Versiones
- 13-01-2021 (5)
- 13-01-2021 (4)
- 13-01-2021 (3)
- 18-12-2020 (2)
- 18-12-2020 (1)
Palabras clave
Anticuerpo monoclonal
Mepolizumab
Agente biológico.
Resumen
El asma grave es una enfermedad heterogénea y compleja que afecta aproximadamente al 5% de los pacientes con asma y se asocia a una importante carga de síntomas, exacerbaciones graves frecuentes e impactos negativos en la funcionalidad y calidad de vida. Diferentes estrategias de innovación han actualizado las opciones terapéuticas disponibles para estos pacientes, pero los anticuerpos monoclonales representan las alternativas con mayor relevancia clínica. Como especialistas en asma es importante mantenernos actualizados para poder identificar correctamente a aquellos pacientes que pueden beneficiarse del tratamiento con estos medicamentos. Este artículo ofrece una revisión actualizada y práctica enfocada en mepolizumab, un anticuerpo monoclonal humanizado anti-IL5 aprobado como tratamiento complementario en pacientes con asma grave eosinofílica. Los autores hemos realizado una síntesis de las evidencias de eficacia, seguridad y efectividad de mepolizumab con el objetivo de proveer una herramienta de consulta y apoyo en la toma de decisiones para el especialista que evalúa, diagnostica y trata pacientes con asma grave. Mepolizumab ha documentado en condiciones controladas de ensayos clínicos, y en estudios de vida real reducir consistente y significativamente las exacerbaciones de asma, mejorar el control de la enfermedad, mejorar la calidad de vida de los pacientes, y disminuir la dosis o retirar la exposición a corticoesteroides sistémicos.
Referencias
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. Eur Respir J. 2014;43(2):343-373. DOI: 10.1183/09031936.00202013
Proceedings of the ATS workshop on refractory asthma: current understanding, recommendations, and unanswered questions. American Thoracic Society. Am J Respir Crit Care Med. 2000;162(6):2341-2351. DOI: 10.1164/ajrccm.162.6.ats9-00
Busse WW. Definition and Impact. En: Chung KF, Israel E, Gibson PG, editores. Severe asthma. Reino Unido: European Respiratory Society; 2019.
McDonald VM, Kennington E, Hyland ME. Understanding the experience of people living with severe asthma. En: Chung KF, Israel E, Gibson PG, editores. Severe asthma. Reino Unido: European Respiratory Society; 2019.
Lane S, Molina J, Plusa T. An international observational prospective study to determine the cost of asthma exacerbations (COAX). Respir Med. 2006;100(3):434-450. DOI: 10.1016/j.rmed.2005.06.012
Asher MI, Montefort S, Björkstén B, Lai CKW, Strachan DP, Weikand Sk, et al. Worldwide time trends in the prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and eczema in childhood: ISAAC Phases One and Three repeat multicountry cross-sectional surveys. Lancet. 2006;368(9537):733-743. DOI: 10.1016/S0140-6736(06)69283-0
Menezes AM, Hallal P, Montes-de Oca M, Muino A, López-Varela, Talamo C, et al. Prevalence of asthma in Latin American middle-aged and older adults and its overlap with diagnosis of COPD. Eur Respir J. 2011;38(Suppl 55):4136.
The Global Asthma Report 2018. Nueva Zelanda: Global Asthma Network; 2018. Disponible en: http://globalasthmareport.org/Global%20Asthma%20Report%202018.pdf
Población [Internet]. México: Instituto Nacional de Estadística y Geografía; 2020. Disponible en: https://www.inegi.org.mx/temas/estructura/default.html#Informacion_general
Holguín F, Cardet JC, Chung KF, Diver S, Ferreira DS, Gaga M, et al. Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2020;55(1):1900588. DOI: 10.1183/13993003.00588-2019
Hekking PPW, Wener RR, Amelink M, Zwinderman AH, Bouvy ML, Bel EH. The prevalence of severe refractory asthma. J Allergy Clin Immunol. 2015;135(4):896-902. DOI: 10.1016/j.jaci.2014.08.042
Global Strategy for Asthma Management and Prevention [Internet]. EE. UU.: Global Initiative for Asthma; 2020. Disponible en: https://ginasthma.org/wp-content/uploads/2020/06/GINA-2020-report_20_06_04-1-wms.pdf
British guideline on the management of asthma [Internet]. Escocia: Health Improvement Scotland; 2019. Disponible en: https://www.sign.ac.uk/sign-158-british-guideline-on-the-management-of-asthma
GEMA 4.4. Guía española para el manejo del asma. GEMA44 Guía española para el manejo del asma. España: Luzán 5; 2019. Disponible en: https://semg.es/images/documentos/GEMA_4_4.pdf
Expert panel report 3: guidelines for the diagnosis and management of asthma. EE. UU.: National Heart, Lung, and Blood Institute/National Asthma Education and Prevention Program; 2007. Disponible en: https://www.nhlbi.nih.gov/sites/default/files/media/docs/EPR-3_Asthma_Full_Report_2007.pdf
Larenas-Linnemann D, Salas-Hernández J, Vázquez-García JC, Ortiz-Aldana I, Fernández-Vega M, del Río-Navarro BE, et al. Guía Mexicana del Asma: GUIMA 2017. Rev Alerg Mex. 2017;64(Supl 1):S11-S128. Disponible en: https://revistaalergia.mx/ojs/index.php/ram/article/download/272/406/2129
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
Greenfeder S, Umland SP, Cuss FM, Chapman RW, Egan RW. Th2 cytokines and asthma. The role of interleukin-5 in allergic eosinophilic disease. Respir Res. 2001;2(2):71-79. DOI: 10.1186/rr41
Indicación para prescribir amplia - Nucala [Internet]. Canadá: GSKpro; 2016.
Haldar P, Pavord ID, Shaw DE, Berry MA, Thomas M, Brightling CE, et al. Cluster analysis and clinical asthma phenotypes. Am J Respir Crit Care Med. 2008;178(3):218-224. DOI: 10.1164/rccm.200711-1754OC
de Carvalho-Pinto RM, Cukier A, Angelini L, Antonangelo L, Maud T, Rabe KF, et al. Clinical characteristics and possible phenotypes of an adult severe asthma population. Respir Med. 2012;106(1):47-56. DOI: 10.1016/j.rmed.2011.08.013
Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):651-659. DOI: 10.1016/S0140-6736(12)60988-X
Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitxGerald JM, Chetta A, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-1207. DOI: 10.1056/NEJMoa1403290
Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189-1197. DOI: 10.1056/NEJMoa1403291
Chupp GL, Bradford ES, Albers FC, et al. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017;5(5):390-400. DOI: 10.1016/S2213-2600(17)30125-X
Ortega HG, Yancey SW, Mayer B, Gunsoy NB, Keene ON, Bleecker ER, et al. Severe eosinophilic asthma treated with mepolizumab stratified by baseline eosinophil thresholds: a secondary analysis of the DREAM and MENSA studies. Lancet Respir Med. 2016;4(7):549-556. DOI: 10.1016/S2213-2600(16)30031-5
Humbert M, Albers FC, Bratton DJ, Yancey SW, Liu MC, Hozawa S, et al. Effect of mepolizumab in severe eosinophilic asthma according to omalizumab eligibility. Respir Med. 2019;154:69-75. DOI: 10.1016/j.rmed.2019.06.004
Khatri S, Moore W, Gibson PG, Leigh R, Bourdin A, Maspero J, 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
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
Khurana S BG, Bel EH, FitzGerald JM, Masoli M, et.al. Long-term safety and clinical benefit of mepolizumab in patients with the most severe eosinophilic asthma: the COSMEX study. Clin Ther. 2019;41(10):2041-2056.e5. DOI: 10.1016/j.clinthera.2019.07.007
Jeimy S, Tsoulis MW, Hachey J, Kim H. Eligibility of monoclonal antibody-based therapy for patients with severe asthma: a Canadian cross-sectional perspective. Allergy Asthma Clin Immunol. 2018;14(68):68. DOI: 10.1186/s13223-018-0301-6
Menzella F, Galeone C, Ruggiero P, Bagnasco D, Catellani C, Facciolongo N. Biologics and bronchial Thermoplasty for severe refractory asthma treatment: from eligibility criteria to real practice. A cross-sectional study. Pulm Pharmacol Ther. 2020;60(101874):101874. DOI: 10.1016/j.pupt.2019.101874
Cockle SM, Stynes G, Gunsoy NB, Parks D, Alfonso-Cristancho R, Wex J, et al. Comparative effectiveness of mepolizumab and omalizumab in severe asthma: an indirect treatment comparison. Respir Med. 2017;123:140-148. DOI: 10.1016/j.rmed.2016.12.009
Nachef Z, Krishnan A, Mashtare T, Zhuang T, Jeffery M. Omalizumab versus mepolizumab as add-on therapy in asthma patients not well controlled on at least an inhaled corticosteroid: a network metaanalysis. J Asthma. 2018;55(1):89-100. DOI: 10.1080/02770903.2017.1306548
Wang FP, Liu T, Lan Z, Li SY, Mao H. Efficacy and safety of anti-interleukin-5 therapy in patients with asthma: a systematic review and meta-analysis. PLoS One. 2016;11(11):e0166833. DOI: 10.1371/journal.pone.0166833
Farne HA WA, Powell C, Bax L, Milan SJ. Anti-IL5 therapies for asthma. Cochrane Database Syst Rev. 2017(9):1-102. DOI: 10.1002/14651858.CD010834.pub3
He LL, Zhang L, Jiang L, Xu F, Fei DS. Efficacy and safety of anti-interleukin-5 therapy in patients with asthma: a pairwise and Bayesian network meta-analysis. Int Immunopharmacol. 2018;64:223-31. DOI: 10.1016/j.intimp.2018.08.031
Bourdin A, Husereau D, Molinari N, Golam S, Linder L, Xu X, et al. Matching-adjusted indirect comparison of benralizumab versus interleukin-5 inhibitors for the treatment of severe asthma: a systematic review. Eur Respir J. 2018;52(5):1801393. DOI: 10.1183/13993003.01393-2018
Henriksen DP, Bodtger U, Sidenius K, et al. Efficacy, adverse events, and inter-drug comparison of mepolizumab and reslizumab anti-IL-5 treatments of severe asthma-a systematic review and meta-analysis. Eur Clin Respir J. 2018;5(1):1536097. DOI: 10.1080/20018525.2018.1536097.
Yan K, Balijepalli C, Sharma R, Barakat S, Sun SX, Falcao S, et al. Reslizumab and mepolizumab for moderate-to-severe poorly controlled asthma: an indirect comparison meta-analysis. Immunotherapy. 2019;11(17):1491-1505. DOI: 10.2217/imt-2019-0113
Casale TB, Pacou M, Mesana L, et al. Reslizumab compared with benralizumab in patients with eosinophilic asthma: a systematic literature review and network meta-analysis. J Allergy Clin Immunol Pract. 2019;7(1):122-130.e1. DOI: 10.1016/j.jaip.2018.08.036
Busse W, Chupp G, Nagase H, Albers FC, Doyle S, Shen Q, et al. Anti-IL-5 treatments in patients with severe asthma by blood eosinophil thresholds: indirect treatment comparison. J Allergy Clin Immunol. 2019;143(1):190-200.e20. DOI: 10.1016/j.jaci.2018.08.031
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
Calzetta L MM, Rogliani P. Monoclonal antibodies in severe asthma: is it worth it? Expert Opinion Drug Metab Toxicol. 2019;15(6):517-520. DOI: 10.1080/17425255.2019.1621837
Agache I, Beltran J, Akdis C, Akdis M, Canelo-Aybar C, Casale 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
Ramonell RP, Iftikhar IH. Effect of anti-IL5, anti-IL5R, anti-IL13 therapy on asthma exacerbations: a network meta-analysis. Lung. 2020;198(1):95-103. DOI: 10.1007/s00408-019-00310-8
Eichler HG, Abadie E, Breckenridge A, Flamion B, Leufkens H, et al. Bridging the efficacy-effectiveness gap: a regulator’s perspective on addressing variability of drug response. Nat Rev Drug Discov. 2011;10(7):495-506. DOI: 10.1038/nrd3501
Hernández-Martin I, Barranco P, Sanchez-Jareño M, Palao-Ocharan P, Domínguez-Ortega J, Luna-Porta JA, et al. Patients with severe eosinophilic asthma treated with mepolizumab: results from our clinical practice. J Allergy Clin Immunol. 2019;143(2). DOI: 10.1016/j.jaci.2018.12.287
Feijoo-Paz, . Clinical utility of mepolizumab in real-life practice in severe asthma unit of Madrid (Spain). Allergy. 2018;73(Suppl 105):671.
Kurosawa M, Sutoh E. Prospective open-label study of 48-week subcutaneous administration of mepolizumab in Japanese patients with severe eosinophilic asthma. J Investig Allergol Clin Immunol. 2019;29(1):40-45. DOI: 10.18176/jiaci.0285. PubMed PMID: 29957591
Bjerrum AS, Schmid J, Skjold T. Oral glucocorticoid-sparing effects of mepolizumab. A real-life study. Eur Respir J. 2018;52:601. DOI: 10.1183/13993003.congress-2018.PA601
Bjerrum AS, Skjold T, Schmidt J. Baseline characteristics of 36 mepolizumab-patients. Experiences from the clinical practice. Eur Respir J. 2017;50:PA3588. DOI: 10.1183/1393003.congress-2017.PA3588
Farah CS, Badal T, Reed N, Rogers PG, King GG, Thamrin C, et al. Mepolizumab improves small airway function in severe eosinophilic asthma. Respir Med. 2019;148:49-53. DOI: 10.1016/j.rmed.2019.01.016
Seccombe L, Rogers P, Reed N, Badal T, Thamrin C, King G, et al. Mepolizumab improves small airway function in severe eosinophilic asthma. Eur Respir J. 2018;52:PA2434. DOI: 10.1183/13993003.congress-2018.PA2434
d’Ancona G, Liu B, Wei L, Green L, Fernandes M, Roxas C, et al. S81 does adherence to inhaled therapy change following initiation of mepolizumab in the treatment of severe asthma? Thorax. 2018;73(Suppl 4):A50-A51. DOI: 10.1136/thorax-2018-212555.87
Llanos JP, Bell CF, Packnett E, Thiel E, Irwin DE, Hahn B, et al. Real-world characteristics and disease burden of patients with asthma prior to treatment initiation with mepolizumab or omalizumab: a retrospective cohort database study. J Asthma Allergy. 2019;12:43-58. DOI: 10.2147/JAA.S189676
Ortega H, Hahn B, Tran JN, Bell C, Shams SA, Llanos JP. Disease burden in patients with asthma before initiating biologics: a retrospective cohort database study. Allergy Asthma Proc. 2019;40(3):146-153. DOI: 10.2500/aap.2019.40.4220
LaHood NA, Robinson LB, Long AA. Clinical indication and outcomes of mepolizumab therapy at an academic medical center. J Allergy Clin Immunol. 2019;143(2):AB96. DOI:10.1016/j.jaci.2018.12.293
Weir E, Paton J. Mepolizumab in adolescents with severe eosinophilic asthma not eligible for omalizumab: one center’s early clinical experience. J Asthma. 2020;57(5):521-524. DOI: 10.1080/02770903.2019.1579833
Zhang P, Vitari CA, Wenzel SE. Real world effectiveness and safety of anti-IL-5/mepolizumab in an academic severe asthma clinic. Am J Respir Crit Care Med. 2020;201:A3187.
Kavanagh J, Green L, Fernandes M, Bolton M, d’Ancona G, Roxas C, et al. Assessment of early responder characteristics to mepolizumab in steroid-dependent eosinophilic asthma. Am J Respir Crit Care Med. 2020;197:A1363.
Harrison T, Canonica G, Gemzoe K, Maxwell A, Yang S, Joksaite S, et al. Effectiveness and safety of mepolizumab in real-world clinical practice: the REALITI-A study. Pneumologie. 2020;74. DOI: 10.1055/s-0039-3403114
Strauss RA, Jawhari N. Mepolizumab in the treatment of severe eosinophilic asthma: results from a physician in the field. Ann Allergy Asthma Immunol. 2018;121(1):121-123. DOI: 10.1016/j.anai.2018.04.016
Benjamin MR, Bochner BS, Peters AT. Mepolizumab use: post-approval academic practice experience. Ann Allegy Asthma Immunol. 2018;121(1):126-128. DOI: 10.1016/j.anai.2018.04.001
Gruber A, Taillé C, Chanez P, Devouassoux G, Didier A, Pison C, et al. Real-life experience with mepolizumab in the French early access program for severe eosinophilic asthma. Eur Respir J. 2019;54:PA1654. DOI: 10.1183/13993003.congress-2019.PA1654
Pelaia C, Busceti MT, Solinas S, et al. Real-life evaluation of the clinical, functional, and hematological effects of mepolizumab in patients with severe eosinophilic asthma: results of a single-centre observational study. Pulm Pharmacol Ther. 2018;53:1-5. DOI: 10.1016/j.pupt.2018.09.006
Venkata-Subramani M, Saygin D, McCarroll S, Micklewright S, Ibrahim L, Taliercio RM, et al. Mepolizumab treatment in severe asthma: a case series. Am J Respir Crit Care Med. 2020;201:A5334.
Hahn B, Llanos-Ackert JP, Ortega H, Packnett E, Irwin D, Riehle E, et al. Disease severity and baseline characteristics of patients receiving mepolizumab or omalizumab in employer claims database: a real-world experience. 2018;141(2):AB10. DOI: 10.1016/j.jaci.2017.12.033
Bagnasco D, Milanese M, Rolla G, Lombardi C, Bucca C, Heffler E, et al. The North-Western Italian experience with anti IL-5 therapy and comparison with regulatory trials. World Allergy Organ J. 2018;11(1):34. DOI: 10.1186/s40413-018-0210-7
Antonicelli L, Gobbi A, Bilò MB, Garritani MS, Brianzoni MF, Dellacà. Change of lung function in severe eosinophilic asthma undergoing treatment with anti-interleukin-5 monoclonal antibody. Eur Respir J. 2018;52:PA1133. DOI: 10.1183/13993003.congress-2018.PA1133
Esta obra está bajo una licencia internacional Creative Commons Atribución-NoComercial 4.0.
Derechos de autor 2020 Revista Alergia México