Анти-IgE терапия тяжелой атопической бронхиальной астмы

Обложка

Цитировать

Полный текст

Аннотация

Первым таргетным (целевым) препаратом, который применяется у пациентов с неконтролируемой среднетяжелой и тяжелой бронхиальной астмой (БА), стал анти-IgE препарат омализумаб (Ксолар®). Этот препарат назначается пациентам со среднетяжелой и тяжелой атопической БА, которая не контролируется базисной терапией, соответствующей ступени 4 (уровень доказательности А). Клинические исследования убедительно продемонстрировали, что у пациентов с тяжелой астмой, требующих терапии высокими дозами ингаляционных кортикостероидов или пероральными глюкокортикостероидами, лечение препаратом Ксолар® снижает частоту обострений БА, уменьшает степень тяжести астмы и позволяет при стероидозависимой БА отменять или значительно снижать дозы системных кортикостероидов. Кроме того, доказан противовоспалительный эффект препарата. Исследования последних лет приводят все больше данных о положительном влиянии омализумаба на ремоделирование дыхательных путей.

Об авторах

Надежда Павловна Княжеская

ФГБОУ ВО РНИМУ им. Н.И. Пирогова

Email: kniajeskaia@mail.ru
кандидат медицинских наук, доцент, зав. учебной частью кафедры пульмонологии ФДПО

Андрей Станиславович Белевский

ФГБОУ ВО РНИМУ им. Н.И. Пирогова

доктор медицинских наук, профессор, зав. кафедрой пульмонологии ФДПО

Елена Викторовна Сафошкина

ФГБОУ ВО РНИМУ им. Н.И. Пирогова; ФКУЗ «МСЧ МВД России по г. Москве»

соискатель ученой степени кандидата наук кафедры пульмонологии ФДПО; врач-терапевт поликлиники № 1

Список литературы

  1. Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma. UPDATED 2014. www.ginas-thma.org.
  2. Rabe KF, Vermeire PA, Soriano JB, Maier WC. Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur Respir J. 2000;16:802-807.
  3. 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. NPJ Prim Care Respir Med. 2014;24:14009. Price D. et al. Clin Exp Allergy. 2005;35:282-287.
  4. Romagnoli M., Caramori G., Braccioni F., Ravenna F., Barreiro E., Siafakas NM, Vignola AM, Chanez P., Fabbri LM, Papi A; ENFUMOSA Study Group. Near-fatal asthma phenotype in the ENFUMOSA Cohort. Clin Exp Allergy. 2007;37(4):552-557.
  5. Osborne M., Deffebach M. The epidemiology and natural history of asthma: Outcomes and Treatment Regimens (TENOR) study. Ann Allergy Asthma Immunol. 2004;92(1):3-4.
  6. Pearce N., Beasley R., Crane J., Burgess C., Jackson R. End of the New Zealand asthma mortality epidemic. Lancet. 1995;345:41-44.
  7. Kinoshita H., Kubota A., Kasuda S., Nishiguchi M., Ouchi H., Minami T., Matsui K., Yamamura T., Motomura H., Ohtsu N., Yoshida S., Adachi N., Aoki S., Komeda M., Hishida S. An autopsy case of asthmatic death - usefulness of biochemical examination. Vojnosanit Pregl. 2008;65(5):404-406.
  8. Емельянов АВ, Горячкина ЛА, Астафьева НГ, Фассахов РС, Черняк БА, Абелевич ММ, Игнатова ГЛ, Куделя ЛМ, Жестков АВ, Лещенко ИВ, Собко ЕА, Алексеенко ВА, Бурлачук ВТ, Лобанов КИ, Фролова СА, Галимова ЕС, Хассанова РБ, Королева МГ Аллергический ринит и бронхиальная астма в реальной клинической практике: результаты российского многоцентрового исследования. Российский Аллергологический Журнал. 2012;1:29-33
  9. Shaaban R., Zureik M., Soussan D., Neukirch C., Heinrich J., Sunyer J., Wjst M., Cerveri I., Pin I., Bousquet J., Jarvis D., Burney PG, Neukirch F., Leynaert B. Rhinitis and onset of asthma: a longitudinal population-based study. Lancet. 2008;372(9643):1049-1057.
  10. Fokkens W., Lund V., Mullol J. European position paper on rhinosinusitis and nasal polyps 2007. Rhinol. 2007;20:1-139.
  11. Hellings PW, Fokkens WJ. Allergic rhinitis and its impact on otorhinolaryngology. Allergy. 2006;61(6):656-664.
  12. Brozek JL, Bousquet J., Agache I., Agarwal A., Bachert C., Bosnic-Anticevich S., Brignardello-Petersen R., Canonica GW Casale T., Chavannes NH, Correia de Sousa J., Cruz AA, Cuello-Garcia CA, Demoly P., Dykewicz M., Etxeandia-Ikobaltzeta I., Florez ID, Fokkens W., Fonseca J., Hellings PW, Klimek L., Kowalski S., Kuna P., Laisaar KT, Larenas-Linnemann DE, Lodrup Carlsen KC, Manning PJ, Meltzer E., Mullol J., Muraro A., O’Hehir R., Ohta K., Panzner P., Papadopoulos N., Park HS, Passalacqua G., Pawankar R., Price D., Riva JJ, Roldan Y., Ryan D., Sadeghirad B., Samolinski B., Schmid-Grendelmeier P., Sheikh A., Togias A., Valero A., Valiulis A., Valovirta E., Ventresca M., Wallace D., Waserman S., Wickman M., Wiercioch W., Yepes-Nunez JJ, Zhang L., Zhang Y., Zidarn M., Zuberbier T., Schünemann HJ. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines-2016 revision. J. Allergy Clin Immunol. 2017;140(4):950-958.
  13. Worldwide variations in the prevalence of symptoms of asthma, allergic rhinoconjuctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergy in Childhood. Lancet. 1998;351:1225-1232.
  14. Ayres JG, Higgins B., Chilvers ER, Ayre G., Blogg M., Fox H. Efficacy and tolerability of anti-immunoglobulin E. therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma. Allergy. 2004;59(7):701-708.
  15. MacGlashan DW, Bochner BS, Adelman DC, Jardieu PM, Togias A., McKenzie-White J., Sterbinsky SA, Hamilton RG, Lichtenstein LM. Down-regulation of FyRI expression on human basophils during in vivo treatment of atopic patients with anti-IgE antibody. J. Immunol. 1997;(158):1438-1445.
  16. Matucci A., Vultaggio A., Maggi E., Kasujee I. Is IgE or eosinophils the key player in allergic asthma pathogenesis? Are we asking the right question? Respir Res. 2018;19(1):113.
  17. Palomares O., Sanchez-Ramon S., Davila I., Prieto L., Pérez de Llano L., Lleonart M., Domingo C., Nieto A. dIvergEnt: How IgE Axis Contributes to the Continuum of Allergic Asthma and Anti-IgE Therapies. Int J. Mol Sci. 2017;18:е13-28.
  18. Djukanovic R., Wilson SJ, Kraft M., Jarjour NN, Steel M., Chung KF, Bao W., Fowler-Taylor A., Matthews J., Busse WW, Holgate ST, Fahy JV Effects of Treatment with Anti-immunoglobulin E. Antibody Omalizumab on Airway Inflammation in Allergic Asthma. Am J. Respir Crit Care Med. 2004;170(6):583-593.
  19. Van Rensen EL, Evertse CE, van Schadewijk WAA, van Wijngaarden S., Ayre G., Mauad T., Hiemstra PS, Sterk PJ, Rabe KF. Eosinophils in bronchial mucosa of asthmatics after allergen challenge: effect of anti-IgE treatment.in severe asthma compared to moderate asthma. Chest. 2008;133:420-426.
  20. Van Rensen ELJ, Evertse CE, van Schadewijk WAA, van Wijngaarden S., Ayre G., Mauad T. Anti-IgE omalizumab treatment reduces allergen-induced eosinophilia in biopsies and sputum in patients. Abstract presented at: American Thoracic Society International Conference; May 20-25, 2005; San Diego, CA.
  21. Noga O., Hanf G., Brachmann I., Klucken AC, Kleine-Tebbe J., Rosseau S., Kunkel G., Suttorp N., Seybold J. Effect of omalizumab treatment on peripheral eosinophil and T-lym-phocyte function in patients with allergic asthma. J. Allergy Clin Immunol. 2006;117:1493-1499.
  22. James A. Airway remodeling in asthma. Curr Opin Pulm Med. 2005;11:1-6.
  23. Pascual RM, Peters SP. Airway remodeling contributes to the progressive loss of lung function in asthma: an overview. J. Allergy Clin Immunol. 2005;116:477-486.
  24. James AL, Wenzel S. Clinical relevance of airway remodelling in airway diseases. Eur Respir J. 2007;30:134-155.
  25. Redhu NS, Shan L., Al-Subait D., Ashdown HL, Movassagh H., Lamkhioued B., Abdelilah S. Gounni. IgE induces proliferationin human airway smooth muscle cells: role of MAPK and STAT3 pathways. Allergy Asthma Clin Immunol. 2013;9:41.
  26. Roth M., Zhong J., Zumkeller C., S’ng CT, Goulet S., Tamm M. The role of IgE-receptors in IgE-dependent airway smooth muscle cell remodelling. PLoS One. 2013;8:e56015.
  27. Redhu NS, Gounni AS. The high affinity IgE receptor (FceRI) expression and function in airway smooth muscle. Pulm Pharmacol Ther. 2013;26:86-94.
  28. Riccio AM, Mauri P., De Ferrari L., Rossi R., Di Silvestre D., Benazzi L., Chiappori A., Dal Negro RW, Micheletto C., Canonica GW. Galectin 3: an early predictive biomarker of modulation of airway remodeling in patients with severe asthma treated with omalizumab for 36 months. Clin Transl Allergy. 2017;7:6.
  29. Riccio AM, Dal Negro RW, Micheletto C., De Ferrari L., Folli C., Chiappori A., Canonica GW Omalizumab modulates bronchial reticular basement membrane thickness and eosinophil infiltration in severe persistent allergic asthma patients. Int J. Immunopathol Pharmacol. 2012;25:475-484.
  30. Hoshino M., Ohtawa J. Effects of adding omalizumab, an anti-immunoglobulin E. antibody, on airway wall thickening in asthma. Respiration. 2012;83(6):520-528.
  31. Tajiri T., Niimi A., Matsumoto H., Ito I., Oguma T., Otsuka K., Takeda T., Nakaji H., Inoue H., Iwata T., Nagasaki T., Kanemitsu Y., Izuhara Y., Mishima M. Comprehensive efficacy of omalizumab for severe refractory asthma: a time-series observational study. Ann Allergy Asthma Immunol. 2014;113:470-475.
  32. Mauri P., Riccio AM, Rossi R., Dario Di Silvestre, Louise Benazzi, Laura De Ferrari, Roberto Walter Dal Negro, Stephen T. Holgate, Giorgio Walter Canonica. Proteomics of bronchial biopsies: galectin-3 as a predictive biomarker of airway remodelling modulation in omalizumab-treated severe asthma patients. Immunol Lett. 2014;162(1 Pt A):2-10.
  33. Chipps B., Buhl R., Beeh KM, Fox H., Thomas K., Reisner C. Improvement in quality of life with omalizumab in patients with severe allergic asthma. Curr Med Res Opin. 2006;22:2201-2208.
  34. Ledford DK. Omalizumab: overview of pharmacology and efficacy in asthma. Expert Opin Biol Ther. 2009;9(7):933-943.
  35. Holgate ST, Chuchalin AG, Hébert J., Lötvall J., Persson GB, Chung KF, Bousquet J., Kerstjens HA, Fox H., Thirlwell J., Cioppa GD. Omalizumab 011 International Study Group. Efficacy and safety of a recombinant anti-immunoglobulin E. antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy. 2004;34(4):632-638.
  36. Humbert M., Beasley R., Ayres J., Slavin R., Hébert J., Bousquet J., Beeh KM, Ramos S., Canonica GW, Hedgecock S., Fox H., Blogg M., Surrey K. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy. 2005;60:309-316.
  37. Holgate S., Bousquet J., Wenzel S., Fox H., Liu J., Castellsague J. Efficacy of omalizumab, an anti-immunoglobulin E. antibody, in patients with allergic asthma at high risk of serious asthma-related morbidity and mortality. Curr Med Res Opin. 2001;17(4):233-240.
  38. Bousquet J., Rabe K., Humbert M., Chung KF, Berger W. Fox H., Ayre G., Chen H., Thomas K., Blogg M., Holgate S. Predicting and evaluating response to omalizumab in patients with severe allergic asthma. Respir Med. 2007;101(7):1483-1492. Epub 2007 Mar 6.
  39. Canonica GW, Rottoli P., Bucca C., Zappa MC, Michetti G., Macciocchi B., Caruso C., Santus P., Bartezaghi M., Rigoni L. and on behalf of PROXIMA study centers. Improvement of patient-reported outcomes in severe allergic asthma by omalizumab treatment: the real life observational PROXIMA study. World Allergy Organ J. 2018;11(1):33.
  40. Braunstahl 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(1):30.
  41. Humbert M., Taillé C., Mala L., Le Gros V., Just J., Molimard M.; STELLAIR investigatorsl. Omalizumab effectiveness in patients with severe allergic asthma according to blood eosinophil count: the STELLAIR study. Eur Respir J. 2018;51(5).
  42. Bousquet J., Siergiejko Z., Swiebocka M., Humbert E., Rabe KF, Smith N., Leo J., Peckitt C., Maykut R., Peachey G. Persistency of response to omalizumab therapy in severe allergic (IgE-mеdiated) asthma. Allergy. 2011;66(5):671-678.
  43. Menzella F., Facciolongo N., Castagnetti C., Simonazzi A., Zucchi L. Omalizumab: when the non-responder is a late-responder. Eur Ann Allergy Clin Immunol. 2009;41(5):155-159.
  44. Kallieri M., Papaioannou AI, Papathanasiou E., Ntontsi P., Papiris S., Loukides S. Predictors of response to therapy with omalizumab in patients with severe allergic asthma - a real life study. Postgrad Med. 2017;129(6):598-604.
  45. Nopp A., Johansson SGO, Adedoyin J., Ankerst J., Palmqvist M., Oman H. After 6 years with Xolair; a 3-year withdrawal follow-up. Allergy. 2010;65:56-60.
  46. Molimard M., Mala L., Bourdeix I., Le Gros V. Observational study in severe asthmatic patients after discontinuation of omalizumab for good asthma control. Respiratory Medicine. 2014;108:571-576.
  47. Bargagli E., Madioni C., Olivieri C., Penza F., Rottoli P. Churg-Strauss vasculitis in a patient treated with omalizumab. J. Asthma. 2008;45(2):115-116.
  48. Townley RG, Agrawal S., Sapkota K. Omalizumab for pediatric asthma. Expert Opin Biol Ther. 2010;10(11):1595-1608.
  49. Milgrom H., Berger W., Nayak A., Gupta N., Pollard S., McA-lary M., Taylor A., Rohane P. Treatment of childhood asthma with anti-immunoglobulin E. antibody. Pediatrics. 2001; 108:E36.
  50. Kim DH, Park KY, Kim BJ, Kim MN, Mun SK. Anti-immunoglobulin E. in the treatment of refractory atopic dermatitis. Clin Exp Dermatol. 2012 Oct 22.
  51. Naclerio RM, Baroody FM, Pinto JM. Should clinicians use omalizumab for the treatment of nasal polyps? J. Allergy Clin Immunol. 2013 May 16.
  52. Gevaert P., Calus L., Van Zele T., Blomme K., De Ruyck N., Bauters W., Hellings P., Brusselle G., De Bacquer D., van Cauwenberge P., Bachert C. Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. J. Allergy Clin Immunol. 2013;131(1):110-116.
  53. Lieberman JA, Chehade M. Use of omalizumab in the treatment of food allergy and anaphylaxis. Curr Allergy Asthma Rep. 2013;13(1):78-84.
  54. Genentech FDA Grants Breakthrough Therapy Designation for Xolair (Omalizumab) for Food Allergies. Press release Aug 12, 2018.
  55. Maurer M., Rosén K., Hsieh HJ, Saini S., Grattan C., Gimenéz-Arnau A., Agarwal S., Doyle R., Canvin J., Kaplan A., Casale T. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N. Engl J. Med. 2013;368(10):924-935.
  56. Инструкция по применению лекарственного препарата для медицинского применения Ксолар (ЛСР-000082 от 29.05.2007)

© Фармарус Принт Медиа, 2019

Данный сайт использует cookie-файлы

Продолжая использовать наш сайт, вы даете согласие на обработку файлов cookie, которые обеспечивают правильную работу сайта.

О куки-файлах