Efficacy and safety of anti-Interleukin-5 Therapy in patients with asthma: A systematic review and meta-Analysis

PLoS ONE

Volumn 11, Issue 11, 2016, Pages

  Wang, Fa Ping ^a   Liu, Ting ^a   Lan, Zhu ^b   Li, Su Yun ^c   Mao, Hui ^a  

^a SICHUAN UNIVERSITY   (China)

^b SICHUAN UNIVERSITY   (China)

^c THE FIRST AFFILIATED HOSPITAL OF HENAN UNIVERSITY OF TRADITIONAL CHINESE MEDICINE   (China)

Author keywords

[No Author keywords available]

Indexed keywords

BENRALIZUMAB; BETA ADRENERGIC RECEPTOR STIMULATING AGENT; HISTAMINE; INTERLEUKIN 5 ANTIBODY; MEPOLIZUMAB; RESLIZUMAB; SHORT ACTING DRUG; IL5 PROTEIN, HUMAN; INTERLEUKIN 5; MONOCLONAL ANTIBODY;

ADVERSE OUTCOME; ARTICLE; ASTHMA; ASTHMA QUALITY OF LIFE QUESTIONNAIRE SCORE; CALCULATION; DISEASE EXACERBATION; DRUG EFFICACY; DRUG SAFETY; EOSINOPHIL COUNT; FORCED EXPIRATORY VOLUME; HUMAN; INCIDENCE; LUNG FUNCTION; PEAK EXPIRATORY FLOW; PREDICTIVE VALUE; QUALITY OF LIFE; QUESTIONNAIRE; RISK ASSESSMENT; RISK FACTOR; SCORING SYSTEM; SYSTEMATIC REVIEW; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; ANTAGONISTS AND INHIBITORS; FEMALE; LUNG; MALE; META ANALYSIS; PATHOPHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ANTIBODIES, MONOCLONAL, HUMANIZED; ASTHMA; FEMALE; HUMANS; INTERLEUKIN-5; LUNG; MALE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84996484048     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0166833     Document Type: Article

References (43)

1. The Global Asthma Report 2014. Auckland, New Zealand: Global Asthma Network, 2014. Available: http://www.globalasthmareport.org/resources/Global-Asthma-Report-2014.pdf.
2. Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald M, et al. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008; 31(1):143-78. doi: 10.1183/09031936.00138707 PMID: 18166595.
3. Masoli M, Fabian D, Holt S, Beasley R, Global Initiative for Asthma P. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004; 59(5):469-78. doi: 10. 1111/j.1398-9995.2004.00526.x PMID: 15080825.
4. McIvor RA. Emerging therapeutic options for the treatment of patients with symptomatic asthma. Ann Allergy Asthma Immunol. 2015; 115(4):265-71.e5. doi: 10.1016/j.anai.2015.07.011
5. Torrego A, Sola I, Munoz AM, Roque IFM, Yepes-Nunez JJ, Alonso-Coello P, et al. Bronchial thermoplasty for moderate or severe persistent asthma in adults. Cochrane Database Syst Rev. 2014;(3: ): CD009910. doi: 10.1002/14651858.CD009910.pub2 PMID: 24585221.
6. Chung KF. Targeting the interleukin pathway in the treatment of asthma. The Lancet. 2015; 386 (9998):1086-96. doi: 10.1016/S0140-6736(15)00157-9
7. Mitchell PD, El-Gammal AI, O'Byrne PM. Emerging monoclonal antibodies as targeted innovative therapeutic approaches to asthma. Clin Pharmacol Ther. 2016; 99(1):38-48. doi: 10.1002/cpt.284
8. Cardet JC, Israel E. Update on reslizumab for eosinophilic asthma. Expert Opin Biol Ther. 2015; 15 (10):1531-9. doi: 10.1517/14712598.2015.1090972
9. Yamaguchi Y, Suda T, Suda J, Eguchi M, Miura Y, Harada N, et al. Purified interleukin 5 supports the terminal differentiation and proliferation of murine eosinophilic precursors. J Exp Med. 1988; 167(1):43-56. PMID: 3257253
10. Garcia G, Taille C, Laveneziana P, Bourdin A, Chanez P, Humbert M. Anti-interleukin-5 therapy in severe asthma. Eur Respir Rev. 2013; 22(129):251-7. doi: 10.1183/09059180.00004013
11. Takatsu K, Nakajima H. IL-5 and eosinophilia. Curr Opin Immunol. 2008; 20(3):288-94. doi: 10.1016/j. coi.2008.04.001
12. Patterson MF, Borish L, Kennedy JL. The past, present, and future of monoclonal antibodies to IL-5 and eosinophilic asthma: A review. J Asthma Allergy. 2015; 8:125-34. doi: 10.2147/JAA.S74178
13. Durham AL, Caramori G, Chung KF, Adcock IM. Targeted anti-inflammatory therapeutics in asthma and chronic obstructive lung disease. Transl Res. 2016; 167(1):192-203. doi: 10.1016/j.trsl.2015.08. 004
14. Higgins J. Green S. Cochrane handbook for systematic reviews of interventions version 5.1. 0. The Cochrane Collaboration, 2011. 2013.
15. Mittlbock M, Heinzl H. A simulation study comparing properties of heterogeneity measures in metaanalyses. Stat Med. 2006; 25(24):4321-33. doi: 10.1002/sim.2692 PMID: 16991104.
16. Ioannidis JP, Patsopoulos NA, Evangelou E. Uncertainty in heterogeneity estimates in meta-analyses. BMJ (Clinical researched). 2007; 335(7626):914-6. doi: 10.1136/bmj.39343.408449.80 PMID: 17974687; PubMed Central PMCID: PMC2048840.
17. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002; 21 (11):1539-58. doi: 10.1002/sim.1186 PMID: 12111919.
18. Leckie MJ, Ten Brinke A, Khan J, Diamant Z, O'Connor BJ, Walls CM, et al. Effects of an interleukin-5 blocking monoclonal antibody on eosinophils, airway hyper-responsiveness, and the late asthmatic response. The Lancet. 2000; 356(9248.):2144-8. doi: 10.1016/S0140-6736(00)03496-6
19. Flood-Page P, Menzies-Gow A, Phipps S, Ying S, Wangoo A, Ludwig MS, et al. Anti-IL-5 treatment reduces deposition of ECM proteins in the bronchial subepithelial basement membrane of mild atopic asthmatics. Am J Respir Crit Care Med. 2003; 112(7):1029-36. doi: 10.1172/JCI17974 PMID: 14523040.
20. Büttner C, Lun A, Splettstoesser T, Kunkel G, Renz H. Monoclonal anti-interleukin-5 treatment suppresses eosinophil but not T-cell functions. Eur Respir J. 2003; 21(5):799-803. doi: 10.1183/ 09031936.03.00027302
21. Flood-Page P, Swenson C, Faiferman I, Matthews J, Williams M, Brannick L, et al. A study to evaluate safety and efficacy of mepolizumab in patients with moderate persistent asthma. Am J Respir Crit Care Med. 2007; 176(11):1062-71. doi: 10.1164/rccm.200701-085OC
22. Haldar P, Brightling CE, Hargadon B, Gupta S, Monteiro W, Sousa A, et al. Mepolizumab and exacerbations of refractory eosinophilic asthma. N Engl J Med. 2009; 360(10):973-84. doi: 10.1056/ NEJMoa0808991
23. Nair P, Pizzichini MMM, Kjarsgaard M, Inman MD, Efthimiadis A, Pizzichini E, et al. Mepolizumab for prednisone-dependent asthma with sputum eosinophilia. N Engl J Med. 2009; 360(10):985-93. doi: 10. 1056/NEJMoa0805435
24. Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, et al. Mepolizumab for severe eosinophilic asthma (DREAM): A multicentre, double-blind, placebo-controlled trial. The Lancet. 2012; 380 (9842):651-9. doi: 10.1016/S0140-6736(12)60988-X
25. Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, et al. Oral glucocorticoidsparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014; 371(13):1189-97. doi: 10. 1056/NEJMoa1403291
26. Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014; 371(13):1198-207. doi: 10.1056/ NEJMoa1403290 PMID: 25199059.
27. Kips JC, O'Connor BJ, Langley SJ, Woodcock A, Kerstjens HA, Postma DS, et al. Effect of SCH55700, a humanized anti-human interleukin-5 antibody, in severe persistent asthma: a pilot study. Am J Respir Crit Care Med. 2003; 167(12):1655-9. Epub 2003/03/22. doi: 10.1164/rccm.200206-525OC PMID: 12649124.
28. Castro M, Mathur S, Hargreave F, Boulet LP, Xie F, Young J, et al. Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2011; 184 (10):1125-32. Epub 2011/08/20. doi: 10.1164/rccm.201103-0396OC PMID: 21852542.
29. Castro M, Zangrilli J, Wechsler ME, Bateman ED, Brusselle GG, Bardin P. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, doubleblind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015; 3(5):355-66. doi: 10. 1016/S2213-2600(15)00042-9 PMID: 25736990
30. Corren J, Weinstein S, Janka L, Zangrilli J, Garin M. Phase 3 Study of Reslizumab in Patients with Poorly Controlled Asthma: Effects Across a Broad Range of Eosinophil Counts. Chest. 2016; 45715-6. doi: 10.1016/j.chest.2016.03.018 PMID: 27018175.
31. Bjermer L, Lemiere C, Maspero J, Weiss S, Zangrilli J, Germinaro M. Reslizumab for Inadequately Controlled Asthma with Elevated Blood Eosinophil Levels: a Randomized Phase 3 Study. Chest. 2016; 47551-3. doi: 10.1016/j.chest.2016.03.032 PMID: 27056586.
32. Laviolette M, Gossage DL, Gauvreau G, Leigh R, Olivenstein R, Katial R, et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol. 2013; 132 (5):1086-96.e5. doi: 10.1016/j.jaci.2013.05.020
33. Castro M, Wenzel SE, Bleecker ER, Pizzichini E, Kuna P, Busse WW, et al. Benralizumab, an anti-interleukin 5 receptor alpha monoclonal antibody, versus placebo for uncontrolled eosinophilic asthma: A phase 2b randomised dose-ranging study. Lancet Respir Med. 2014; 2(11):878-90. doi: 10.1016/ S2213-2600(14)70201-2 PMID: 25306557.
34. Nowak RM, Parker JM, Silverman RA, Rowe BH, Smithline H, Khan F. A randomized trial of benralizumab, an antiinterleukin 5 receptor alpha monoclonal antibody, after acute asthma. Am J Emerg Med. 2015; 33(1):14-20. doi: 10.1016/j.ajem.2014.09.036 PMID: 25445859.
35. Park HS, Kim MK, Imai N, Nakanishi T, Adachi M, Ohta K, et al. A phase 2a study of benralizumab for patients with eosinophilic asthma in South Korea and Japan. Int Arch Allergy Immunol. 2016; 169 (3):135-45. doi: 10.1159/000444799
36. Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016. doi: 10.1016/S0140-6736(16)31324-1 PMID: 27609408.
37. FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, et al. Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016. doi: 10.1016/S0140-6736(16)31322-8 PMID: 27609406.
38. Powell C, Milan SJ, Dwan K, Bax L, Walters N. Mepolizumab versus placebo for asthma. Cochrane Database Syst Rev. 2015;7: :CD010834. doi: 10.1002/14651858.CD010834.pub2 PMID: 26214266.
39. Liu Y, Zhang S, Li DW, Jiang SJ. Efficacy of Anti-Interleukin-5 Therapy with Mepolizumab in Patients with Asthma: A Meta-Analysis of Randomized Placebo-Controlled Trials. PloS one. 2013; 8(3):e59872. doi: 10.1371/journal.pone.0059872 PMID: 23544105.
40. Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease-specific Quality of Life Questionnaire. J Clin Epidemiol. 1994; 47(1):81-7. doi: 10.1016/0895-4356(94) 90036-1 PMID: 8283197.
41. Global Initiative for Asthma. Global strategy for asthma management and prevention, 2016. Available: http://ginasthma.org/wp-content/uploads/2016/04/GINA-2016-main-report-tracked.pdf.
42. Kontopantelis E, Springate DA, Reeves D. A re-analysis of the Cochrane Library data: the dangers of unobserved heterogeneity in meta-analyses. PloS one. 2013; 8(7):e69930. doi: 10.1371/journal.pone. 0069930 PMID: 23922860; PubMed Central PMCID: PMC3724681.
43. Ortega HG, Yancey SW, Mayer B, Gunsoy NB, Keene ON, Bleecker ER, et al. Severe eosinophilic asthma treated with mepolizumab stratified by baseline eosinophil thresholds: a secondary analysis of the DREAM and MENSA studies. Lancet Respir Med. 2016; 4(7):549-56. doi: 10.1016/S2213-2600 (16)30031-5 PMID: 27177493.