Papel dos medicamentos biológicos na rinossinusite crónica com pólipos nasais - Revisão sistemática com meta-análise
DOI:
https://doi.org/10.34631/sporl.1063Palavras-chave:
Rinossinusite crónica, Pólipos nasais, Anticorpos monoclonais, BiológicosResumo
Introdução: A rinossinusite crónica com pólipos nasais é uma doença inflamatória associada a elevada morbilidade e diminuição da qualidade de vida. O objetivo deste artigo é avaliar a eficácia das novas terapias monoclonais no controlo da doença refratária às terapêuticas disponíveis e discutir os múltiplos fatores que devem ser tidos em conta no uso destes fármacos.
Métodos: Revisão sistemática com meta-análise sobre a eficácia das terapias biológicas na rinossinusite crónica com pólipos nasais. Foi efetuada também a revisão da literatura pertinente acerca do custo-benef ício dos medicamentos biológicos.
Resultados: No total, a meta-análise incluiu 11 ensaios clínicos randomizados, que avaliaram 4 anticorpos monoclonais em que todos os anticorpos demonstraram melhorias na qualidade de vida e diminuição da extensão da doença, acarretando no entanto um elevado custo financeiro.
Conclusão: Nesta revisão sistemática verificou-se que o dupilumab foi o anticorpo monoclonal com mais impacto, tanto na qualidade de vida como na extensão da doença. No entanto, são necessários mais estudos que avaliem o efeito a longo prazo destas novas terapêuticas. Além disso, dado o impacto económico que implica a utilização de medicamentos biológicos, é imperioso que se avalie de forma eficiente quais os doentes que mais beneficiam com esta terapêutica.
Referências
Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S. et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020 [Internet]. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600. Disponível em: https://www.rhinologyjournal.com/Documents/Supplements/supplement_29.pdf
Veloso-Teles R, Roque-Farinha R, Buchwald C. Study of the etiopathogenesis of chronic rhinosinusitis with nasal polyps: focus on the host-environment interaction [master's thesis] [Covilhã, Portugal]: Universidade da Beira Interior; 2020. 150 p. Available from: http://hdl.handle.net/10400.6/10315
Brown WC, Senior B. A Critical look at the efficacy and costs of biologic therapy for chronic rhinosinusitis with nasal polyposis. Curr Allergy Asthma Rep. 2020 Apr 22;20(6):16. doi: 10.1007/s11882-020-00910-y.
Cerejeira R, Veloso-teles R, Lousan N, Moura CP. Prevalence of nasal polyps in Northern Portugal: a cadaver endoscopic study. Rhinology. 2014 Dec;52(4):386-9. doi: 10.4193/Rhino14.016.
Veloso-teles R, Cerejeira R, Roque-farinha R, Buchwald C Von. Higher prevalence of nasal polyposis among textile workers: an endoscopic based and controlled study. Rhinology. 2018 Jun 1;56(2):99-105. doi: 10.4193/Rhin17.228
Veloso-teles R, Cerejeira R. Endoscopic sinus surgery for chronic rhinosinusitis with nasal polyps: clinical outcome and predictive factors of recurrence. Am J Rhinol Allergy. 2017 Jan 1;31(1):56-62. doi: 10.2500/ajra.2017.31.4402.
Dalziel K, Hons BHS, Stein K, Round A, Garside R, Royle P. Endoscopic sinus surgery for the excision of nasal polyps: a systematic review of safety and effectiveness. Am J Rhinol. Sep-Oct 2006;20(5):506-19. doi: 10.2500/ajr.2006.20.2923.
Willson TJ, Naclerio RM, Lee SE. Monoclonal antibodies for the treatment of nasal polyps. Immunol Allergy Clin North Am. 2017 May;37(2):357-367. doi: 10.1016/j.iac.2017.01.008.
Higgins JPT, Altman DG SJ. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Churchill R, Chandler J CM, editor. Cochrane Handbook for Systematic Reviews of Interventions [Internet]. version 5. 2017. p. 1–73. Disponível em: https://training.cochrane.org/handbook/current/chapter-08
Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
Chowdhury NI, Mace JC, Bodner TE, Alt JA, Deconde AS, Levy JM. et al. Investigating the minimal clinically important difference for SNOT-22 symptom domains in surgically managed chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017 Dec;7(12):1149-1155. doi: 10.1002/alr.22028.
Meltzer EO, Hamilos DL, Hadley JA, Lanza DC, Marple BF, Nicklas RA. et al. Rhinosinusitis: developing guidance for clinical trials. J Allergy Clin Immunol. 2006 Nov;118(5 Suppl):S17-61. doi: 10.1016/j.jaci.2006.09.005.
Lund VJ, Mackay IS. Staging in rhinosinusitus. Rhinology [Internet]. 1993;31(4):183–4. Disponível em: https://www.researchgate.net/publication/15059640_Staging_in_Rhinosinusitis
Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE. et al. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019 Nov 2;394(10209):1638-1650. doi: 10.1016/S0140-6736(19)31881-1.
Gevaert P, Omachi TA, Corren J, Mullol J, Han J, Lee SE. et al. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol. 2020 Sep;146(3):595-605. doi: 10.1016/j.jaci.2020.05.032.
Bachert C, Mannent L, Naclerio RM, Mullol J, Ferguson BJ, Gevaert P. et al. Effect of subcutaneous dupilumab on nasal polyp burden in patients with chronic sinusitis and nasal polyposis: a randomized clinical trial. JAMA. 2016 Feb 2;315(5):469-79. doi: 10.1001/jama.2015.19330.
Gevaert P, Calus L, Van Zele T, Blomme K, De Ruyck N, Bauters W. et al. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J Allergy Clin Immunol. 2013 Jan;131(1):110-6.e1. doi: 10.1016/j.jaci.2012.07.047.
Gevaert P, Van Bruaene N, Cattaert T, Van Steen K, Van Zele T, Acke F. et al. Mepolizumab, a humanized anti-IL-5 mAb, as a treatment option for severe nasal polyposis. J Allergy Clin Immunol. 2011 Nov;128(5):989-95.e1-8. doi: 10.1016/j.jaci.2011.07.056.
Han JK, Bachert C, Fokkens W, Desrosiers M, Wagenmann M, Lee SE. et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 Oct;9(10):1141-1153. doi: 10.1016/S2213-2600(21)00097-7.
Bachert C, Sousa AR, Lund VJ, Scadding GK, Gevaert P, Nasser S. et al. Reduced need for surgery in severe nasal polyposis with mepolizumab: Randomized trial. J Allergy Clin Immunol. 2017 Oct;140(4):1024-1031.e14. doi: 10.1016/j.jaci.2017.05.044.
Tversky J, Lane AP, Azar A. Benralizumab effect on severe chronic rhinosinusitis with nasal polyps (CRSwNP): A randomized double-blind placebo-controlled trial. Clin Exp Allergy. 2021 Jun;51(6):836-844. doi: 10.1111/cea.13852.
Bachert C, Han JK, Desrosiers MY, Gevaert P, Heffler E, Hopkins C. et al. Efficacy and safety of benralizumab in chronic rhinosinusitis with nasal polyps: A randomized, placebo-controlled trial. J Allergy Clin Immunol. 2022 Apr;149(4):1309-1317.e12. doi: 10.1016/j.jaci.2021.08.030.
FDA. FASENRA® (Benralizumab) Highlights of Prescribing Information [Internet]. Fda. 2019 [cited 2022 mar 31]. p. 23. Disponível em: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761070s005lbl.pdf
EMA. Fansera : EPAR - Product Information [Internet]. Vol. 16, Netherlands Yearbook of International Law. 1985 [cited 2022 mar 31]. p. 51. Disponível em: https://www.ema.europa.eu/en/documents/product-information/fasenra-epar-product-information_en.pdf
FDA. DUPIXENT® (Dupilumab) Highlights of Prescribing Information [Internet]. Fda. 2021 [cited 2022 mar 31]. p. 47. Disponível em: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s021s027s033lbl.pdf
FDA. XOLAIR® (Omalizumab) Highlights of Prescribing Information [Internet]. Vol. 50, 2021 [cited 2022 mar 31]. p. 52. Disponível em: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5239lbl.pdf
FDA. NUCALA® (Mepolizumab) Highlights of Prescribing Information [Internet]. 2019 [cited 2022 mar 31]. p. 41. Disponível em: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761122s008,125526s019lbl.pdf
EMA. Dupixent: EPAR - Product Information [Internet]. Vol. 16, Netherlands Yearbook of International Law. 1985 [cited 2022 mar 31. p. 171. Disponível em: https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf
EMA. Xolair : EPAR - Product Information [Internet]. Vol. 16, Netherlands Yearbook of International Law. 1985 [cited 2022 mar 31]. p. 165. Disponível em: https://www.ema.europa.eu/en/documents/product-information/xolair-epar-product-information_en.pdf
EMA. Nucala : EPAR - Product Information [Internet]. Vol. 16, Netherlands Yearbook of International Law. 1985 [cited 2022 mar 31]. p. 62. Disponível em: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf
Weinstein MC, Torrance G, McGuire A. QALYs: The basics. Value Health. 2009 Mar;12 Suppl 1:S5-9. doi: 10.1111/j.1524-4733.2009.00515.x.
Rudmik L, Soler ZM, Mace JC, Schlosser RJ, Smith TL. Economic evaluation of endoscopic sinus surgery versus continued medical therapy for refractory chronic rhinosinusitis. Laryngoscope. 2015 Jan;125(1):25-32. doi: 10.1002/lary.24916.
Scangas GA, Wu AW, Ting JY, Metson R, Walgama E, Shrime MG. et al. Cost utility analysis of endoscopic sinus surgery for chronic rhinosinusitis with and without nasal polyposis. Laryngoscope. 2021 Jan;131(1):E26-E33. doi: 10.1002/lary.28648.
Scangas GA, Wu AW, Ting JY, Metson R, Walgama E, Shrime MG. et al. Cost Utility analysis of dupilumab versus endoscopic sinus surgery for chronic rhinosinusitis with nasal polyps. Laryngoscope. 2021 Jan;131(1):E26-E33. doi: 10.1002/lary.28648.
Fokkens WJ, Lund V, Bachert C, Mullol J, Bjermer L, Bousquet J. et al. EUFOREA consensus on biologics for CRSwNP with or without asthma. Allergy. 2019 Dec;74(12):2312-2319. doi: 10.1111/all.13875.
Wu Q, Zhang Y, Kong W, Wang X, Yuan L, Zheng R. et al. Which is the best biologic for nasal polyps: Dupilumab, Omalizumab, or Mepolizumab? A network meta-analysis. Int Arch Allergy Immunol. 2022;183(3):279-288. doi: 10.1159/000519228.
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