: an open-label study. Respir Med 102: 1371-1378.
52. No authors listed (2002) Omalizumab: anti-IgE monoclonal antibody E25, E25 humanised anti-IgE Mab, IgE 025, monoclonal antibody E25, Omalizumab, Xolair, rhuMab-E25. BioDrugs 16: 380-386.
53. Noga, O., Hanf, G. and Kunkel, G. (2003) Immunological and clinical changes in allergic asthmatics following treatment with omalizumab. Int Arch Allergy Immunol 131: 46-52.
54. Noga, O., Hanf, G., Brachmann, I., Klucken, A.C., Kleine-Tebbe, J., Rosseau, S. et al. (2006) Effect of omalizumab treatment on peripheral eosinophil and T-lymphocyte function in patients with allergic asthma. J Allergy Clin Immunol 117: 1493-1499.
55. Nopp, A., Johansson, S.G.O., Ankerst, J., Palmqvist, M. and Oman, H. (2007) CD-sens and clinical changes during withdrawal of Xolair after 6 years of treatment. Allergy 62: 1175-1181.
56. Pabst, S., Tiyerili, V. and Grohé, C. (2008) Apparent response to anti-IgE therapy in two patients with refractory ’forme fruste’ of Churg-Strauss syndrome. Thorax 63: 747-748.
57. Parks, K.W. and Casale, T.B. (2006) Anti-immunoglobulin E monoclonal antibody administered with immunotherapy. Allergy Asthma Proc 27: S33-S36.
58. Pascual, R.M. and Peters, S.P. (2005) Airway remodeling contributes to the progressive loss of lung function in asthma: an overview. J Allergy Clin Immunol 116: 477-486.
59. Pelaia, G., Vatrella, A., Calabrese, C., Mazzarella, G. and Marsico, S.A. (2000) New perspectives in asthma treatment. Allergy 55(Suppl. 61): 60-66.
60. Presta, L.G., Lahr, S.J., Shields, R.L., Porter, J.P., Gorman, C.M., Fendly, B.M. et al. (1993) Humanization of an antibody directed against IgE. J Immunol 151: 2623-2632.
61. Presta, L., Shields, R., O'Connell, L., Lahr, S., Porter, J., Gorman, C. et al. (1994). The binding site of a human immunoglobulin E for its high affinity receptor. J Biol Chem 269: 26368-26373.
62. Price, D. (2008) The use of omalizumab in asthma. Prim Care Respir J 17: 62-72.
63. Price, K.S. and Hamilton, R.G. (2007) Anaphylactoid reactions in two patients after omalizumab administration after successful long-term therapy. Allergy Asthma Proc 28: 313-319.
64. Prieto, L., Gutiérrez, V., Colas, C., Tabar, A., Pérez-Francés, C., Bruno, L. et al. (2006) Effect of omalizumab on adenosine 5’-monophosphate responsiveness in subjects with allergic asthma. Int Arch Allergy Immunol 139: 122-131.
65. Puéchal, X., Rivereau, P. and Vinchon, F. (2008) Churg-Strauss syndrome associated with omalizumab. Eur J Intern Med 19: 364-366.
66. Ruppert, A.M., Averous, G., Stanciu, D., Deroide, N., Riehm, S., Poindron, V. et al. (2008) Development of Churg-Strauss syndrome with controlled asthma during omalizumab treatment. J Allergy Clin Immunol 121: 253-254.
67. Saini, S.S., MacGlashan Jr., D.W., Sterbinsky, S.A., Togias, A., Adelman, D.C., Lichtenstein, L.M. et al. (1999) 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 162: 5624-5639.
68. Silkoff, P.E., Romeo, F.A., Gupta, N., Townley, R.G. and Milgrom, H. (2004) Exhaled nitric oxide in children with asthma receiving Xolair (omalizumab), a monoclonal anti-immunoglobulin E antibody. Pediatrics 113: e308-e312.
69. Solér, M., Matz, J., Townley, R., Buhl, R., O'Brien, J., Fox, H. et al. (2001) The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J 18: 254-261.
70. Spector, S. (2004) Omalizumab efficacy in allergic disease. Panminerva Med 46: 141-148.
71. Sullivan, S.D. and Turk, F. (2008) An evaluation of the cost-effectiveness of omalizumab for the treatment of severe allergic asthma. Allergy 63: 670-684.
72. Tarantini, F., Baiardini, I., Passalacqua, G., Braido, F. and Canonica, GW (2007) Asthma treatment: ’magic bullets which seek their own targets’. Allergy 62: 605-610.
73. Taylor, D.R., Bateman, E.D., Boulet, L.P., Boushey, H.A., Busse, W.W., Casale, T.B. et al. (2008) A new perspective on concepts of asthma severity and control. Eur Respir J 32: 545-554.
74. Verbruggen, K., Van Cauwenberge, P. and Bachert, C. (2009) Anti-IgE for the treatment of allergic rhinitis - and eventually nasal polyps?. Int Arch Allergy Immunol 148: 87-98.
75. Vignola, A.M., Humbert, M., Bousquet, J., Boulet, L.P., Hedgecock, S., Blogg, M. et al. (2004) Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with concomitant allergic asthma and persistent allergic rhinitis: SOLAR. Allergy 59: 709-717.
76. Wenzel, S.E., Fahy, J.V., Irvin, C.G., Peters, S.P., Spector, S. and Szefler, S.J. (2000) Proceedings of the ATS workshop on refractory asthma: current understanding, recommendations and unanswered questions. Am J Respir Crit Care Med 162: 2341-2351.
77. Wenzel, S.E. and Busse, W.W. (2007) Severe asthma: lessons from the severe asthma research program. J Allergy Clin Immunol 119: 14-21.
78. Winchester, D.E. (2006) Omalizumab for asthma. N Engl J Med 355: 1281-1282.