Benralizumab for the add-on maintenance treatment of patients with severe asthma aged 12 years and older with an eosinophilic phenotype

References

• Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention 2017. [cited 2018 Mar 01]. Available from: www.ginasthma.org.
   Google Scholar
• Wenzel S. Severe asthma: epidemiology, pathophysiology and treatment. The Mt Sinai J Med. 2003 May;70(3):185–190.
   PubMedGoogle Scholar
• Bahadori K, Doyle-Waters MM, Marra C, et al. Economic burden of asthma: a systematic review. BMC Pulm Med. 2009;9:24.
   PubMedGoogle Scholar
• Wenzel SE. Asthma phenotypes: the evolution from clinical to molecular approaches. Nat Med. 2012 May 04;18(5):716–725.
   PubMed Web of Science ®Google Scholar
• Lotvall J, Akdis CA, Bacharier LB, et al. Asthma endotypes: a new approach to classification of disease entities within the asthma syndrome. J Allergy and Clin Immunol. 2011 Feb;127(2):355–360.
   PubMed Web of Science ®Google Scholar
• Robinson DS, Ying S, Bentley AM, et al. Relationships among numbers of bronchoalveolar lavage cells expressing messenger ribonucleic acid for cytokines, asthma symptoms, and airway methacholine responsiveness in atopic asthma. J Allergy and Clin Immunol. 1993;92(3):397–403.
   PubMed Web of Science ®Google Scholar
• Aleman F, Lim HF, Nair P. Eosinophilic Endotype of Asthma. Immunol Allergy Clin North Am. 2016 Aug;36(3):559–568.
   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
• Normansell R, Walker S, Milan SJ, et al. Omalizumab for asthma in adults and children. Cochrane Database of Syst Rev. 2014 Jan;13(1):Cd003559.
   Google Scholar
• Mepolizumab (NUCALA): GlaxoSmithKline Inc.; 2016 [11 May 2017]. Available from: http://ca.gsk.com/media/1209435/nucala.pdf
   Google Scholar
• Reslizumab (Cinqair) Prescribing Information: teva Respiratory; 2016. [cited 2017May 11]. Available from: http://www.cinqair.com/pdf/PrescribingInformation.pdf
   Google Scholar
• Castro M, Corren J, Pavord ID, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018;378(26):2486–2496.
   PubMed Web of Science ®Google Scholar
• Rabe KF, Nair P, Brusselle G, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med. 2018 May 21;378:2475–2485.
   PubMed Web of Science ®Google Scholar
• Panettieri RA Jr., Sjobring U, Peterffy A, et al. Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials. Lancet Respir Med. 2018 May 18;6:511–525.
   PubMed Web of Science ®Google Scholar
• Russell RJ, Chachi L, FitzGerald JM, et al. Effect of tralokinumab, an interleukin-13 neutralising monoclonal antibody, on eosinophilic airway inflammation in uncontrolled moderate-to-severe asthma (MESOS): a multicentre, double-blind, randomised, placebo-controlled phase 2 trial. The Lancet Respiratory Medicine. 2018;6(7):499–510.
   PubMed Web of Science ®Google Scholar
• Hanania NA, Korenblat P, Chapman KR, et al. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016 Oct;4(10):781–796.
   PubMed Web of Science ®Google Scholar
• Koike M, Nakamura K, Furuya A, et al. Establishment of humanized anti-interleukin-5 receptor alpha chain monoclonal antibodies having a potent neutralizing activity. Hum Antibodies. 2009;18(1–2):17–27.
   PubMedGoogle Scholar
• Busse WW, Katial R, Gossage D, et al. Safety profile, pharmacokinetics, and biologic activity of MEDI-563, an anti-IL-5 receptor alpha antibody, in a phase I study of subjects with mild asthma. J Allergy and Clin Immunol. 2010 Jun;125(6):1237–1244.e2.
   PubMed Web of Science ®Google Scholar
• Matera MG, Calzetta L, Rinaldi B, et al. Pharmacokinetic/pharmacodynamic drug evaluation of benralizumab for the treatment of asthma. Expert Opin Drug Metab Toxicol. 2017 Sep;13(9):1007–1013.
   PubMed Web of Science ®Google Scholar
• Kolbeck R, Kozhich A, Koike M, et al. MEDI-563, a humanized anti-IL-5 receptor alpha mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy and Clin Immunol. 2010 Jun;125(6):1344–1353.e2.
   PubMed Web of Science ®Google Scholar
• Laviolette M, Gossage DL, Gauvreau G, et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy and Clin Immunol. 2013 Nov;132(5):1086–1096.e5.
   PubMed Web of Science ®Google Scholar
• Castro M, Wenzel SE, Bleecker ER, et al. Benralizumab, an anti-interleukin 5 receptor α monoclonal antibody, versus placebo for uncontrolled eosinophilic asthma: A phase 2b randomised dose-ranging study. Lancet Respir Med. 2014;2(11):878–890.
   Web of Science ®Google Scholar
• Khatry DB, Gossage DL, Geba GP, et al. editors. A simple index utilising peripheral blood leukocytes predicts sputum eosinophilic and non-eosinophilic asthma phenotypes. Am J Respir Crit Care Med. 2014;1893(2014):A4257. San Diego: ATS.
   Google Scholar
• Park HS, Kim MK, Imai N, 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):135–145.
   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 Jan;33(1):14–20.
   PubMed Web of Science ®Google Scholar
• Bleecker ER, FitzGerald JM, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β 2 -agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;6736(16):1–13.
   Google Scholar
• FitzGerald JM, Bleecker ER, Nair P, et al. Benralizumab, an anti-interleukin-5 receptor α 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;6736(16):1–14.
   Google Scholar
• FitzGerald JM, Bleecker ER, Menzies-Gow A, et al. Predictors of enhanced response with benralizumab for patients with severe asthma: pooled analysis of the SIROCCO and CALIMA studies. Lancet Respir Med. 2018 Jan 6(1):51–64.
   PubMed Web of Science ®Google Scholar
• Nair P, Wenzel S, Rabe KF, et al. Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017 May 22;376(25):2448–2458.
   PubMed Web of Science ®Google Scholar
• Ferguson GT, FitzGerald JM, Bleecker ER, et al. Benralizumab for patients with mild to moderate, persistent asthma (BISE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2017 Jul;5(7):568–576.
   PubMed Web of Science ®Google Scholar
• Ferguson GT, Mansur AH, Jacobs JS, et al. Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma. J Asthma Allergy. 2018;11:63–72.
   PubMed Web of Science ®Google Scholar
• FDA. Division Director Summery Review BLA 761070 Benralizumab 2016. [cited 2018 Mar 01]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761070Orig1s000SumR.pdf.
   Google Scholar
• Lefebvre P, Duh MS, Lafeuille MH, et al. Burden of systemic glucocorticoid-related complications in severe asthma. Curr Med Res Opin. 2017 Jan;33(1):57–65.
   PubMed Web of Science ®Google Scholar
• Lefebvre P, Duh MS, Lafeuille M-H, et al. Acute and chronic systemic corticosteroid-related complications in patients with severe asthma. J Allergy and Clin Immunol. 2015;136(6):1488–1495.
   PubMed Web of Science ®Google Scholar
• Dalal AA, Duh MS, Gozalo L, et al. Dose-Response Relationship Between Long-Term Systemic Corticosteroid Use and Related Complications in Patients with Severe Asthma. J Manag Care Spec Pharm. 2016 Jul;22(7):833–847.
   PubMedGoogle Scholar
• Sullivan PW, Ghushchyan VH, Globe G, et al. Oral corticosteroid exposure and adverse effects in asthmatic patients. J Allergy and Clin Immunol. 2018 Apr 27;141(1):110–116.
   PubMed Web of Science ®Google Scholar
• Whittington MD, McQueen RB, Ollendorf DA, et al. Assessing the value of mepolizumab for severe eosinophilic asthma: a cost-effectiveness analysis. Ann Allergy Asthma Immunol. 2017 Feb;118(2):220–225.
   PubMed Web of Science ®Google Scholar
• Nachef Z, Krishnan A, Mashtare T, et al. Omalizumab versus Mepolizumab as add-on therapy in asthma patients not well controlled on at least an inhaled corticosteroid: A network meta-analysis. J Asthma. 2018 Jan;55(1):89–100.
   PubMed Web of Science ®Google Scholar
• Wang FP, Xiong XF, Liu T, et al. Anti-interleukin 5 Therapy for Eosinophilic Asthma: a Meta-analysis of Randomized Clinical Trials. Clin Rev Allergy Immunol. 2018 April;54(2):318–330.
   PubMed Web of Science ®Google Scholar
• Cabon Y, Molinari N, Marin G, et al. Comparison of anti-interleukin-5 therapies in patients with severe asthma: global and indirect meta-analyses of randomized placebo-controlled trials. Clin Exp Allergy. 2017 Jan;47(1):129–138.
   PubMed Web of Science ®Google Scholar
• Bachert C, Mannent L, Naclerio RM, et al. Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial. JAMA. 2016 Feb 02;315(5):469–479.
   PubMed Web of Science ®Google Scholar
• Corren J, Parnes JR, Wang L, et al. Tezepelumab in Adults with Uncontrolled Asthma. N Engl J Med. 2017 Sep 7;377(10):936–946.
   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 Aug;70(8):748–756.
   PubMed Web of Science ®Google Scholar