Biological Drugs for the Treatment of Uncontrolled Severe Asthma in Children


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Resumo

The introduction of biological drugs for the treatment of severe allergic asthma in chil- dren, 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.

Sobre autores

Cristiana Indolfi

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"Studi della Campania "Luigi Vanvitelli"

Email: info@benthamscience.net

Angela Klain

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"

Email: info@benthamscience.net

Chiara Bencivenga

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli",

Email: info@benthamscience.net

Elisabetta D'Addio

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli",

Email: info@benthamscience.net

Giulio Dinardo

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli",

Email: info@benthamscience.net

Alberto Decimo

Department of Mental, Physical Health and Preventive Medicine, University of Campania "Luigi Vanvitelli",

Email: info@benthamscience.net

Michele del Giudice

Department of Woman, Child and General and Specialized Surgery,, University of Campania "Luigi Vanvitelli"

Autor responsável pela correspondência
Email: info@benthamscience.net

Bibliografia

  1. Ciprandi G, Cioffi L, Schiavetti I, et al. Factors associated with wheezing recurrence in clinical practice. J Asthma 2022; 1-2 doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 10.3390/children7120286
  13. 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 10.1056/NEJMoa1703501 PMID: 28530840
  46. European Medicines Agency. Available from: https://www.ema.europa.eu/en/documents/overview/fasenra-epar-medicine-overview_en.pdf
  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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 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. doi: 10.1111/all.14221 PMID: 32034960

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