Real-World Safety and Effectiveness of Benralizumab in Japanese Patients with Severe Asthma: A Multicenter Prospective Observational Study

References

• The Global Asthma Report 2022. Available from: http://globalasthmareport.org/burden/burden.php. Accessed April 11, 2023.
   Google Scholar
• GINA Main Report 2022. Available from: https://ginasthma.org/wp-content/uploads/2022/07/GINA-Main-Report-2022-FINAL-22-07-01-WMS.pdf. Accessed April 11, 2023.
   Google Scholar
• Nagase H, Adachi M, Matsunaga K, et al. Prevalence, disease burden, and treatment reality of patients with severe, uncontrolled asthma in Japan. Allergol Int. 2020;69(1):53–60. doi:10.1016/j.alit.2019.06.003
   PubMed Web of Science ®Google Scholar
• Wang E, Wechsler ME, Tran TN, et al. Characterization of severe asthma worldwide: data from the International Severe Asthma Registry. Chest. 2020;157(4):790–804. doi:10.1016/j.chest.2019.10.053
   PubMed Web of Science ®Google Scholar
• Scichilone N, Barnes PJ, Battaglia S, et al. The hidden burden of severe asthma: from patient perspective to new opportunities for clinicians. J Clin Med. 2020;9(8):2397. doi:10.3390/jcm9082397
   PubMed Web of Science ®Google Scholar
• Inoue H, Kozawa M, Milligan KL, Funakubo M, Igarashi A, Loefroth E. A retrospective cohort study evaluating healthcare resource utilization in patients with asthma in Japan. NPJ Prim Care Respir Med. 2019;29(1):13. doi:10.1038/s41533-019-0128-8
   PubMedGoogle Scholar
• Heaney LG, Perez de Llano L, Al-Ahmad M, et al. Eosinophilic and noneosinophilic asthma: an expert consensus framework to characterize phenotypes in a global real-life severe asthma cohort. Chest. 2021;160(3):814–830. doi:10.1016/j.chest.2021.04.013
   PubMed Web of Science ®Google Scholar
• Louis R, Lau LC, Bron AO, Roldaan AC, Radermecker M, Djukanović R. The relationship between airways inflammation and asthma severity. Am J Respir Crit Care Med. 2000;161(1):9–16. doi:10.1164/ajrccm.161.1.9802048
   PubMed Web of Science ®Google Scholar
• Talini D, Novelli F, Bacci E, et al. Sputum eosinophilia is a determinant of FEV1 decline in occupational asthma: results of an observational study. BMJ Open. 2015;5(1):e005748. doi:10.1136/bmjopen-2014-005748
   PubMed Web of Science ®Google Scholar
• Belda J, Parameswaran K, Lemiere C, Kamada D, O’Byrne PM, Hargreave FE. Predictors of loss of asthma control induced by corticosteroid withdrawal. Can Resp J. 2006;13:129–133.
   PubMedGoogle 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. doi:10.1016/S0140-6736(16)31322-8
   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.e2. doi:10.1016/j.jaci.2010.04.004
   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. doi:10.1016/S0140-6736(16)31324-1
   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. doi:10.1056/NEJMoa1703501
   PubMed Web of Science ®Google Scholar
• Tan YY, Papez V, Chang WH, Mueller SH, Denaxas S, Lai AG. Comparing clinical trial population representativeness to real-world populations: an external validity analysis encompassing 43 895 trials and 5 685 738 individuals across 989 unique drugs and 286 conditions in England. Lancet Healthy Longev. 2022;3(10):e674–e689. doi:10.1016/S2666-7568(22)00186-6
   PubMedGoogle Scholar
• AstraZeneca PLC. Fasenra (Benralizumab) Package Insert. AstraZeneca PLC; 2018.
   Google Scholar
• Nakamura Y, Tamaoki J, Nagase H, et al. Japanese guidelines for adult asthma 2020. Allergol Int. 2020;69(4):519–548. doi:10.1016/j.alit.2020.08.001
   PubMed Web of Science ®Google Scholar
• Adachi M, Kozawa M, Yoshisue H, et al. Real-world safety and efficacy of omalizumab in patients with severe allergic asthma: a long-term post-marketing study in Japan. Respir Med. 2018;141:56–63. doi:10.1016/j.rmed.2018.06.021
   PubMed Web of Science ®Google Scholar
• Tsuboi E. [Evaluation of long-term safety and efficacy of recombinant mepolizumab in bronchial asthma patients under actual use: interim report of a specific use-results survey]. Therapeutic Research. 2023;44(6):405–421. In Japanese.
   Google Scholar
• Menzies-Gow AN, McBrien C, Unni B, et al. Real world biologic use and switch patterns in severe asthma: data from the International Severe Asthma Registry and the US CHRONICLE Study. J Asthma Allergy. 2022;15:63–78. doi:10.2147/JAA.S328653
   PubMed Web of Science ®Google Scholar
• Pilette C, Canonica GW, Chaudhuri R, et al. REALITI-A Study: real-world oral corticosteroid-sparing effect of mepolizumab in severe asthma. J Allergy Clin Immunol Pract. 2022;10(10):2646–2656. doi:10.1016/j.jaip.2022.05.042
   PubMed Web of Science ®Google Scholar
• Thelen JC, van Zelst CM, van Brummelen SE, et al. Efficacy and safety of dupilumab as add-on therapy for patients with severe asthma: a real-world Dutch cohort study. Respir Med. 2023;206:107058. doi:10.1016/j.rmed.2022.107058
   PubMed Web of Science ®Google Scholar
• Eger K, Kroes JA, Ten Brinke A, Bel EH. Long-term therapy response to anti-IL-5 biologics in severe asthma—a real-life evaluation. J Allergy Clin Immunol Pract. 2021;9(3):1194–1200. doi:10.1016/j.jaip.2020.10.010
   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. doi:10.2147/JAA.S176026
   PubMed Web of Science ®Google Scholar
• Inghammar M, Engström G, Kahlmeter G, Ljungberg B, Löfdahl CG, Egesten A. Invasive pneumococcal disease in patients with an underlying pulmonary disorder. Clin Microbiol Infect. 2013;19(12):1148–1154. doi:10.1111/1469-0691.12182
   PubMed Web of Science ®Google Scholar
• Gleich GJ, Klion AD, Lee JJ, Weller PF. The consequences of not having eosinophils. Allergy. 2013;68(7):829–835. doi:10.1111/all.12169
   PubMed Web of Science ®Google Scholar
• Legrand F, Klion AD. Biologic therapies targeting eosinophils: current status and future prospects. J Allergy Clin Immunol Pract. 2015;3(2):167–174. doi:10.1016/j.jaip.2015.01.013
   PubMed Web of Science ®Google Scholar
• Poddighe D, Kovzel E. Impact of anti-type 2 inflammation biologic therapy on COVID-19 clinical course and outcome. J Inflamm Res. 2021;14:6845–6853. doi:10.2147/JIR.S345665
   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;7(1):46–59. doi:10.1016/S2213-2600(18)30406-5
   PubMed Web of Science ®Google Scholar
• Jackson DJ, Korn S, Mathur SK, et al. Safety of eosinophil-depleting therapy for severe, eosinophilic asthma: focus on benralizumab. Drug Saf. 2020;43(5):409–425. doi:10.1007/s40264-020-00926-3
   PubMed Web of Science ®Google Scholar
• Jacobsen EA, Helmers RA, Lee JJ, Lee NA. The expanding role(s) of eosinophils in health and disease. Blood. 2012;120(19):3882–3890. doi:10.1182/blood-2012-06-330845
   PubMed Web of Science ®Google Scholar
• Lombardi C, Berti A, Cottini M. The emerging roles of eosinophils: implications for the targeted treatment of eosinophilic-associated inflammatory conditions. Curr Res Immunol. 2022;3:42–53. doi:10.1016/j.crimmu.2022.03.002
   PubMedGoogle Scholar
• Senna G, Aliani M, Altieri E, et al. Clinical features and efficacy of benralizumab in patients with blood eosinophil count between 300 and 450 cells/mm3: a post hoc analysis from the ANANKE study. J Asthma Allergy. 2022;15:1593–1604. doi:10.2147/JAA.S383012
   PubMed Web of Science ®Google Scholar
• Kavanagh JE, Hearn AP, Dhariwal J, et al. Real-world effectiveness of benralizumab in severe eosinophilic asthma. Chest. 2021;159(2):496–506. doi:10.1016/j.chest.2020.08.2083
   PubMed Web of Science ®Google Scholar
• Numata T, Araya J, Okuda K, et al. Long-term efficacy and clinical remission after benralizumab treatment in patients with severe eosinophilic asthma: a retrospective study. J Asthma Allergy. 2022;15:1731–1741. doi:10.2147/JAA.S391807
   PubMed Web of Science ®Google Scholar
• Al-Hazaymeh A, Patrie J, Adams JC, Borish L, McGowan EC. Asthma-related outcomes during the SARS-CoV2 pandemic: a single-center observational study. J Allergy Clin Immunol Pract. 2021;9(9):3483–3486.e2. doi:10.1016/j.jaip.2021.05.034
   PubMed Web of Science ®Google Scholar
• Abe K, Miyawaki A, Nakamura M, Ninomiya H, Kobayashi Y. Trends in hospitalizations for asthma during the COVID-19 outbreak in Japan. J Allergy Clin Immunol Pract. 2021;9(1):494–496.e1. doi:10.1016/j.jaip.2020.09.060
   PubMed Web of Science ®Google Scholar