Skip to main content
Top
Published in: BMC Pulmonary Medicine 1/2020

Open Access 01-12-2020 | Rhinosinusitis | Research article

Efficacy of benralizumab for patients with severe eosinophilic asthma: a retrospective, real-life study

Authors: Takanori Numata, Hanae Miyagawa, Saiko Nishioka, Keitaro Okuda, Hirofumi Utsumi, Mitsuo Hashimoto, Shunsuke Minagawa, Takeo Ishikawa, Hiromichi Hara, Jun Araya, Kazuyoshi Kuwano

Published in: BMC Pulmonary Medicine | Issue 1/2020

Login to get access

Abstract

Background

Benralizumab, an anti-interleukin-5 (IL-5) receptor α monoclonal antibody, significantly reduces the number of annual exacerbations and oral corticosteroid (OCS) maintenance doses for patients with severe eosinophilic asthma (SEA). However, few studies on the efficacy of this biologic in real life are available. The aim was to elucidate the efficacy of benralizumab by evaluating changes in clinical parameters after benralizumab treatment in patients with SEA.

Methods

From July 2018 to December 2019, 24 Japanese patients with SEA received benralizumab at Jikei University Hospital. We retrospectively evaluated the patients’ characteristics, parameters, numbers of exacerbations and maintenance OCS doses.

Results

Among the 24 patients, eleven patients had received mepolizumab treatment and were directly switched to benralizumab. The peripheral blood eosinophil and basophil counts significantly decreased after benralizumab treatment regardless of previous mepolizumab treatment. Pulmonary function, Asthma Control Test scores, the numbers of annual exacerbations and maintenance OCS doses in patients without previous mepolizumab treatment tended to improve without significant differences. Fourteen patients (58%) were responders according to the Global Evaluation of Treatment Effectiveness (GETE) score. The proportion of GETE responders among patients with aspirin-exacerbated respiratory disease (AERD) tended to be lower than that among patients without AERD (p = 0.085). After benralizumab treatment, the change in the forced expiratory volume in 1 s from baseline was 200 ml or greater in eight patients (33%), including three patients who were switched from mepolizumab.

Conclusion

Benralizumab treatment improved and controlled asthma symptoms based on the GETE score.
Appendix
Available only for authorised users
Literature
2.
go back to reference Hekking PPW, Wener RR, Amelink M, Zwinderman AH, Bouvy ML, Bel EH. The prevalence of severe refractory asthma. J Allergy Clin Immunol. 2015;135:896–902.CrossRef Hekking PPW, Wener RR, Amelink M, Zwinderman AH, Bouvy ML, Bel EH. The prevalence of severe refractory asthma. J Allergy Clin Immunol. 2015;135:896–902.CrossRef
4.
go back to reference Global initiative for asthma: Asthma management and prevention, 2019. 2019; 49. Accessed 21 Octorber 2019. Global initiative for asthma: Asthma management and prevention, 2019. 2019; 49. Accessed 21 Octorber 2019.
6.
go back to reference Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker 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;388:2115–27.CrossRef Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker 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;388:2115–27.CrossRef
7.
go back to reference FitzGerald JM, Bleecker ER, Menzies-Gow A, Zangrilli JG, Hirsch I, Metcalfe P, 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;6:51–64.CrossRef FitzGerald JM, Bleecker ER, Menzies-Gow A, Zangrilli JG, Hirsch I, Metcalfe P, 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;6:51–64.CrossRef
8.
go back to reference FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, 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;388:2128–41.CrossRef FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, 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;388:2128–41.CrossRef
9.
go back to reference Nair P, Wenzel S, Rabe KF, Bourdin A, Lugogo NL, Kuna P, et al. Oral glucocorticoid–sparing effect of Benralizumab in severe asthma. N Engl J Med. 2017;376:2448–58.CrossRef Nair P, Wenzel S, Rabe KF, Bourdin A, Lugogo NL, Kuna P, et al. Oral glucocorticoid–sparing effect of Benralizumab in severe asthma. N Engl J Med. 2017;376:2448–58.CrossRef
10.
go back to reference Shimoda T, Odajima H, Okamasa A, Kawase M, Komatsubara M, Mayer B, et al. Efficacy and safety of mepolizumab in Japanese patients with severe eosinophilic asthma. Allergol Int. 2017;66:445–51.CrossRef Shimoda T, Odajima H, Okamasa A, Kawase M, Komatsubara M, Mayer B, et al. Efficacy and safety of mepolizumab in Japanese patients with severe eosinophilic asthma. Allergol Int. 2017;66:445–51.CrossRef
11.
go back to reference Numata T, Nakayama K, Utsumi H, Kobayashi K, Yanagisawa H, Hashimoto M, et al. Efficacy of mepolizumab for patients with severe asthma and eosinophilic chronic rhinosinusitis. BMC Pulm Med. 2019;19(176):1–9. Numata T, Nakayama K, Utsumi H, Kobayashi K, Yanagisawa H, Hashimoto M, et al. Efficacy of mepolizumab for patients with severe asthma and eosinophilic chronic rhinosinusitis. BMC Pulm Med. 2019;19(176):1–9.
12.
go back to reference Ohta K, Adachi M, Tohda Y, Kamei T, Kato M, Mark Fitzgerald J, et al. Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma. Allergol Int. 2018;67:266–72.CrossRef Ohta K, Adachi M, Tohda Y, Kamei T, Kato M, Mark Fitzgerald J, et al. Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma. Allergol Int. 2018;67:266–72.CrossRef
13.
go back to reference Ichinose M, Sugiura H, Nagase H, Yamaguchi M, Inoue H, Sagara H, et al. Japanese guidelines for adult asthma 2017. Allergol Int. 2017;66:163–89.CrossRef Ichinose M, Sugiura H, Nagase H, Yamaguchi M, Inoue H, Sagara H, et al. Japanese guidelines for adult asthma 2017. Allergol Int. 2017;66:163–89.CrossRef
14.
go back to reference Santanello NC, Zhang J, Seidenberg B, Reiss TF, Barber BL. What are minimal important changes for asthma measures in a clinical trial? Eur Respir J. 1999;14:23–7.CrossRef Santanello NC, Zhang J, Seidenberg B, Reiss TF, Barber BL. What are minimal important changes for asthma measures in a clinical trial? Eur Respir J. 1999;14:23–7.CrossRef
15.
go back to reference Tepper RS, Wise RS, Covar R, Irvin CG, Kercsmar CM, Kraft M, et al. Asthma outcomes: pulmonary physiology. J Allergy Clin Immunol. 2012;129:S65–87.CrossRef Tepper RS, Wise RS, Covar R, Irvin CG, Kercsmar CM, Kraft M, et al. Asthma outcomes: pulmonary physiology. J Allergy Clin Immunol. 2012;129:S65–87.CrossRef
16.
go back to reference Pertzov B, Avraham U, Osnat S, Dorit S, Dror R, Reuven KM. Efficacy and safety of mepolizumab in a real-world cohort of patients with severe eosinophilic asthma. J Asthma. 2019:1–6. Pertzov B, Avraham U, Osnat S, Dorit S, Dror R, Reuven KM. Efficacy and safety of mepolizumab in a real-world cohort of patients with severe eosinophilic asthma. J Asthma. 2019:1–6.
17.
go back to reference American Thoracic Society ERS. American Thoracic Society Documents ATS / ERS Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide , 2005. Am J Respir Crit Care Med. 2005;171:912–30.CrossRef American Thoracic Society ERS. American Thoracic Society Documents ATS / ERS Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide , 2005. Am J Respir Crit Care Med. 2005;171:912–30.CrossRef
18.
go back to reference Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P, et al. The minimally important difference of the asthma control test. J Allergy Clin Immunol. 2009;124:719–23.CrossRef Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P, et al. The minimally important difference of the asthma control test. J Allergy Clin Immunol. 2009;124:719–23.CrossRef
19.
go back to reference Zierau L, Walsted ES, Thomsen SF, Backer V. Response to omalizumab in patients with severe allergic asthma: a real-life study. Respir Med. 2017;131:109–13.CrossRef Zierau L, Walsted ES, Thomsen SF, Backer V. Response to omalizumab in patients with severe allergic asthma: a real-life study. Respir Med. 2017;131:109–13.CrossRef
20.
go back to reference Kanda Y. Investigation of the freely available easy-to-use software “EZR” for medical statistics. Bone Marrow Transplant. 2013;48:452–8.CrossRef Kanda Y. Investigation of the freely available easy-to-use software “EZR” for medical statistics. Bone Marrow Transplant. 2013;48:452–8.CrossRef
21.
go back to reference Magnan A, Bourdin A, Prazma CM, Albers FC, Price RG, Yancey SW, et al. Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment. Allergy. 2016;71:1335–44.CrossRef Magnan A, Bourdin A, Prazma CM, Albers FC, Price RG, Yancey SW, et al. Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment. Allergy. 2016;71:1335–44.CrossRef
23.
go back to reference Morales DR, Guthrie B, Lipworth BJ, Jackson C, Donnan PT, Santiago VH. NSAID-exacerbated respiratory disease: a meta-analysis evaluating prevalence, mean provocative dose of aspirin and increased asthma morbidity. Allergy. 2015;70:828–35.CrossRef Morales DR, Guthrie B, Lipworth BJ, Jackson C, Donnan PT, Santiago VH. NSAID-exacerbated respiratory disease: a meta-analysis evaluating prevalence, mean provocative dose of aspirin and increased asthma morbidity. Allergy. 2015;70:828–35.CrossRef
24.
go back to reference Tuttle K, Buchheit K, Laidlaw T, Cahill K. A retrospective analysis of mepolizumab in subjects with aspirin-exacerbated respiratory disease. J Allergy Clin Immunol Pract. 2018;6:1045–7.CrossRef Tuttle K, Buchheit K, Laidlaw T, Cahill K. A retrospective analysis of mepolizumab in subjects with aspirin-exacerbated respiratory disease. J Allergy Clin Immunol Pract. 2018;6:1045–7.CrossRef
25.
go back to reference DuBuske L, Newbold P, Wu Y, Trudo F. Seasonal variability of exacerbations of severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab. Allergy Asthma Proc. 2018;39:345–9.CrossRef DuBuske L, Newbold P, Wu Y, Trudo F. Seasonal variability of exacerbations of severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab. Allergy Asthma Proc. 2018;39:345–9.CrossRef
26.
go back to reference Bourdin A, Husereau D, Molinari N, Golam S, Siddiqui MK, Lindner L, 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;52:1801393.CrossRef Bourdin A, Husereau D, Molinari N, Golam S, Siddiqui MK, Lindner L, 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;52:1801393.CrossRef
27.
go back to reference Busse W, Chupp G, Nagase H, Albers FC, Doyle S, Shen Q, et al. Anti–IL-5 treatments in patients with severe asthma by blood eosinophil thresholds: indirect treatment comparison. J Allergy Clin Immunol. 2019;143:2336.CrossRef Busse W, Chupp G, Nagase H, Albers FC, Doyle S, Shen Q, et al. Anti–IL-5 treatments in patients with severe asthma by blood eosinophil thresholds: indirect treatment comparison. J Allergy Clin Immunol. 2019;143:2336.CrossRef
29.
go back to reference Hayashi H, Mitsui C, Nakatani E, Fukutomi Y, Kajiwara K, Watai K, et al. Omalizumab reduces cysteinyl leukotriene and 9α,11β-prostaglandin F2 overproduction in aspirin-exacerbated respiratory disease. J Allergy Clin Immunol. 2016;137:1585–7 e4.CrossRef Hayashi H, Mitsui C, Nakatani E, Fukutomi Y, Kajiwara K, Watai K, et al. Omalizumab reduces cysteinyl leukotriene and 9α,11β-prostaglandin F2 overproduction in aspirin-exacerbated respiratory disease. J Allergy Clin Immunol. 2016;137:1585–7 e4.CrossRef
30.
go back to reference Taniguchi M, Mitsui C, Hayashi H, Ono E, Kajiwara K, Mita H, et al. Aspirin-exacerbated respiratory disease (AERD): current understanding of AERD. Allergol Int. 2019;68:289–95.CrossRef Taniguchi M, Mitsui C, Hayashi H, Ono E, Kajiwara K, Mita H, et al. Aspirin-exacerbated respiratory disease (AERD): current understanding of AERD. Allergol Int. 2019;68:289–95.CrossRef
31.
go back to reference Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, et al. Baseline patient factor impact on the clinical efficacy of Benralizumab for severe asthma. Eur Respir J. 2018;52:1800936.CrossRef Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, et al. Baseline patient factor impact on the clinical efficacy of Benralizumab for severe asthma. Eur Respir J. 2018;52:1800936.CrossRef
32.
go back to reference Stevens WW, Peters AT, Hirsch AG, Nordberg CM, Schwartz BS, Mercer DG, et al. Clinical characteristics of patients with chronic Rhinosinusitis with nasal polyps, asthma, and aspirin-exacerbated respiratory disease. J Allergy Clin Immunol Pract. 2017;5:1061–70.CrossRef Stevens WW, Peters AT, Hirsch AG, Nordberg CM, Schwartz BS, Mercer DG, et al. Clinical characteristics of patients with chronic Rhinosinusitis with nasal polyps, asthma, and aspirin-exacerbated respiratory disease. J Allergy Clin Immunol Pract. 2017;5:1061–70.CrossRef
33.
go back to reference Stevens WW, Ocampo CJ, Berdnikovs S, Sakashita M, Mahdavinia M, Suh L, et al. Cytokines in chronic rhinosinusitis role in eosinophilia and aspirin-exacerbated respiratory disease. Am J Respir Crit Care Med. 2015;192:682–94.CrossRef Stevens WW, Ocampo CJ, Berdnikovs S, Sakashita M, Mahdavinia M, Suh L, et al. Cytokines in chronic rhinosinusitis role in eosinophilia and aspirin-exacerbated respiratory disease. Am J Respir Crit Care Med. 2015;192:682–94.CrossRef
34.
go back to reference Losol P, Kim SH, Shin YS, Ye YM, Park HS. A genetic effect of IL-5 receptor α polymorphism in patients with aspirin-exacerbated respiratory disease. Exp Mol Med. 2013;45:e14.CrossRef Losol P, Kim SH, Shin YS, Ye YM, Park HS. A genetic effect of IL-5 receptor α polymorphism in patients with aspirin-exacerbated respiratory disease. Exp Mol Med. 2013;45:e14.CrossRef
Metadata
Title
Efficacy of benralizumab for patients with severe eosinophilic asthma: a retrospective, real-life study
Authors
Takanori Numata
Hanae Miyagawa
Saiko Nishioka
Keitaro Okuda
Hirofumi Utsumi
Mitsuo Hashimoto
Shunsuke Minagawa
Takeo Ishikawa
Hiromichi Hara
Jun Araya
Kazuyoshi Kuwano
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Pulmonary Medicine / Issue 1/2020
Electronic ISSN: 1471-2466
DOI
https://doi.org/10.1186/s12890-020-01248-x

Other articles of this Issue 1/2020

BMC Pulmonary Medicine 1/2020 Go to the issue
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discuss last year's major advances in heart failure and cardiomyopathies.