Mepolizumab for the reduction of exacerbations in severe eosinophilic asthma

References

• Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention [Internet]. 2015. [cited 2015 Nov 23]. Available from: http://www.ginasthma.org
   Google Scholar
• Bousquet J, Mantzouranis E, Cruz AA, et al. Uniform definition of asthma severity, control, and exacerbations: document presented for the World Health Organization consultation on severe asthma. J Allergy Clin Immunol. 2010;126(5):926–938.
   PubMed Web of Science ®Google Scholar
• World Health Organisation. The global burden of disease: 2004 update. Geneva: WHO Press; 2004.
   Google Scholar
• Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the global burden of disease study 2010. Lancet. 2012;380(9859):2095–2128.
   PubMed Web of Science ®Google Scholar
• Royal College of Physicians. Why asthma still kills: the National Review of Asthma Deaths (NRAD) confidential enquiry report. London: RCP; 2014.
   Google Scholar
• Taylor DR, Bateman ED, Boulet L-P, et al. A new perspective on concepts of asthma severity and control. Eur Respir J. 2008;32(3):545–554.
   PubMed Web of Science ®Google Scholar
• National Heart, Lung and Blood Institute. National asthma education and prevention program, expert panel report 3: guidelines for the diagnosis and management of asthma [Internet]. 2007. [cited 2015 Nov 23]. Available from: http://www.nhlbi.nih.gov
   Google Scholar
• British Thoracic Society/Scottish Intercollegiate Network. British guideline on the management of asthma. Thorax. 2014. [cited 69 Suppl 1]; i1-i192]. Available from: https://www.brit-thoracic.org.uk/document-library/clinical-information/asthma/btssign-asthma-guideline-2014/
   Web of Science ®Google Scholar
• Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43(2):343–373.
   PubMed Web of Science ®Google Scholar
• Barnes PJ. Severe asthma: advances in current management and future therapy. J Allergy Clin Immunol. 2012;129(1):48–59.
   PubMed Web of Science ®Google Scholar
• Wenzel SE. Asthma phenotypes: the evolution from clinical to molecular approaches. Nat Med. 2012;18(5):716–725.
   PubMed Web of Science ®Google Scholar
• Green RH, Brightling CE, Woltmann G, et al. Analysis of induced sputum in adults with asthma: identification of subgroup with isolated sputum neutrophilia and poor response to inhaled corticosteroids. Thorax. 2002;57(10):875–879.
   PubMed Web of Science ®Google Scholar
• McGrath KW, Icitovic N, Boushey HA, et al. A large subgroup of mild-to-moderate asthma is persistently noneosinophilic. Am J Respir Crit Care Med. 2012;185(6):612–619.
   PubMed Web of Science ®Google Scholar
• Choy DF, Hart KM, Borthwick LA, et al. TH2 and TH17 inflammatory pathways are reciprocally regulated in asthma. Sci Transl Med. 2015;7(301):301ra129.
   PubMed Web of Science ®Google Scholar
• Thomas B, Rutman A, Hirst RA, et al. Ciliary dysfunction and ultrastructural abnormalities are features of severe asthma. J Allergy Clin Immunol. 2010;126(4):722–729.e2.
   PubMed Web of Science ®Google Scholar
• Berair R, Brightling CE. Asthma therapy and its effect on airway remodelling. Drugs. 2014;74(12):1345–1369.
   PubMed Web of Science ®Google Scholar
• Sutcliffe A, Hollins F, Gomez E, et al. Increased nicotinamide adenine dinucleotide phosphate oxidase 4 expression mediates intrinsic airway smooth muscle hypercontractility in asthma. Am J Respir Crit Care Med. 2012;185(3):267–274.
   PubMed Web of Science ®Google Scholar
• Douwes J, Gibson P, Pekkanen J, et al. Non-eosinophilic asthma: importance and possible mechanisms. Thorax. 2002;57(7):643–648.
   PubMed Web of Science ®Google Scholar
• Eltboli O, Brightling CE. Eosinophils as diagnostic tools in chronic lung disease. Expert Rev Respir Med. 2013;7(1):33–42.
   PubMed Web of Science ®Google Scholar
• Boorsma M, Lutter R, van de Pol MA, et al. Repeatability of inflammatory parameters in induced sputum of COPD patients. COPD. 2007;4(4):321–329.
   PubMedGoogle Scholar
• Pizzichini E, Pizzichini MM, Efthimiadis A, et al. Indices of airway inflammation in induced sputum: reproducibility and validity of cell and fluid-phase measurements. Am J Respir Crit Care Med. 1996;154(2 Pt 1):308–317.
   PubMed Web of Science ®Google Scholar
• Jatakanon A, Lim S, Barnes PJ. Changes in sputum eosinophils predict loss of asthma control. Am J Respir Crit Care Med. 2000;161(1):64–72.
   PubMed Web of Science ®Google Scholar
• Hanania NA, Noonan M, Corren J, et al. Lebrikizumab in moderate-to-severe asthma: pooled data from two randomised placebo-controlled studies. Thorax. 2015;70(8):748–756.
   PubMed Web of Science ®Google Scholar
• Sweeney J, Brightling CE, Menzies-Gow A, et al. Clinical management and outcome of refractory asthma in the UK from the British thoracic society difficult asthma registry. Thorax. 2012;67(8):754–756.
   PubMed Web of Science ®Google Scholar
• ten Brinke A, Zwinderman AH, Sterk PJ, et al. “Refractory” eosinophilic airway inflammation in severe asthma: effect of parenteral corticosteroids. Am J Respir Crit Care Med. 2004;170(6):601–605.
   PubMed Web of Science ®Google Scholar
• Mancinelli L, Navarro L, Sharma OP. Intramuscular high-dose triamcinolone acetonide in the treatment of severe chronic asthma. West J Med. 1997;167(5):322–329.
   PubMedGoogle Scholar
• Pavord ID, Brightling CE, Woltmann G, et al. Non-eosinophilic corticosteroid unresponsive asthma. Lancet. 1999;353(9171):2213–2214.
   PubMed Web of Science ®Google Scholar
• Brightling CE, Monteiro W, Ward R, et al. Sputum eosinophilia and short-term response to prednisolone in chronic obstructive pulmonary disease: a randomised controlled trial. Lancet. 2000;356(9240):1480–1485.
   PubMed Web of Science ®Google Scholar
• Pratter MR, Brightling CE, Boulet LP, et al. An empiric integrative approach to the management of cough: ACCP evidence-based clinical practice guidelines. Chest. 2006;129(1 Suppl):222s–231s.
   PubMed Web of Science ®Google Scholar
• Green RH, Brightling CE, McKenna S, et al. Asthma exacerbations and sputum eosinophil counts: a randomised controlled trial. Lancet. 2002;360(9347):1715–1721.
   PubMed Web of Science ®Google Scholar
• Chlumsky J, Striz I, Terl M, et al. Strategy aimed at reduction of sputum eosinophils decreases exacerbation rate in patients with asthma. J Int Med Res. 2006;34(2):129–139.
   PubMed Web of Science ®Google Scholar
• Jayaram L, Pizzichini MM, Cook RJ, et al. Determining asthma treatment by monitoring sputum cell counts: effect on exacerbations. Eur Respir J. 2006;27(3):483–494.
   PubMed Web of Science ®Google Scholar
• Petsky HL, Cates CJ, Lasserson TJ, et al. A systematic review and meta-analysis: tailoring asthma treatment on eosinophilic markers (exhaled nitric oxide or sputum eosinophils). Thorax. 2012;67(3):199–208.
   PubMed Web of Science ®Google Scholar
• Green RH, Brightling CE, McKenna S, et al. Comparison of asthma treatment given in addition to inhaled corticosteroids on airway inflammation and responsiveness. Eur Respir J. 2006;27(6):1144–1151.
   PubMed Web of Science ®Google Scholar
• Kerstjens HA, Engel M, Dahl R, et al. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med. 2012;367(13):1198–1207.
   PubMed Web of Science ®Google Scholar
• Anderson DE, Kew KM, Boyter AC. Long-acting muscarinic antagonists (LAMA) added to inhaled corticosteroids (ICS) versus the same dose of ICS alone for adults with asthma. Cochrane Database Syst Rev. 2015;8:CD011397.
   PubMedGoogle Scholar
• Miligkos M, Bannuru RR, Alkofide H, et al. Leukotriene-receptor antagonists versus placebo in the treatment of asthma in adults and adolescents: a systematic review and meta-analysis. Ann Intern Med. 2015;163(10):756–767.
   PubMed Web of Science ®Google Scholar
• Ducharme FM. Addition of anti-leukotriene agents to inhaled corticosteroids for chronic asthma. Cochrane Database Syst Rev. 2004;(1):CD003133.
   Google Scholar
• Nie H, Zhang G, Liu M, et al. Efficacy of theophylline plus salmeterol/fluticasone propionate combination therapy in patients with asthma. Respir Med. 2013;107(3):347–354.
   PubMed Web of Science ®Google Scholar
• Normansell R, Walker S, Milan SJ, et al. Omalizumab for asthma in adults and children. Cochrane Database Syst Rev. 2014;1:CD003559.
   PubMed Web of Science ®Google Scholar
• Gouder C, West LM, Montefort S. The real-life clinical effects of 52 weeks of omalizumab therapy for severe persistent allergic asthma. Int J Clin Pharm. 2015;37(1):36–43.
   PubMed Web of Science ®Google Scholar
• Tajiri T, Niimi A, Matsumoto H, et al. Comprehensive efficacy of omalizumab for severe refractory asthma: a time-series observational study. Ann Allergy Asthma Immunol. 2014;113(4):470–475.e2.
   PubMed Web of Science ®Google Scholar
• 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(6):583–593.
   PubMed Web of Science ®Google Scholar
• Hanania NA, Wenzel S, Rosén K, et al. Exploring the effects of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med. 2013;187(8):804–811.
   PubMed Web of Science ®Google Scholar
• Woodcock A, Forster L, Matthews E, et al. Control of exposure to mite allergen and allergen-impermeable bed covers for adults with asthma. N Engl J Med. 2003;349(3):225–236.
   PubMed Web of Science ®Google Scholar
• Normansell R, Kew KM, Bridgman AL. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2015;8:CD011293.
   PubMed Web of Science ®Google Scholar
• Boyle RJ, Pedroletti C, Wickman M, et al. Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial. Thorax. 2012;67(3):215–221.
   PubMed Web of Science ®Google Scholar
• Kew KM, Undela K, Kotortsi I, et al. Macrolides for chronic asthma. Cochrane Database Syst Rev. 2015;9:Cd002997.
   PubMed Web of Science ®Google Scholar
• Brusselle GG, Vanderstichele C, Jordens P, et al. Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial. Thorax. 2013;68(4):322–329.
   PubMed Web of Science ®Google Scholar
• Alexander AG, Barnes NC, Kay AB. Trial of cyclosporin in corticosteroid-dependent chronic severe asthma. Lancet. 1992;339(8789):324–328.
   PubMed Web of Science ®Google Scholar
• Evans DJ, Cullinan P, Geddes DM, et al. Cyclosporin as an oral corticosteroid sparing agent in stable asthma. Cochrane Database Syst Rev. 2001;(4):CD002993.
   Google Scholar
• Davies H, Olson L, Gibson P. Methotrexate as a steroid sparing agent for asthma in adults. Cochrane Database Syst Rev. 2000;(3):CD000391.
   Google Scholar
• Pavord ID, Cox G, Thomson NC, et al. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. Am J Respir Crit Care Med. 2007;176(12):1185–1191.
   PubMed Web of Science ®Google Scholar
• Castro M, Rubin AS, Laviolette M, et al. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med. 2010;181(2):116–124.
   PubMed Web of Science ®Google Scholar
• Wechsler ME, Laviolette M, Rubin AS, et al. Bronchial thermoplasty: long-term safety and effectiveness in patients with severe persistent asthma. J Allergy Clin Immunol. 2013;132(6):1295–1302.
   PubMed Web of Science ®Google Scholar
• Hilvering B, Xue L, Pavord ID. Evidence for the efficacy and safety of anti-interleukin-5 treatment in the management of refractory eosinophilic asthma. Ther Adv Respir Dis. 2015;9(4):135–145.
   PubMed Web of Science ®Google Scholar
• Flood-Page P, Swenson C, Faiferman I, 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):1062–1071.
   PubMed Web of Science ®Google Scholar
• Haldar P, Brightling CE, Hargadon B, et al. Mepolizumab and exacerbations of refractory eosinophilic asthma. N Engl J Med. 2009;360(10)):973–984.
   PubMed Web of Science ®Google Scholar
• Nair P, Pizzichini MMM, Kjarsgaard M, et al. Mepolizumab for prednisone-dependent asthma with sputum eosinophilia. N Engl J Med. 2009;360(10):985–993.
   PubMed Web of Science ®Google Scholar
• Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):651–659.
   PubMed Web of Science ®Google Scholar
• Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198–1207.
   PubMed Web of Science ®Google Scholar
• Bel EH, Wenzel SE, Thompson PJ, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189–1197.
   PubMed Web of Science ®Google Scholar
• Haldar P, Brightling CE, Singapuri A, et al. Outcomes after cessation of mepolizumab therapy in severe eosinophilic asthma: a 12-month follow-up analysis. J Allergy Clin Immunol. 2014;133(3):921–923.
   PubMed Web of Science ®Google Scholar
• Teva Pharmaceutical Industries Research Pipeline. 2015 [cited 2015 Nov 27]. Available from: http://www.tevapharm.com/research_development/rd_focus/pipeline/
   Google Scholar
• Castro M, Zangrilli J, Wechsler ME, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015;3(5):355–366.
   PubMed Web of Science ®Google Scholar
• Castro M, Wenzel SE, Bleecker ER, 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):879–890.
   PubMed Web of Science ®Google Scholar
• Nowak RM, Parker JM, Silverman RA, et al. A randomized trial of benralizumab, an antiinterleukin 5 receptor alpha monoclonal antibody, after acute asthma. Am J Emerg Med. 2015;33(1):14–20.
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.gov Clinical Studies Registry. 2015 [cited 2015 Nov 27]. Available from: https://clinicaltrials.gov/
   Google Scholar
• Brightling CE, Chanez P, Leigh R, et al. Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Respir Med. 2015;3(9):692–701.
   PubMed Web of Science ®Google Scholar
• Vatrella A, Fabozzi I, Calabrese C, et al. Dupilumab: a novel treatment for asthma. J Asthma Allergy. 2014;7:123–130.
   PubMedGoogle Scholar
• Wenzel S, Ford L, Pearlman D, et al. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013;368(26):2455–2466.
   PubMed Web of Science ®Google Scholar
• Berair R, Gonem S, Singapuri A, et al. Effect of QAW039, an oral prostaglandin D2 receptor (DP2/CRTH2) antagonist, upon sputum and bronchial eosinophilic inflammation and clinical outcomes in treatment-resistant asthma: a phase 2a randomized placebo-controlled trial. Eur Respir J. 2015;46(Suppl. 59):OA290.
   Google Scholar
• Gonem S, Berair R, Singapuri A, et al. Late-breaking abstract: phase 2a randomized placebo-controlled trial of the oral prostaglandin D2 receptor (DP2/CRTh2) antagonist QAW039 in eosinophilic asthma. Eur Respir J. 2014;44(Suppl. 58):2908
   Google Scholar
• U.S. Food and Drug Administration. [ cited 2016 Mar 9]. Available from: http://www.fda.gov
   Google Scholar
• European Medicines Agency. [ cited 2016 Mar 9]. Available from: http://www.ema.europa.eu
   Google Scholar
• UK Medicines Information. [ cited 2016 Mar 9]. Available from: http://www.ukmi.nhs.uk/
   Google Scholar
• GlaxoSmithKline 2015 Quarter 2 Press Release. [ cited 2015 Sep 24]. Available from: https://www.gsk.com/en-gb/media
   Google Scholar
• Powell C, Milan SJ, Dwan K, et al. Mepolizumab versus placebo for asthma. Cochrane Database Syst Rev. 2015;7:CD010834.
   PubMed Web of Science ®Google Scholar