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Reviews

Personalized medicine with biologics for severe type 2 asthma: current status and future prospects

, , , &
Pages 34-45 | Received 22 Sep 2017, Accepted 11 Oct 2017, Published online: 14 Nov 2017

References

  • Reddel HK, Bateman ED, Becker A, Boulet LP, Cruz AA, Drazen JM, Haahtela T, Hurd SS, Inoue H, de Jongste JC, et al. A summary of the new GINA strategy: a roadmap to asthma control. Eur Respir J. 2015;46:622–39. doi:10.1183/13993003.00853-2015. PMID:26206872.
  • Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2013;43(2):343–73. doi:10.1183/09031936.00202013. PMID:24337046.
  • Ray A, Oriss TB, Wenzel SE. Emerging molecular phenotypes of asthma. Am J Physiol Lung Cell Mol Physiol. 2015;308:L130–L40. doi:10.1152/ajplung.00070.2014. PMID:25326577.
  • Lambrecht BN, Hammad H. The immunology of asthma. Nat Immunol. 2015;16:45–56. doi:10.1038/ni.3049. PMID:25521684.
  • Kumar R, Singh J. Biosimilar drugs: current status. Int J Appl Basic Med Res. 2014;4:63–6. doi:10.4103/2229-516X.136774. PMID:25143877.
  • Braido F. Failure in asthma control: reasons and consequences. Scientifica. 2013;2013:549252. doi:10.1155/2013/549252. PMID:24455432.
  • Sullivan PW, Ghushchyan VH, Slejko JF, Belozeroff V, Globe DR, Lin SL. The burden of adult asthma in the United States: evidence from the Medical Expenditure Panel Survey. J Allergy Clin Immunol. 2011;127:363–9. doi:10.1016/j.jaci.2010.10.042. PMID:21281868.
  • Chipps BE, Peters SP. Biologic Therapies of Immunologic Diseases. Immunol Allergy Clin North Am. 2017;37:xvii–xviii. doi:10.1016/j.iac.2017.02.001. PMID:28366489.
  • Arron JR, Townsend MJ, Keir ME, Yaspan BL, Chan AC. Stratified medicine in inflammatory disorders: from theory to practice. Clin Immunol. 2015;161:11–22. doi:10.1016/j.clim.2015.04.006. PMID:25934386.
  • Colburn W, DeGruttola VG, DeMets DL, Downing GJ, Hoth DF, Oates JA, et al. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Biomarkers Definitions Working Group. Clinical Pharmacology & Therapeutics 2001; 69:89–95. doi:10.1067/mcp.2001.113989. PMID:11240971
  • de Roos E, Braunstahl GJ, Lahousse L, Brusselle G. Targeted Therapy for Older Patients with Uncontrolled Severe Asthma: Current and Future Prospects. Drugs & Aging. 2016;33:619–28. doi:10.1007/s40266-016-0397-7.
  • Doyle R. Drug Development and Biologics in Asthma. A New Era. Annals of the American Thoracic Society 2016; 13:S83–S4. doi:10.1513/AnnalsATS.201509-573MG. PMID:27027958
  • Gauthier M, Ray A, Wenzel SE. Evolving concepts of asthma. Am J Respir Crit Care Med. 2015;192:660–8. doi:10.1164/rccm.201504-0763PP. PMID:26161792.
  • Zissler U, Esser‐von Bieren J, Jakwerth C, Chaker A, Schmidt‐Weber C. Current and future biomarkers in allergic asthma. Allergy. 2016;71(4):475–94. doi:10.1111/all.12828. PMID:26706728.
  • Bayes HK, Cowan DC. Biomarkers and asthma management: an update. Curr Opin Allergy Clin Immunol. 2016;16:210–7. doi:10.1097/ACI.0000000000000263. PMID:27057795.
  • Staton TL, Choy DF, Arron JR. Biomarkers in the clinical development of asthma therapies. Biomarkers 2016; 10:165–76. doi:10.2217/bmm.15.116. PMID:26764286
  • Hanania NA, Noonan M, Corren J, Korenblat P, Zheng Y, Fischer SK, Cheu M, Putnam WS, Murray E, Scheerens H, et al. Lebrikizumab in moderate-to-severe asthma: pooled data from two randomised placebo-controlled studies. Thorax. 2015;70:748–56. doi:10.1136/thoraxjnl-2014-206719. PMID:26001563.
  • Demarche S, Schleich F, Henket M, Paulus V, Van Hees T, Louis R. Detailed analysis of sputum and systemic inflammation in asthma phenotypes: are paucigranulocytic asthmatics really non-inflammatory? BMC Pulm Med. 2016;16:46. doi:10.1186/s12890-016-0208-2. PMID:27044366.
  • Kauffman HF, Tamm M, Timmerman JAB, Borger P. House dust mite major allergens Der p 1 and Der p 5 activate human airway-derived epithelial cells by protease-dependent and protease-independent mechanisms. Clin Mol Allergy. 2006;4:5. doi:10.1186/1476-7961-4-5. PMID:16569217.
  • Galli SJ, Tsai M, Piliponsky AM. The development of allergic inflammation. Nature. 2008;454:445–54. doi:10.1038/nature07204. PMID:18650915.
  • Gordon ED, Simpson LJ, Rios CL, Ringel L, Lachowicz-Scroggins ME, Peters MC, et al. Alternative splicing of interleukin-33 and type 2 inflammation in asthma. Proceedings of the National Academy of Sciences 2016; 113:8765–70. doi:10.1073/pnas.1601914113. PMID:27432971
  • Grünig G, Warnock M, Wakil AE, Venkayya R, Brombacher F, Rennick DM, Sheppard D, Mohrs M, Donaldson DD, Locksley RM, et al. Requirement for IL-13 independently of IL-4 in experimental asthma. Science. 1998;282:2261–3. doi:10.1126/science.282.5397.2261. PMID:9856950.
  • Wills-Karp M, Luyimbazi J, Xu X, Schofield B, Neben TY, Karp CL, Donaldson DD. Interleukin-13: central mediator of allergic asthma. Science. 1998;282:2258–61. doi:10.1126/science.282.5397.2258. PMID:9856949.
  • Chatila TA. Interleukin-4 receptor signaling pathways in asthma pathogenesis. Trends Mol Med. 2004;10:493–9. doi:10.1016/j.molmed.2004.08.004. PMID:15464449.
  • Allakhverdi Z, Comeau MR, Jessup HK, Yoon BRP, Brewer A, Chartier S, Paquette N, Ziegler SF, Sarfati M, Delespesse G. Thymic stromal lymphopoietin is released by human epithelial cells in response to microbes, trauma, or inflammation and potently activates mast cells. J Exp Med. 2007;204:253–8. doi:10.1084/jem.20062211. PMID:17242164.
  • Van Dyken SJ, Nussbaum JC, Lee J, Molofsky AB, Liang HE, Pollack JL, Gate RE, Haliburton GE, Ye CJ, Marson A, et al. A tissue checkpoint regulates type 2 immunity. Nature Immunol. 2016;17:1381–7. doi:10.1038/ni.3582. PMID:27749840.
  • Guo L, Huang Y, Chen X, Hu-Li J, Urban JF Jr, Paul WE. Innate Immune Function of TH2 Cells in vivo. Nature Immunol. 2015;16:1051–9. doi:10.1038/ni.3244. PMID:26322482.
  • Dweik RA, Sorkness RL, Wenzel S, Hammel J, Curran-Everett D, Comhair SA, Bleecker E, Busse W, Calhoun WJ, Castro M, et al. Use of exhaled nitric oxide measurement to identify a reactive, at-risk phenotype among patients with asthma. Am J Respir Crit Care Med. 2010;181:1033–41. doi:10.1164/rccm.200905-0695OC. PMID:20133930.
  • McGrath KW, Icitovic N, Boushey HA, Lazarus SC, Sutherland ER, Chinchilli VM, Asthma Clinical Research Network of the National Heart, Lung, and Blood Institute. A large subgroup of mild-to-moderate asthma is persistently noneosinophilic. Am J Respir Crit Care Med. 2012;185:612–9. doi:10.1164/rccm.201109-1640OC. PMID:22268133.
  • Woodruff PG, Modrek B, Choy DF, Jia G, Abbas AR, Ellwanger A, Koth LL, Arron JR, Fahy JV. T-helper type 2–driven inflammation defines major subphenotypes of asthma. Am J Respir Crit Care Med. 2009;180:388–95. doi:10.1164/rccm.200903-0392OC. PMID:19483109.
  • Moore WC, Meyers DA, Wenzel SE, Teague WG, Li H, Li X, D'Agostino R Jr, Castro M, Curran-Everett D, Fitzpatrick AM, et al. Identification of asthma phenotypes using cluster analysis in the Severe Asthma Research Program. Am J Respir Crit Care Med. 2010;181:315–23. doi:10.1164/rccm.200906-0896OC. PMID:19892860.
  • Wu W, Bleecker E, Moore W, Busse WW, Castro M, Chung KF, Calhoun WJ, Erzurum S, Gaston B, Israel E, et al. Unsupervised phenotyping of Severe Asthma Research Program participants using expanded lung data. J Allergy Clin Immunol. 2014;133:1280–8. doi:10.1016/j.jaci.2013.11.042. PMID:24589344.
  • Miranda C, Busacker A, Balzar S, Trudeau J, Wenzel SE. Distinguishing severe asthma phenotypes: role of age at onset and eosinophilic inflammation. J Allergy Clin Immunol. 2004;113:101–8. doi:10.1016/j.jaci.2003.10.041. PMID:14713914.
  • Dixon AE, Pratley RE, Forgione PM, Kaminsky DA, Whittaker-Leclair LA, Griffes LA, Garudathri J, Raymond D, Poynter ME, Bunn JY, et al. Effects of obesity and bariatric surgery on airway hyperresponsiveness, asthma control, and inflammation. Journal of Allergy and Clinical Immunology. 2011;128:508–15. doi:10.1016/j.jaci.2011.06.009. PMID:21782230.
  • McKinley L, Alcorn JF, Peterson A, DuPont RB, Kapadia S, Logar A, Henry A, Irvin CG, Piganelli JD, Ray A, et al. TH17 cells mediate steroid-resistant airway inflammation and airway hyperresponsiveness in mice. J Immunol. 2008;181:4089–97. doi:10.4049/jimmunol.181.6.4089. PMID:18768865.
  • Shaw DE, Berry MA, Hargadon B, McKenna S, Shelley MJ, Green RH, et al. Association between neutrophilic airway inflammation and airflow limitation in adults with asthma. CHEST Journal 2007; 132:1871–5. doi:10.1378/chest.07-1047. PMID:17925424
  • Manni ML, Trudeau JB, Scheller EV, Mandalapu S, Elloso MM, Kolls JK, Wenzel SE, Alcorn JF. The complex relationship between inflammation and lung function in severe asthma. Mucosal Immunology. 2014;7:1186–98. doi:10.1038/mi.2014.8. PMID:24549277.
  • Holgate ST, Holloway J, Wilson S, Bucchieri F, Puddicombe S, Davies DE. Epithelial–mesenchymal communication in the pathogenesis of chronic asthma. Proc Am Thorac Soc. 2004;1:93–8. doi:10.1513/pats.2306034. PMID:16113419.
  • Belliveau PP. Omalizumab: a monoclonal anti-IgE antibody. Med Gen Med. 2005;7:27. PMID:16369332.
  • D'Amato G, Liccardi G, Noschese P, Salzillo A, D'Amato M, Cazzola M. Anti-IgE monoclonal antibody (omalizumab) in the treatment of atopic asthma and allergic respiratory diseases. Current Drug Targets-Inflammation & Allergy 2004; 3:227–9. doi:10.2174/1568010043343615. PMID:15379589
  • Guilliams M, Bruhns P, Saeys Y, Hammad H, Lambrecht BN. The function of Fc [gamma] receptors in dendritic cells and macrophages. Nat Rev Immunol. 2014;14:94–108. doi:10.1038/nri3582. PMID:24445665.
  • Wu AC, Paltiel AD, Kuntz KM, Weiss ST, Fuhlbrigge AL. Cost-effectiveness of omalizumab in adults with severe asthma: results from the Asthma Policy Model. J Allergy Clin Immunol. 2007;120:1146–52. doi:10.1016/j.jaci.2007.07.055. PMID:17904628.
  • Fajt ML, Wenzel SE. Asthma phenotypes and the use of biologic medications in asthma and allergic disease: the next steps toward personalized care. J Allergy Clin Immunol. 2015;135:299–310. doi:10.1016/j.jaci.2014.12.1871. PMID:25662302.
  • Hanania NA, Alpan O, Hamilos DL, Condemi JJ, Reyes-Rivera I, Zhu J, Rosen KE, Eisner MD, Wong DA, Busse W. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011;154:573–82. doi:10.7326/0003-4819-154-9-201105030-00002. PMID:21536936.
  • Hanania NA, Wenzel S, Rosén K, Hsieh HJ, Mosesova S, Choy DF, Lal P, Arron JR, Harris JM, Busse W. Exploring the effects of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med. 2013;187:804–11. doi:10.1164/rccm.201208-1414OC. PMID:23471469.
  • Ledford D, Busse W, Trzaskoma B, Omachi TA, Rosén K, Chipps BE, et al. A Randomized, Multicenter Study Evaluating Xolair® Persistency Of Response After Long-Term Therapy (XPORT). J Allergy Clin Immunol. 2016;140:162–9. doi:10.1016/j.jaci.2016.08.054. PMID:27826098.
  • Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin Immunol. 2009;124:1210–6. doi:10.1016/j.jaci.2009.09.021. PMID:19910033.
  • Ultsch M, Bevers J, Nakamura G, Vandlen R, Kelley RF, Wu LC, Eigenbrot C. Structural basis of signaling blockade by anti-IL-13 antibody lebrikizumab. J Mol Biol. 2013;425:1330–9. doi:10.1016/j.jmb.2013.01.024. PMID:23357170.
  • Corren J, Lemanske RF Jr, Hanania NA, Korenblat PE, Parsey MV, Arron JR, Harris JM, Scheerens H, Wu LC, Su Z, et al. Lebrikizumab treatment in adults with asthma. N Engl J Med. 2011;365:1088–98. doi:10.1056/NEJMoa1106469. PMID:21812663.
  • Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, Yokoyama A, Olsson J, Gray S, Holweg CT, et al. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016;4:781–96. doi:10.1016/S2213-2600(16)30265-X. PMID:27616196.
  • Piper E, Brightling C, Niven R, Oh C, Faggioni R, Poon K, She D, Kell C, May RD, Geba GP, et al. A phase II placebo-controlled study of tralokinumab in moderate-to-severe asthma. Eur Respir J. 2013;41:330–8. doi:10.1183/09031936.00223411. PMID:22743678.
  • Brightling CE, Chanez P, Leigh R, O'Byrne PM, Korn S, She D, May RD, Streicher K, Ranade K, Piper E. Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Respir Med. 2015;3:692–701. doi:10.1016/S2213-2600(15)00197-6. PMID:26231288.
  • Panettieri RA Jr, Brightling C, Sjobring U, Péterffy A, Tornling G, Daoud SZ, et al. STRATOS 1 and 2: considerations in clinical trial design for a fully human monoclonal antibody in severe asthma. J Clin Invest. 2015;5:701–11. doi:10.4155/cli.15.38.
  • 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 β 2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. The Lancet 2016; 388:31–44. doi:10.1016/S0140-6736(16)30307-5. PMID:27130691
  • Bachert C, Mannent L, Naclerio RM, Mullol J, Ferguson BJ, Gevaert P, Hellings P, Jiao L, Wang L, Evans RR, et al. Effect of subcutaneous dupilumab on nasal polyp burden in patients with chronic sinusitis and nasal polyposis: a randomized clinical trial. JAMA. 2016;315:469–79. doi:10.1001/jama.2015.19330. PMID:26836729.
  • 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. The Lancet 2012; 380:651–9. doi:10.1016/S0140-6736(12)60988-X. PMID:22901886
  • Castro M, Mathur S, Hargreave F, Boulet LP, Xie F, Young J, Wilkins HJ, Henkel T, Nair P, Res-5-0010 Study Group. Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2011;184:1125–32. doi:10.1164/rccm.201103-0396OC. PMID:21852542.
  • Haldar P, Brightling CE, Hargadon B, Gupta S, Monteiro W, Sousa A, Marshall RP, Bradding P, Green RH, Wardlaw AJ, et al. Mepolizumab and exacerbations of refractory eosinophilic asthma. N Engl J Med. 2009;360:973–84. doi:10.1056/NEJMoa0808991. PMID:19264686.
  • Nair P, Pizzichini MM, Kjarsgaard M, Inman MD, Efthimiadis A, Pizzichini E, Hargreave FE, O'Byrne PM. Mepolizumab for prednisone-dependent asthma with sputum eosinophilia. N Engl J Med. 2009;360:985–93. doi:10.1056/NEJMoa0805435. PMID:19264687.
  • Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371:1198–207. doi:10.1056/NEJMoa1403290. PMID:25199059.
  • Castro M, Zangrilli J, Wechsler ME, Bateman ED, Brusselle GG, Bardin P, Murphy K, Maspero JF, O'Brien C, Korn S. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015;3:355–66. doi:10.1016/S2213-2600(15)00042-9. PMID:25736990.
  • Kolbeck R, Kozhich A, Koike M, Peng L, Andersson CK, Damschroder MM, Reed JL, Woods R, Dall'acqua WW, Stephens GL, et al. MEDI-563, a humanized anti–IL-5 receptor α mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol. 2010;125:1344–53. doi:10.1016/j.jaci.2010.04.004. PMID:20513525.
  • Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β 2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. The Lancet 2016; 388:2115–27. doi:10.1016/S0140-6736(16)31324-1. PMID:27609408
  • FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet 2016; 388:2128–41. doi:10.1016/S0140-6736(16)31322-8. PMID:27609406
  • Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J. Clinical development success rates for investigational drugs. Nat Biotechnol. 2014;32:40–51. doi:10.1038/nbt.2786. PMID:24406927.
  • Arron JR, Scheerens H, Matthews JG, David R. Redefining approaches to asthma: developing targeted biologic therapies. Adv Pharmacol. 2013;66:1–49. doi:10.1016/B978-0-12-404717-4.00001-9. PMID:23433454.
  • Wenzel SE. Asthma phenotypes: the evolution from clinical to molecular approaches. Nat Med. 2012;18:716–25. doi:10.1038/nm.2678. PMID:22561835.
  • Simpson JL, Scott R, Boyle MJ, Gibson PG. Inflammatory subtypes in asthma: assessment and identification using induced sputum. Respirology. 2006;11:54–61. doi:10.1111/j.1440-1843.2006.00784.x. PMID:16423202.
  • Barnes P, Adcock I, Ito K. Histone acetylation and deacetylation: importance in inflammatory lung diseases. Eur Respir J. 2005;25:552–63. doi:10.1183/09031936.05.00117504. PMID:15738302.
  • Umland SP, Schleimer RP, Johnston SL. Review of the molecular and cellular mechanisms of action of glucocorticoids for use in asthma. Pulm Pharmacol Ther. 2002;15:35–50. doi:10.1006/pupt.2001.0312.
  • Dahl R. Systemic side effects of inhaled corticosteroids in patients with asthma. Respir Med. 2006;100:1307–17. doi:10.1016/j.rmed.2005.11.020. PMID:16412623.
  • Hansbro PM, Kaiko GE, Foster PS. Cytokine/anti‐cytokine therapy–novel treatments for asthma? Br J Pharmacol. 2011;163:81–95. doi:10.1111/j.1476-5381.2011.01219.x. PMID:21232048.
  • Choy DF, Hart KM, Borthwick LA, Shikotra A, Nagarkar DR, Siddiqui S, Jia G, Ohri CM, Doran E, Vannella KM, et al. TH2 and TH17 inflammatory pathways are reciprocally regulated in asthma. Sci Transl Med. 2015;7:301ra129. doi:10.1126/scitranslmed.aab3142. PMID:26290411.