Benralizumab: an updated treatment of eosinophilic asthma

References

• Soriano JB, Abajobir AA, Abate KH, et al. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2017;5(9):691–706.
   PubMed Web of Science ®Google Scholar
• Vos TAA, Abate KH, Abbafati C, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211–1259.
   PubMed Web of Science ®Google Scholar
• Yaghoubi M, Adibi A, Safari A, et al. The projected economic and health burden of uncontrolled asthma in the United States. Am J Respir Crit Care Med. 2019;200(9):1102–1112.
   PubMed 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 Feb;43(2):343–373.
   PubMed Web of Science ®Google Scholar
• (GINA) GINA. Global strategy for asthma management and prevention; 2019. Available from www.ginasthma.org.
   Google Scholar
• Zeiger RS, Schatz M, Dalal AA, et al. Utilization and costs of severe uncontrolled asthma in a managed-care setting. The Journal of Allergy and Clinical Immunology in Practice. 2016 Jan–Feb;4(1):120–9.e3.
   PubMed Web of Science ®Google Scholar
• Wenzel SE. Asthma phenotypes: the evolution from clinical to molecular approaches. Nat Med. 2012 May 4;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 Clin Immunol. 2011 Feb;127(2):355–360.
   PubMed Web of Science ®Google Scholar
• Brusselle GG, Maes T, Bracke KR. Eosinophils in the spotlight: eosinophilic airway inflammation in nonallergic asthma. Nat Med. 2013 Aug;19(8):977–979..
   PubMed Web of Science ®Google Scholar
• Menzies-Gow A, Robinson DS. Eosinophil chemokines and chemokine receptors: their role in eosinophil accumulation and activation in asthma and potential as therapeutic targets. J Asthma. 2001 Dec;38(8):605–613.
   PubMed Web of Science ®Google Scholar
• Eileen W, Wechsler ME, Tran TN, et al. Characterization of severe asthma worldwide: data from the International Severe Asthma Registry (ISAR). Chest. Published Online 2019 Nov 27. In Press.
   Google Scholar
• Johansson MW. Activation states of blood eosinophils in asthma. Clin Exp Allergy. 2014;44(4):482–498.
   PubMed Web of Science ®Google Scholar
• Rosenberg HF, Dyer KD, Foster PS. Eosinophils: changing perspectives in health and disease. Nat Rev Immunol. 2013;13(1):9–22.
   PubMed Web of Science ®Google Scholar
• McBrien CN, Menzies-Gow A. The biology of eosinophils and their role in asthma. Front Med (Lausanne). 2017;4:93.
   PubMed Web of Science ®Google Scholar
• Bousquet J, Chanez P, Lacoste JY, et al. Eosinophilic inflammation in asthma. N Engl J Med. 1990 Oct 11;323(15):1033–1039.
   PubMed Web of Science ®Google Scholar
• Sur S, Gleich GJ, Swanson MC, et al. Eosinophilic inflammation is associated with elevation of interleukin-5 in the airways of patients with spontaneous symptomatic asthma. J Allergy Clin Immunol. 1995 Nov;96(5 Pt 1):661–668.
   PubMed Web of Science ®Google Scholar
• Farne HA, Wilson A, Powell C, et al. Anti-IL5 therapies for asthma. Cochrane Database Syst Rev. 2017 Sep 21;9:Cd010834.
   PubMed Web of Science ®Google Scholar
• Blanchard C, Rothenberg ME. Biology of the eosinophil. Adv Immunol. 2009;101:81–121.
   PubMed Web of Science ®Google Scholar
• F, Cardet JCChung KF, et al. Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2020 Jan 1; 55 (1);1900588.
   Google Scholar
• Kolbeck R, Kozhich A, Koike M, et al. MEDI-563, a humanized anti–IL-5 receptor α mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol. 2010;125(6):1344–1353. e2.
   PubMed Web of Science ®Google Scholar
• Pereira NA, Chan KF, Lin PC, et al. The “less-is-more” in therapeutic antibodies: afucosylated anti-cancer antibodies with enhanced antibody-dependent cellular cytotoxicity. mAbs. 2018 Jul;10(5):693–711.
   PubMed Web of Science ®Google Scholar
• Pelaia C, Vatrella A, Bruni A, et al. Benralizumab in the treatment of severe asthma: design, development and potential place in therapy. Drug Des Devel Ther. 2018;12:619–628..
   PubMed Web of Science ®Google Scholar
• Pelaia C, Calabrese C, Vatrella A, et al. Benralizumab: from the basic mechanism of action to the potential use in the biological therapy of severe eosinophilic asthma. Biomed Res Int. 2018;2018:4839230.
   PubMed Web of Science ®Google Scholar
• Busse WW, Katial R, Gossage D, et al. Safety profile, pharmacokinetics, and biologic activity of MEDI-563, an anti–IL-5 receptor α antibody, in a phase I study of subjects with mild asthma. J Allergy Clin Immunol. 2010;125(6):1237–1244. 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 Clin Immunol. 2013 Nov;132(5):1086–1096.e5.
   PubMed Web of Science ®Google Scholar
• Yan L, Wang B, Chia YL, et al. Population pharmacokinetic modeling of benralizumab in adult and adolescent patients with asthma. Clin Pharmacokinet. 2019;58(7):943–958.
   PubMed Web of Science ®Google Scholar
• Wang B, Yan L, Yao Z, et al. Population pharmacokinetics and pharmacodynamics of Benralizumab in healthy volunteers and patients with asthma. CPT Pharmacometrics Syst Pharmacol. 2017 Apr;6(4):249–257.
   PubMedGoogle 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 Nov;2(11):879–890.
   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 beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115–2127..
   PubMed Web of Science ®Google Scholar
• FitzGerald JM, Bleecker ER, Nair P, 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 Oct 29;388(10056):2128–2141..
   PubMed Web of Science ®Google Scholar
• B, Yan LHutmacher M, et al. Exposure-response analysis for determination of benralizumab optimal dosing regimen in adults with asthma. A32. NEW ASTHMA THERAPIES: CLINICAL STUDIES: American Thoracic Society International Conference; San Diego 2014. p. A1324–A1324.
   Google Scholar
• Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid-sparing effect of Benralizumab in severe asthma. N Engl J Med. 2017 Jun 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
• Liu W, Ma X, Zhou W. Adverse events of benralizumab in moderate to severe eosinophilic asthma: a meta-analysis. Medicine (Baltimore). 2019;98(22):e15868–e15868.
   PubMed Web of Science ®Google Scholar
• Busse WW, Bleecker ER, FitzGerald JM, et al. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019 Jan;7(1):46–59..
   PubMed Web of Science ®Google Scholar
• FitzGerald JM, Bleecker ER, Bourdin A, et al. Two-year integrated efficacy and safety analysis of Benralizumab in severe asthma. J Asthma Allergy. 2019;12:401–413.
   PubMed Web of Science ®Google Scholar
• Bourdin A, Shaw D, Menzies-Gow A, et al. Two-year integrated steroid-sparing analysis and safety of benralizumab for severe asthma. J Asthma. 2019 Dec;26:1–9.
   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
• Bleecker ER, Wechsler ME, FitzGerald JM, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018 Oct;52(4):1800936.
   PubMed Web of Science ®Google Scholar
• Chipps BE, Hirsch I, Trudo F, et al. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Jan;124(1):79–86.
   PubMed Web of Science ®Google Scholar
• Jackson DJ, Humbert M, Hirsch I, et al. Ability of serum IgE concentration to predict exacerbation risk and Benralizumab efficacy for patients with severe eosinophilic asthma. Adv Ther. 2019 Dec 14
   Web of Science ®Google Scholar
• Chipps BE, Newbold P, Hirsch I, et al. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):504–511.e4.
   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
• 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
• Castro M, Mathur S, Hargreave F, et al. Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2011 Nov 15;184(10):1125–1132.
   PubMed Web of Science ®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 May;3(5):355–366.
   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
• Bjermer L, Lemiere C, Maspero J, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil levels: a randomized phase 3 study. Chest. 2016 Oct;150(4):789–798.
   PubMed Web of Science ®Google Scholar
• Busse W, Chupp G, Nagase H, et al. Anti-IL-5 treatments in patients with severe asthma by blood eosinophil thresholds: indirect treatment comparison. J Allergy Clin Immunol. 2019 Jan;143(1):190–200.e20.
   PubMed Web of Science ®Google Scholar
• Bourdin A, Husereau D, Molinari N, et al. Matching-adjusted indirect comparison of benralizumab versus interleukin-5 inhibitors for the treatment of severe asthma: a systematic review. Eur Respir J. 2018;52(5):1801393.
   PubMed Web of Science ®Google Scholar
• Edris A, De Feyter S, Maes T, et al. Monoclonal antibodies in type 2 asthma: a systematic review and network meta-analysis. Respir Res. 2019 Aug 8;20(1):179.
   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 Jun 28;378(26):2475–2485.
   PubMed Web of Science ®Google Scholar
• Benralizumab Product Information. [cited 2020 Feb 23]. Available from: https://medicalinformation.astrazeneca-us.com/home/prescribing-information/fasenra-pi.html
   Google Scholar
• Barker P, Ferguson GT, Cole J, et al. Single-use autoinjector functionality and reliability for at-home Benralizumab administration: GRECO trial results. J Allergy Clin Immunol. 2019;143(2):AB96.
   Web of Science ®Google Scholar
• U.S. National Library of Medicine. Available from: www.ClinicalTrials.gov.
   Google Scholar
• Criner GJ, Celli BR, Brightling CE, et al. Benralizumab for the prevention of COPD exacerbations. N Engl J Med. 2019 Sep 12;381(11):1023–1034.
   PubMed Web of Science ®Google Scholar
• Menzella F, Biava M, Bagnasco D, et al. Efficacy and steroid-sparing effect of benralizumab: has it an advantage over its competitors? Drugs Context. 2019;8:212580.
   PubMedGoogle Scholar
• ER, Menzies-Gow ANPrice DB, et al. Systematic literature review of systemic corticosteroid use for asthma management. Am J Respir Crit Care Med. 2020 Feb 1;201(3):276-293.
   PubMed Web of Science ®Google Scholar
• Menzies-Gow A, Corren J, Bel EH, et al. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial. ERJ Open Res. 2019 Jul;5(3). DOI:10.1183/23120541.00009-2019
   PubMedGoogle Scholar
• Reichman H, Karo-Atar D, Munitz A. Emerging roles for eosinophils in the tumor microenvironment. Trends Cancer. 2016;2(11):664–675.
   PubMed Web of Science ®Google Scholar
• Prizment AE, Anderson KE, Visvanathan K, et al. Inverse association of eosinophil count with colorectal cancer incidence: atherosclerosis risk in communities study. Cancer Epidemiol Biomarkers Prev. 2011;20(9):1861–1864.
   PubMed Web of Science ®Google Scholar
• Varricchi G, Galdiero MR, Loffredo S, et al. Eosinophils: the unsung heroes in cancer? Oncoimmunology. 2017;7(2):e1393134–e1393134.
   PubMed Web of Science ®Google Scholar
• Klion AD, Nutman TB. The role of eosinophils in host defense against helminth parasites. J Allergy Clin Immunol. 2004;113(1):30–37.
   PubMed Web of Science ®Google Scholar
• Huang L, Appleton JA. Eosinophils in Helminth infection: defenders and dupes. Trends Parasitol. 2016;32(10):798–807.
   PubMed Web of Science ®Google Scholar
• Flood-Page PT, Menzies-Gow AN, Kay AB, et al. Eosinophil’s role remains uncertain as anti-interleukin-5 only partially depletes numbers in asthmatic airway. Am J Respir Crit Care Med. 2003 Jan 15;167(2):199–204.
   PubMed Web of Science ®Google Scholar