The Efficacy of Omalizumab in Patients with Severe Allergic Asthma: A Meta-analysis_Chinese Journal of Respiratory and Critical Care Medicine

Authors：

MiaoWeiwei ^1,2 , WangFengfeng ¹ , ChenZi ¹ , MaYuan ¹ , XieLinyan ³ , SongLili ³ , ChenYuping ³ , HuangMao ¹ ,  ZhouLinfu ^1,3

1. Department of Respiratory Medicine, The First Affiliated Hospital, Nanjing Medical University, Nanjing, Jiangsu, 210029, China;
2. ;
3. ;

Corresponding author：

ZhouLinfu, Email: lfzhou@njmu.edu.cn

Keywords：

Severe asthma; Omalizumab; IgE; Anti-IgE antibody; Meta analysis

DOI：

10.7507/1671-6205.2015111

Video：

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Objective To determine the efficacy of omalizumab in patients (12~75 years of age) with severe allergic asthma, and guide its clinical application. Methods Databases, including Pubmed, Web of Science and Embase, were searched to collect randomized controlled trials (RCTs).Data were extracted, and the quality of included RCTs was assessed by two reviewers, followed by meta-analyses using Review Manage 5.1 software. Results Meta-analyses of ten included RCTs showed that, compared with placebo, omalizumab reduced the rate of exacerbation per patient during both stable-steroid phase [RR=0.56, 95% CI(0.42, 0.75), P < 0.000 1] and steroid-reduction phase for patients with severe asthma [RR=0.53, 95% CI(0.48, 0.60), P < 0.000 01], reduced the number of patients experienced at least one exacerbation [RR=0.71, 95% CI(0.61, 0.84), P < 0.000 01], and significantly reduced the dosage of beclomethasone dipropionate (≥50%) [RR=1.51, 95% CI(1.24, 1.84), P < 0.001].Omalizumab significantly improved asthma-related quality of life [RR=1.25, 95% CI(1.13, 1.38), P < 0.000 01], albeit no indications of omalizumab reducing the rate of emergency visits [RR=0.63, 95% CI(0.28, 1.44), P < 0.001]. Conclusion The addition of omalizumab to standard asthma therapy reduces asthma exacerbations, decreases inhaled corticosteroid and rescue medication use, and improves the quality of life in severe asthma patients.

Citation： MiaoWeiwei, WangFengfeng, ChenZi, MaYuan, XieLinyan, SongLili, ChenYuping, HuangMao, ZhouLinfu. The Efficacy of Omalizumab in Patients with Severe Allergic Asthma: A Meta-analysis. Chinese Journal of Respiratory and Critical Care Medicine, 2015, 14(5): 449-455. doi: 10.7507/1671-6205.2015111 Copy

1.	Zhou LF, Zhang MS, Hu AH, et al.Selective blockade of NF-κB by novel mutated IκBαsuppresses CD3/CD28-induced activation of memory CD4⁺ T cells in asthma.Allergy, 2008, 63:509-517.
2.	中华医学会呼吸病学分会哮喘学组.难治性哮喘诊断与处理专家共识.中华结核和呼吸杂志, 2010, 33:572-577.
3.	Jadad AR, Moore RA, Carroll D, et al.Assessing the quality of reports of randomized clinical trials:is blinding necessary? Control Clin Trials, 1996, 17:1-12.
4.	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.
5.	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.
6.	Bousquet J, Wenzel S, Holgate S, et al.Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma.Chest, 2004, 125:1378-1386.
7.	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, 20:73-78.
8.	Holgate ST, Chuchalin AG, Hébert 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.
9.	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.
10.	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, 59:701-708.
11.	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.
12.	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, 14:1156-1165.
13.	Hanania NA, Alpan O, Hamilos DL, et al.Omalizumab in severe allergic asthma inadequately controlled with standard therapy.Ann Intern Med, 2011, 154:573-582.
14.	苗伟伟, 汪凤凤, 刘洪泱, 等.奥马珠单抗在难治性哮喘治疗中的价值.中华结核和呼吸杂志, 2012, 35:198-200.
15.	苗伟伟, 汪凤凤, 刘洪泱, 等.支气管哮喘气道重塑的新视角:免疫球蛋白E.中华结核和呼吸杂志, 2013, 36:367-370.
16.	Korn S, Thielen A, Seyfried S, et al.Omalizumab in patients with severe persistent allergic asthma in a real-life setting in Germany.Respir Med, 2009, 103:1725-1731.
17.	Hitt E.Omalizumab improves asthma control in inner-city children.N Engl J Med, 2011, 364:1005-1015.
18.	Wahn U, Martin C, Freeman P, et al.Relationship between pretreatment specific IgE and the response to omalizumab therapy.Allergy, 2009, 64:1780-1787.
19.	Busse WW, Wayne J.Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children.N Engl J Med, 2011, 364:1005-1015.
20.	FDA says asthma drug Xolair raises risk of heart, brain problems.Reuters.2014-0926.http://www.reuters.com/article/2014/09/26/us-roche-xolair-safety-idUSKCN0HL2EN20140926.

1. Zhou LF, Zhang MS, Hu AH, et al.Selective blockade of NF-κB by novel mutated IκBαsuppresses CD3/CD28-induced activation of memory CD4⁺ T cells in asthma.Allergy, 2008, 63:509-517.
2. 中华医学会呼吸病学分会哮喘学组.难治性哮喘诊断与处理专家共识.中华结核和呼吸杂志, 2010, 33:572-577.
3. Jadad AR, Moore RA, Carroll D, et al.Assessing the quality of reports of randomized clinical trials:is blinding necessary? Control Clin Trials, 1996, 17:1-12.
4. 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.
5. 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.
6. Bousquet J, Wenzel S, Holgate S, et al.Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma.Chest, 2004, 125:1378-1386.
7. 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, 20:73-78.
8. Holgate ST, Chuchalin AG, Hébert 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.
9. 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.
10. 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, 59:701-708.
11. 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.
12. 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, 14:1156-1165.
13. Hanania NA, Alpan O, Hamilos DL, et al.Omalizumab in severe allergic asthma inadequately controlled with standard therapy.Ann Intern Med, 2011, 154:573-582.
14. 苗伟伟, 汪凤凤, 刘洪泱, 等.奥马珠单抗在难治性哮喘治疗中的价值.中华结核和呼吸杂志, 2012, 35:198-200.
15. 苗伟伟, 汪凤凤, 刘洪泱, 等.支气管哮喘气道重塑的新视角:免疫球蛋白E.中华结核和呼吸杂志, 2013, 36:367-370.
16. Korn S, Thielen A, Seyfried S, et al.Omalizumab in patients with severe persistent allergic asthma in a real-life setting in Germany.Respir Med, 2009, 103:1725-1731.
17. Hitt E.Omalizumab improves asthma control in inner-city children.N Engl J Med, 2011, 364:1005-1015.
18. Wahn U, Martin C, Freeman P, et al.Relationship between pretreatment specific IgE and the response to omalizumab therapy.Allergy, 2009, 64:1780-1787.
19. Busse WW, Wayne J.Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children.N Engl J Med, 2011, 364:1005-1015.
20. FDA says asthma drug Xolair raises risk of heart, brain problems.Reuters.2014-0926.http://www.reuters.com/article/2014/09/26/us-roche-xolair-safety-idUSKCN0HL2EN20140926.

Chinese Journal of Respiratory and Critical Care Medicine

The Efficacy of Omalizumab in Patients with Severe Allergic Asthma: A Meta-analysis

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