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Current Pediatric Reviews

Editor-in-Chief

ISSN (Print): 1573-3963
ISSN (Online): 1875-6336

Review Article

Biological Drugs for the Treatment of Uncontrolled Severe Asthma in Children

Author(s): Cristiana Indolfi, Angela Klain, Chiara Lucia Bencivenga, Elisabetta D'Addio, Giulio Dinardo, Alberto Decimo and Michele Miraglia del Giudice*

Volume 20, Issue 3, 2024

Published on: 18 September, 2023

Page: [265 - 270] Pages: 6

DOI: 10.2174/1573396320666230912103115

Price: $65

Abstract

The introduction of biological drugs for the treatment of severe allergic asthma in children, almost twenty years ago, had a substantial impact on both the pathology's clinical course and the quality of life of the patients who receive treatment. Over the years, several molecules have been developed that inhibit molecular targets involved in the pathogenesis of the asthmatic disease. Biological drugs demonstrate a significant improvement in several key clinical parameters in patients with severe asthma. In this review, we provide a concise summary of the evidence on biological therapy for children and adolescents with severe asthma.

Graphical Abstract

[1]
Ciprandi G, Cioffi L, Schiavetti I, et al. Factors associated with wheezing recurrence in clinical practice. J Asthma 2022; 1-2
[http://dx.doi.org/10.1080/02770903.2022.2087187] [PMID: 35666209]
[2]
Ahmed H, Turner S. Severe asthma in children : A review of definitions, epidemiology, and treatment options in 2019. Pediatr Pulmonol 2019; 54(6): 778-87.
[http://dx.doi.org/10.1002/ppul.24317] [PMID: 30884194]
[3]
Di Cicco ME, Leone M, Scavone M, et al. Intermittent and mild persistent asthma: How therapy has changed. Acta Biomed 2021; 92(S7): e2021523.
[http://dx.doi.org/10.23750/abm.v92iS7.12422]
[4]
Pelaia C, Paoletti G, Puggioni F, et al. Interleukin-5 in the pathophysiology of severe asthma. Front Physiol Published 2019; 10: 1514.
[http://dx.doi.org/10.3389/fphys.2019.01514] [PMID: 31920718]
[5]
Hall S, Agrawal DK. Key mediators in the immunopathogenesis of allergic asthma. Int Immunopharmacol 2014; 23(1): 316-29.
[http://dx.doi.org/10.1016/j.intimp.2014.05.034] [PMID: 24933589]
[6]
Gour N, Wills-Karp M. IL-4 and IL-13 signaling in allergic airway disease. Cytokine 2015; 75(1): 68-78.
[http://dx.doi.org/10.1016/j.cyto.2015.05.014] [PMID: 26070934]
[7]
Ridolo E, Pucciarini F, Nizi MC, et al. Mabs for treating asthma: Omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab. Hum Vaccin Immunother 2020; 16(10): 2349-56.
[http://dx.doi.org/10.1080/21645515.2020.1753440] [PMID: 32401603]
[8]
Ferrante G, Tenero L, Piazza M, et al. Severe pediatric asthma therapy: Dupilumab. Front Pediatr 2022; 10: 963610.
[http://dx.doi.org/10.3389/fped.2022.963610]
[9]
Marseglia GL, Licari A, Tosca MA, Ciprandi G. Biologics to treat severe asthma in children and adolescents: A practical update. Pediatr Allergy Immunol Pulmonol 2020; 33(4): 168-76.
[http://dx.doi.org/10.1089/ped.2020.1212] [PMID: 35921565]
[10]
Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43(2): 343-73.
[http://dx.doi.org/10.1183/09031936.00202013] [PMID: 24337046]
[11]
Castagnoli R, Marseglia A, Brambilla I, Marseglia GL, Licari A. Severe uncontrolled asthma in children: Practical approach on diagnosis and management. Minerva Pediatr 2020; 72(3): 196-205.
[http://dx.doi.org/10.23736/S0026-4946.20.05818-1] [PMID: 32108455]
[12]
Porcaro F, Ullmann N, Allegorico A, et al. Difficult and severe asthma in children. Children 2020; 7(12): 286.
[http://dx.doi.org/10.3390/children7120286]
[13]
2022 GINA Main Report - Global Initiative for Asthma - GINA. 2022. Available from: https://ginasthma.org/gina-reports/ (Accessed on: 2022 Dec 24).
[14]
Summary of product characteristics. Available from: https://farmaci.agenziafarmaco.gov.it/aifa/servlet/PdfDownloadServlet?pdfFileName=footer _004789_036892_RCP.pdf (Accessed on: 2022 Dec 24).
[15]
Summary of product characteristics. Available from: https://farmaci.agenziafarmaco.gov.it/aifa/servlet/PdfDownloadServlet?pdfFileName=footer _003792_045676_RCP.pdf (Accessed on: 2022 Dec 24).
[16]
Summary of product characteristics. Available from: https://farmaci.agenziafarmaco.gov.it/aifa/servlet/PdfDownloadServlet?pdfFileName=footer _003438_044648_RCP.pdf (Accessed on: 2022 Dec 24).
[17]
Summary of product characteristics. Available from: https://farmaci.agenziafarmaco.gov.it/aifa/servlet/PdfDownloadServlet?pdfFileName=footer _002351_044992_RCP.pdf (Accessed on: 2022 Dec 24).
[18]
Summary of product characteristics. Available from: https://farmaci.agenziafarmaco.gov.it/aifa/servlet/PdfDownloadServlet?pdfFileName=footer _000690_045931_RCP.pdf (Accessed on: 2022 Dec 24).
[19]
Harb H, Chatila TA. Mechanisms of dupilumab. Clin Exp Allergy 2020; 50(1): 5-14.
[http://dx.doi.org/10.1111/cea.13491] [PMID: 31505066]
[20]
Castro M, Corren J, Pavord ID, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med 2018; 378(26): 2486-96.
[http://dx.doi.org/10.1056/NEJMoa1804092] [PMID: 29782217]
[21]
Rabe KF, Nair P, Brusselle G, et al. Efficacy and safety of dupilumab in glucocorticoiddependent severe asthma. N Engl J Med 2018; 378(26): 2475-85.
[http://dx.doi.org/10.1056/NEJMoa1804093] [PMID: 29782224]
[22]
Wechsler ME, Ford LB, Maspero JF, et al. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): An open-label extension study. Lancet Respir Med 2022; 10(1): 11-25.
[http://dx.doi.org/10.1016/S2213-2600(21)00322-2] [PMID: 34597534]
[23]
Bacharier LB, Maspero JF, Katelaris CH, et al. Dupilumab in children with uncontrolled moderate-to-severe asthma. N Engl J Med 2021; 385(24): 2230-40.
[http://dx.doi.org/10.1056/NEJMoa2106567] [PMID: 34879449]
[24]
Agache I, Song Y, Rocha C, et al. Efficacy and safety of treatment with dupilumab for severe asthma: A systematic review of the EAACI guidelines—Recommendations on the use of biologicals in severe asthma. Allergy 2020; 75(5): 1058-68.
[http://dx.doi.org/10.1111/all.14268] [PMID: 32154939]
[25]
Spergel BL, Ruffner MA, Godwin BC, et al. Improvement in eosinophilic esophagitis when using dupilumab for other indications or compassionate use. Ann Allergy Asthma Immunol 2022; 128(5): 589-93.
[http://dx.doi.org/10.1016/j.anai.2022.01.019] [PMID: 35085819]
[26]
Licari A, Marseglia A, Caimmi S, et al. Omalizumab in children. Paediatr Drugs 2014; 16(6): 491-502.
[http://dx.doi.org/10.1007/s40272-014-0107-z] [PMID: 25404353]
[27]
Paganin F, Mangiapan G, Proust A, et al. Lung function parameters in omalizumab responder patients: An interesting tool? Allergy 2017; 72(12): 1953-61.
[http://dx.doi.org/10.1111/all.13202] [PMID: 28517027]
[28]
Licari A, Castagnoli R, Denicolò C, et al. Omalizumab in children with severe allergic asthma: The Italian real-life experience. Curr Respir Med Rev 2017; 13(1): 36-42.
[http://dx.doi.org/10.2174/1573398X13666170426094536] [PMID: 29213221]
[29]
Yu L, Zhang H, Pan J, Ye L. Pediatric usage of Omalizumab: A promising one. World Allergy Organ J 2021; 14(12): 100614.
[http://dx.doi.org/10.1016/j.waojou.2021.100614]
[30]
Corren J, Kavati A, Ortiz B, et al. Efficacy and safety of omalizumab in children and adolescents with moderate-to-severe asthma: A systematic literature review. Allergy Asthma Proc 2017; 38(4): 250-63.
[http://dx.doi.org/10.2500/aap.2017.38.4067] [PMID: 28631599]
[31]
Chipps BE, Lanier B, Milgrom H, et al. Omalizumab in children with uncontrolled allergic asthma: Review of clinical trial and real-world experience. J Allergy Clin Immunol 2017; 139(5): 1431-44.
[http://dx.doi.org/10.1016/j.jaci.2017.03.002] [PMID: 28477722]
[32]
Fu Z, Xu Y, Cai C. Efficacy and safety of omalizumab in children with moderate-to-severe asthma: A meta-analysis. J Asthma 2021; 58(10): 1350-8.
[http://dx.doi.org/10.1080/02770903.2020.1789875] [PMID: 32602383]
[33]
Cheng L, Yang T, Ma X, et al. Effectiveness and safety studies of omalizumab in children and adolescents with moderate-to-severe asthma. J Pharm Pract 2021; 8971900211038251.
[http://dx.doi.org/10.1177/08971900211038251] [PMID: 34384308]
[34]
Chen M, Choo E, Yoo B, et al. No difference in omalizumab efficacy in patients with asthma by number of asthma-related and allergic comorbidities. Ann Allergy Asthma Immunol 2021; 126(6): 666-73.
[http://dx.doi.org/10.1016/j.anai.2021.01.015] [PMID: 33465457]
[35]
Yilmaz O, Yuksel H. Where does current and future pediatric asthma treatment stand? Remodeling and inflammation: Bird’s eye view. Pediatr Pulmonol 2016; 51(12): 1422-9.
[http://dx.doi.org/10.1002/ppul.23488] [PMID: 27233079]
[36]
Stelmach I, Majak P, Jerzyńska J, Bojo M, Cichalewski Ł, Smejda K. Letter to the editor children with severe asthma can start allergen immunotherapy after controlling asthma with omalizumab: A case series from Poland. Arch Med Sci 2015; 4(4): 901-4.
[http://dx.doi.org/10.5114/aoms.2015.48546] [PMID: 26322106]
[37]
Braido F, Corsico A, Rogkakou A, Ronzoni V, Baiardini I, Canonica GW. The relationship between allergen immunotherapy and omalizumab for treating asthma. Expert Rev Respir Med 2015; 9(2): 129-34.
[http://dx.doi.org/10.1586/17476348.2015.1000866] [PMID: 25578528]
[38]
Incorvaia C, Mauro M, Russello M, Formigoni C, Ridolo E, Riario-Sforza . Omalizumab, an anti-immunoglobulin E antibody: State of the art. Drug Des Devel Ther 2014; 8: 197-207.
[http://dx.doi.org/10.2147/DDDT.S49409] [PMID: 24532966]
[39]
Dávila González I, Moreno Benítez F, Quirce S. Benralizumab: A new approach for the treatment of severe eosinophilic asthma. J Investig Allergol Clin Immunol 2019; 29(2): 84-93.
[http://dx.doi.org/10.18176/jiaci.0385] [PMID: 31017107]
[40]
Cushen B, Menzies-Gow A. Benralizumab: An updated treatment of eosinophilic asthma. Expert Rev Respir Med 2020; 14(5): 435-44.
[http://dx.doi.org/10.1080/17476348.2020.1739526] [PMID: 32133878]
[41]
Bagnasco D, Caminati M, Ferrando M, et al. Anti-IL-5 and IL-5Ra: Efficacy and safety of new therapeutic strategies in severe uncontrolled asthma. Biomed Res Int 2018; 2018: 5698212.
[http://dx.doi.org/10.1155/2018/5698212]
[42]
Kupczyk M, Kuna P. Benralizumab: An anti-IL-5 receptor α monoclonal antibody in the treatment of asthma. Immunotherapy 2018; 10(5): 349-59.
[http://dx.doi.org/10.2217/imt-2017-0161] [PMID: 29359607]
[43]
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): 2115-27.
[http://dx.doi.org/10.1016/S0140-6736(16)31324-1] [PMID: 27609408]
[44]
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): 2128-41.
[http://dx.doi.org/10.1016/S0140-6736(16)31322-8] [PMID: 27609406]
[45]
Nair P, Wenzel S, Rabe KF, et al. Oral glucocorticoid-sparing effect of benralizumab in severe asthma. N Engl J Med 2017; 376(25): 2448-58.
[http://dx.doi.org/10.1056/NEJMoa1703501] [PMID: 28530840]
[47]
Nucala prescribing information. 2022. Available from:www.gsk source.com/pharma/content/dam/GlaxoSmithKline/US/en/ Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFUCOMBINED.PDF (Accessed July Dec 24, 2022.).
[48]
Nucala EMA product information. Available from:www.ema.europa.eu/en/documents/product-information/nucalaepar-productinformation_en.pdf (Accessed July Dec 24, 2022.).
[49]
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): 651-9.
[http://dx.doi.org/10.1016/S0140-6736(12)60988-X] [PMID: 22901886]
[50]
Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371(13): 1198-207.
[http://dx.doi.org/10.1056/NEJMoa1403290] [PMID: 25199059]
[51]
Bel EH, Wenzel SE, Thompson PJ, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014; 371(13): 1189-97.
[http://dx.doi.org/10.1056/NEJMoa1403291] [PMID: 25199060]
[52]
Lugogo N, Domingo C, Chanez P, et al. Long-term efficacy and safety of mepolizumab in patients with severe eosinophilic asthma: A multi-center, open-label, phase IIIb study. Clin Ther 2016; 38(9): 2058-2070.e1.
[http://dx.doi.org/10.1016/j.clinthera.2016.07.010] [PMID: 27553751]
[53]
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 2019; 143(5): 1742-1751.e7.
[http://dx.doi.org/10.1016/j.jaci.2018.09.033] [PMID: 30359681]
[54]
Pediatric postmarketing pharmacovigilance review: cinqair® (Reslizumab). Available from: https://www.fda.gov/media/114068/download (Accessed on: Dec 24, 2022.).
[55]
Cooper K, Frampton G, Harris P, Rose M, Chorozoglou M, Pickett K. Reslizumab for treating asthma with elevated blood eosinophils inadequately controlled by inhaled corticosteroids: An evidence review group perspective of a NICE single technology appraisal. PharmacoEconomics 2018; 36(5): 545-53.
[http://dx.doi.org/10.1007/s40273-017-0608-z] [PMID: 29582406]
[56]
Teva. Cinqair (reslizumab) prescribing information. Available from: https://hcp.cinqair.com/dosage-and-administration.aspx (Accessed Dec 24, 2022.).
[57]
Murphy K, Jacobs J, Bjermer L, et al. Long-term safety and efficacy of reslizumab in patients with eosinophilic asthma. J Allergy Clin Immunol Pract 2017; 5(6): 1572-1581.e3.
[http://dx.doi.org/10.1016/j.jaip.2017.08.024] [PMID: 29122156]
[58]
Mukherjee M, Aleman Paramo F, Kjarsgaard M, et al. Weight-adjusted intravenous reslizumab in severe asthma with inadequate response to fixed-dose subcutaneous mepolizumab. Am J Respir Crit Care Med 2018; 197(1): 38-46.
[http://dx.doi.org/10.1164/rccm.201707-1323OC] [PMID: 28915080]
[59]
Logan JK, Harinstein L, Mun˜oz M. Pediatric Postmarketing Pharmacovigilance Review: Cinqair (Reslizumab). Available from: www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ UCM610723.pdf (Accessed on: Dec 24, 2022.).
[60]
Agache I, Beltran J, Akdis C, et al. Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma. Allergy 2020; 75(5): 1023-42.
[http://dx.doi.org/10.1111/all.14221] [PMID: 32034960]

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