Palabras clave
asma
eosinófilo
IL-5
Cómo citar
Plaudit
Resumen
Resumen
El asma grave conlleva una carga de salud desproporcionadamente alta y cerca de la mitad de los adultos con esta patología tiene un fenotipo eosinofílico. En estos pacientes aunado a la producción de eosinófilos en médula ósea, se activan mecanismos de eosinopoyesis local en tejido pulmonar. Benralizumab es un anticuerpo monoclonal humanizado, que se une con alta afinidad y especificidad a la subunidad alfa del receptor de IL-5 (IL-5Rα) sobre la superficie de eosinófilos y otras células. El principal diferenciador de su mecanismo de acción se relaciona con la remoción de un residuo de fucosa en la Fc, lo cual incrementa hasta 50 veces la afinidad a células NK con apoptosis de eosinófilos mediante citotoxicidad celular dependiente de anticuerpos (CCDA), resultando en una reducción rápida y cercana al 100% tanto en suero como en médula ósea. Adicionalmente, benralizumab reduce >90% de los eosinófilos en tejido pulmonar y esputo. En diversos estudios clínicos controlados y en vida real se ha demostrado que esto se traduce en incremento actual del control del asma y disminución del riesgo futuro. El perfil de seguridad es adecuado sin haberse documentado infestaciones parasitarias ni efectos adversos a largo plazo relacionados con la reducción de los eosinófilos.
Referencias
Dharmage S, Perret J, Custovic A. Epidemiology of asthma in children and adults. Fron Pediat. 2019;7:246. DOI: 10.3389/fped.2019.00246
Dávila-González I, Moreno-Benítez F, Quirce S. Benralizumab: a new approach for the treatment of severe eosinophilic asthma. J Invest Allergol Clin Immunol. 2019; 29(2):84-93. DOI: 10.18176/jiaci.0385
Carr TF, Zeki AA, Kraft M. Eosinophilic and noneosinophilic asthma. Am J Respir Crit Care Med. 2018;197(1):22-37. DOI: 10.1164/rccm.201611-2232PP
Bakakos A, Loukides S, Bakakos P. Severe eosinophilic asthma. J Clin Med. 2019;8(9):1375. DOI: 10.3390/jcm8091375
Jacoby D, Gleich G, Fryer AD. Human eosinophil major basic protein is an endogenous allosteric antagonist at the inhibitory muscarinic M2 receptor. J Clin Invest. 1993;91(4):1314–1318-1318. DOI: 10.1172/JCI116331
Humbles A, Lloyd C, McMillan SJ, Friend DS, Xanthou G, McKenna EE, et al. A critical role for eosinophils in allergic airways remodeling. Science. 2004;305(5691):1776-1779. DOI: 10.1126/science.1100283
Patterson MF, Borish L, Kennedy JL. The past, present, and future of monoclonal antibodies to IL5 eosinophilic asthma: a review. J Asthma Allergy. 2015;8:125-134. DOI: 10.2147/JAA.S74178
Louis R, Lau L, Bron A O. The relationship between airways inflammation and asthma severity. Am J Respir Crit Care Med. 2000;161(1):9-16. DOI: 10.1164/ajrccm.161.1.9802048
Broekema M, Volbeda F, Timens W, Dijkstra A, Lee NA, Postma DS, et al. Airway eosinophilia in remission and progression of asthma: accumulation with a fast decline of FEV(1). Respir Med. 2010;104(9):1254-1262. DOI: 10.1016/j.rmed.2010.03.030
Price DB, Rigazio A, Campbell J, Bleecker ER, Corrigan CJ, Thomas M, et al. Blood eosinophil count and prospective annual asthma disease burden: a UK cohort study. Lancet Respir Med. 2015;3(11):849-858. DOI: 10.1016/S2213-2600(15)00367-7
Boonpiyathad T, Sözener ZC, Satitsuksanoa P, Akdis CA. Immunologic mechanisms in asthma. Semin Immunol. 2019;46:101333. DOI: 10.1016/j.smim.2019.101333
McBrien C, Menzies-Gow A. The biology of eosinophils and their role in asthma. Front Med (Lausanne). 2017;4:93. DOI: 10.3389/fmed.2017.00093
Molfino N, Kolbeck D, Parker J, Geba GP. Molecular and clinical rationale for therapeutic targeting of interleukin-5 and its receptor. Clin Exp Allergy. 2012;42(5):712-737. DOI: 10.1111/j.1365-2222.2011.03854.x
Bhalla A, Mukherjee M, Nair P. Airway eosinophilopoietic and autoimmune mechanisms of eosinophilia in severe asthma. Immunol Allergy Clin North Am. 2018;38(4):639-654. DOI: 10.1016/j.iac.2018.06.003
Walford HH, Doherty TA. Diagnosis and management of eosinophilic asthma: a US perspective. J Asthma Allergy. 2014:7:53-65. DOI: 10.2147/JAA.S39119
Wagener AH, de Nijs SB, Lutter R, Sousa AR, Bel EH, Sterk PJ, et al. External validation of blood eosinophils, FE(NO) and serum periostin as surrogates for sputum eosinophils in asthma. Thorax. 2015;70(2):115-120. DOI: 10.1136/thoraxjnl-2014-205634
Ortega H, Katz L, Gunsoy N, Keene O, Yancey S. Blood eosinophils counts predict treatment response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2015;136(3):825-826. DOI: 10.1016/j.jaci.2015.05.039
Kolbeck R, Kozhich A, Koike M, Peng L, Andersson CK, Reed JL, et al. MEDI-563 a humanized anti-IL-5 receptor alpha mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol. 2010;125(6):1344-1135. DOI: 10.1016/j.jaci.2010.04.004
Koike M, Kazuyasy N, Akiko F, Iida A, Anazawa H, Takatsu K, et al. Establishment of humanized anti-interleukin-5 receptor alpha chain monoclonal antibodies having a potent neutralizing activity. Hum Antibodies. 2009;18:17-27. DOI: 10.3233/HAB-2009-0198
Sakae Y, Satoh T, Yagi H, Yanaka S, Isoda Y, Iida S, et al. Conformational effects of N-glycan core fucosylation of immunog lobulin G Fc region on its interaction with Fcγ receptor IIIa. Sci Rep. 2017;7:13780. DOI: 10.1038/s41598-017-13845-8
Laviolette M, Gossage DL, Gauvreau G, Leigh R, Katial R, Busse WW, et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol. 2013;132(5):1086-1096. DOI: 10.1016/j.jaci.2013.05.020
Tuyet-Hang P, Damera G, Newbold P, Ranade K. Reduction in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016;111:21-29. DOI: 10.1016/j.rmed.2016.01.003
Pelaia C, Vatrella A, Bruni A, Terracciano R, Pelaia G. Benralizumab in the treatment of severe asthma: design, development and potential place in therapy. Drug Des Devel Ther. 2018;2:619-628. DOI: 10.2147/DDDT.S155307
Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, et al. Efficacy and safety of benralizmumab for patients with severe asthma uncontrolled with high-dosage inhaled corticoesteroids and long-acting β2 – agonist (SIROCCO): a randomized, multicenter, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-2127. DOI: 10.1016/S0140-6736(16)31324-1
FitzGerald J, Bleecker E, Nair P, Korn S, Ohta K, Busse WW, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomized, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-2141. DOI: 10.1016/S0140-6736(16)31322-8
Nair P, Wenzel S, Rabe K. Oral glucocorticoid-sparing effect of benralizumab in severe asthma. N Engl J Med. 2017;376:2448-2458. DOI: 10.1056/NEJMoa1703501
Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia-Gil E. Ability of serum IgE concentration to predict exacerbation risk and benralizumab efficacy for patients with severe eosinophilic asthma. Adv Ther. 2020;37(2):718-729. DOI: 10.1007/s12325-019-01191-2
FitzGeral JM, Bleecker EM, Menzies-Gow A, Zangrilli JG, Hirsch I, Metcalfe P, et al. Predictors of enhanced response with benralizumab for patients with severe asthma: pooled analysis of the SIROCCO and CALIMA studies. Lancet Respir Med. 2018;6(1):51-64. DOI: 10.1016/S2213-2600(17)30344-2
Bleecker E, Wechsler M, FitzGerarld M, Menzies-Gow A, Wu Y, Hirsch I, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018;52(4):1800936. DOI: 10.1183/13993003.00936-2018
Harrison T W, Chanez P, Menzella F. Exacerbation reduction and early and sustained improvements in SGRQ, lung function, and symptoms of nasal polyposis with benralizumab for severe, eosinophilic asthma: phase IIIb ANDHI trial. Am J Respir Crit Care Med. 2020;201:A4274. DOI: 10.1164/ajrccm-conference.2020.201.1_MeetingAbstracts.A4274
Menzies-Gow A, Corren J, Bel E, Maspero J, Gurnell M, Wessman P, et al. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial. ERJ Open Res. 2019;5(3):00009-2019. DOI: 10.1183/23120541.00009-2019
Jackson D, Kent B D, Humbert M et al. Enabling reductions in maintenance ICS/LABA therapy using as needed anti-inflammatory reliever for patients with severe eosinophilic asthma controlled with benralizumab: SHAMAL phase IV clinical study. Am J Respir Crit Care Med. 2020;201:A3020. DOI: 10.1164/ajrccm-conference.2020.201.1_MeetingAbstracts.A3020
Busse W, Bleecker E, FitzGerald J M, et al. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019;7(1):46-59. DOI: 10.1016/S2213-2600(18)30406-5
A safety extension study with benralizumab for asthmatic adults on inhaled corticosteroid plus long-acting β2 agonist (MELTEMI). Clinicaltrials.gov NCT02808819.
Zeitlin P, Leong M, Cole J, Mallory RM, Shih VH, Olsson RF, et al. Benralizumab does not impair antibody response to seasonal influenza vaccination in adolescent and young adult patients with moderate to severe asthma: results from the Phase IIIb ALIZE trial. J Asthma Allergy. 2018;11:181-192. DOI: 10.2147/JAA.S172338
Likura M, Tsukada A, Hirashima J et al. The clinical effectiveness and safety of benralizumab for Japanese patients with severe asthma. Am J Respir Crit Care Med. 2019;199:A1312. DOI: 10.1164/ajrccm-conference.2019.199.1_MeetingAbstracts.A1312
Izumo T, Tone M, Kuse N, Awano N, Tanaka A, Jo T, et al. Effectiveness and safety of benralizumab for severe asthma in clinical practice (J-BEST): a prospective study. Ann Transl Med. 2020;8(7):438. DOI: 10.21037/atm.2020.04.01
Pelaia C, Busceti MT, Vatrella A, Rago GF, Crimi C, Pelaia G, et al. Real-life of benralizumab effects in patients with severe allergic eosinophilic asthma: assessment of blood eosinophils, symptom control, lung function and oral corticosteroid intake after first drug dose. Pulm Pharmacol Ther. 2019;58:1-5. DOI: 10.1016/j.pupt.2019.101830
Panettieri RA, Welte T, Shenoy K, Korn S, Jandl M, Kerwin EM, et al. Onset of effect, changes in airflow obstruction and lung volume, and health-related quality of life improvements with benralizumab for patients with severe eosinophilic asthma: phase IIIb randomized, controlled trial (SOLANA). J Asthma Allergy. 2020;13:115-126. DOI: 10.2147/JAA.S240044
Kavanagh J, Roxas C, Thomson L, et al. P89 real-world 1 year effectiveness of benralizumab in severe eosinophilc asthma. Thorax. 2019;74(Suppl 2):A1-A262. DOI: 10.1136/thorax-2019-BTSabstracts2019.232
Jackson D, Dube S, Morris T. Improvement of clinical outcomes in severe eosinophilic asthma patients treated with benralizumab in real-world clinical practice in England: XALOC Study Programme. Am J Respir Crit Care Med. 2020;201:A3028. DOI: 10.1164/ajrccm-conference.2020.201.1_MeetingAbstracts.A3028
d´Ancona G, Bains S, Green L et al. P86 does adherence to ICS/LABA therapy change following initiation of benralizumab in the treatment of severe asthma and does this affect outcome? Thorax. 2019;74(Suppl 2):A1-A262. DOI: 10.1136/thorax-2019-BTSabstracts2019.229
Mavissakalian M, Brady S. The current state of biologic therapies for treatment of refractory asthma. Clin Rev Allergy Immunol. 2020;59(2):195-207. DOI: 10.1007/s12016-020-08776-8.
de Groot J, Ten Brinke A, Bel E. Management of the patient with eosinophilic asthma: a new era begins. ERJ Open Res. 2015;1(1):00024-2015. DOI: 10.1183/23120541.00024-2015
Información para Prescribir Ampliada – Fasenra. AstraZeneca Mexico 2018.
Rose DM, Hrncir DE. Primary eosinophilic lung diseases. Allergy Asthma Proc. 2013;34(1):19-25. DOI: 10.2500/aap.2013.34.3628
Ramirez GA, Yacoub MR, Ripa M, Mannina D, Cariddi A, Ciceri F, et al. Eosinophils from physiology to disease: a comprehensive review. Biomed Res Int. 2018;2018:9095275. DOI: 10.1155/2018/9095275
Long H, Zhang G, Wang L, Lu Q. Eosinophilic skin diseases: a comprehensive review. Clin Rev Allergy Immunol. 2016;50(2):189-213. DOI: 10.1007/s12016-015-8485-8
Ramakrishnan S, Camp JR, Vijayakumar B, et al. The use of benralizumab in the treatment of near-fatal asthma: a new approach. Am J Respir Crit Care Med. 2020;201(11):1441-1443. DOI: 10.1164/rccm.202001-0093LE
Ferguson GT, Cole J, Aurivillius M, Roussel P, Barker P, Martin BJ, et al. Single-use autoinjector functionality and reliability for at-home administration of benralizumab for patients with severe asthma: GRECO trial results. J Asthma Allergy. 2019;12:363-373. DOI: 10.2147/JAA.S224266
Ferguson G, Mansur A, Jacobs J, Hebert J, Clawson C, Tao W, et al. Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma. J Asthma Allergy. 2018;11:63-72. DOI: 10.2147/JAA.S157762.
Martin UJ, Fuhr R, Forte P, Barker P, Axley MJ, Yan L, et al. Comparison of autoinjector with accessorized prefilled syringe for benralizumab pharmacokinetic exposure: AMES trial results. J Asthma. 2019;1-9. DOI: 10.1080/02770903.2019.1663428
Benralizumab for treating severe eosinophilic asthma. EE. UU.: National Institute for Health and Care Excellence; 2019.
GINA difficult-to-treat and 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
Custovic A, Johnston SL, Pavord I, Gaga M, Fabbri L, Bel EH, et al. EAACI position statement on asthma exacerbations and severe asthma. Allergy. 2013;68(12):1520-1531. DOI: 10.1111/all.12275
Mukherjee M, Bakakos P, Loukides S. New paradigm in asthma management: switching between biologics! Allergy. 2020;75(4):743-745. DOI: 10.1111/all.14038.
Esta obra está bajo una licencia internacional Creative Commons Atribución-NoComercial 4.0.
Derechos de autor 2020 Revista Alergia México