Benralizumab in severe eosinophilic asthma: A real-world, single-center, observational study from Mexico
Main Article Content
Keywords
Asthma, Benralizumab, Exacerbation, Quality of Life, Subcutaneous
Abstract
Introduction: Urbanization has increased the prevalence of asthma in lower- and middle-income countries. Severe eosinophilic asthma (SEA), a subtype of asthma, can be refractory to standard therapy. Biologics such as benralizumab target interleukin-5 and have demonstrated effectiveness in managing SEA. There exists no real-world evidence on the effectiveness of benralizumab in Mexico. Therefore, this study presents data on the role of benralizumab in managing SEA in Mexican patients.
Objective: The effectiveness of benralizumab on the quality of life (QoL), asthma control, lung function, symptoms of asthma, and benralizumab’s safety profile were assessed.
Methods: The study sample comprised 10 patients with SEA treated with a subcutaneous (SC) administration of benralizumab 30 mg once in 4 weeks for the first three doses followed by a dose every 8 weeks for 2 years. Laboratory tests, resting spirometry, and skin prick tests were conducted. Levels of fractional exhaled nitric oxide (FeNO) were evaluated, when possible, with the intent to phenotype asthma, as T2 high or non-T2, before starting benralizumab therapy. The Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ), and Asthma Control Test (ACT) were administered to evaluate the effectiveness of benralizumab on asthma control and QoL.
Results: All patients showed significant symptom control, QoL, and lung function over 2 years. Mild adverse effects, such as headache and arthralgia, were observed.
Conclusion: Benralizumab appears to be a promising agent in controlling SEA. This study has focused on measuring tangible outcomes, such as a reduction in symptoms, a reduction in exacerbation, and an improvement in QoL. Thus, benralizumab may constitute an important addition to the arsenal of medications against SEA.
References
2. Global Health Metrics, Asthma level 3 cause. [cited 2022 May 16]. Available from: https://www.thelancet.com/pb-assets/Lancet/gbd/summaries/diseases/asthma.pdf
3. Carrillo G, Mendez-Domínguez N, Datta-Banik R, Figueroa-Lopez F, Estrella-Chan B, Alvarez-Baeza A, et al. Asthma mortality and hospitalizations in Mexico from 2010 to 2018: Retrospective epidemiologic profile. Int J Environ Res Public Health. 2020;17(14):5071–82. 10.3390/ijerph17145071
4. Beran D, Zar HJ, Perrin C, Menezes AM, Burney P, for the Forum of International Respiratory Societies working group collaboration. Burden of asthma and chronic obstructive pulmonary disease and access to essential medicines in low-income and middle-income countries. Lancet Respir Med. 2015;3(2):159–70. 10.1016/S2213-2600(15)00004-1
5. Rodriguez A, Brickley E, Rodrigues L. Urbanisation and asthma in low-income and middle-income countries: A systematic review of the urban–rural differences in asthma prevalence. Thorax. 2019;74(11):1020–30. 10.1136/thoraxjnl-2018-211793
6. Stolbrink M, Thomson H, Hadfield RM, Ozoh OB, Nantanda R, Jayasooriya S, et al. The availability, cost, and affordability of essential medicines for asthma and COPD in low-income and middle-income countries: A systematic review. Lancet Glob Health. 2022;10(10):e1423–e1442. 10.1016/S2214-109X(22)00330-8
7. Thompson K. Two new medications for severe eosinophilic asthma. US Pharm. 2017;42(7):16–9.
8. 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):1194–200. 10.1016/j.jaip.2020.10.010
9. Laviolette M, Gossage DL, Gauvreau G, Leigh R, Olivenstein R, Katial R, Busse WW, et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol. 2013;132(5):1086–96. 10.1016/j.jaci.2013.05.020
10. Korn S, Bourdin A, Chupp G, Cosio BG, Arbetter D, Shah M, et al. Integrated safety and efficacy among patients receiving benralizumab for up to 5 Years. J Allergy Clin Immunol Pract. 2021;9(12):4381–92. 10.1016/j.jaip.2021.07.058
11. Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43(2):343–73. 10.1183/09031936.00202013
12. Del Giacco SR, Bakirtas A, Bel E, et al. Allergy in severe asthma. Allergy. 2017;72(2):207–20. 10.1111/all.13072
13. Vanjare N, Chhowala S, Madas S, et al. Use of spirometry among chest physicians and primary care physicians in India. Npj Prim Care Respirat Med. 2016;26:1–5. 10.1038/npjpcrm.2016.36
14. Miralles López JC, Escudero Pastor AI, Carbonell Martínez A, Garrido CN, Pacheco YB, Petrik YP. Benralizumab in Real Life. J Investig Allergol Clin Immunol. 2021;31(1):87–8. 10.18176/jiaci.0599
15. 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(10056):2128–41. 10.1016/S0140-6736(16)31322-8
16. Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsh I, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018;52(4):1800936–948. 10.1183/13993003.00936-2018
17. The Global Asthma Report. The Global Asthma Report 2018. [cited 2022 May 16]. Available from: http://globalasthmareport.org/2018/index.html.
18. GINA Global Initiative for Asthma. 2022; Global strategy for asthma management and prevention. [cited 2022 Oct 01]. Available from: https://ginasthma.org/wp-content/uploads/2022/07/GINA-Main-Report-2022-FINAL-22-07-01-WMS.pdf
19. Menzella F, Bonavia M, Bonini M, Amato MD, Lombardo S, Murgia N, et al. Real-world experience with benralizumab in patients with severe eosinophilic asthma: A case series. JAA. 2021;14:149–61. 10.2147/JAA.S295676
20. Menzella F, Ruggiero P, Galeone C, Scelfo C, Bagnasco D, Facciolongo N. Significant improvement in lung function and asthma control after benralizumab treatment for severe refractory eosinophilic asthma. Pulm Pharmacol Ther. 2020;64:101966–71. 10.1016/j.pupt.2020.101966
21. Padilla-Galo A, Levy-Abitbol RCh, Olveira C, Valencia Azcona B, Morales MP, Rivas-Ruis F, et al. Real-life experience with benralizumab during 6 months. BMC Pulm Med. 2020;20(1):163–76. 10.1186/s12890-020-01220-9
22. Khurana S, Lyness JM, Mallett S, Nelsen LM, Prazma CM, Albers FC, et al. Association of depressive symptoms with health status and markers of uncontrolled severe asthma. Allergy Asthma Proc. 2019;40(4):230–9. 10.2500/aap.2019.40.4229
23. Hossny E, Caraballo L, Casale T, El-Gamal Y, Rosenwasser L. Severe asthma and quality of life. World Allergy Organ J. 2017;10:28–35. 10.1186/s40413-017-0159-y
24. Gao J, Wu F. Association between fractional exhaled nitric oxide, sputum induction and peripheral blood eosinophil in uncontrolled asthma. Allergy Asthma Clin Immunol. 2018;14(1):1–9. 10.1186/s13223-018-0248-7
25. Sridhar S, Liu H, Pham TH, Damera G, Newbold P. Modulation of blood inflammatory markers by benralizumab in patients with eosinophilic airway diseases. Respir Res. 2019;20(1):14–25. 10.1186/s12931-018-0968-8
26. Pelaia C, Busceti MT, Vatrella A, Rago GF, Crimi C, Terracciano R, et al. Real-life rapidity of benralizumab effects in patients with severe allergic eosinophilic asthma: Assessment of blood eosinophils, symptom control, lung function and oral corticosteroid intake after the first drug dose. Pulm Pharmacol Ther. 2019;58:101830–4. 10.1016/j.pupt.2019.101830
27. Canonica GW, Harrison TW, Chanez P, Menzella F, Louis R, Cosio BG, et al. Benralizumab improves symptoms of patients with severe, eosinophilic asthma with a diagnosis of nasal polyposis. Allergy. 2022;77(1):150–61. 10.1111/all.14902
28. FitzGerald JM, Bleecker ER, Bourdin A, Busse WW, Ferguson TT, Brooks L, et al. Two-year integrated efficacy and safety analysis of benralizumab in severe asthma. J Asthma Allergy. 2019;12:401–13. 10.2147/JAA.S227170
29. Jackson DJ, Korn S, Mathur SK, Barker P, Meka VG, et al. Safety of eosinophil-depleting therapy for severe, eosinophilic asthma: Focus on benralizumab. Drug saf. 2020;43(5):409–25. 10.1007/s40264-020-00926-3s