Dupilumab en el tratamiento del asma

Versiones

Palabras clave

asma
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 inflamación tipo 2, predominante en los pacientes con asma. Los ensayos clínicos que evalúan la eficacia de dupilumab incluyen tres ensayos pivotales controlados vs. placebo fase 2b o 3 de 24 a 52 semanas en pacientes ≥ 12 años, con asma moderada a grave (no controlado con dosis media a alta de corticosteroides inhalados) o asma grave [dependiente de corticosteroides orales (CSO)]. En estos estudios, la suma de dupilumab a la terapia 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 (HR-QOL), de igual forma redujo las dosis de CSO sin afectar el control. Dupilumab mostró eficacia en varios subgrupos de pacientes, aunque aquellos con inflamación tipo 2, mostraron un beneficio del tratamiento más destacado. Dupilumab está indicado (y es opción de tratamiento valiosa) en pacientes ≥ 12 años que tienen asma de moderada a grave con una inflamación tipo 2 / fenotipo eosinofílico descontrolada a pesar de los tratamientos convencionales o que tienen dependencia de CSO 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.

Busse WW. Biological treatments for severe asthma: A major advance in asthma care. Allergol Int. 2019;68(2):158-166.

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.

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.

Corren J. New Targeted Therapies for Uncontrolled Asthma. J Allergy Clin Immunol Pract. 2019;7(5):1394-1403.

Diamont Z DS-E. Type 2 inflammation and the evolving profile of uncontrolled persistent asthma. Eur Med J. 2018;3((4)):24–33.

Sanofi-Aventis. Dupixent (dupilumab) injection: US prescribing information. 2019. In: FDA, ed. http://www.accessdata.fda.gov.2020.

Sanofi-Aventis. Dupilumab solution for injection: summary of product characteristics. In:EMA

Grey A, Katelaris CH. Dupilumab in the treatment of asthma. Immunotherapy. 2019;11(10):859-872.

Wenzel S, Ford L, Pearlman D, et al. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013;368(26):2455-2466.

Wenzel S, Castro M, Corren J, 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.

Busse WW, Maspero JF, Rabe KF, 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.

Rabe KF, Nair P, Brusselle G, et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018;378(26):2475-2485.

Corren J, Castro M, Ford LB, et al. Dupilumab improves asthma outcomes irrespective of frequency of previous asthma exacerbation history. Ann Allergy Asthma Immunol. 2019;123(2):222-224 e221.

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):2486-2496.

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).

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.

Bachert C, Hellings PW, Mullol J, 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 e2442.

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) [abstract 620]. J Allergy Clin Immunol. 2016;137:AB190.

Dupixent subcutaneous injection: Japanese prescribing information. 2020. http://www.pmda.go.jp/PmdaSearch/iyaku Detai l/780069_4490405G1024_1_04#WARNINGS.

Li Z, Radin A, Li M, et al. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2020.

Matera MG, Calzetta L, Rogliani P, Cazzola M. Monoclonal antibodies for severe asthma: Pharmacokinetic profiles. Respir Med. 2019;153:3-13.

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.

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.

Wenzel SE, Wang L, Pirozzi G. Dupilumab in persistent asthma. N Engl J Med. 2013;369(13):1276.

Corren J, Castro M, Chanez P, et al. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann Allergy Asthma Immunol. 2019;122(1):41-49 e42.

Katial RK, Bensch GW, Busse WW, 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.

Papi A, Swanson B, Staudinger H, al. e. Dupilumab rapidly and significantly improves lung function and decreases inflammation by 2 weeks after treatment initiation in patients with uncontrolled persistent asthma [abstract]. Am J Resp Crit Care Med.2017;195:A6444.

Castro M, W. B, Zhang B, al. e. Dupilumab treatment produces rapid and sustained improvements in FEV1 in patients with uncontrolled, moderate-to-severe asthma from the LIBERTY ASTHMA QUEST study [abstract]. Am J Resp Crit Care Med. 2018;197:A6489.

Corren J, Bousquet J, W. B, et 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.

Ramsahai JM, Hansbro PM, Wark PAB. Mechanisms and Management of Asthma Exacerbations. Am J Respir Crit Care Med. 2019;199(4):423-432.

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 [abstract no. P44]. Thorax. 2018;73:A121–122.

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.

Busse WW, J. M, Hanania NA, al. e. 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 [abstract no. 293]. J Allergy Clin Immunol. 2019;143:AB97.

Katelaris C, Rabe K, Corren J, al. e. Dupilumab improves asthma outcomes regardless of baseline lung function. Respirology. 2019;24:110.

Agache I, Rocha C, Beltran J, 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.

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):1023-1042.

Korn S, J. C, Castro M, al. e. Dupilumab improved asthma control in patients with uncontrolled, moderate-to-severe asthma, regardless of exacerbations in the previous year [abstract plus poster]. Pneumologie. 2019;73.

Castro M, Rabe KF, Brusselle G, al. e. 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 [abstract]. Eur J Allergy Clin Immunol. 2019;74(106):77.

Weinstein SF, Katial R, Jayawardena S, et al. Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. J Allergy Clin Immunol. 2018;142(1):171-177 e171.

Maspero J, Busse WW, Katelaris CH, al. e. 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 [abstract no. 0050]. Eur J Allergy Clin Immunol. 2018;73:30-31.

J. M, Rabe KF, Castro M, al. e. Dupilumab improves health-related quality of life in patients with oral corticosteroiddependent, severe asthma with comorbid chronic rhinosinusitis with and without nasal polyps [abstract]. Eur J Allergy Clin Immunol. 2019;74:35-36.

Akinlade B, Guttman-Yassky E, de Bruin-Weller M, et al. Conjunctivitis in dupilumab clinical trials. Br J Dermatol. 2019;181(3):459-473.

Raherison C, Deschildre A, Garcia G, 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.

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.

Hogan AD, Bernstein JA. GINA updated 2019: Landmark changes recommended for asthma management. Ann Allergy Asthma Immunol. 2020;124(4):311-313.

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.

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.

McDonald VM, Yorke J. Adherence in severe asthma: time to get it right. Eur Respir J. 2017;50(6).

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).

Rogliani P, Calzetta L, Matera MG, et al. Severe Asthma and Biological Therapy: When, Which, and for Whom. Pulm Ther. 2020;6(1):47-66.

Asthma: Updated Diagnosis and Management Recommendations from GINA. Am Fam Physician. 2020;101(12):762-763.

Global Initiative for Asthma Scientific C. Difficult-to-treat & severe asthma in adolescent and adult patients. Diagnosis and management. 2019.

Agache I, Akdis C, Akdis M, et al. EAACI Biologicals Guidelines - Recommendations for severe asthma. Allergy. 2020.

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):1058-1068.

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.

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.

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.

Jonstam K, Swanson BN, Mannent LP, et al. Dupilumab reduces local type 2 pro-inflammatory biomarkers in chronic rhinosinusitis with nasal polyposis. Allergy. 2019;74(4):743-752.

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.

Laidlaw TM, Mullol J, Fan C, 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 e2461.

Bachert C, Han JK, Desrosiers M, 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.

Thaci D, E LS, Deleuran M, 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.

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.

Gandhi NA, et al. Nat Rev Drug Discov. 2016;15(1):35-50.

Creative Commons License

Esta obra está bajo una licencia internacional Creative Commons Atribución-NoComercial 4.0.

Derechos de autor 2020 Revista Alergia México

Descargas

##plugins.themes.healthSciences.displayStats.noStats##