Algorithm of biophenotyping and choice of medication for targeted therapy of severe uncontrolled asthma with eosinophilic type of airways inflammation



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Abstract

The article is based on the resolution of the Expert Council, including experts from Russian Association of Allergists and Clinical Immunologists (RAACI) and Russian Respiratory Society (RRS) dated November 20, 2016, and the review of clinical studies results and publications on the biomarker-based diagnosis and biological treatment of severe uncontrolled asthma. The aim of this work is to develop a phenotype-oriented algorithm of diagnostics and treatment of severe asthma, supported by the biomarker testing for subsequent selection of appropriate immunobiological treatment. The article constitutes the summary of results of clinical studies and expert opinions on the treatment of asthma in patients who do not achieve disease control with standard treatment regimens including high doses of inhaled corticosteroids in the combination with long-acting beta-agonists, tiotropium, and medications from other pharmacological groups according to Russian Respiratory Society (2016) and GINA (2016-2017) guidelines. The article summarizes the results of international randomized clinical studies performed to assess safety and efficacy of new class of biological treatments, monoclonal antibodies acting against major cytokines that are responsible for inflammation, in patients with severe asthma, including a new anti-IL-5 antibody, reslizumab (Cinqaero).

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About the authors

N I Ilina

National research center «Institute of Immunology» Federal medical-biological agency

N M Nenasheva

Russian Medical Academy for Continuous Professional Education

Email: 1444031@gmail.com

S N Avdeev

National research center «Institute of Pulmonology» Federal medical-biological agency

Z R Aisanov

National research center «Institute of Pulmonology» Federal medical-biological agency

V V Arkhipov

Russian Medical Academy for Continuous Professional Education

A A Vizel

Kazan state medical university

A V Emelyanov

North-Western State Medical University named after I.I. Mechnikov

N P Knyazheskaya

The Pirogov Russian National Research Medical University

O M Kurbacheva

National research center «Institute of Immunology» Federal medical-biological agency

I V Leshchenko

Ural State Medical University

G L Osipova

National research center «Institute of Pulmonology» Federal medical-biological agency

E A Styrt

Russian Medical Academy for Continuous Professional Education

O N Titova

The 1st Saint Petersburg Pavlov state medical university, Scientific research institute of pulmonology

R S Fassakhov

The Kazan Federal University

S V Fedosenko

«Teva» LLC

References

  1. Winer R., Qin X., Harrington T., Moorman J., Zahran H. Asthma incidence among children and adults: findings from the Behavioral Risk Factor Surveillance system asthma callback survey-United States, 2006-2008. Journal of Asthma. 2012, v. 49, p. 16-22.
  2. Омельяновский В.В. Социально-экономическое бремя бронхиальной астмы и хронической обструктивной болезни легких в Российской Федерации. Отчет по исследованию за 2008-2009 годы. M., 2010, с. 3-82.
  3. Chuchalin A.G., Khaltaev N., Аntonov N. Chronic respiratory diseases and risk factors in 12 regions of the Russian Federation. Int. J. COPD. 2014, v. 9, p. 963-974.
  4. Национальная программа «Бронхиальная астма у детей. Стратегия лечения и профилактика». IV изд. M., 2012, 109 с.
  5. Bousqet J., Mantzouranis E., Cruz A.A. 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, v. 126, p. 926-938.
  6. Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2017. Available from: http://www.ginasthma.org.
  7. Ненашева H.M. Биологическая терапия бронхиальной астмы: настоящее и будущее. Consilium Medicum. 2016, № 18, с. 30-38.
  8. Peters S.P., Jones S.P., Haselkorn S.P. et al. Real-World Evaluation of Asthma Control and Treatment (REACT): Findings from a National Web-Based Survey. J. Allergy Clin. Immunol. 2007, v. 119, p. 1454-1461.
  9. Price D., Fletcher M., van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. Primary Care Respiratory Medicine. 2014, v. 24, doi: 10.1038/npjpcrm.2014.9.
  10. Casciano J., Krishnan J., Dotiwala Z. et al. Cost-Consequence of Elevated Versus Normal EOS among Patients that Followed Medication Use Recommended by Guidelines for Severe Asthma. ISPOR 20th Annual International Meeting, 2015.
  11. Архипов В.В., Григорьева Е.В., Гавришина Е.В. Контроль над бронхиальной астмой в России: результаты многоцентрового наблюдательного исследования НИКА. Пульмонология. 2011, № 6, с. 87-93. doi: 10.18093/0869-0189-2011-0-6-87-93.
  12. Hekking P.P., Wener R.R., Amelink M. et al. The prevalence of severe refractory asthma. J Allergy Clin. Immunol. 2015, v. 135, p. 896-902.
  13. Chung K.F. Asthma phenotyping: a necessity for improved therapeutic precision and new targeted therapies. J. Intern. Med. 2016, v. 279, p. 192-204.
  14. Jarjour N.N., Erzurum S.C., Bleecker E.R. et al. Severe Asthma. Lessons Learned from the National Heart, Lung, and Blood Institute Severe Asthma Research Program. Am. J. Respir. Crit. Care Med. 2012, v. 15, p. 356-362.
  15. Li B.W., Hendriks R.W. Group 2 innate lymphoid cells in lung inflammation. Immunology. 2013, v. 140, p. 281-287.
  16. Schleich F., Brusselle G., Louis R. et al. Heterogeneity of phenotypes in severe asthmatics. The Belgian Severe Asthma Registry (BSAR). Respiratory Medicine. 2014, v. 108, p. 1723-1732.
  17. Simpson J.L., Scott R., Boyle M.J., Gibson P.G. Inflammatory subtypes in asthma: assessment and identification using induced sputum. Respirology. 2006, v. 11, p. 54-61.
  18. Курбачева О.М., Павлова К.С. Фенотипы и эндотипы бронхиальной астмы: от патогенеза и клинической картины к выбору терапии. Рос. Аллергол. Журн. 2013, № 1, с. 15-24.
  19. Сергеева Г.Р., Емельянов А.В. Коровина О.В. и соавт. Тяжелая бронхиальная астма: характеристика пациентов в клинической практике. Терапевтический архив. 2015, № 12, с. 22-27.
  20. Kita H. Eosinophils: multifunctional and distinctive properties. Int. Arch. Allergy Immunol. 2013, v. 161, p. 3-9.
  21. Bradding P. Asthma: Eosinophil Disease, Mast Cell Disease, or Both? Allergy, Asthma, and Clinical Immunology. 2008, v. 4, p. 84-90.
  22. Bousquet J., Chanez P., Lacoste J.I. et al. Eosinophilic inflammation in asthma. N. Engl. J. Med. 1990, v. 323, p. 1033-1039.
  23. Walford H.H., Doherty T.A. Distinguishing severe asthma phenotypes: role of age at onset and eosinophilic inflammation. J. Allergy Clin. Immunol. 2004, v. 113, p. 101-108.
  24. Куликов E.C, Огородова Л.М., Фрейдин M.Б. и соавт. Mолекулярные механизмы тяжелой бронхиальной астмы. Mолекулярная медицина. 2013, № 2, с. 24-32.
  25. Zeiger R.S., Schatz M., Li Q. et al. High blood eosinophil count is a risk factor for future asthma exacerbations in adult persistent asthma. J. of Allergy and Clin. Immunol. 2014, v. 2, p. 741-750.
  26. Ali Z., Dirks C.G., Ulrik C.S. Long-term Mortality Among Adults with Asthma: a 25-year follow-up of 1,075 outpatients with asthma. Chest. 2013, v. 143, p. 1649-1655.
  27. Quaedvlieg V., Sele J., Henket M., Louis R. Association between asthma control and bronchial hyperresponsiveness and airways inflammation: a cross-sectional study in daily practice. Clinical and Experimental Allergy. 2009, v. 39, p. 1822-1829.
  28. Buhl R., Humbert M., Bjermer L. et al. Severe eosinophilic asthma: a roadmap to consensus. Eur. Respir. J. 2017, v. 49, 1700634. doi: 10.1183/13993003.00634-2017.
  29. Castro M., Zangrilli J., Wechsler M.E. et al. 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, v. 3, p. 355-366.
  30. Haldar P., Pavord I.D., Shaw D.E. et al. Cluster analysis and clinical asthma phenotypes. Am. J. Respir. Crit. Care Med. 2008, v. 178, p. 218-224.
  31. Groot J.C., Storm H., Amelink M. et al. Clinical profile of patients with adult-onset eosinophilic asthma. ERJ Open Res. 2016. doi: 10.1183/23120541.00100-2015.
  32. Arbes S.J. Jr. Do all asthmatics with atopy have atopic asthma? J. Allergy Clin. Immunol. 2012, v. 130, p. 1202-1204.
  33. Fahy J. Eosinophilic and neutrophilic inflammation in asthma: insights from clinical studies. Proc. Am. Thorac. Soc. 2009, v. 6, p. 256-259.
  34. Walford H.H., Doherty T.A. Diagnosis and management of eosinophilic asthma: a US perspective. Journal of Asthma and Allergy. 2014, v. 7, p. 53-65.
  35. Nutman T. Evaluation and differential diagnosis of marked, persistent eosinophilia. Immunol. Allergy Clin. North Am. 2007, v. 27, p. 529-549.
  36. Wardlaw A.J., Brightling C., Green R. et al. Eosinophils in asthma and other allergic. British Medical Bulletin. 2000, v. 256, p. 985-1003.
  37. Van Veen I.H., ten Brinke A., Gauw S.A. et al. Consistency of sputum eosinophilia in difficult-to-treat asthma: a 5-year follow-up study. J. Allergy Clin. Immunol. 2009, v. 124, p. 615-617.
  38. Ulrik C. Peripheral eosinophil counts as a marker of disease activity in intrinsic and extrinsic asthma. Clin. Exp. Allergy. 1995, v. 25, p. 820-827.
  39. Berry M., Morgan A., Shaw D.E. et al. Pathological features and inhaled corticosteroid response of eosinophilic and non-eosinophilic asthma. Thorax. 2007, v. 62, p. 1043-1049.
  40. Haldar P., Brightling C.E., Hargadon B. et al. Mepolizumab and Exacerbations of Refractory Eosinophilic Asthma. The New England Journal of Medicine. 2009, v. 360, p. 973-984.
  41. Schleich F.N., Chevremont A., Paulus V. et al. Importance of concomitant local and systemic eosinophilia in uncontrolled asthma. European Respiratory Journal. 2014, v. 44, p. 97-108.
  42. Warke T.J., Fitch P.S., Brown V. et al. Exhaled nitric oxide correlates with airway eosinophils in childhood asthma. Thorax. 2002, v. 57, p. 383-387.
  43. Payne D.N., Adcock I.M., Wilson N.M. et al. Relationship between exhaled nitric oxide and mucosal eosinophilic inflammation in children with difficult asthma, after treatment with oral prednisolone. Am. J. Respir. Crit. Care Med. 2001, v. 164, p. 1376-1381.
  44. Jia G., Erickson R.W., Choy D. et al. Periostin is a systemic biomarker of eosinophilic airway inflammation in asthmatic patients. J. Allergy Clin. Immunol. 2012, v. 130, p. 647-654.
  45. Scheerens H., Arron J.R., 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, v. 127, p. AB164.
  46. Hanania N.A., Noonan M.J., 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, v. 133, p. AB402.
  47. Brightling C.E., Chanez P., Leigh R. et al. Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial. The Lancet. 2015, v. 3, p. 692-701.
  48. Hanania N.A., Wenzel S., Rosen K. et al. Exploring the effects of omalizumab in allergic asthma: an analysis of biomarkers in the EXTRA study. Am. J. Respir. Crit. Care Med. 2013, v. 187, p. 804-811.
  49. Caminati M., Senna G., Stefanizzi G. et al. and on behalf of North East Omalizumab Network study group. Drop-out rate among patients treated with omalizumab for severe asthma: Literature review and real-life experience. BMC Pulmonary Medicine. 2016, v. 16, p. 128.
  50. Brandström J., Vetander M., Lilja G. et al. Individually dosed omalizumab: an effective treatment for severe peanut allergy. Clin. Exp. Allergy. 2017, v. 47, p. 540-550.
  51. Konradsen J.R., Nordlund B., Nilsson O.B. et al. High basophil allergen sensitivity (CD-sens) is associated with severe allergic asthma in children. Pediatr Allergy Immunol. 2012, v. 23, p. 376-384.
  52. Lambrecht B.N., Hammad H. The immunology of asthma. Nat. Immunol. 2015, v. 16, p. 45-56.
  53. Pelaia G., Vatrella A., Busceti M.T. et al. Cellular mechanisms underlying eosinophilic and neutrophilic airway inflammation in asthma. Mediators Inflamm. 2015, v. 2015, p. 879783.
  54. Brusselle G.G., Maes T., Bracke K.R. Eosinophils in the spotlight: Eosinophilic airway inflammation in nonallergic asthma. Nat. Med. 2013, v. 19, p. 977-979.
  55. Rosenberg H.F., Dyer K.D., Foster P.S. Eosinophils: changing perspectives in health and disease. Nat. Rev. Immunol. 2013, v. 13, p. 9-22.
  56. Louis R., Sele J., Henket M. et al. Sputum eosinophil count in a large population of patients with mild to moderate steroid-naive asthma: distribution and relationship with methacholine bronchial hyperresponsiveness. Allergy. 2002, v. 57, p. 907-912.
  57. Janeway C.A. Jr, Travers P., Walport M. et al. Immunobiology: The Immune System in Health and Disease, 5th edition 2001; New York: Garland Science.
  58. Walsh G.M. Profile of reslizumab in eosinophilic disease and its potential in the treatment of poorly controlled eosinophilic asthma. Biologics. 2013, v. 7, p. 7-11.
  59. Инструкция по медицинскому применению препарата Синкейро (реслизумаб).
  60. Egan R.W., Athwal D., Bodmer M.W et al. Effect of Sch 55700, a humanized monoclonal antibody to human interleukin-5, on eosinophilic responses and bronchial hyperreactivity. Arzneimittelforschung. 1999, v. 49, p. 779-790.
  61. Murphy K., Jacobs J., Bjermer L. et al. Long-term safety and efficacy of reslizumab in patients with inadequately controlled, moderate-to-severe asthma and elevated blood eosinophil counts: an open-label extension study. Presented at the American Thoracic Society (ATS) International Conference; 15-20 May 2015.
  62. Denver, CO, USA. Poster #1025; Corren J., Weinstein S., Janka L. et al. A randomized Phase 3 study of reslizumab efficacy in relation to blood eosinophil levels in patients with moderate to severe asthma. Presented at the European Respiratory Society (ERS) International Congress; 6-10 September 2014; Munich, Germany. Oral 4673.
  63. Bjermer L., Lemiere C., Maspero J. et al. A randomized Phase 3 study of the efficacy and safety of reslizumab in subjects with asthma with elevated eosinophils. Presented at the European Respiratory Society (ERS) International Congress. 6-10 September 2014; Munich, Germany. Poster P4375.
  64. Data on file (Clinical study report: a 12-month, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Reslizumab [3.0 mg/kg] in the reduction of clinical asthma exacerbations in patients [12-75 years of age] with eosinophilic asthma. Study C38072/3082). Summary 15.47. Horsham, PA: Teva Respiratory, LLC; January 2015].
  65. Cinqair prescribing information. Horsham, PA: Teva pharmaceuticals, LLC.
  66. Castro M., Mathur S., Hargreave F. et al. Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebo-controlled study. Am. J. Respir. Crit. Care Med. 2011, v. 184, p. 1125-1132.
  67. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur. Respir J. 2014, v. 43, p. 343-373.
  68. Клинические рекомендации. Бронхиальная астма. Российское респираторное общество. 2016, 64 с.
  69. Инструкция по медицинскому применению препарата Ксолар (омализумаб).
  70. Jarjour N.N., Erzurum S.C., Bleecker E.R. et al. Severe asthma: lessons learned from the National Heart, Lung, and Blood Institute Severe Asthma Research Program. Am. J. Respir. Crit. Care Med. 2012, v. 15, p. 356-362.
  71. Fowler S.J., Tavernier G., Niven R. High blood eosinophil counts predict sputum eosinophilia in patients with severe asthma. J. Allergy Clin. Immunol. 2015, v. 135, p. 822-824.
  72. Ahmad A.L., Obaidi A.H., Mohamed A.L. et al. The predictive value of IgE as biomarker in asthma. J. Asthma. 2008, v. 45, p. 654-663.
  73. Sandeep T., Roopakala M.S., Silvia C.R. et al. Evaluation of serum immunoglobulin E levels in bronchial asthma. Lung India. 2010, v. 27, p. 138-140.
  74. Korn S., Haasler I., Fliedner F. et al. Monitoring free serum IgE in severe asthma patients treated with omalizumab. Respir. Med. 2012, v. 106, p. 1494-1500.
  75. Davila I., Valero A., Entrenas L.M. et al. SIGE Study Group. Relationship between serum total IgE and disease severity in patients with allergic asthma in Spain. J. Investig. Allergol. Clin. Immunol. 2015, v. 25, p. 120-127.

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