Anti-Immunoglobulin E Therapy

World Allergy Organization Journal

Thomas B Casale¹  Jeffrey R Stokes¹  Manav Segal¹ 

[1] Division of Allergy and Immunology, Department of Medicine, Creighton University School of Medicine, 601 North 30th Street, Suite 3M100, Omaha, NE 68131

关键词: safety;    asthma;    omalizumab;    anti-IgE;   

Others  :  824468
DOI  :  10.1097/WOX.0b013e318187a310

 received in 2008-05-11, accepted in 2008-07-21,  发布年份 2008

【 摘 要 】

The importance of immunoglobulin E (IgE) in atopic disorders such as asthma, allergic rhinitis, food allergies, and atopic dermatitis is well established. Elevation of total serum IgE is typically found in many atopic patients, and in predisposed individuals, allergen-specific IgE is produced. The availability of humanized monoclonal antibodies against IgE has provided a new therapeutic option and tool to explore the role IgE in allergic diseases and the effects of inhibiting IgE itself. Omalizumab is a humanized, monoclonal antibody that recognizes and binds to the Fc portion of the IgE molecule. Administration of omalizumab results in a rapid and substantial decrease in free IgE in serum. Consequently, the activity of cell populations involved in allergic inflammation, including mast cells, eosinophils, basophils, and antigen-presenting cells, is affected as well. Clinically, anti-IgE therapy has already been proven to be useful in the treatment of asthma and allergic rhinitis. The aim of this review is to provide an overview of the mechanisms of action of anti-IgE therapy as well as its efficacy in the treatment of allergic diseases, especially asthma. Considerations regarding dosing and safety of omalizumab will be addressed as well.

【 授权许可】

   
2008 World Allergy Organization; licensee BioMed Central Ltd.

【 图 表 】

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【 参考文献 】

• [1]Ishizaka K, Ishizaka T, Terry WD: Antigenic structure of gamma-E-globulin and reaginic antibody. J Immunol 1967, 99:849-858.
• [2]Brownell J, Casale TB: Anti-IgE therapy. Immunol Allergy Clin North Am 2004, 24:551-568. v
• [3]Boushey HA Jr: Experiences with monoclonal antibody therapy for allergic asthma. J Allergy Clin Immunol 2001, 108:S77-S83.
• [4]Presta LG, Lahr SJ, Shields RL, et al.: Humanization of an antibody directed against IgE. J Immunol 1993, 151:2623-2632.
• [5]Shields RL, Whether WR, Zioncheck K, et al.: Inhibition of allergic reactions with antibodies to IgE. Int Arch Allergy Immunol 1995, 107:308-312.
• [6]Liu J, Lester P, Builder S, Shire SJ: Characterization of complex formation by humanized anti-IgE monoclonal antibody and monoclonal human IgE. Biochemistry 1995, 34:10474-10482.
• [7]Easthope S, Jarvis B: Omalizumab. Drugs 2001, 61:253-260. [discussion 61]
• [8]MacGlashan D Jr, Lichtenstein LM, McKenzie-White J, et al.: Upregulation of FcepsilonRI on human basophils by IgE antibody is mediated by interaction of IgE with FcepsilonRI. J Allergy Clin Immunol 1999, 104:492-498.
• [9]Tsicopoulos A, Joseph M: The role of CD23 in allergic disease. Clin Exp Allergy 2000, 30:602-605.
• [10]Saini SS, MacGlashan DW Jr, Sterbinsky SA, et al.: Down-regulation of human basophil IgE and FC epsilon RI alpha surface densities and mediator release by anti-IgE-infusions is reversible in vitro and in vivo. J Immunol 1999, 162:5624-5630.
• [11]Lin H, Boesel KM, Griffith DT, et al.: Omalizumab rapidly decreases nasal allergic response and FcepsilonRI on basophils. J Allergy Clin Immunol 2004, 113:297-302.
• [12]Prussin C, Griffith DT, Boesel KM, Lin H, Foster B, Casale TB: Omalizumab treatment downregulates dendritic cell FcepsilonRI expression. J Allergy Clin Immunol 2003, 112:1147-1154.
• [13]Beck LA, Marcotte GV, MacGlashan D, Togias A, Saini S: Omalizumabinduced reductions in mast cell Fce psilon RI expression and function. J Allergy Clin Immunol 2004, 114:527-530.
• [14]Maurer D, Fiebiger E, Reininger B, et al.: Fc epsilon receptor I on dendritic cells delivers IgE-bound multivalent antigens into a cathepsin S-dependent pathway of MHC class II presentation. J Immunol 1998, 161:2731-2739.
• [15]Rissoan MC, Soumelis V, Kadowaki N, et al.: Reciprocal control of T helper cell and dendritic cell differentiation. Science 1999, 283:1183-1186.
• [16]Foster B, Metcalfe DD, Prussin C: Human dendritic cell 1 and dendritic cell 2 subsets express FcepsilonRI: correlation with serum IgE and allergic asthma. J Allergy Clin Immunol 2003, 112:1132-1138.
• [17]Cheng YX, Foster B, Holland SM, et al.: CD2 identifies a monocyte subpopulation with immunoglobulin E-dependent, high-level expression of Fc epsilon RI. Clin Exp Allergy 2006, 36:1436-1445.
• [18]Ong YE, Menzies-Gow A, Barkans J, et al.: Anti-IgE (omalizumab) inhibits late-phase reactions and inflammatory cells after repeat skin allergen challenge. J Allergy Clin Immunol 2005, 116:558-564.
• [19]Silkoff PE, Romero FA, Gupta N, Townley RG, Milgrom H: Exhaled nitric oxide in children with asthma receiving Xolair (omalizumab), a monoclonal anti-immunoglobulin E antibody. Pediatrics 2004, 113:e308-e312.
• [20]Plewako H, Arvidsson M, Petruson K, et al.: The effect of omalizumab on nasal allergic inflammation. J Allergy Clin Immunol 2002, 110:68-71.
• [21]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, 155:1828-1834.
• [22]Noga O, Hanf G, Kunkel G: Immunological and clinical changes in allergic asthmatics following treatment with omalizumab. Int Arch Allergy Immunol 2003, 131:46-52.
• [23]Hanf G, Brachmann I, Kleine-Tebbe J, et al.: Omalizumab decreased IgE-release and induced changes in cellular immunity in patients with allergic asthma. Allergy 2006, 61:1141-1144.
• [24]Djukanovic R, Wilson SJ, Kraft M, et al.: Effects of treatment with anti-immunoglobulin E antibody omalizumab on airway inflammation in allergic asthma. Am J Respir Crit Care Med 2004, 170:583-593.
• [25]Prieto L, Gutierrez V, Colas C, et al.: Effect of omalizumab on adenosine 5Ô-monophosphate responsiveness in subjects with allergic asthma. Int Arch Allergy Immunol 2006, 139:122-131.
• [26]Boulet LP, Chapman KR, Cote J, et al.: Inhibitory effects of an anti-IgE antibody E25 on allergen-induced early asthmatic response. Am J Respir Crit Care Med 1997, 155:1835-1840.
• [27]Kitaura J, Song J, Tsai M, et al.: 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 2003, 100:12911-12916.
• [28]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, 117:1493-1499.
• [29]Stokes JR, Casale TB: Anti-IgE therapy. In Middleton's allergy principles & practice. 7th edition. Philadelphia (PA): Elsevier; 2008:in press.
• [30]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, 108:184-190.
• [31]Milgrom H, Berger W, Nayak A, et al.: Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics 2001, 108-E36.
• [32]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, 18:254-261.
• [33]Corren J, Casale T, Deniz Y, Ashby M: Omalizumab, a recombinant humanized anti-IgE antibody, reduces asthma-related emergency room visits and hospitalizations in patients with allergic asthma. J Allergy Clin Immunol 2003, 111:87-90.
• [34]Bousquet J, Wenzel S, Holgate S, Freeman P, Fox H: Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma. Chest 2004, 125:1378-1386.
• [35]Holgate S, Bousquet J, Wenzel S, Fox H, Liu J, Castellsague J: Efficacy of omalizumab, an anti-immunoglobulin E antibody, in patients with allergic asthma at high risk of serious asthma-related morbidity and mortality. Curr Med Res Opin 2001, 17:233-240.
• [36]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, 34:632-638.
• [37]Oba Y, Salzman GA: Cost-effectiveness analysis of omalizumab in adults and adolescents with moderate-to-severe allergic asthma. J Allergy Clin Immunol 2004, 114:265-269.
• [38]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, 59:701-708.
• [39]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, 60:309-316.
• [40]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, 60:302-308.
• [41]Casale TB, Condemi J, LaForce C, et al.: Effect of omalizumab on symptoms of seasonal allergic rhinitis: a randomized controlled trial. JAMA 2001, 286:2956-2967.
• [42]Adelroth E, Rak S, Haahtela T, et al.: Recombinant humanized mAb-E25, an anti-IgE mAb, in birch pollen-induced seasonal allergic rhinitis. J Allergy Clin Immunol 2000, 106:253-259.
• [43]Hanf G, Noga O, O'Connor A, Kunkel G: Omalizumab inhibits allergen challenge-induced nasal response. Eur Respir J 2004, 23:414-418.
• [44]Okubo K, Ogino S, Nagakura T, Ishikawa T: Omalizumab is effective and safe in the treatment of Japanese cedar pollen-induced seasonal allergic rhinitis. Allergol Int 2006, 55:379-386.
• [45]Nagakura T, Ogino S, Okubo K, Sato N, Takahashi M, Ishikawa T: Omalizumab is more effective than suplatast tosilate in the treatment of Japanese cedar pollen-induced seasonal allergic rhinitis. Clin Exp Allergy 2008, 38:329-337.
• [46]Chervinsky P, Casale T, Townley R, et al.: Omalizumab, an anti-IgE antibody, in the treatment of adults and adolescents with perennial allergic rhinitis. Ann Allergy Asthma Immunol 2003, 91:160-167.
• [47]Bousquet J, Van Cauwenberge P, Khaltaev N: Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol 2001, 108:S147-334.
• [48]Corren J, Manning BE, Thompson SF, Hennessy S, Strom BL: Rhinitis therapy and the prevention of hospital care for asthma: a case-control study. J Allergy Clin Immunol 2004, 113:415-419.
• [49]Dykewicz M: Rhinitis and sinusitis.Implications for severe asthma. Immunol Allergy Clin North Am 2001, 21:427-436.
• [50]Greenberger PA: Interactions between rhinitis and asthma. Allergy Asthma Proc 2004, 25:89-93.
• [51]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, 59:709-717.
• [52]Akdis CA, Blesken T, Akdis M, Wuthrich B, Blaser K: Role of interleukin 10 in specific immunotherapy. J Clin Invest 1998, 102:98-106.
• [53]Muller U, Akdis CA, Fricker M, et al.: Successful immunotherapy with T-cell epitope peptides of bee venom phospholipase A2 induces specific T-cell anergy in patients allergic to bee venom. J Allergy Clin Immunol 1998, 101:747-754.
• [54]Yssel H, Lecart S, Pene J: Regulatory T cells and allergic asthma. Microbes Infect 2001, 3:899-904.
• [55]Guerra F, Carracedo J, Solana-Lara R, Sanchez-Guijo P, Ramirez R: Th2 lymphocytes from atopic patients treated with immunotherapy undergo rapid apoptosis after culture with specific allergens. J Allergy Clin Immunol 2001, 107:647-653.
• [56]Gehlhar K, Schlaak M, Becker W, Bufe A: Monitoring allergen immunotherapy of pollen-allergic patients: the ratio of allergen-specific IgG4 to IgG1 correlates with clinical outcome. Clin Exp Allergy 1999, 29:497-506.
• [57]Durham SR, Till SJ: Immunologic changes associated with allergen immunotherapy. J Allergy Clin Immunol 1998, 102:157-164.
• [58]Kuehr J, Brauburger J, Zielen S, et al.: Efficacy of combination treatment with anti-IgE plus specific immunotherapy in polysensitized children and adolescents with seasonal allergic rhinitis. J Allergy Clin Immunol 2002, 109:274-280.
• [59]Rolinck-Werninghaus C, Hamelmann E, Keil T, et al.: 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, 59:973-979.
• [60]Casale TB, Busse WW, Kline JN, et al.: Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis. J Allergy Clin Immunol 2006, 117:134-140.
• [61]Leung DY, Nicklas RA, Li JT, et al.: Disease management of atopic dermatitis: an updated practice parameter. Joint Task Force on Practice Parameters. Ann Allergy Asthma Immunol 2004, 93:S1-21.
• [62]Novak N, Bieber T: Allergic and nonallergic forms of atopic diseases. J Allergy Clin Immunol 2003, 112:252-262.
• [63]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.
• [64]Vigo PG, Girgis KR, Pfuetze BL, Critchlow ME, Fisher J, Hussain I: Efficacy of anti-IgE therapy in patients with atopic dermatitis. J Am Acad Dermatol 2006, 55:168-170.
• [65]Krathen RA, Hsu S: Failure of omalizumab for treatment of severe adult atopic dermatitis. J Am Acad Dermatol 2005, 53:338-340.
• [66]Belloni B, Ziai M, Lim A, et al.: Low-dose anti-IgE therapy in patients with atopic eczema with high serum IgE levels. J Allergy Clin Immunol 2007, 120:1223-1225.
• [67]Leung DY, Sampson HA, Yunginger JW, et al.: Effect of anti-IgE therapy in patients with peanut allergy. N Engl J Med 2003, 348:986-993.
• [68]Sampson HA: Food allergy. J Allergy Clin Immunol 2003, 111:S540-S547.
• [69]Kontou-Fili K: High omalizumab dose controls recurrent reactions to venom immunotherapy in indolent systemic mastocytosis. Allergy 2008, 63:376-378.
• [70]Schulze J, Rose M, Zielen S: Beekeepers anaphylaxis: successful immunotherapy covered by omalizumab. Allergy 2007, 62:963-964.
• [71]Grundmann SA, Hemfort PB, Luger TA, Brehler R: Anti-IgE (omalizumab): a new therapeutic approach for chronic rhinosinusitis. J Allergy Clin Immunol 2008, 121:257-258.
• [72]Penn R, Mikula S: The role of anti-IgE immunoglobulin therapy in nasal polyposis: a pilot study. Am J Rhinol 2007, 21:428-432.
• [73]Metz M, Bergmann P, Zuberbier T, Maurer M: Successful treatment of cholinergic urticaria with anti-immunoglobulin E therapy. Allergy 2008, 63:247-249.
• [74]Spector SL, Tan RA: Effect of omalizumab on patients with chronic urticaria. Ann Allergy Asthma Immunol 2007, 99:190-193.
• [75]Sands MF, Blume JW, Schwartz SA: Successful treatment of 3 patients with recurrent idiopathic angioedema with omalizumab. J Allergy Clin Immunol 2007, 120:979-981.
• [76]Foroughi S, Foster B, Kim N, et al.: Anti-IgE treatment of eosinophilassociated gastrointestinal disorders. J Allergy Clin Immunol 2007, 120:594-601.
• [77]Siebenhaar F, Kuhn W, Zuberbier T, Maurer M: Successful treatment of cutaneous mastocytosis and Meniere disease with anti-IgE therapy. J Allergy Clin Immunol 2007, 120:213-215.
• [78]Leynadier F, Doudou O, Gaouar H, et al.: Effect of omalizumab in health care workers with occupational latex allergy. J Allergy Clin Immunol 2004, 113:360-361.
• [79]van der Ent CK, Hoekstra H, Rijkers GT: Successful treatment of allergic bronchopulmonary aspergillosis with recombinant anti-IgE antibody. Thorax 2007, 62:276-277.
• [80]Xolair (omalizumab) East Hanover (NJ): Aventis; 2006. [package insert]
• [81]Strunk RC, Bloomberg GR: Omalizumab for asthma. N Engl J Med 2006, 354:2689-2695.
• [82]Hamilton RG: Accuracy of US Food and Drug Administration-cleared IgE antibody assays in the presence of anti-IgE (omalizumab). J Allergy Clin Immunol 2006, 117:759-766.
• [83]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, 121:506-511.
• [84]Nopp A, Johansson SG, Ankerst J, Palmqvist M, Oman H: CD-sens and clinical changes during withdrawal of Xolair after 6 years of treatment. Allergy 2007, 62:1175-1181.
• [85]Prescribing information: summary of product characteristics Available at: http://www.xolair.com webcite
• [86]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, 91:182-188.
• [87]Chipps B: Systemic reaction to omalizumab. Ann Allergy Asthma Immunol 2006, 97:267.
• [88]Pilette C, Coppens N, Houssiau FA, Rodenstein DO: Severe serum sickness-like syndrome after omalizumab therapy for asthma. J Allergy Clin Immunol 2007, 120:972-973.
• [89]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 Joint Task Force Report on omalizumab-associated anaphylaxis. J Allergy Clin Immunol 2007, 120:1373-1377.
• [90]Limb SL, Starke PR, Lee CE, Chowdhury BA: Delayed onset and protracted progression of anaphylaxis after omalizumab administration in patients with asthma. J Allergy Clin Immunol 2007, 120:1378-1381.
• [91]Cruz AA, Lima F, Sarinho E, et al.: Safety of anti-immunoglobulin E therapy with omalizumab in allergic patients at risk of geohelminth infection. Clin Exp Allergy 2007, 37:197-207.