Time effect of dupilumab to treat severe uncontrolled asthma in adolescents: A pilot study
Main Article Content
Keywords
asthma, dupilumab, children, asthma control, quality of life
Abstract
Background: Dupilumab is a new biological drug approved for the treatment of type 2 inflammatory diseases, such as asthma. Dupilumab is a fully humanized monoclonal antibody that acts against both interleukin-4 and interleukin-13 receptors. This study evaluated the time-dependent effect of dupilumab on asthma exacerbations and quality of life in adolescents with uncontrolled severe asthma.
Materials and Methods: Five adolescents suffering from uncontrolled severe asthma and treated with dupilumab were recruited. All subjects were evaluated for 4, 12, and 24 weeks after the first dose of dupilumab. Outcome measures included lung function, fractional exhaled nitric oxide, asthma control and quality of life assessed by validated questionnaires (Asthma Control Test and Asthma Control Questionnaire).
Results: The quality of life improved quickly after 4 weeks of treatment and 80% of adolescents halved the dose of inhaled corticosteroids necessary to control asthma symptoms. These results were still maintained for 24 weeks after start of the therapy. None of the patients had any asthma exacerbation during the study period.
Conclusion: Results of this study demonstrated that dupilumab was quickly effective to reduce asthma exacerbation and ameliorate quality of life in severe asthmatic adolescents.
References
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2. Klain A, Indolfi C, Dinardo G, Decimo F, Tosca MA, Miraglia Del Giudice M, et al. Comparing available treatments for pollen-induced allergic rhinitis in children [Internet]. 2022 [cited 2022 Sep 15]. Expert Rev Clin Immunol. 2022;18(8):835–43. 10.1080/1744666X.2022.2093188
3. Galli E, Cinicola B, Carello R, Caimmi S, Brindisi G, De Castro G, et al. Atopic dermatitis. Atenei Parm [Internet]. 2020 [cited 2022 Sep 15]. Acta Bio Medica. 2020;91(Suppl 11):1–10.
4. Maiello N, Giannetti A, Ricci G, Cinicola B, Carello R, Indolfi C, et al. Atopic dermatitis and atopic march: Which link? [Internet]. 2021 Nov 29 [cited 2022 Sep 15]. Acta Biomed. 2021;92(S7):e2021525.
5. 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 [Internet]. 2014 Feb 1 [cited 2021 Apr 7]. Eur Respir J. 2014;43(2):343–73.
6. Castagnoli R, Marseglia A, Brambilla I, Marseglia GL, Licari A. Severe uncontrolled asthma in children: Practical approach on diagnosis and management. Minerva Pediatr. 2020, Jun 1;72(3):196–205. 10.23736/S0026-4946.20.05818-1
7. de Benedictis F, del Giudice MM, Vetrella M, Tressanti F, Tronci A, Testi R, et al. Nebulized fluticasone propionate vs. budesonide as adjunctive treatment in children with asthma exacerbation [Internet]. 2005 Jun 1 [cited 2022 Sep 13]. J Asthma. 42(5):331–6. 10.1081/JAS-200062966
8. Del Giudice MM, Pezzulo A, Capristo C, Alterio E, Caggiano S, de Benedictis D, et al. Leukotriene modifiers in the treatment of asthma in children [Internet]. 2009 [cited 2022 Sep 13]. Ther Adv Respir Dis. 2009;3(5):245–51. 10.1177/1753465809348014
9. Di Cicco ME, Leone M, Scavone M, Del Giudice MM, Licari A, Duse M, et al. Intermittent and mild persistent asthma: How therapy has changed [Internet]. 2021 Nov 29 [cited 2022 Sep 13]. Acta Biomed. 2021;92(S7):e2021523. 10.23750/abm.v92iS7.12422
10. Indolfi C, Dinardo G, Rosaria Umano G, Klain A, Contieri M, Decimo A, et al. Mometasone furoate nasal spray in Italian children with seasonal allergic rhinitis: A comprehensive assessment [Internet]. 2022 Sep 1 [cited 2022 Sep 13]. Allergol Immunopathol (Madr). 2022;50(5):61–7. 10.15586/aei.v50i5.643
11. Miraglia del Giudice M, Piacentini GL, Capasso M, Capristo C, Maiello N, Boner AL, et al. Formoterol, montelukast, and budesonide in asthmatic children: Effect on lung function and exhaled nitric oxide [Internet]. 2007 Aug [cited 2022 Sep 13]. Respir Med. 2007;101(8):1809–13. 10.1016/j.rmed.2007.02.010
12. Ahmed H, Turner S. Severe asthma in children–A review of definitions, epidemiology, and treatment options in 2019 [Internet]. 2019 Jun 1 [cited 2022 May 26]. Pediatr Pulmonol. 54(6):778–87. 10.1002/ppul.24317
13. Ciprandi G, Cioffi L, Schiavetti I, del Giudice MM, Tosca MA. Factors associated with wheezing recurrence in clinical practice [Internet]. 2022 Jun 10 [cited 2022 Jun 30]. J Asthma. 2023;60(4):843-844. 10.1080/02770903.2022.2087187
14. Marseglia GL, Manti S, Chiappini E, Brambilla I, Caffarelli C, Calvani M, et al. Chronic cough in childhood: A systematic review for practical guidance by the Italian Society of Pediatric Allergy and Immunology [Internet]. 2021 [cited 2022 Jun 30]. Allergol Immunopathol (Madr). 49(2):133–54. 10.15586/aei.v49i2.44
15. Duse M, Santamaria F, Verga MC, Bergamini M, Simeone G, Leonardi L, et al. Inter-society consensus for the use of inhaled corticosteroids in infants, children and adolescents with airway diseases [Internet]. 2021 Dec 1 [cited 2022 Jun 30]. Ital J Pediatr. 2021;47(1):1–24. 10.1186/s13052-021-01013-8
16. Tozzi AE, Armenio L, Bernardini R, Boner A, Calvani M, Cardinale F, et al. Pediatric allergy and immunology in Italy [Internet]. 2011 May [cited 2022 Jun 30]. Pediatr Allergy Immunol. 2011;22(3):267–76. 10.1111/j.1399-3038.2011.01157.x
17. Del Giudice MM, Brunese FP, Piacentini GL, Pedullà M, Capristo C, Decimo F, et al. Fractional exhaled nitric oxide (FeNO), lung function and airway hyperresponsiveness in naïve atopic asthmatic children [Internet]. 2004 [cited 2022 Sep 13]. J Asthma. 2004;41(7):759–65. 10.1081/JAS-200027862
18. Global Initiative for Asthma (GINA). GINA main report [Internet]. 2022 [cited 2022 Jun 29]. Available from https://ginasthma.org/gina-reports/
19. Arasi S, Costa S, Magazzù G, Ieni A, Crisafulli G, Caminiti L, et al. Omalizumab therapy in a 13-year-old boy with severe persistent asthma and concomitant eosinophilic esophagitis [Internet]. 2016 Mar 22 [cited 2022 Jun 30]. Ital J Pediatr. 2016;42(1):32. 10.1186/s13052-016-0243-x.
20. Cutrera R, Baraldi E, Indinnimeo L, Miraglia Del Giudice M, Piacentini G, Scaglione F, et al. Management of acute respiratory diseases in the pediatric population: The role of oral corticosteroids [Internet]. 2017 Mar 23 [cited 2022 Jun 30]. Ital J Pediatr. 2017;43(1):31. 10.1186/s13052-017-0348-x
21. EMA. Dupilumab European Medicines Agency. Summary of product characteristics [Internet]. [cited 2023 Jul 9]. Available from: https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf
22. AIFA. Agenzia Italiana del Farmaco. Annex I summary of product characteristics [Internet]. [cited 2023 Jul 9]. Available from: https://farmaci.agenziafarmaco.gov.it/aifa/servlet/PdfDownloadServlet?pdfFileName=footer_003792_045676_RCP.pdf&sys=m0b1l3
23. Harb H, Chatila TA. Mechanisms of Dupilumab [Internet]. 2020 Jan 1 [cited 2022 Jun 28]. Clin Exp Allergy. 2020;50(1):5–14. 10.1111/cea.13491
24. Hall S, Agrawal DK. Key mediators in the immunopathogenesis of allergic asthma [Internet]. 2014 [cited 2022 Jun 28]. Int Immunopharmacol. 2014;23(1):316–29. 10.1016/j.intimp.2014.05.034
25. Bagnasco D, Ferrando M, Varricchi G, Passalacqua G, Canonica GW. A critical evaluation of anti-IL-13 and anti-IL-4 strategies in severe asthma [Internet]. 2016 Aug 1 [cited 2022 Jun 28]. Int Arch Allergy Immunol. 2016;170(2):122–31. 10.1159/000447692
26. Calzavara-Pinton P, Fortina AB, Bonamonte D, Marseglia GL, Del Giudice MM, Musarra A, et al. Diagnosis and management of moderate-to-severe atopic dermatitis in adolescents. A consensus by the Italian Society of Dermatology and Venereology (SIDeMaST), the Italian Association of Hospital Dermatologists and Public Health (ADOI), the Italian Association of Hospital and Territorial Allergists and Immunologists (AAIITO), the Italian Society of Allergy, Asthma and Clinical Immunology (SIAAIC), the Italian Society of Pediatric Allergy and Immunology (SIAIP), the Italian Society of Allergologic [Internet]. 2021 Apr 1 [cited 2022 Jun 30]. Ital J Dermatol Venereol. 2021;156(2):184–97. 10.23736/S2784-8671.20.06654-7
27. Licari A, Castagnoli R, Marseglia A, Olivero F, Votto M, Ciprandi G, et al. Dupilumab to treat type 2 inflammatory diseases in children and adolescents [Internet]. 2020 Jun 1 [cited 2022 Jun 28]. Paediatr Drugs. 2020;22(3):295–310. 10.1007/s40272-020-00387-2
28. Food and Drug Administration (FDA). Dupilumab FDA prescribing information [Internet]. 2019 [cited 2021 Apr 12]. Available from: www.fda.gov/medwatch.
29. Cloutier MM, Schatz M, Castro M, Clark N, Kelly HW, Mangione-Smith R, et al. Asthma outcomes: composite scores of asthma control [Internet]. 2012 Mar [cited 2022 Jun 28]. J Allergy Clin Immunol. 2012;129(3 Suppl):S24–33. 10.1016/j.jaci.2011.12.980.
30. Juniper EF, Gruffydd-Jones K, Ward S, Svensson K. Asthma control questionnaire in children: Validation, measurement properties, interpretation [Internet]. Eur Respir J. 2010;36(6):1410–6. 10.1183/09031936.00117509
31. Dinakar C, Chipps BE, Matsui EC, Abramson SL, Irani AM, Kim JS, et al. Clinical tools to assess asthma control in children [Internet]. Pediatrics. 2017;139(1):e20163438. 10.1542/peds.2016-3438.
32. Van Dijk BCP, Svedsater H, Heddini A, Nelsen L, Balradj JS, Alleman C. Relationship between the Asthma Control Test (ACT) and other outcomes: A targeted literature review [Internet]. 2020 Apr 3 [cited 2022 Jun 28]. BMC Pulm Med. 2020;20(1):1–9. 10.1186/s12890-020-1090-5
33. Korn S, Both J, Jung M, Hbner M, Taube C, Buhl R. Prospective evaluation of current asthma control using ACQ and ACT compared with GINA criteria [Internet]. 2011 [cited 2022 Jun 28]. Ann Allergy Asthma Immunol. 2011;107(6):474–9. 10.1016/j.anai.2011.09.001
34. Dupin C, Belhadi D, Guilleminault L, Gamez AS, Berger P, De Blay F, et al. Effectiveness and safety of dupilumab for the treatment of severe asthma in a real-life French multi--centre adult cohort [Internet]. 2020 Jul 1 [cited 2022 Jun 28]. Clin Exp Allergy. 2020;50(7):789–98. 10.1111/cea.13614
35. Numata T, Araya J, Miyagawa H, Okuda K, Takekoshi D, Hashimoto M, et al. Real-world effectiveness of dupilumab for patients with severe asthma: A retrospective study [Internet]. 2022 [cited 2022 Jun 28]. J Asthma Allergy. 2022;15:395–405. 10.2147/JAA.S357548
36. Campisi R, Crimi C, Nolasco S, Beghè B, Antonicelli L, Guarnieri G, et al. Real-world experience with dupilumab in severe asthma: One-year data from an Italian named patient program [Internet]. 2021 [cited 2022 Jun 28]. J Asthma Allergy. 2021;14:575–83. 10.2147/JAA.S312123
37. Maspero JF, FitzGerald JM, Pavord ID, Rice MS, Maroni J, Rowe PJ, et al. Dupilumab efficacy in adolescents with uncontrolled, moderate-to-severe asthma: LIBERTY ASTHMA QUEST [Internet]. 2021 Aug 1 [cited 2022 Jun 28]. Allergy. 2021;76(8):2621–4. 10.1111/all.14872
38. Agache I, Song Y, Rocha C, Beltran J, Posso M, Steiner 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 [Internet]. 2020 May 1 [cited 2022 Jun 28]. Allergy. 2020;75(5):1058–68. 10.1111/all.14268
39. Wechsler ME, Ford LB, Maspero JF, Pavord ID, Papi A, Bourdin A, et al. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): An open-label extension study [Internet]. 2022 Jan 1 [cited 2022 Jun 28]. Lancet Respir Med. 2022;10(1):11–25. 10.1016/S2213-2600(21)00322-2
40. Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma [Internet]. 2018 Jun 28 [cited 2021 Apr 7]. N Engl J Med. 2018;378(26):2486–96. 10.1056/NEJMoa1804092
41. Bansal A, Simpson EL, Paller AS, Siegfried EC, Blauvelt A, de Bruin-Weller M, et al. Conjunctivitis in dupilumab clinical trials for adolescents with atopic dermatitis or asthma [Internet]. 2021 Jan 1 [cited 2022 Jun 28]. Am J Clin Dermatol. 2021;22(1):101–15. 10.1007/s40257-020-00577-1
42. Akinlade B, Guttman-Yassky E, de Bruin-Weller M, Simpson EL, Blauvelt A, Cork MJ, et al. Conjunctivitis in dupilumab clinical trials [Internet]. 2019 Sep 1 [cited 2022 Jun 28]. Br J Dermatol. 2019;181(3):459–73. 10.1111/bjd.17869
43. Dinardo G, Indolfi C, Klain A, Decimo F, Miraglia Del Giudice M. Treatment of severe asthma: fast action of dupilumab in the pediatric setting [Internet]. 2023 Apr 1 [cited 2023 Jul 10]. Minerva Pediatr;75(2):312–3. 10.23736/S2724-5276.21.06437-5
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Indolfi, C., Dinardo, G., Klain, A., Contieri, M., Umano, G. R., Decimo, A., Ciprandi, G., & del Giudice, M. M. (2023). Time effect of dupilumab to treat severe uncontrolled asthma in adolescents: A pilot study. Allergologia Et Immunopathologia, 51(5), 12-18. https://doi.org/10.15586/aei.v51i5.877
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Indolfi, C., Dinardo, G., Klain, A., Contieri, M., Umano, G. R., Decimo, A., Ciprandi, G., & del Giudice, M. M. (2023). Time effect of dupilumab to treat severe uncontrolled asthma in adolescents: A pilot study. Allergologia Et Immunopathologia, 51(5), 12-18. https://doi.org/10.15586/aei.v51i5.877