Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Биологическая терапия бронхиальной астмы: настоящее и будущее
Биологическая терапия бронхиальной астмы: настоящее и будущее
Ненашева Н.М. Биологическая терапия бронхиальной астмы: настоящее и будущее. Consilium Medicum. 2016; 18 (11): 30–38. DOI: 10.26442/2075-1753_2016.11.30-38
________________________________________________
Материалы доступны только для специалистов сферы здравоохранения. Авторизуйтесь или зарегистрируйтесь.
Аннотация
Данная обзорная статья посвящена настоящим и будущим возможностям применения биологических молекул в лечении бронхиальной астмы. За последние 20 лет произошел прорыв в области биологической терапии тяжелой бронхиальной астмы с помощью молекул моноклональных антител. Три биологических препарата (омализумаб, меполизумаб и реслизумаб) уже одобрены для применения в обычной клинической практике в ряде стран, а омализумаб уже давно и успешно применяется повсеместно, в том числе в нашей стране.
Ключевые слова: тяжелая астма, биологическая терапия астмы, интерлейкины 5, 4, 13, 17, омализумаб, меполизумаб, реслизумаб, бенрализумаб, лебрикизумаб, тралокинумаб, дупилумаб.
Ключевые слова: тяжелая астма, биологическая терапия астмы, интерлейкины 5, 4, 13, 17, омализумаб, меполизумаб, реслизумаб, бенрализумаб, лебрикизумаб, тралокинумаб, дупилумаб.
________________________________________________
This review article focuses on the present and future possibilities of biological molecules use in the treatment of bronchial asthma. Over the past 20 years there has been a breakthrough in the field of biological treatment of severe asthma with monoclonal antibody molecules. Three biological treatment (omalizumab, mepolizumab and reslizumab) is already approved for use in routine clinical practice in a number of countries, as omalizumab has long and successfully applied everywhere, including in our country.
Key words: severe asthma, asthma biological therapy, interleukin 5, 4, 13, 17, omalizumab, mepolizumab, reslizumab, benralizumab, lebrikizumab, tralokinumab, dupilumab.
Key words: severe asthma, asthma biological therapy, interleukin 5, 4, 13, 17, omalizumab, mepolizumab, reslizumab, benralizumab, lebrikizumab, tralokinumab, dupilumab.
Полный текст
Список литературы
1. GINA 2016 www.ginasthma.org
2. Chuchalin AG, Khaltaev N, Аntonov N. Chronic respiratory diseases and risk factors in 12 regions of the Russian Federation. Int J COPD 2014; 9: 963–74.
3. Национальная программа «Бронхиальная астма у детей. Стратегия лечения и профилактика». IV изд. М., 2012. / Natsional'naia programma «Bronkhial'naia astma u detei. Strategiia lecheniia i profilaktika». IV izd. M., 2012. [in Russian]
4. Bousqet J, Mantzouranis E, Cruz AA et al. Uniform definition of asthma severity, control and exacerbations: document presented for the World Health Organization Consultation on Severe Asthma. J Allergy Clin Immunol 2010; 126: 926–38.
5. Chung KF, Wenzel S, Brozek J et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43: 343–73.
6. Locksley RM. Asthma and allergic inflammation. Cell 2010; 140 (6): 777–83.
7. Li BW, Hendriks RW: Group 2 innate lymphoid cells in lung inflammation. Immunology 2013; 140 (3): 281–7.
8. Kita H. Eosinophils: multifunctional and distinctive properties. Int Arch Allergy Immunol 2013; 161 (Suppl. 2): 3–9.
9. Bousquet J, Chanez P, Lacoste JY et al. Eosinophilic inflammation in asthma. N Engl J Med 1990; 323: 1033–9.
10. Blanchard C, Rothenberg ME. Biology of the eosinophil. Adv Immunol 2009; 101: 81–121.
11. Melo RC, Liu L, Xenakis JJ et al. Eosinophil-derived cytokines in health and disease: unraveling novel mechanisms of selective secretion. Allergy 2013; 68 (3): 274–84.
12. Fahy JV. Eosinophilic and neutrophilic inflammation in asthma: insights fr om clinical studies. Proc Am Thorac Soc 2009; 6 (3): 256–9.
13. Duncan CJ, Lawrie A, Blaylock MG et al. Reduced eosinophil apoptosis in induced sputum correlates with asthma severity. Eur Respir J 2003; 22: 484–90.
14. Kupczyk M, ten Brinke A, Sterk P et al. Frequent exacerbators – a distinct phenotype of severe asthma. Clin Experim Allergy 2013; 44: 212–21.
15. Schleich FN, Manise M, Sele J et al. Distribution of sputum cellular phenotype in a large asthma cohort: predicting factors for eosinophilic vs neutrophilic inflammation. BMC Pulm Med 2013; 13: 11.
16. Moore WC, Meyers DA, Wenzel SE 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.
17. Haldar P, Pavord ID, Shaw DE et al. Cluster analysis and clinical asthma phenotypes. Am J Respir Crit Care Med 2008; 178: 218–24.
18. Siroux V, Basagana X, Boudier A et al. Identifying adult asthma phenotypes using a clustering approach. Eur Respir J 2011; 38: 310–7.
19. Chung KF, Bel EH, Wenzel SE. Difficult-to-Treat Severe Asthma. Eur Respir Soc Monograph 2011; 51: 310.
20. Shaw D, Sousa A, Fowler S et al. Clinical and inflammatory characteristics of the European U-BIOPRED adult severe asthma cohort. Eur Respir J 2015; 46: 1308–21.
21. Trevor JL, Deshane JS. Refractory asthma: mechanisms, targets, and therapy. Allergy 2014; 69: 817–27.
22. Kuhl K, Hanania NA. Targeting IgE in asthma. Curr Opin Pulm Med 2012; 18: 1–5.
23. Walker S, Monteil M, Phelan K et al. Anti-IgE for chronic asthma in adults and children. Cochrane Database Syst Rev 2006; 2: CD003559.
24. Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Efficacy and safety of subcutaneous omalizumab vs placebo as add-on therapy to corticosteroids for children and adults with asthma: a systematic review. Chest 2011; 139 (1): 28–35.
25. Normansell R, Walker S, Milan S et al. Omalizumab for asthma in adults and children. Cochrane Database Syst Rev 2014; 1: CD003559.
26. Brusselle G, Michils A, Louis R et al. “Real-life” effectiveness of omalizumab in patients with severe persistent allergic asthma: the PERSIST study. Resp Med 2009; 103: 1633–42.
27. Braunsthl GJ, Chlumsky J, Peachey G, Chen CW. Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real-world setting. Allergy Asthma Clin Immunol 2013; 9: 47.
28. Чучалин А.Г., Пашкова Т.Л., Осипова Г.Л., Сучкова Ю.Б. Оценка эффективности и безопасности омализумаба в комплексной терапии больных с тяжелой неконтролируемой атопической бронхиальной астмой в течение 12 месяцев наблюдения. Пульмонология. 2009; 3: 75–80. / Chuchalin A.G., Pashkova T.L., Osipova G.L., Suchkova Iu.B. Otsenka effektivnosti i bezopasnosti omalizumaba v kompleksnoi terapii bol'nykh s tiazheloi nekontroliruemoi atopicheskoi bronkhial'noi astmoi v techenie 12 mesiatsev nabliudeniia. Pul'monologiia. 2009; 3: 75–80. [in Russian]
29. Salvin RG, Feroli C, Tannenbaum SJ et al. Asthma symptom re-emergence after omalizumab withdrawal correlates well with increasing pharmacokinetic concentations. J Allergy Clin Immunol 2009; 123: 107–13.
30. Molimard M, Mala L, Bourdeix I, Le Gros V. Observation study in severe asthmatic patients after discontinuation of omalizumab for good asthma control. Respir Med 2014; 108: 571–6.
31. Bousquet J, Rabe K, Humbert M et al. Predicting and evaluating responce to omalizumab in patients with severe allergic asthma. Respir Med 2007; 101: 1483–92.
32. Wahn U, Martin C, Freeman P et al. Relationship between pretreatment specific IgE and the responce to omalizumab therapy. Allergy 2009; 64: 1780–7.
33. Hanania NA, Wenzel S, Rosen K et al. Exploring the effect of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med 2013; 187: 804–11.
34. Massanari M, Holgate ST, Busse WW et al. Effect of omalizumab on peripheral blood eosinophilia in allergic asthma. Respir Med 2010; 104 (2): 188–96.
35. Djukanović R, Wilson SJ, Kraft M et al. Effects of treatment with anti-immunoglobulin E antibody omalizumab on airway inflammation in allergic asthma. Am J Respir Crit Care Med 2004; 170 (6): 583–93.
36. Инструкция к применению препарата Ксолар. / Instruktsiia k primeneniiu preparata Ksolar. [in Russian]
37. Luijk B, Lindemans C, Kanters D et al. Gradual increase in priming of human eosinophils during extravasation from peripheral blood to the airways in response to allergen challenge. J Allergy Clin Immunol 2005; 115: 997–1003
38. Kouro T, Takatsu T. IL-5- and eosinophil-mediated inflammation: from discovery to therapy. Int Immunol 2009; 21 (12): 1303–9.
39. Flood-Page P, Menzies-Gow A, Phipps S et al. Anti-IL-5 treatment reduces deposition of ECM proteins in the bronchial subepitelial basement membrance of mild atopic astmatics. J Clin Invest 2003; 112: 1029–36.
40. Menzies-Gow A, Flood-Page P, Sehmi R et al. Anti-IL-5 (mepolizumab) therapy induces bone marrow eosinophil maturational arrest and decreases eosinophil progenitors in the bronchial mucosa of atopic asyhmatics. J Allergy Clin Immunol 2003; 111: 714–9.
41. Leckie MJ, ten Brinke A, Khan J et al. Effects of an interleukin-5 blocking monoclonal antibody on eosinophils, airways hyperresponsiveness, and the late asthmatic responce. Lancet 2000; 356: 2144–8.
42. Nair P, Pizzichini M, Kjarsgaard M et al. Mepolizumab for prednison-dependent asthma with sputum eosinophilia. N Engl J Med 2009; 360: 985–93.
43. Haldar P, Brighting C, Hargardon B et al. Mepolizumab and exacerbations of refractory eosinophilic asthma. N Engl J Med 2009; 360: 973–84.
44. Pavord ID, Korn S, Howarth P et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet 2012; 380: 651–9.
45. Ortega HG, Liu MC, Pavord ID et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371: 1198–207.
46. Bel EH, Wenzel SE, Thompson PJ et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014; 371: 1189–97.
47. Haldar P, Brighting C, Singapuri A et al. Outcomes after cessation of mepolizumab therapy in severe eosinophilic asthma: a 12-month follow-up analysis. J Allergy Clin Immunol 2014; 133: 921–3.
48. Castro M, Mathur S, Hargreave F et al. Reslizumab for poorlycontrolled, eosinophilic asthma: a randomized, placebo-controlledstudy. Am J Respir Crit Care Med 2011; 184: 1125–32.
49. Castro M, Zangrilli J, Wechlser ME et al. Reslizumab foe inadequately controlled asthma with elevated blood eosinophil counts: results from two multicenter, parallel, double-blind, randomized, placebo-controlled, phase 3 trials. Lancet Respir Med 2015; 3: 355–66.
50. Kolbeck R, Kozhich A, Koike M 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 (1): 1344–53.
51. Busse WW, Katial R, Gossage D et al. Safety profile, pharmacokinetics, and biologic activity of MEDI-563, an anti-IL-5 receptor antibody, in a phase I study of subjects with mild asthma. J Allergy Clin Immunol 2010; 125: 1237–44.
52. Laviolette M, Gossage DL, Gaureau G et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol 2013; 132: 1086–96.
53. Castro M, Wenzel SE, Bleecker ER et al. Benralizumab, an anti-interleukin 5 receptor a monoclonal antibody, versus placebo for uncontrolled eosinophilic asthma: a phase 2b randomised dose-ranging study. Lancet Respir Med 2014; 2 (11): 879–90.
54. Oh CK, Geba GP, Molfino N et al. Investigational therapeutics targeting the IL-4/IL-13/STAT-6 pathway for the treatment of asthma. Eur Respir Rev 2010; 19: 46–54.
55. Jia G, Erickson RW, Choy D et al. Periostin is a systemic biomarker of eosinophilic airway inflammation in asthmatic patients J Allergy Clin Immunol 2012; 130: 647–54.
56. Corren J, Lemanske RF, Hanania NA et al. Lebrikizumab treatment in adults with asthma. N Engl J Med 2011; 365 (12): 1088–98.
57. Scheerens H, Arron JR, Su Z et al. Predictive and pharmacodynamic biomarkers of interleukin-13 blockade: effect of lebrikizumab on late phase asthmatic response to allergen challenge. J Allergy Clin Immunol 2011; 127 (Suppl. 2): AB164.
58. Hanania NA, Noonan MJ, Corren J et al. Efficacy and safety of lebrikizumab in severe uncontrolled asthma: results from the lute and verse phase II randomized, double-blind, placebo-controlled trials. J Allergy Clin Immunol 2014; 133 (2): AB402.
59. Blanchard C, Mishra A, Sito-Hakel H et al. Inhibition of human interleukin-13-induced respiratory and esophageal inflammation by antihuman interleukin-13 antibody (CAT-354). Clin Exp Allergy 2005; 35: 1096–103.
60. Piper E, Brightling C, Niven R et al. A phase II placebo-controlled study of tralocinumab in moderate-to-severe asthma. Eur Respir J 2013; 41: 330–8.
61. Brightling C, Chanez P, Leigh R, O’Byrne P et al. 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 (9): 692–701.
62. Wenzel S, Ford L, Pearlman D et al. Dupilumab in Persistent Asthma with Elevated Eosinophil Levels. N Engl J Med 2013; 368 (26): 2455–66.
63. 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 b2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet 2016; 388: 31–44.
64. Wang YH, Wills-Karp M. The potential role of interleukin-17 in severe asthma. Curr Allergy Asthma Rep 2011; 11 (5): 388–94.
65. Kudo M, Melton AC, Chen C et al. IL-17A produced by alphabeta T cells drives airway hyperresponsiveness in mice and enhances mouse and human airway smooth muscle contraction. Nat Med 2012; 18 (4): 547–54.
66. Min Xie, Wenzel SE. A global perspective in asthma: from phenotype to endotype. Chinese Med J 2013; 126 (1): 166–74.
67. Chesne J, Braza F, Mahay G et al. IL-17 in Severe Asthma. Wh ere Do We Stand? Am J Respir and Crit Care Med 2014; 190 (10): 1094–101.
68. Busse WW, Holgate S, Kerwin E et al. Randomized, double-blinde, placebo-controlled study of brodalumab, a human anti-IL17 receptor monoclonal antibody, in moderate to severe asthma. Am J Respir Crit Care Med 2013; 188: 1294–302.
69. Newcomb DC, Peebles RS Jr. Th17-mediated inflammation in asthma. Curr Opin Immunol 2013; 25: 755–60.
70. Morishima Y, Ano S, Ichii Y et al. Th17-associated cytokines as a therapeutic target for steroid-insensitive asthma. Clin Dev Immunol 2013; 609: 395.
71. McCracken J, Tripple J, Calhoun WJ. Biologic therapy in the management of asthma. Allergy Clin Immunol 2016; 16 (4): 375–82.
2. Chuchalin AG, Khaltaev N, Аntonov N. Chronic respiratory diseases and risk factors in 12 regions of the Russian Federation. Int J COPD 2014; 9: 963–74.
3. Natsional'naia programma «Bronkhial'naia astma u detei. Strategiia lecheniia i profilaktika». IV izd. M., 2012. [in Russian]
4. Bousqet J, Mantzouranis E, Cruz AA et al. Uniform definition of asthma severity, control and exacerbations: document presented for the World Health Organization Consultation on Severe Asthma. J Allergy Clin Immunol 2010; 126: 926–38.
5. Chung KF, Wenzel S, Brozek J et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43: 343–73.
6. Locksley RM. Asthma and allergic inflammation. Cell 2010; 140 (6): 777–83.
7. Li BW, Hendriks RW: Group 2 innate lymphoid cells in lung inflammation. Immunology 2013; 140 (3): 281–7.
8. Kita H. Eosinophils: multifunctional and distinctive properties. Int Arch Allergy Immunol 2013; 161 (Suppl. 2): 3–9.
9. Bousquet J, Chanez P, Lacoste JY et al. Eosinophilic inflammation in asthma. N Engl J Med 1990; 323: 1033–9.
10. Blanchard C, Rothenberg ME. Biology of the eosinophil. Adv Immunol 2009; 101: 81–121.
11. Melo RC, Liu L, Xenakis JJ et al. Eosinophil-derived cytokines in health and disease: unraveling novel mechanisms of selective secretion. Allergy 2013; 68 (3): 274–84.
12. Fahy JV. Eosinophilic and neutrophilic inflammation in asthma: insights fr om clinical studies. Proc Am Thorac Soc 2009; 6 (3): 256–9.
13. Duncan CJ, Lawrie A, Blaylock MG et al. Reduced eosinophil apoptosis in induced sputum correlates with asthma severity. Eur Respir J 2003; 22: 484–90.
14. Kupczyk M, ten Brinke A, Sterk P et al. Frequent exacerbators – a distinct phenotype of severe asthma. Clin Experim Allergy 2013; 44: 212–21.
15. Schleich FN, Manise M, Sele J et al. Distribution of sputum cellular phenotype in a large asthma cohort: predicting factors for eosinophilic vs neutrophilic inflammation. BMC Pulm Med 2013; 13: 11.
16. Moore WC, Meyers DA, Wenzel SE 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.
17. Haldar P, Pavord ID, Shaw DE et al. Cluster analysis and clinical asthma phenotypes. Am J Respir Crit Care Med 2008; 178: 218–24.
18. Siroux V, Basagana X, Boudier A et al. Identifying adult asthma phenotypes using a clustering approach. Eur Respir J 2011; 38: 310–7.
19. Chung KF, Bel EH, Wenzel SE. Difficult-to-Treat Severe Asthma. Eur Respir Soc Monograph 2011; 51: 310.
20. Shaw D, Sousa A, Fowler S et al. Clinical and inflammatory characteristics of the European U-BIOPRED adult severe asthma cohort. Eur Respir J 2015; 46: 1308–21.
21. Trevor JL, Deshane JS. Refractory asthma: mechanisms, targets, and therapy. Allergy 2014; 69: 817–27.
22. Kuhl K, Hanania NA. Targeting IgE in asthma. Curr Opin Pulm Med 2012; 18: 1–5.
23. Walker S, Monteil M, Phelan K et al. Anti-IgE for chronic asthma in adults and children. Cochrane Database Syst Rev 2006; 2: CD003559.
24. Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Efficacy and safety of subcutaneous omalizumab vs placebo as add-on therapy to corticosteroids for children and adults with asthma: a systematic review. Chest 2011; 139 (1): 28–35.
25. Normansell R, Walker S, Milan S et al. Omalizumab for asthma in adults and children. Cochrane Database Syst Rev 2014; 1: CD003559.
26. Brusselle G, Michils A, Louis R et al. “Real-life” effectiveness of omalizumab in patients with severe persistent allergic asthma: the PERSIST study. Resp Med 2009; 103: 1633–42.
27. Braunsthl GJ, Chlumsky J, Peachey G, Chen CW. Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real-world setting. Allergy Asthma Clin Immunol 2013; 9: 47.
28. Chuchalin A.G., Pashkova T.L., Osipova G.L., Suchkova Iu.B. Otsenka effektivnosti i bezopasnosti omalizumaba v kompleksnoi terapii bol'nykh s tiazheloi nekontroliruemoi atopicheskoi bronkhial'noi astmoi v techenie 12 mesiatsev nabliudeniia. Pul'monologiia. 2009; 3: 75–80. [in Russian]
29. Salvin RG, Feroli C, Tannenbaum SJ et al. Asthma symptom re-emergence after omalizumab withdrawal correlates well with increasing pharmacokinetic concentations. J Allergy Clin Immunol 2009; 123: 107–13.
30. Molimard M, Mala L, Bourdeix I, Le Gros V. Observation study in severe asthmatic patients after discontinuation of omalizumab for good asthma control. Respir Med 2014; 108: 571–6.
31. Bousquet J, Rabe K, Humbert M et al. Predicting and evaluating responce to omalizumab in patients with severe allergic asthma. Respir Med 2007; 101: 1483–92.
32. Wahn U, Martin C, Freeman P et al. Relationship between pretreatment specific IgE and the responce to omalizumab therapy. Allergy 2009; 64: 1780–7.
33. Hanania NA, Wenzel S, Rosen K et al. Exploring the effect of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med 2013; 187: 804–11.
34. Massanari M, Holgate ST, Busse WW et al. Effect of omalizumab on peripheral blood eosinophilia in allergic asthma. Respir Med 2010; 104 (2): 188–96.
35. Djukanović R, Wilson SJ, Kraft M et al. Effects of treatment with anti-immunoglobulin E antibody omalizumab on airway inflammation in allergic asthma. Am J Respir Crit Care Med 2004; 170 (6): 583–93.
36. Instruktsiia k primeneniiu preparata Ksolar. [in Russian]
37. Luijk B, Lindemans C, Kanters D et al. Gradual increase in priming of human eosinophils during extravasation from peripheral blood to the airways in response to allergen challenge. J Allergy Clin Immunol 2005; 115: 997–1003
38. Kouro T, Takatsu T. IL-5- and eosinophil-mediated inflammation: from discovery to therapy. Int Immunol 2009; 21 (12): 1303–9.
39. Flood-Page P, Menzies-Gow A, Phipps S et al. Anti-IL-5 treatment reduces deposition of ECM proteins in the bronchial subepitelial basement membrance of mild atopic astmatics. J Clin Invest 2003; 112: 1029–36.
40. Menzies-Gow A, Flood-Page P, Sehmi R et al. Anti-IL-5 (mepolizumab) therapy induces bone marrow eosinophil maturational arrest and decreases eosinophil progenitors in the bronchial mucosa of atopic asyhmatics. J Allergy Clin Immunol 2003; 111: 714–9.
41. Leckie MJ, ten Brinke A, Khan J et al. Effects of an interleukin-5 blocking monoclonal antibody on eosinophils, airways hyperresponsiveness, and the late asthmatic responce. Lancet 2000; 356: 2144–8.
42. Nair P, Pizzichini M, Kjarsgaard M et al. Mepolizumab for prednison-dependent asthma with sputum eosinophilia. N Engl J Med 2009; 360: 985–93.
43. Haldar P, Brighting C, Hargardon B et al. Mepolizumab and exacerbations of refractory eosinophilic asthma. N Engl J Med 2009; 360: 973–84.
44. Pavord ID, Korn S, Howarth P et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet 2012; 380: 651–9.
45. Ortega HG, Liu MC, Pavord ID et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371: 1198–207.
46. Bel EH, Wenzel SE, Thompson PJ et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014; 371: 1189–97.
47. Haldar P, Brighting C, Singapuri A et al. Outcomes after cessation of mepolizumab therapy in severe eosinophilic asthma: a 12-month follow-up analysis. J Allergy Clin Immunol 2014; 133: 921–3.
48. Castro M, Mathur S, Hargreave F et al. Reslizumab for poorlycontrolled, eosinophilic asthma: a randomized, placebo-controlledstudy. Am J Respir Crit Care Med 2011; 184: 1125–32.
49. Castro M, Zangrilli J, Wechlser ME et al. Reslizumab foe inadequately controlled asthma with elevated blood eosinophil counts: results from two multicenter, parallel, double-blind, randomized, placebo-controlled, phase 3 trials. Lancet Respir Med 2015; 3: 355–66.
50. Kolbeck R, Kozhich A, Koike M 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 (1): 1344–53.
51. Busse WW, Katial R, Gossage D et al. Safety profile, pharmacokinetics, and biologic activity of MEDI-563, an anti-IL-5 receptor antibody, in a phase I study of subjects with mild asthma. J Allergy Clin Immunol 2010; 125: 1237–44.
52. Laviolette M, Gossage DL, Gaureau G et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol 2013; 132: 1086–96.
53. Castro M, Wenzel SE, Bleecker ER et al. Benralizumab, an anti-interleukin 5 receptor a monoclonal antibody, versus placebo for uncontrolled eosinophilic asthma: a phase 2b randomised dose-ranging study. Lancet Respir Med 2014; 2 (11): 879–90.
54. Oh CK, Geba GP, Molfino N et al. Investigational therapeutics targeting the IL-4/IL-13/STAT-6 pathway for the treatment of asthma. Eur Respir Rev 2010; 19: 46–54.
55. Jia G, Erickson RW, Choy D et al. Periostin is a systemic biomarker of eosinophilic airway inflammation in asthmatic patients J Allergy Clin Immunol 2012; 130: 647–54.
56. Corren J, Lemanske RF, Hanania NA et al. Lebrikizumab treatment in adults with asthma. N Engl J Med 2011; 365 (12): 1088–98.
57. Scheerens H, Arron JR, Su Z et al. Predictive and pharmacodynamic biomarkers of interleukin-13 blockade: effect of lebrikizumab on late phase asthmatic response to allergen challenge. J Allergy Clin Immunol 2011; 127 (Suppl. 2): AB164.
58. Hanania NA, Noonan MJ, Corren J et al. Efficacy and safety of lebrikizumab in severe uncontrolled asthma: results from the lute and verse phase II randomized, double-blind, placebo-controlled trials. J Allergy Clin Immunol 2014; 133 (2): AB402.
59. Blanchard C, Mishra A, Sito-Hakel H et al. Inhibition of human interleukin-13-induced respiratory and esophageal inflammation by antihuman interleukin-13 antibody (CAT-354). Clin Exp Allergy 2005; 35: 1096–103.
60. Piper E, Brightling C, Niven R et al. A phase II placebo-controlled study of tralocinumab in moderate-to-severe asthma. Eur Respir J 2013; 41: 330–8.
61. Brightling C, Chanez P, Leigh R, O’Byrne P et al. 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 (9): 692–701.
62. Wenzel S, Ford L, Pearlman D et al. Dupilumab in Persistent Asthma with Elevated Eosinophil Levels. N Engl J Med 2013; 368 (26): 2455–66.
63. 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 b2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet 2016; 388: 31–44.
64. Wang YH, Wills-Karp M. The potential role of interleukin-17 in severe asthma. Curr Allergy Asthma Rep 2011; 11 (5): 388–94.
65. Kudo M, Melton AC, Chen C et al. IL-17A produced by alphabeta T cells drives airway hyperresponsiveness in mice and enhances mouse and human airway smooth muscle contraction. Nat Med 2012; 18 (4): 547–54.
66. Min Xie, Wenzel SE. A global perspective in asthma: from phenotype to endotype. Chinese Med J 2013; 126 (1): 166–74.
67. Chesne J, Braza F, Mahay G et al. IL-17 in Severe Asthma. Wh ere Do We Stand? Am J Respir and Crit Care Med 2014; 190 (10): 1094–101.
68. Busse WW, Holgate S, Kerwin E et al. Randomized, double-blinde, placebo-controlled study of brodalumab, a human anti-IL17 receptor monoclonal antibody, in moderate to severe asthma. Am J Respir Crit Care Med 2013; 188: 1294–302.
69. Newcomb DC, Peebles RS Jr. Th17-mediated inflammation in asthma. Curr Opin Immunol 2013; 25: 755–60.
70. Morishima Y, Ano S, Ichii Y et al. Th17-associated cytokines as a therapeutic target for steroid-insensitive asthma. Clin Dev Immunol 2013; 609: 395.
71. McCracken J, Tripple J, Calhoun WJ. Biologic therapy in the management of asthma. Allergy Clin Immunol 2016; 16 (4): 375–82.
2. Chuchalin AG, Khaltaev N, Аntonov N. Chronic respiratory diseases and risk factors in 12 regions of the Russian Federation. Int J COPD 2014; 9: 963–74.
3. Национальная программа «Бронхиальная астма у детей. Стратегия лечения и профилактика». IV изд. М., 2012. / Natsional'naia programma «Bronkhial'naia astma u detei. Strategiia lecheniia i profilaktika». IV izd. M., 2012. [in Russian]
4. Bousqet J, Mantzouranis E, Cruz AA et al. Uniform definition of asthma severity, control and exacerbations: document presented for the World Health Organization Consultation on Severe Asthma. J Allergy Clin Immunol 2010; 126: 926–38.
5. Chung KF, Wenzel S, Brozek J et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43: 343–73.
6. Locksley RM. Asthma and allergic inflammation. Cell 2010; 140 (6): 777–83.
7. Li BW, Hendriks RW: Group 2 innate lymphoid cells in lung inflammation. Immunology 2013; 140 (3): 281–7.
8. Kita H. Eosinophils: multifunctional and distinctive properties. Int Arch Allergy Immunol 2013; 161 (Suppl. 2): 3–9.
9. Bousquet J, Chanez P, Lacoste JY et al. Eosinophilic inflammation in asthma. N Engl J Med 1990; 323: 1033–9.
10. Blanchard C, Rothenberg ME. Biology of the eosinophil. Adv Immunol 2009; 101: 81–121.
11. Melo RC, Liu L, Xenakis JJ et al. Eosinophil-derived cytokines in health and disease: unraveling novel mechanisms of selective secretion. Allergy 2013; 68 (3): 274–84.
12. Fahy JV. Eosinophilic and neutrophilic inflammation in asthma: insights fr om clinical studies. Proc Am Thorac Soc 2009; 6 (3): 256–9.
13. Duncan CJ, Lawrie A, Blaylock MG et al. Reduced eosinophil apoptosis in induced sputum correlates with asthma severity. Eur Respir J 2003; 22: 484–90.
14. Kupczyk M, ten Brinke A, Sterk P et al. Frequent exacerbators – a distinct phenotype of severe asthma. Clin Experim Allergy 2013; 44: 212–21.
15. Schleich FN, Manise M, Sele J et al. Distribution of sputum cellular phenotype in a large asthma cohort: predicting factors for eosinophilic vs neutrophilic inflammation. BMC Pulm Med 2013; 13: 11.
16. Moore WC, Meyers DA, Wenzel SE 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.
17. Haldar P, Pavord ID, Shaw DE et al. Cluster analysis and clinical asthma phenotypes. Am J Respir Crit Care Med 2008; 178: 218–24.
18. Siroux V, Basagana X, Boudier A et al. Identifying adult asthma phenotypes using a clustering approach. Eur Respir J 2011; 38: 310–7.
19. Chung KF, Bel EH, Wenzel SE. Difficult-to-Treat Severe Asthma. Eur Respir Soc Monograph 2011; 51: 310.
20. Shaw D, Sousa A, Fowler S et al. Clinical and inflammatory characteristics of the European U-BIOPRED adult severe asthma cohort. Eur Respir J 2015; 46: 1308–21.
21. Trevor JL, Deshane JS. Refractory asthma: mechanisms, targets, and therapy. Allergy 2014; 69: 817–27.
22. Kuhl K, Hanania NA. Targeting IgE in asthma. Curr Opin Pulm Med 2012; 18: 1–5.
23. Walker S, Monteil M, Phelan K et al. Anti-IgE for chronic asthma in adults and children. Cochrane Database Syst Rev 2006; 2: CD003559.
24. Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Efficacy and safety of subcutaneous omalizumab vs placebo as add-on therapy to corticosteroids for children and adults with asthma: a systematic review. Chest 2011; 139 (1): 28–35.
25. Normansell R, Walker S, Milan S et al. Omalizumab for asthma in adults and children. Cochrane Database Syst Rev 2014; 1: CD003559.
26. Brusselle G, Michils A, Louis R et al. “Real-life” effectiveness of omalizumab in patients with severe persistent allergic asthma: the PERSIST study. Resp Med 2009; 103: 1633–42.
27. Braunsthl GJ, Chlumsky J, Peachey G, Chen CW. Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real-world setting. Allergy Asthma Clin Immunol 2013; 9: 47.
28. Чучалин А.Г., Пашкова Т.Л., Осипова Г.Л., Сучкова Ю.Б. Оценка эффективности и безопасности омализумаба в комплексной терапии больных с тяжелой неконтролируемой атопической бронхиальной астмой в течение 12 месяцев наблюдения. Пульмонология. 2009; 3: 75–80. / Chuchalin A.G., Pashkova T.L., Osipova G.L., Suchkova Iu.B. Otsenka effektivnosti i bezopasnosti omalizumaba v kompleksnoi terapii bol'nykh s tiazheloi nekontroliruemoi atopicheskoi bronkhial'noi astmoi v techenie 12 mesiatsev nabliudeniia. Pul'monologiia. 2009; 3: 75–80. [in Russian]
29. Salvin RG, Feroli C, Tannenbaum SJ et al. Asthma symptom re-emergence after omalizumab withdrawal correlates well with increasing pharmacokinetic concentations. J Allergy Clin Immunol 2009; 123: 107–13.
30. Molimard M, Mala L, Bourdeix I, Le Gros V. Observation study in severe asthmatic patients after discontinuation of omalizumab for good asthma control. Respir Med 2014; 108: 571–6.
31. Bousquet J, Rabe K, Humbert M et al. Predicting and evaluating responce to omalizumab in patients with severe allergic asthma. Respir Med 2007; 101: 1483–92.
32. Wahn U, Martin C, Freeman P et al. Relationship between pretreatment specific IgE and the responce to omalizumab therapy. Allergy 2009; 64: 1780–7.
33. Hanania NA, Wenzel S, Rosen K et al. Exploring the effect of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med 2013; 187: 804–11.
34. Massanari M, Holgate ST, Busse WW et al. Effect of omalizumab on peripheral blood eosinophilia in allergic asthma. Respir Med 2010; 104 (2): 188–96.
35. Djukanović R, Wilson SJ, Kraft M et al. Effects of treatment with anti-immunoglobulin E antibody omalizumab on airway inflammation in allergic asthma. Am J Respir Crit Care Med 2004; 170 (6): 583–93.
36. Инструкция к применению препарата Ксолар. / Instruktsiia k primeneniiu preparata Ksolar. [in Russian]
37. Luijk B, Lindemans C, Kanters D et al. Gradual increase in priming of human eosinophils during extravasation from peripheral blood to the airways in response to allergen challenge. J Allergy Clin Immunol 2005; 115: 997–1003
38. Kouro T, Takatsu T. IL-5- and eosinophil-mediated inflammation: from discovery to therapy. Int Immunol 2009; 21 (12): 1303–9.
39. Flood-Page P, Menzies-Gow A, Phipps S et al. Anti-IL-5 treatment reduces deposition of ECM proteins in the bronchial subepitelial basement membrance of mild atopic astmatics. J Clin Invest 2003; 112: 1029–36.
40. Menzies-Gow A, Flood-Page P, Sehmi R et al. Anti-IL-5 (mepolizumab) therapy induces bone marrow eosinophil maturational arrest and decreases eosinophil progenitors in the bronchial mucosa of atopic asyhmatics. J Allergy Clin Immunol 2003; 111: 714–9.
41. Leckie MJ, ten Brinke A, Khan J et al. Effects of an interleukin-5 blocking monoclonal antibody on eosinophils, airways hyperresponsiveness, and the late asthmatic responce. Lancet 2000; 356: 2144–8.
42. Nair P, Pizzichini M, Kjarsgaard M et al. Mepolizumab for prednison-dependent asthma with sputum eosinophilia. N Engl J Med 2009; 360: 985–93.
43. Haldar P, Brighting C, Hargardon B et al. Mepolizumab and exacerbations of refractory eosinophilic asthma. N Engl J Med 2009; 360: 973–84.
44. Pavord ID, Korn S, Howarth P et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet 2012; 380: 651–9.
45. Ortega HG, Liu MC, Pavord ID et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371: 1198–207.
46. Bel EH, Wenzel SE, Thompson PJ et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014; 371: 1189–97.
47. Haldar P, Brighting C, Singapuri A et al. Outcomes after cessation of mepolizumab therapy in severe eosinophilic asthma: a 12-month follow-up analysis. J Allergy Clin Immunol 2014; 133: 921–3.
48. Castro M, Mathur S, Hargreave F et al. Reslizumab for poorlycontrolled, eosinophilic asthma: a randomized, placebo-controlledstudy. Am J Respir Crit Care Med 2011; 184: 1125–32.
49. Castro M, Zangrilli J, Wechlser ME et al. Reslizumab foe inadequately controlled asthma with elevated blood eosinophil counts: results from two multicenter, parallel, double-blind, randomized, placebo-controlled, phase 3 trials. Lancet Respir Med 2015; 3: 355–66.
50. Kolbeck R, Kozhich A, Koike M 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 (1): 1344–53.
51. Busse WW, Katial R, Gossage D et al. Safety profile, pharmacokinetics, and biologic activity of MEDI-563, an anti-IL-5 receptor antibody, in a phase I study of subjects with mild asthma. J Allergy Clin Immunol 2010; 125: 1237–44.
52. Laviolette M, Gossage DL, Gaureau G et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol 2013; 132: 1086–96.
53. Castro M, Wenzel SE, Bleecker ER et al. Benralizumab, an anti-interleukin 5 receptor a monoclonal antibody, versus placebo for uncontrolled eosinophilic asthma: a phase 2b randomised dose-ranging study. Lancet Respir Med 2014; 2 (11): 879–90.
54. Oh CK, Geba GP, Molfino N et al. Investigational therapeutics targeting the IL-4/IL-13/STAT-6 pathway for the treatment of asthma. Eur Respir Rev 2010; 19: 46–54.
55. Jia G, Erickson RW, Choy D et al. Periostin is a systemic biomarker of eosinophilic airway inflammation in asthmatic patients J Allergy Clin Immunol 2012; 130: 647–54.
56. Corren J, Lemanske RF, Hanania NA et al. Lebrikizumab treatment in adults with asthma. N Engl J Med 2011; 365 (12): 1088–98.
57. Scheerens H, Arron JR, Su Z et al. Predictive and pharmacodynamic biomarkers of interleukin-13 blockade: effect of lebrikizumab on late phase asthmatic response to allergen challenge. J Allergy Clin Immunol 2011; 127 (Suppl. 2): AB164.
58. Hanania NA, Noonan MJ, Corren J et al. Efficacy and safety of lebrikizumab in severe uncontrolled asthma: results from the lute and verse phase II randomized, double-blind, placebo-controlled trials. J Allergy Clin Immunol 2014; 133 (2): AB402.
59. Blanchard C, Mishra A, Sito-Hakel H et al. Inhibition of human interleukin-13-induced respiratory and esophageal inflammation by antihuman interleukin-13 antibody (CAT-354). Clin Exp Allergy 2005; 35: 1096–103.
60. Piper E, Brightling C, Niven R et al. A phase II placebo-controlled study of tralocinumab in moderate-to-severe asthma. Eur Respir J 2013; 41: 330–8.
61. Brightling C, Chanez P, Leigh R, O’Byrne P et al. 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 (9): 692–701.
62. Wenzel S, Ford L, Pearlman D et al. Dupilumab in Persistent Asthma with Elevated Eosinophil Levels. N Engl J Med 2013; 368 (26): 2455–66.
63. 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 b2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet 2016; 388: 31–44.
64. Wang YH, Wills-Karp M. The potential role of interleukin-17 in severe asthma. Curr Allergy Asthma Rep 2011; 11 (5): 388–94.
65. Kudo M, Melton AC, Chen C et al. IL-17A produced by alphabeta T cells drives airway hyperresponsiveness in mice and enhances mouse and human airway smooth muscle contraction. Nat Med 2012; 18 (4): 547–54.
66. Min Xie, Wenzel SE. A global perspective in asthma: from phenotype to endotype. Chinese Med J 2013; 126 (1): 166–74.
67. Chesne J, Braza F, Mahay G et al. IL-17 in Severe Asthma. Wh ere Do We Stand? Am J Respir and Crit Care Med 2014; 190 (10): 1094–101.
68. Busse WW, Holgate S, Kerwin E et al. Randomized, double-blinde, placebo-controlled study of brodalumab, a human anti-IL17 receptor monoclonal antibody, in moderate to severe asthma. Am J Respir Crit Care Med 2013; 188: 1294–302.
69. Newcomb DC, Peebles RS Jr. Th17-mediated inflammation in asthma. Curr Opin Immunol 2013; 25: 755–60.
70. Morishima Y, Ano S, Ichii Y et al. Th17-associated cytokines as a therapeutic target for steroid-insensitive asthma. Clin Dev Immunol 2013; 609: 395.
71. McCracken J, Tripple J, Calhoun WJ. Biologic therapy in the management of asthma. Allergy Clin Immunol 2016; 16 (4): 375–82.
________________________________________________
2. Chuchalin AG, Khaltaev N, Аntonov N. Chronic respiratory diseases and risk factors in 12 regions of the Russian Federation. Int J COPD 2014; 9: 963–74.
3. Natsional'naia programma «Bronkhial'naia astma u detei. Strategiia lecheniia i profilaktika». IV izd. M., 2012. [in Russian]
4. Bousqet J, Mantzouranis E, Cruz AA et al. Uniform definition of asthma severity, control and exacerbations: document presented for the World Health Organization Consultation on Severe Asthma. J Allergy Clin Immunol 2010; 126: 926–38.
5. Chung KF, Wenzel S, Brozek J et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43: 343–73.
6. Locksley RM. Asthma and allergic inflammation. Cell 2010; 140 (6): 777–83.
7. Li BW, Hendriks RW: Group 2 innate lymphoid cells in lung inflammation. Immunology 2013; 140 (3): 281–7.
8. Kita H. Eosinophils: multifunctional and distinctive properties. Int Arch Allergy Immunol 2013; 161 (Suppl. 2): 3–9.
9. Bousquet J, Chanez P, Lacoste JY et al. Eosinophilic inflammation in asthma. N Engl J Med 1990; 323: 1033–9.
10. Blanchard C, Rothenberg ME. Biology of the eosinophil. Adv Immunol 2009; 101: 81–121.
11. Melo RC, Liu L, Xenakis JJ et al. Eosinophil-derived cytokines in health and disease: unraveling novel mechanisms of selective secretion. Allergy 2013; 68 (3): 274–84.
12. Fahy JV. Eosinophilic and neutrophilic inflammation in asthma: insights fr om clinical studies. Proc Am Thorac Soc 2009; 6 (3): 256–9.
13. Duncan CJ, Lawrie A, Blaylock MG et al. Reduced eosinophil apoptosis in induced sputum correlates with asthma severity. Eur Respir J 2003; 22: 484–90.
14. Kupczyk M, ten Brinke A, Sterk P et al. Frequent exacerbators – a distinct phenotype of severe asthma. Clin Experim Allergy 2013; 44: 212–21.
15. Schleich FN, Manise M, Sele J et al. Distribution of sputum cellular phenotype in a large asthma cohort: predicting factors for eosinophilic vs neutrophilic inflammation. BMC Pulm Med 2013; 13: 11.
16. Moore WC, Meyers DA, Wenzel SE 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.
17. Haldar P, Pavord ID, Shaw DE et al. Cluster analysis and clinical asthma phenotypes. Am J Respir Crit Care Med 2008; 178: 218–24.
18. Siroux V, Basagana X, Boudier A et al. Identifying adult asthma phenotypes using a clustering approach. Eur Respir J 2011; 38: 310–7.
19. Chung KF, Bel EH, Wenzel SE. Difficult-to-Treat Severe Asthma. Eur Respir Soc Monograph 2011; 51: 310.
20. Shaw D, Sousa A, Fowler S et al. Clinical and inflammatory characteristics of the European U-BIOPRED adult severe asthma cohort. Eur Respir J 2015; 46: 1308–21.
21. Trevor JL, Deshane JS. Refractory asthma: mechanisms, targets, and therapy. Allergy 2014; 69: 817–27.
22. Kuhl K, Hanania NA. Targeting IgE in asthma. Curr Opin Pulm Med 2012; 18: 1–5.
23. Walker S, Monteil M, Phelan K et al. Anti-IgE for chronic asthma in adults and children. Cochrane Database Syst Rev 2006; 2: CD003559.
24. Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Efficacy and safety of subcutaneous omalizumab vs placebo as add-on therapy to corticosteroids for children and adults with asthma: a systematic review. Chest 2011; 139 (1): 28–35.
25. Normansell R, Walker S, Milan S et al. Omalizumab for asthma in adults and children. Cochrane Database Syst Rev 2014; 1: CD003559.
26. Brusselle G, Michils A, Louis R et al. “Real-life” effectiveness of omalizumab in patients with severe persistent allergic asthma: the PERSIST study. Resp Med 2009; 103: 1633–42.
27. Braunsthl GJ, Chlumsky J, Peachey G, Chen CW. Reduction in oral corticosteroid use in patients receiving omalizumab for allergic asthma in the real-world setting. Allergy Asthma Clin Immunol 2013; 9: 47.
28. Chuchalin A.G., Pashkova T.L., Osipova G.L., Suchkova Iu.B. Otsenka effektivnosti i bezopasnosti omalizumaba v kompleksnoi terapii bol'nykh s tiazheloi nekontroliruemoi atopicheskoi bronkhial'noi astmoi v techenie 12 mesiatsev nabliudeniia. Pul'monologiia. 2009; 3: 75–80. [in Russian]
29. Salvin RG, Feroli C, Tannenbaum SJ et al. Asthma symptom re-emergence after omalizumab withdrawal correlates well with increasing pharmacokinetic concentations. J Allergy Clin Immunol 2009; 123: 107–13.
30. Molimard M, Mala L, Bourdeix I, Le Gros V. Observation study in severe asthmatic patients after discontinuation of omalizumab for good asthma control. Respir Med 2014; 108: 571–6.
31. Bousquet J, Rabe K, Humbert M et al. Predicting and evaluating responce to omalizumab in patients with severe allergic asthma. Respir Med 2007; 101: 1483–92.
32. Wahn U, Martin C, Freeman P et al. Relationship between pretreatment specific IgE and the responce to omalizumab therapy. Allergy 2009; 64: 1780–7.
33. Hanania NA, Wenzel S, Rosen K et al. Exploring the effect of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am J Respir Crit Care Med 2013; 187: 804–11.
34. Massanari M, Holgate ST, Busse WW et al. Effect of omalizumab on peripheral blood eosinophilia in allergic asthma. Respir Med 2010; 104 (2): 188–96.
35. Djukanović R, Wilson SJ, Kraft M et al. Effects of treatment with anti-immunoglobulin E antibody omalizumab on airway inflammation in allergic asthma. Am J Respir Crit Care Med 2004; 170 (6): 583–93.
36. Instruktsiia k primeneniiu preparata Ksolar. [in Russian]
37. Luijk B, Lindemans C, Kanters D et al. Gradual increase in priming of human eosinophils during extravasation from peripheral blood to the airways in response to allergen challenge. J Allergy Clin Immunol 2005; 115: 997–1003
38. Kouro T, Takatsu T. IL-5- and eosinophil-mediated inflammation: from discovery to therapy. Int Immunol 2009; 21 (12): 1303–9.
39. Flood-Page P, Menzies-Gow A, Phipps S et al. Anti-IL-5 treatment reduces deposition of ECM proteins in the bronchial subepitelial basement membrance of mild atopic astmatics. J Clin Invest 2003; 112: 1029–36.
40. Menzies-Gow A, Flood-Page P, Sehmi R et al. Anti-IL-5 (mepolizumab) therapy induces bone marrow eosinophil maturational arrest and decreases eosinophil progenitors in the bronchial mucosa of atopic asyhmatics. J Allergy Clin Immunol 2003; 111: 714–9.
41. Leckie MJ, ten Brinke A, Khan J et al. Effects of an interleukin-5 blocking monoclonal antibody on eosinophils, airways hyperresponsiveness, and the late asthmatic responce. Lancet 2000; 356: 2144–8.
42. Nair P, Pizzichini M, Kjarsgaard M et al. Mepolizumab for prednison-dependent asthma with sputum eosinophilia. N Engl J Med 2009; 360: 985–93.
43. Haldar P, Brighting C, Hargardon B et al. Mepolizumab and exacerbations of refractory eosinophilic asthma. N Engl J Med 2009; 360: 973–84.
44. Pavord ID, Korn S, Howarth P et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet 2012; 380: 651–9.
45. Ortega HG, Liu MC, Pavord ID et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med 2014; 371: 1198–207.
46. Bel EH, Wenzel SE, Thompson PJ et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med 2014; 371: 1189–97.
47. Haldar P, Brighting C, Singapuri A et al. Outcomes after cessation of mepolizumab therapy in severe eosinophilic asthma: a 12-month follow-up analysis. J Allergy Clin Immunol 2014; 133: 921–3.
48. Castro M, Mathur S, Hargreave F et al. Reslizumab for poorlycontrolled, eosinophilic asthma: a randomized, placebo-controlledstudy. Am J Respir Crit Care Med 2011; 184: 1125–32.
49. Castro M, Zangrilli J, Wechlser ME et al. Reslizumab foe inadequately controlled asthma with elevated blood eosinophil counts: results from two multicenter, parallel, double-blind, randomized, placebo-controlled, phase 3 trials. Lancet Respir Med 2015; 3: 355–66.
50. Kolbeck R, Kozhich A, Koike M 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 (1): 1344–53.
51. Busse WW, Katial R, Gossage D et al. Safety profile, pharmacokinetics, and biologic activity of MEDI-563, an anti-IL-5 receptor antibody, in a phase I study of subjects with mild asthma. J Allergy Clin Immunol 2010; 125: 1237–44.
52. Laviolette M, Gossage DL, Gaureau G et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol 2013; 132: 1086–96.
53. Castro M, Wenzel SE, Bleecker ER et al. Benralizumab, an anti-interleukin 5 receptor a monoclonal antibody, versus placebo for uncontrolled eosinophilic asthma: a phase 2b randomised dose-ranging study. Lancet Respir Med 2014; 2 (11): 879–90.
54. Oh CK, Geba GP, Molfino N et al. Investigational therapeutics targeting the IL-4/IL-13/STAT-6 pathway for the treatment of asthma. Eur Respir Rev 2010; 19: 46–54.
55. Jia G, Erickson RW, Choy D et al. Periostin is a systemic biomarker of eosinophilic airway inflammation in asthmatic patients J Allergy Clin Immunol 2012; 130: 647–54.
56. Corren J, Lemanske RF, Hanania NA et al. Lebrikizumab treatment in adults with asthma. N Engl J Med 2011; 365 (12): 1088–98.
57. Scheerens H, Arron JR, Su Z et al. Predictive and pharmacodynamic biomarkers of interleukin-13 blockade: effect of lebrikizumab on late phase asthmatic response to allergen challenge. J Allergy Clin Immunol 2011; 127 (Suppl. 2): AB164.
58. Hanania NA, Noonan MJ, Corren J et al. Efficacy and safety of lebrikizumab in severe uncontrolled asthma: results from the lute and verse phase II randomized, double-blind, placebo-controlled trials. J Allergy Clin Immunol 2014; 133 (2): AB402.
59. Blanchard C, Mishra A, Sito-Hakel H et al. Inhibition of human interleukin-13-induced respiratory and esophageal inflammation by antihuman interleukin-13 antibody (CAT-354). Clin Exp Allergy 2005; 35: 1096–103.
60. Piper E, Brightling C, Niven R et al. A phase II placebo-controlled study of tralocinumab in moderate-to-severe asthma. Eur Respir J 2013; 41: 330–8.
61. Brightling C, Chanez P, Leigh R, O’Byrne P et al. 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 (9): 692–701.
62. Wenzel S, Ford L, Pearlman D et al. Dupilumab in Persistent Asthma with Elevated Eosinophil Levels. N Engl J Med 2013; 368 (26): 2455–66.
63. 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 b2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet 2016; 388: 31–44.
64. Wang YH, Wills-Karp M. The potential role of interleukin-17 in severe asthma. Curr Allergy Asthma Rep 2011; 11 (5): 388–94.
65. Kudo M, Melton AC, Chen C et al. IL-17A produced by alphabeta T cells drives airway hyperresponsiveness in mice and enhances mouse and human airway smooth muscle contraction. Nat Med 2012; 18 (4): 547–54.
66. Min Xie, Wenzel SE. A global perspective in asthma: from phenotype to endotype. Chinese Med J 2013; 126 (1): 166–74.
67. Chesne J, Braza F, Mahay G et al. IL-17 in Severe Asthma. Wh ere Do We Stand? Am J Respir and Crit Care Med 2014; 190 (10): 1094–101.
68. Busse WW, Holgate S, Kerwin E et al. Randomized, double-blinde, placebo-controlled study of brodalumab, a human anti-IL17 receptor monoclonal antibody, in moderate to severe asthma. Am J Respir Crit Care Med 2013; 188: 1294–302.
69. Newcomb DC, Peebles RS Jr. Th17-mediated inflammation in asthma. Curr Opin Immunol 2013; 25: 755–60.
70. Morishima Y, Ano S, Ichii Y et al. Th17-associated cytokines as a therapeutic target for steroid-insensitive asthma. Clin Dev Immunol 2013; 609: 395.
71. McCracken J, Tripple J, Calhoun WJ. Biologic therapy in the management of asthma. Allergy Clin Immunol 2016; 16 (4): 375–82.
Авторы
Н.М.Ненашева
ФГБОУ ДПО Российская медицинская академия непрерывного профессионального образования Минздрава России. 125993, Россия, Москва, ул. Баррикадная, д. 2/1
1444031@gmail.com
ФГБОУ ДПО Российская медицинская академия непрерывного профессионального образования Минздрава России. 125993, Россия, Москва, ул. Баррикадная, д. 2/1
1444031@gmail.com
________________________________________________
N.M.Nenasheva
Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation. 125993, Russian Federation, Moscow, ul. Barrikadnaia, d. 2/1
1444031@gmail.com
Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation. 125993, Russian Federation, Moscow, ul. Barrikadnaia, d. 2/1
1444031@gmail.com
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.