Reduction of oral corticosteroids in patients with severe eosinophilic asthma treated with Benralizumab: could it represent a marker of treatment efficacy?

References

• Holgate ST, Wenzel S, Postma DS, et al. Asthma. Nat Rev Dis Prim. 2015;1:15025.
   PubMed Web of Science ®Google Scholar
• Chung BL, Wenzel SE, Brozek JL, et al. The identification of severe asthma tuberculosis biomarkers in human urine samples. Eur Respir J. 2014;43: 1719–1729. Erratum in: Eur Respir J. 2018; 52(1).
   Web of Science ®Google Scholar
• Papi A, Brightling C, Pedersen SE, et al. Asthma. Lancet. 2018;391(10122):783–800.
   PubMed Web of Science ®Google Scholar
• Global Initiative For Asthma. Global strategy for asthma management and prevention; [cited 2018 December 22]. Available from: http://ginasthma.org.
   Google Scholar
• Svenningsen S, Nair P. Asthma endotypes and an overview of targeted therapy for asthma. Front Med (Lausanne). 2017;4:158.
   PubMed Web of Science ®Google Scholar
• Rowe BH, Edmonds ML, Spooner CH, et al. Corticosteroid therapy for acute asthma. Respir Med. 2004;98(4):275–284.
   PubMed Web of Science ®Google Scholar
• Mori F, Barni S, Pucci N, et al. Upper airways disease: role of corticosteroids. Int J Immunopathol Pharmacol. 2010;23(1 Suppl):61–66.
   PubMedGoogle Scholar
• Heffler E, Bagnasco D, Canonica GW. Strategies to reduce corticosteroid-related adverse events in asthma. Curr Opin Allergy Clin Immunol. 2019;19(1):61–67.
   PubMed Web of Science ®Google Scholar
• Price DB, Trudo F, Voorham J, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018;11:193–204.
   PubMed Web of Science ®Google Scholar
• Lefebvre P, Duh MS, Lafeuille MH, et al. Acute and chronic systemic corticosteroid-related complications in patients with severe asthma. J Allergy Clin Immunol. 2015;136(6):1488–1495.
   PubMed Web of Science ®Google Scholar
• Voorham J, Xu X, Price D, et al. Health care resource utilization and costs associated with incremental systemic corticosteroid exposure in asthma. Allergy.  2019;74(2):273–283.
   Google Scholar
• Heffler E, Blasi F, Latorre M, et al. The Severe Asthma Network in Italy (SANI): findings and perspectives. J Allergy Clin Immunol. 2015;136(6):1488–1495.
   Google Scholar
• Lai T, Wang S, Xu Z, et al. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis. Sci Rep. 2015;5:8191.
   PubMed Web of Science ®Google Scholar
• Menzella F, Lusuardi M, Montanari G, et al. Clinical usefulness of mepolizumab in severe eosinophilic asthma. Ther Clin Risk Manag. 2016;12:907–916.
   PubMed Web of Science ®Google Scholar
• Deeks ED, Brusselle G. Reslizumab in eosinophilic asthma: a review. Drugs. 2017 May;77(7):777–784.
   PubMed Web of Science ®Google Scholar
• Sahota J, Robinson DS. Update on new biologics for intractable eosinophilic asthma: impact of reslizumab. Drug Des Devel Ther. 2018;12:1173–1181.
   PubMed Web of Science ®Google Scholar
• Pelaia C, Vatrella A, Gallelli L, et al. Dupilumab for the treatment of asthma. Expert Opin Biol Ther. 2017 Dec;17(12):1565–1572.
   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;378(26):2475–2485.
   PubMed Web of Science ®Google Scholar
• Albers FC, Müllerová H, Gunsoy NB, et al. Biologic treatment eligibility for real-world patients with severe asthma: the IDEAL study. J Asthma. 2018;55(2):152–160.
   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;55(1):89–100.
   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;132(5):1086–1096.
   PubMed Web of Science ®Google Scholar
• Ghazi A, Trikha A, Calhoun WJ. Benralizumab – a humanized mAb to IL-5R alpha with enhanced antibody-dependent cell-mediated cytotoxicity – a novel approach for the treatment of asthma. Expert Opin Biol Ther. 2012;12(1):113–118.
   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
• 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;388(10056):2128–2141.
   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 β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115–2127.
   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
• Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid-sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376(25):2448–2458.
   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 Clin Immunol. 2010;125(6):1344–1353.
   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
• Menzella F, Lusuardi M, Galeone C, et al. The clinical profile of benralizumab in the management of severe eosinophilic asthma. Ther Adv Respir Dis. 2016;10(6):534–548.
   PubMed Web of Science ®Google Scholar
• Lugogo N, Kline JN, Hirsch I, et al. Benralizumab improves morning peak expiratory flow while reducing oral corticosteroid dosages for patients with severe, uncontrolled asthma in the ZONDA phase III trial. Am J Respir Crit Care Med. 2018;197:A2488.
   Web of Science ®Google Scholar
• Mukherjee M, Nair P. Autoimmune responses in severe asthma. Allergy Asthma Immunol Res. 2018;10(5):428–447.
   PubMed Web of Science ®Google Scholar
• Chipps BE, Hirsch I, Trudo F, et al. Demographics, clinical characteristics, and response to benralizumab treatment for patients with severe, eosinophilic asthma and fixed airflow obstruction. Am J Respir Crit Care Med. 2018;197:A2489.
   Web of Science ®Google Scholar
• Trudo F, Hirsch I, Gopalan G, et al. Impact of body mass index on efficacy of benralizumab in patients with severe, uncontrolled eosinophilic asthma: pooled analysis of the SIROCCO and CALIMA trials. Am J Respir Crit Care Med. 2018;197:A2490.
   Web of Science ®Google Scholar
• Gleich GJ, Klion AD, Lee JJ, et al. The consequences of not having eosinophils. Allergy. 2013;68(7):829–835.
   PubMed Web of Science ®Google Scholar
• Bogomolski-Yahalom V, Matzner Y. Disorders of neutrophil function. Blood Rev. 1995;9:183–190.
   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
• Khatri S, Moore W, Gibson PG, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2018 Oct 23;pii: S0091-6749(18)31479-9.
   PubMed Web of Science ®Google Scholar
• Ramsahai JM, P AB W. Appropriate use of oral corticosteroids for severe Asthma. Med J Aust. 2018;209(2 Suppl):S18–S21.
   PubMedGoogle Scholar
• Sehmi R, Smith SG, Kjarsgaard M, et al. Role of local eosinophilopoietic processes in the development of airway eosinophilia in prednisone-dependent severe asthma. Clin Exp Allergy. 2016;46:793–802.
   PubMed Web of Science ®Google Scholar
• Kelly EA, Esnault S, Liu LY, et al. Mepolizumab attenuates airway eosinophil numbers, but not their functional phenotype, in asthma. Am J Respir Crit Care Med. 2017;196(11):1385–1395.
   PubMed Web of Science ®Google Scholar
• Stein ML, Villanueva JM, Buckmeier BK, et al. Anti-IL-5 (mepolizumab) therapy reduces eosinophil activation ex vivo and increases IL-5 and IL-5 receptor levels. J Allergy Clin Immunol. 2008;121(6):1473–1483, 1483.e1–e4.
   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;167(2):199–204.
   PubMed Web of Science ®Google Scholar
• Pham TH, Damera G, Newbold P, et al. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21–29.
   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;52:4.
   Web of Science ®Google Scholar
• Molfino NA, Gossage D, Kolbeck R, et al. Molecular and clinical rationale for therapeutic targeting of interleukin-5 and its receptor. Clin Exp Allergy. 2012;42(5):712–737.
   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
• Stoner KL, Harder H, Fallowfield LJ, et al. Intravenous versus subcutaneous drug administration. Which do patients prefer? A systematic review. Patient. 2015;8(2):145–153.
   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 Apr;5(11):63–72.
   Google Scholar
• van den Bemt BJ, Zwikker HE, van den Ende CH. Medication adherence in patients with rheumatoid arthritis: a critical appraisal of the existing literature. Expert Rev Clin Immunol. 2012;8:337–351.
   PubMed Web of Science ®Google Scholar
• Bhoi P, Bessette L, Bell MJ, et al. Adherence and dosing interval of subcutaneous antitumour necrosis factor biologics among patients with inflammatory arthritis: analysis from a Canadian administrative database. BMJ Open. 2017;7(9):e015872.
   PubMed Web of Science ®Google Scholar