Versiones
Palabras clave
dupilumab
tratamiento
monoclonal
FEV1
exacerbacion
Resumen
Dupilumab es un anticuerpo monoclonal humano contra receptores de interleucina (IL)-4 e IL-4/IL-13. Estas son citocinas clave en la génesis de la inflamación tipo 2, predominante en los pacientes con asma. Los ensayos clínicos que evalúan la eficacia de dupilumab incluyen tres ensayos pivotales controlados versus placebo fase 2b o 3 de 24 a 52 semanas en pacientes ≥ 12 años, con asma moderada a grave (no controlada con dosis media a alta de corticosteroides inhalados) o asma grave (dependiente de corticosteroides orales). En estos estudios, la suma de dupilumab al tratamiento se toleró adecuadamente y redujo la tasa de exacerbaciones graves, mejoró la función pulmonar, así como el control del asma y la calidad de vida, de igual forma redujo las dosis de corticosteroides sistémicos orales sin afectar el control. Dupilumab mostró eficacia en varios subgrupos de pacientes, aunque aquellos con inflamación tipo 2 mostraron un beneficio más destacado. Dupilumab está indicado (y es una opción terapéutica valiosa) en pacientes ≥ 12 años de edad que tienen asma de moderada o grave con inflamación tipo 2/fenotipo eosinofílico, descontrolada a pesar de los tratamientos convencionales o en aquellos con dependencia a corticosteroides sistémicos orales para el control.
Referencias
Fahy JV. Type 2 inflammation in asthma-present in most, absent in many. Nat Rev Immunol. 2015;15(1):57-65. DOI: 10.1038/nri3786
Busse WW. Biological treatments for severe asthma: A major advance in asthma care. Allergol Int. 2019;68(2):158-166. DOI: 10.1016/j.alit.2019.01.004
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. Int Arch Allergy Immunol. 2016;170(2):122-131. DOI: 10.1159/000447692
Kortekaas-Krohn I, Bal SM, Golebski K. The role of innate lymphoid cells in airway inflammation: evolving paradigms. Curr Opin Pulm Med. 2018;24(1):11-17. DOI: 10.1097/MCP.0000000000000435
Corren J. New targeted therapies for uncontrolled asthma. J Allergy Clin Immunol Pract. 2019;7(5):1394-1403. DOI: 10.1016/j.jaip.2019.03.022
Diamont Z DS-E. Type 2 inflammation and the evolving profile of uncontrolled persistent asthma. Eur Med J. 2018;3(4):24-33. Disponible en: https://emj.emg-health.com/wp-content/uploads/sites/2/2018/12/Type-2-Inflammation-and-the-Evolving....pdf
Food and Drug Administration. Dupixent (dupilumab) injection. EE. UU.; 2019. Disponible en: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761055lbl.pdf
Sanofi-Aventis. Dupilumab solution for injection: summary of product characteristics. 2019. [Consultado: 2020 Nov 28]. Disponible en: https://www.ema.europa.eu
Grey A, Katelaris CH. Dupilumab in the treatment of asthma. Immunotherapy. 2019;11(10):859-872. DOI: 10.2217/imt-2019-0008
Wenzel S, Ford L, Pearlman D, Spector S, Sher L, Wang L, et al. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013;368(26):2455-2466. DOI: 10.1056/NEJMoa1304048
Wenzel S, Castro M, Corren J, Maspero J, Wang L, Zhang B, et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting beta2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016;388(10039):31-44. DOI: 10.1016/S0140-6736(16)30307-5
Busse WW, Maspero JF, Rabe KF, Papi A, Wenzel SE, Ford LB, et al. Liberty Asthma QUEST: phase 3 randomized, double-blind, placebo-controlled, parallel-group study to evaluate dupilumab efficacy/safety in patients with uncontrolled, moderate-to-severe asthma. Adv Ther. 2018;35(5):737-748. DOI: 10.1007/s12325-018-0702-4
Rabe KF, Nair P, Brusselle G, Maspero JF, Castro M, Sher L, et al. Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma. N Engl J Med. 2018;378(26):2475-2485. DOI: 10.1056/NEJMoa1804093
Corren J, Castro M, Ford LB, Bernstein A, Maroni J,Rowe P, et al. Dupilumab improves asthma outcomes irrespective of frequency of previous asthma exacerbation history. Ann Allergy Asthma Immunol. 2019;123(2):222-224 e221. DOI: 10.1016/j.anai.2019.04.028
Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, et al. Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma. N Engl J Med. 2018;378(26):2486-2496. DOI: 10.1056/NEJMoa1804092
Castro M, Rabe KF, Corren J, et al. Dupilumab improves lung function in patients with uncontrolled, moderate-to-severe asthma. ERJ Open Res. 2020;6(1):00204-02019. DOI: 10.1183/23120541.00204-2019
Maspero JF, Katelaris CH, Busse WW, et al. Dupilumab efficacy in uncontrolled, moderate-to-severe asthma with self-reported chronic rhinosinusitis. J Allergy Clin Immunol Pract. 2020;8(2):527-539.e529. DOI: 10.1016/j.jaip.2019.07.016
Bachert C, Hellings PW, Mullol J, Naclerio RM, Chao J, Amin N, et al. Dupilumab improves patient-reported outcomes in patients with chronic rhinosinusitis with nasal polyps and comorbid asthma. J Allergy Clin Immunol Pract. 2019;7(7):2447-2449.e2. DOI: 10.1016/j.jaip.2019.03.023
Swanson BN TA, Hamilton JD, et al. Dupilumab suppresses fractional exhaled nitric oxide (FeNO) and biomarkers of type 2 inflammation in adult patients with persistent uncontrolled asthma despite use of medium-to-high dose inhaled corticosteroids plus long-acting beta-agonists (ICS/LABAs). J Allergy Clin Immunol. 2016;137(2):AB190. DOI:https://DOI.org/10.1016/j.jaci.2015.12.752
Pharmaceuticals and Medical Devices Agency [sitio web]. Japón: Report on the Deliberation Results; 2017. [Consultado: 2020 Nov 28]. Disponible en: https://www.pmda.go.jp/files/000235351.pdf
Li Z, Radin A, Li M, et al. Pharmacokinetics, pharmacodynamics, safety, and tolerability of dupilumab in healthy adult subjects. Clin Pharmacol Drug Dev. 2020;9(6). DOI: 10.1002/cpdd.798
Matera MG, Calzetta L, Rogliani P, Cazzola M. Monoclonal antibodies for severe asthma: Pharmacokinetic profiles. Respir Med. 2019;153:3-13. DOI: 10.1016/j.rmed.2019.05.005
Calzetta L, Matera MG, Rogliani P. Monoclonal antibodies in severe asthma: is it worth it? Expert Opin Drug Metab Toxicol. 2019;15(6):517-520. DOI: 10.1080/17425255.2019.1621837
Matera MG, Rinaldi B, Calzetta L, Cazzola M. Pharmacogenetic and pharmacogenomic considerations of asthma treatment. Expert Opin Drug Metab Toxicol. 2017;13(11):1159-1167. DOI: 10.1080/17425255.2017.1391215
Wenzel SE, Wang L, Pirozzi G. Dupilumab in persistent asthma. N Engl J Med. 2013;369(13):1276. DOI: 10.1056/NEJMc1309809
Corren J, Castro M, Chanez P, Fabbri L, Amin N, Mastey V, et al. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann Allergy Asthma Immunol. 2019;122(1):41-49 e42. DOI: 10.1016/j.anai.2018.08.005
Katial RK, Bensch GW, Busse WW, Chipps BE, Denson JL, Gerber AN, et al. Changing paradigms in the treatment of severe asthma: the role of biologic therapies. J Allergy Clin Immunol Pract. 2017;5(2S):S1-S14. DOI: 10.1016/j.jaip.2016.11.029
Papi A, Swanson B, Staudinger H, Rowe P, Maroni J, Hamilton J, et al. Dupilumab rapidly and significantly improves lung function and decreases inflammation by 2 weeks after treatment initiation in patients with uncontrolled persistent asthma. Am J Resp Crit Care Med. 2017;195:A6444.
Castro M, Busse WW, Zhang B, Maroni J, Rowe P, Amin N, Pirozzi G, et al. Dupilumab treatment produces rapid and sustained improvements in FEV1 in patients with uncontrolled, moderate-to-severe asthma from the LIBERTY ASTHMA QUEST study. Am J Resp Crit Care Med. 2018;197:A6489.
Corren J, Bousquet J, Busse WW, Maspero J, Hanania N, Ford LB, al. Dupilumab suppresses inflammatory biomarkers in asthma patients with or without allergic rhinitis: post hoc analysis of the LIBERTY ASTHMA QUEST Study. J Allergy Clin Immunol. 2019;143(2):AB97. DOI: 10.1016/j.jaci.2018.12.297
Ramsahai JM, Hansbro PM, Wark PAB. Mechanisms and management of asthma exacerbations. Am J Respir Crit Care Med. 2019;199(4):423-432. DOI: 10.1164/rccm.201810-1931CI
Pavord I, Ford LB, Corren J, al. e. Dupilumab reduces exacerbations and improves lung function in uncontrolled, moderate-tosevere asthma patients regardless of prior exacerbation history in the phase 3 Liberty Asthma Quest Study. Thorax. 2018;73(Suppl4):A121-122. DOI: 10.1136/thorax-2018-212555.202
Busse WW, Maspero JF, Lu Y, et al. Dupilumab improves clinical outcomes in patients with asthma and perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2020;125(5):565.576. DOI: 10.1016/j.anai.2020.05.026
Busse WW, Maspero JF, Hanania NA, FitzGerald JM, Ford LB, Rice M, et al. Dupilumab improves lung function and reduces severe exacerbation rate in patients with uncontrolled, moderate-to-severe asthma with or without comorbid allergic rhinitis: results from the phase 3 LIBERTY ASTHMA QUEST study. J Allergy Clin Immunol. 2019;143(2):AB97. DOI: 10.1016/j.jaci.2018.12.296
Katelaris C, Rabe K, Corren J, Langton D, Bardin P, Park H, et al. Dupilumab improves asthma outcomes regardless of baseline lung function. Respirology. 2019;24:110.
Agache I, Rocha C, Beltran J, Song Y, Posso M, Akdis C, et al. Efficacy and safety of treatment with biologicals (benralizumab, dupilumab and omalizumab) for severe allergic asthma: a systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma. Allergy. 2020;75(5):1043-1057. DOI: 10.1111/all.14235
Agache I, Beltran J, Akdis C, Akdis M, Casale T, Chivato T, 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):1023-1042. DOI: 10.1111/all.14221
Korn S, Corren J, Castro M, Maspero J, Chen Z, Niemann I, et al. Dupilumab improved asthma control in patients with uncontrolled, moderate-to-severe asthma, regardless of exacerbations in the previous year. Pneumologie. 2019;73. DOI: 10.1055/s-0039-1678039
Castro M, Rabe KF, Brusselle G, Rice MS, Rowe P, Deniz Y, et al. Dupilumab effect on asthma control and health-related quality of life in patients with oral corticosteroid-dependent severe asthma with comorbid chronic rhinosinusitis with and without nasal polyps. Eur J Allergy Clin Immunol. 2019;74(106):77.
Weinstein SF, Katial R, Jayawardena S, Pirozzi G, Eckert L, Jooish VN, et al. Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. J Allergy Clin Immunol. 2018;142(1):171-177.e171. DOI: 10.1016/j.jaci.2017.11.051
Maspero J, Busse WW, Katelaris CH, et al. Dupilumab improves health related quality of life in uncontrolled, moderate-to-severe asthma patients with comorbid allergic rhinitis from the phase 3 LIBERTY ASTHMA QUEST study. Eur J Allergy Clin Immunol. 2018;73:30-31.
Maspero JF, Rabe KF, Castro M, et al. Dupilumab improves health-related quality of life in patients with oral corticosteroid-dependent, severe asthma with comorbid chronic rhinosinusitis with and without nasal polyps. [Abstract]. W 2019;74(Suppl 106):35-36.
Muneswarao J, Hassali MA, Ibrahim B, Saini B, Ali IAH, Verma AK. It is time to change the way we manage mild asthma: an update in GINA 2019. Respir Res. 2019;20(1):183. DOI: 10.1186/s12931-019-1159-y
Akinlade B, Guttman-Yassky E, de Bruin-Weller M, Simpson EL, Blauvelt A, Cork MJ, et al. Conjunctivitis in dupilumab clinical trials. Br J Dermatol. 2019;181(3):459-473. DOI: 10.1111/bjd.17869
Raherison C, Deschildre A, Garcia G, Girodet PO, Taillé C, Moilimard M, et al. Management of mild asthma in 2019-2020: What about new international therapeutic proposals (GINA 2019)? Rev Mal Respir. 2020;37(5):427-432. DOI: 10.1016/j.rmr.2020.03.005
Hogan AD, Bernstein JA. GINA updated 2019: landmark changes recommended for asthma management. Ann Allergy Asthma Immunol. 2020;124(4):311-313. DOI: 10.1016/j.anai.2019.11.005
Settipane RA, Kreindler JL, Chung Y, Tkacz J. Evaluating direct costs and productivity losses of patients with asthma receiving GINA 4/5 therapy in the United States. Ann Allergy Asthma Immunol. 2019;123(6):564-572 e563. DOI: 10.1016/j.anai.2019.08.462
McDonald VM, Maltby S, Gibson PG. Severe asthma: can we fix it? Prologue to seeking innovative solutions for severe asthma. Respirology. 2017;22(1):19-20. DOI: 10.1111/resp.12956
McDonald VM, Yorke J. Adherence in severe asthma: time to get it right. Eur Respir J. 2017;50(6):1702191. DOI: 10.1183/13993003.02191-2017
Boulet LP, Reddel HK, Bateman E, Pedersen S, FitzGerald JM, O’Byrne PM. The Global Initiative for Asthma (GINA): 25 years later. Eur Respir J. 2019;54(2):1900598. DOI: 10.1183/13993003.00598-2019
Rogliani P, Calzetta L, Matera MG, Laitano R, Ritondo BL, Cazzola M, et al. Severe asthma and biological therapy: when, which, and for whom. Pulm Ther. 2020;6(1):47-66. DOI: 10.1007/s41030-019-00109-1
Asthma: updated diagnosis and management recommendations from GINA. Am Fam Physician. 2020;101(12):762-763.
Difficult-to-treat & severe asthma in adolescent and adult patients. Diagnosis and management. EE. UU.: Global Initiative for Asthma; 2019. Disponible en: https://ginasthma.org/wp-content/uploads/2019/04/GINA-Severe-asthma-Pocket-Guide-v2.0-wms-1.pdf
Agache I, Akdis C, Akdis M, Canonica GW, Casale T, Chivato T, et al. EAACI biologicals guidelines - recommendations for severe asthma. Allergy. 2020. DOI: 10.1111/all.14425
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. Allergy. 2020;75(5):1058-1068. DOI: 10.1111/all.14268
Iftikhar IH, Schimmel M, Bender W, Swenson C, Amrol D. Comparative efficacy of anti IL-4, IL-5 and IL-13 drugs for treatment of eosinophilic asthma: a network meta-analysis. Lung. 2018;196(5):517-530. DOI: 10.1007/s00408-018-0151-5
Edris A, de Feyter S, Maes T, Joos G, Lahousse L. Monoclonal antibodies in type 2 asthma: a systematic review and network meta-analysis. Respir Res. 2019;20(1):179. DOI: 10.1186/s12931-019-1138-3
Koczulla AR, Vogelmeier CF, Garn H, Renz H. New concepts in asthma: clinical phenotypes and pathophysiological mechanisms. Drug Discov Today. 2017;22(2):388-396. DOI: 10.1016/j.drudis.2016.11.008
Jonstam K, Swanson BN, Mannent LP, Tian N, Wang Y, Zhang D, et al. Dupilumab reduces local type 2 pro-inflammatory biomarkers in chronic rhinosinusitis with nasal polyposis. Allergy. 2019;74(4):743-752. DOI: 10.1111/all.13685
Xu X, Zheng Y, Zhang X, He Y, Li C. Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults. Oncotarget. 2017;8(65):108480-108491. DOI: 10.18632/oncotarget.22499
Laidlaw TM, Mullol J, Fan C, Zhang D, Amin N, Khan A, et al. Dupilumab improves nasal polyp burden and asthma control in patients with CRSwNP and AERD. J Allergy Clin Immunol Pract. 2019;7(7):2462-2465.e1. DOI: 10.1016/j.jaip.2019.03.044
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;394(10209):1638-1650. DOI: 10.1016/S0140-6736(19)31881-1
Thaci D, Simpson EL, Deleuran M, Kataoka Y, Chen Z, et al. Efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis: a pooled analysis of two phase 3 randomized trials (LIBERTY AD SOLO 1 and LIBERTY AD SOLO 2). J Dermatol Sci. 2019;94(2):266-275. DOI: 10.1016/j.jdermsci.2019.02.002
de Bruin-Weller M, Thaci D, Smith CH, et al. Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical trial (LIBERTY AD CAFE). Br J Dermatol. 2018;178(5):1083-1101. DOI: 10.1111/bjd.16156
Gandhi NA, Bennett BL, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, et al. Nat Rev Drug Discov. 2016;15(1):35-50. DOI: 10.1038/nrd4624
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