Effectiveness and Safety of Omalizumab in Treating Allergy Bronchial Asthma: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

MAI Lin , SUN Rongfei ,  LI Weimin

Respiratory Department, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

LI Weimin, Email: weimi003@yahoo.com

Keywords：

Omalizumab; Anti-IgE; Allergic bronchial asthma; Systematic review; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.20130126

Video：

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Objective 　To systematically evaluate the effectiveness and safety of omalizumab in treating allergic bronchial asthma.
Methods 　The randomized controlled trials (RCTs) about omalizumab in treating allergic bronchial asthma were searched in databases such as MEDILINE, EMbase, The Cochrane Library, CBM, CNKI, VIP and WanFang Data from inception to April 2013. The references of included studies and relevant conference proceedings were also retrieved manually. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and assessed the quality, and then RevMan 5.1 software was used for meta-analysis.
Results 　A total of 13 RCTs involving 4 195 patients were included. The results of meta-analysis showed that: a) Compared with the control group, the trial group revealed lower acute exacerbation of asthma during treatment (RR=0.71, 95%CI 0.65 to 0.77, P lt;0.000 01), and higher rate of patients achieved best/better results in Global Evaluation of Treatment Effectiveness (GETE) (RR=1.61, 95%CI 1.32 to 1.97, P lt;0.000 01). More patients could reduce the inhaled cortisteroid (ICS) by 50% during both treatment (RR=1.40, 95%CI 1.29 to 1.52) and 24-week follow-up period (RR=1.69, 95%CI 1.41 to 2.03). And it also increased the ratio of patients whose Asthma Quality Of Life Questionnaire (AQLQ) score got improved by 0.5 and 1.5 socres. b) There were no significant differences in the incidence of overall adverse events (RR=1.01, 95%CI 0.98 to 1.04) and severe adverse events (RR=0.94, 95CI 0.68 to 1.28). c) There might be the effects of omalzumab in improving lung function and reducing rescue medication use, but they were not obviously observed in the studies.
Conclusion 　In the treatment of asthma, omalizumab can decrease the acute exacerbation of asthma and ICS use, and it is safer to improve the therapeutic effects and quality of life.

Citation： MAI Lin,SUN Rongfei,LI Weimin. Effectiveness and Safety of Omalizumab in Treating Allergy Bronchial Asthma: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2013, 13(6): 709-716. doi: 10.7507/1672-2531.20130126 Copy

1.	GINA report, global strategy for asthma management and prevention. www.ginasthma.com, 2010. Accessed February 25, 2012.
2.	Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. Issued 1995 (NIH pub no. 02–3659); Accessed December 2011.
3.	Prussin C, Metcalfe DD. IgE, mast cells, basophils, and eosinophils. J Allergy Clin Immunol, 2003, 111(2): S486-494.
4.	Chanez P, Contin-Bordes Cc, Garcia G, et al. Omalizumab-induced decrease of FcεRI expression in patients with severe allergic asthma. Respir Med, 2010, 104(11): 1608-1617.
5.	Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated March 2011]. The Cochrane Collaboration, 2011. Available from: http:// www.cochrane-handbook.org.
6.	Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Official Journal of the European Society for Clinical Respiratory Physiology, 2001, 18(2): 254-261.
7.	Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. The Journal of Allergy and Clinical Immunology, 2001, 108(2): 184-190.
8.	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(4): 632-638.
9.	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(7): 701-708.
10.	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(7): 709-717.
11.	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(3): 309-316.
12.	Kopp MV, Hamelmann E, Zielen S, et al. Combination of omalizumab and specific immunotherapy is superior to immunotherapy in patients with seasonal allergic rhinoconjunctivitis and co-morbid seasonal allergic asthma. Clin Exp Allergy, 2009, 39(2): 271-279.
13.	Ohta K, Miyamoto T, Amagasaki T, et al. Efficacy and safety of omalizumab in an Asian population with moderate-to-severe persistent asthma. Respirology, 2009, 14(8): 1156-1165.
14.	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(9): 573-582.
15.	Hoshino M, Ohtawa J. Effects of adding omalizumab, an anti-immunoglobulin E antibody, on airway wall thickening in asthma. Respiration, 2012, 83(6): 520-528.
16.	Rubin AS, Souza-Machado A, Andradre-Lima M, et al. Effect of omalizumab as add-on therapy on asthma-related quality of life in severe allergic asthma: a Brazilian study (QUALITX). Journal of Asthma, 2012, 49(3): 288-293.
17.	Bardelas J, Figliomeni M, Kianifard F, et al. A 26-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the effect of omalizumab on asthma control in patients with persistent allergic asthma. J Asthma, 2012, 49(2): 144-152.
18.	Buhl R, Soler M, Matz J, et al. Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma. Eur Respir J, 2002, 20(1): 73-78.
19.	Lanier BQ, Corren J, Lumry W, et al. Omalizumab is effective in the long-term control of severe allergic asthma. Ann Allergy Asthma Immunol, 2003, 91(2): 154-159.
20.	Juniper EF, Guyatt GH, Epstein RS, et al. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax, 1992, 47(2): 76–83.
21.	Buhl R, Hanf G, Soler M, et al. The anti-IgE antibody omalizumab improves asthma-related quality of life in patients with allergic asthma. Eur Respir J, 2002, 20(5): 1088-1094.
22.	Finn A, Gross G, van Bavel J, et al. Omalizumab improves asthma-related quality of life in patients with severe allergic asthma. J Allergy Clin Immunol, 2003, 111(2): 278-284.
23.	Hendeles L, Sorkness CA. Anti-immunoglobulin E therapy with omalizumab for asthma. The Annals of Pharmacotherapy, 2007, 41(9): 1397-1410.
24.	Siergiejko Z, Swiebocka E, Smith N, et al. Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients. Curr Med Res Opin, 2011, 27(11): 2223-2228.
25.	Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics, 2001, 108(2): E36.
26.	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(6): 1210-1216.
27.	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(11): 1005-1015.
28.	Bousquet J, Siergiejko Z, Swiebocka E, et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy, 2011, 66(5): 671-678.
29.	Menzella F, Facciolongo N, Piro R, et al. Clinical and pharmacoeconomic aspects of omalizumab: a 4-year follow-up. Therapeutic Advances in Respiratory Disease, 2012, 6(2): 87-95.
30.	Tzortzaki EG, Georgiou A, Kampas D, et al. Long-term omalizumab treatment in severe allergic asthma: The South-Eastern Mediterranean “real-life” experience. Pulmonary Pharmacology & Therapeutics, 2012, 25(1): 77-82.
31.	Grossman HL, Schlender A, Alperin P, et al. Modeling the effects of omalizumab over 5 years among patients with moderate-to-severe persistent allergic asthma. Current Medical Research & Opinion, 2010, 26(12): 2779-2793.
32.	Brown R, Turk F, Dale P, et al. Cost-effectiveness of omalizumab in patients with severe persistent allergic asthma. Allergy, 2007, 62(2): 149-153.
33.	Sthoeger ZM, Eliraz A, Asher I, et al. The beneficial effects of Xolair (omalizumab) as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available treatment (GINA 2002 step IV)--the Israeli arm of the INNOVATE study. IMAJ, 2007, 9(6): 472-475.
34.	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(2): 265-269.
35.	Slavin RG, Ferioli C, Tannenbaum SJ, et al. Asthma symptom re-emergence after omalizumab withdrawal correlates well with increasing IgE and decreasing pharmacokinetic concentrations. J Allergy Clin Immunol, 2009, 123(1): 107-113.
36.	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(6): 1493-1499.
37.	van Rensen EL, Evertse CE, van Schadewijk WA, et al. Eosinophils in bronchial mucosa of asthmatics after allergen challenge: effect of anti-IgE treatment. Allergy, 2009, 64(1): 72-80.

1. GINA report, global strategy for asthma management and prevention. www.ginasthma.com, 2010. Accessed February 25, 2012.
2. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. Issued 1995 (NIH pub no. 02–3659); Accessed December 2011.
3. Prussin C, Metcalfe DD. IgE, mast cells, basophils, and eosinophils. J Allergy Clin Immunol, 2003, 111(2): S486-494.
4. Chanez P, Contin-Bordes Cc, Garcia G, et al. Omalizumab-induced decrease of FcεRI expression in patients with severe allergic asthma. Respir Med, 2010, 104(11): 1608-1617.
5. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated March 2011]. The Cochrane Collaboration, 2011. Available from: http:// www.cochrane-handbook.org.
6. Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Official Journal of the European Society for Clinical Respiratory Physiology, 2001, 18(2): 254-261.
7. Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. The Journal of Allergy and Clinical Immunology, 2001, 108(2): 184-190.
8. 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(4): 632-638.
9. 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(7): 701-708.
10. 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(7): 709-717.
11. 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(3): 309-316.
12. Kopp MV, Hamelmann E, Zielen S, et al. Combination of omalizumab and specific immunotherapy is superior to immunotherapy in patients with seasonal allergic rhinoconjunctivitis and co-morbid seasonal allergic asthma. Clin Exp Allergy, 2009, 39(2): 271-279.
13. Ohta K, Miyamoto T, Amagasaki T, et al. Efficacy and safety of omalizumab in an Asian population with moderate-to-severe persistent asthma. Respirology, 2009, 14(8): 1156-1165.
14. 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(9): 573-582.
15. Hoshino M, Ohtawa J. Effects of adding omalizumab, an anti-immunoglobulin E antibody, on airway wall thickening in asthma. Respiration, 2012, 83(6): 520-528.
16. Rubin AS, Souza-Machado A, Andradre-Lima M, et al. Effect of omalizumab as add-on therapy on asthma-related quality of life in severe allergic asthma: a Brazilian study (QUALITX). Journal of Asthma, 2012, 49(3): 288-293.
17. Bardelas J, Figliomeni M, Kianifard F, et al. A 26-week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the effect of omalizumab on asthma control in patients with persistent allergic asthma. J Asthma, 2012, 49(2): 144-152.
18. Buhl R, Soler M, Matz J, et al. Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma. Eur Respir J, 2002, 20(1): 73-78.
19. Lanier BQ, Corren J, Lumry W, et al. Omalizumab is effective in the long-term control of severe allergic asthma. Ann Allergy Asthma Immunol, 2003, 91(2): 154-159.
20. Juniper EF, Guyatt GH, Epstein RS, et al. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax, 1992, 47(2): 76–83.
21. Buhl R, Hanf G, Soler M, et al. The anti-IgE antibody omalizumab improves asthma-related quality of life in patients with allergic asthma. Eur Respir J, 2002, 20(5): 1088-1094.
22. Finn A, Gross G, van Bavel J, et al. Omalizumab improves asthma-related quality of life in patients with severe allergic asthma. J Allergy Clin Immunol, 2003, 111(2): 278-284.
23. Hendeles L, Sorkness CA. Anti-immunoglobulin E therapy with omalizumab for asthma. The Annals of Pharmacotherapy, 2007, 41(9): 1397-1410.
24. Siergiejko Z, Swiebocka E, Smith N, et al. Oral corticosteroid sparing with omalizumab in severe allergic (IgE-mediated) asthma patients. Curr Med Res Opin, 2011, 27(11): 2223-2228.
25. Milgrom H, Berger W, Nayak A, et al. Treatment of childhood asthma with anti-immunoglobulin E antibody (omalizumab). Pediatrics, 2001, 108(2): E36.
26. 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(6): 1210-1216.
27. 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(11): 1005-1015.
28. Bousquet J, Siergiejko Z, Swiebocka E, et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy, 2011, 66(5): 671-678.
29. Menzella F, Facciolongo N, Piro R, et al. Clinical and pharmacoeconomic aspects of omalizumab: a 4-year follow-up. Therapeutic Advances in Respiratory Disease, 2012, 6(2): 87-95.
30. Tzortzaki EG, Georgiou A, Kampas D, et al. Long-term omalizumab treatment in severe allergic asthma: The South-Eastern Mediterranean “real-life” experience. Pulmonary Pharmacology & Therapeutics, 2012, 25(1): 77-82.
31. Grossman HL, Schlender A, Alperin P, et al. Modeling the effects of omalizumab over 5 years among patients with moderate-to-severe persistent allergic asthma. Current Medical Research & Opinion, 2010, 26(12): 2779-2793.
32. Brown R, Turk F, Dale P, et al. Cost-effectiveness of omalizumab in patients with severe persistent allergic asthma. Allergy, 2007, 62(2): 149-153.
33. Sthoeger ZM, Eliraz A, Asher I, et al. The beneficial effects of Xolair (omalizumab) as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available treatment (GINA 2002 step IV)--the Israeli arm of the INNOVATE study. IMAJ, 2007, 9(6): 472-475.
34. 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(2): 265-269.
35. Slavin RG, Ferioli C, Tannenbaum SJ, et al. Asthma symptom re-emergence after omalizumab withdrawal correlates well with increasing IgE and decreasing pharmacokinetic concentrations. J Allergy Clin Immunol, 2009, 123(1): 107-113.
36. 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(6): 1493-1499.
37. van Rensen EL, Evertse CE, van Schadewijk WA, et al. Eosinophils in bronchial mucosa of asthmatics after allergen challenge: effect of anti-IgE treatment. Allergy, 2009, 64(1): 72-80.

Chinese Journal of Evidence-Based Medicine

Effectiveness and Safety of Omalizumab in Treating Allergy Bronchial Asthma: A Systematic Review

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