medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/ms2023-050medsovet-7423Research ArticleХРОНИЧЕСКИЕ ЗАБОЛЕВАНИЯ ЛЕГКИХCHRONIC PULMONARY DISEASESЭффективность двухлетней анти-IgE терапии у больных тяжелой аллергической бронхиальной астмой в Свердловской областиEfficacy of two-year anti-IgE therapy in patients with severe allergic bronchial asthma in Sverdlovsk regionhttps://orcid.org/0000-0002-3028-2657НаумоваВ. В.NaumovaV. V.

Наумова Вероника Викторовна – кандидат медицинских наук, доцент кафедры факультетской терапии, эндокринологии, аллергологии и иммунологии.

620028, Екатеринбург, ул. Репина, д. 3

Veronika V. Naumova - Cand. Sci. (Med.), Assistant Professor of the Department of Faculty Therapy, Endocrinology, Allergology and Immunology, Urals State Medical University.

3, Repin St., Ekaterinburg, 620028

nika.naumova@gmail.comhttps://orcid.org/0000-0003-2485-2243БельтюковЕ. К.BeltyukovЕ. К.

Бельтюков Евгений Кронидович - доктор медицинских наук, профессор, профессор кафедры факультетской терапии, эндокринологии, аллергологии и иммунологии.

620028, Екатеринбург, ул. Репина, д. 3

Evgeny K. Beltyukov - Dr. Sci. (Med.), Professor, Professor of the Department of Faculty Therapy, Endocrinology, Allergology and Immunology, Urals State Medical University.

3, Repin St., Ekaterinburg, 620028

asthma@mail.ruhttps://orcid.org/0000-0002-5825-2222АбдуллаевВ. Х.AbdullaevV. Ch.

Абдуллаев Вугар Ханларович - врач-пульмонолог.

623300, Красноуфимск, ул. Транспортная, д. 12

Vugar Ch. Abdullaev - Pulmonologist, Krasnoufimsk Regional Hospital.

12, Transportnaya St., Krasnoufimsk, 623300

Vuga-222@rambler.ruhttps://orcid.org/0000-0002-5103-2446ПетуховаА. Ю.PetukhovaA. U.

Петухова Анна Юрьевна - кандидат медицинских наук, врач-пульмонолог, врач аллерголог-иммунолог, заведующая городским амбулаторно-консультативным отделением аллергологии и иммунологии.

620102, Екатеринбург, ул. Серафимы Дерябиной, д. 34

Anna U. Petukhova - Cand. Sci. (Med.), Pulmonologist, Allergist-immunologist, Head of the Outpatient Consultation Department of Allergology and Immunology, Central City Clinical Hospital No. 6.

34, Serafima Deryabina St., Ekaterinburg, 620102

anna-petuhova@mail.ruhttps://orcid.org/0000-0002-8104-0017ШтановаА. А.ShtanovaA. A.

Штанова Александра Александровна – студент.

620028, Екатеринбург, ул. Репина, д. 3

Alexandra A. Shtanova - Student, Urals State Medical University.

3, Repin St., Ekaterinburg, 620028

alekshtanova@gmail.comhttps://orcid.org/0000-0001-5365-7792СтепинаД. А.StepinaD. A.

Степина Дарья Артемовна – студент.

620028, Екатеринбург, ул. Репина, д. 3

Daria A. Stepina - Student, Urals State Medical University.

3, Repin St., Ekaterinburg, 620028

d.stepina37@gmail.comУральский государственный медицинский университетРоссияUrals State Medical UniversityRussian FederationКрасноуфимская районная больницаРоссияKrasnoufimsk Regional HospitalRussian FederationЦентральная городская клиническая больница №6 города ЕкатеринбургаРоссияCentral City Clinical Hospital No. 6Russian Federation20231104202304817Copyright © Наумова В.В., Бельтюков Е.К., Абдуллаев В.Х., Петухова А.Ю., Штанова А.А., Степина Д.А., 20232023Наумова В.В., Бельтюков Е.К., Абдуллаев В.Х., Петухова А.Ю., Штанова А.А., Степина Д.А.Naumova V.V., Beltyukov Е.К., Abdullaev V.C., Petukhova A.U., Shtanova A.A., Stepina D.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/7423Введение

Введение. Иccледование эффективности омализумаба у пациентов с тяжелой бронхиальной астмой (ТБА) в рандомизированных клинических исследованиях ограничено сроком до 52 нед. В реальной клинической практике пациенты могут получать препарат значительно дольше.

Цель

Цель. Оценить однолетнюю и двухлетнюю эффективность омализумаба у пациентов с ТБА в Свердловской области. Материалы и методы. В исследование вошли пациенты (n = 54) с ТБА аллергического и смешанного генеза из регистра Свердловской области. Эффективность омализумаба оценивалась за 12 и 24 мес. терапии по динамике частоты обострений астмы, использования ресурсов здравоохранения (РЗО), потребности в короткодействующих бронхолитиках (КДБ) и системных глюкокортикостероидах (СГКС), уровня контроля над астмой по АСТ-тесту, качества жизни по опроснику AQLQ, уровня ОФВ1 и эозинофилов периферической крови.

Результаты

Результаты. За 12 мес. терапии омализумабом снижение частоты обострений астмы составило 63,7% (с 2,01 ± 1,51 на пациента в год до 0,73 ± 1,03) (p < 0,001), что сопровождалось снижением частоты вызовов СМП и госпитализаций по поводу обострений астмы на 92,4 и 84,1% соответственно (p < 0,001). Улучшился контроль над астмой (АСТ) с 9 (Q1-Q3: 7–13) до 20 баллов (Q1-Q3: 16–23); доля пациентов с неконтролируемой ТБА уменьшилась с 97,4 до 48,7% (p < 0,001). Снизилась потребность в КДБ на 92,9% (p < 0,001). Доля пациентов на СГКС уменьшилась с 60,5 до 15,8% (p < 0,001). Значимо улучшилось качество жизни (AQLQ), увеличился ОФВ1 (p < 0,001), снизилось число эозинофилов в крови (р = 0,015). К концу второго года терапии тенденция улучшения показателей эффективности сохранялась.

Выводы

Выводы. За 1 год терапии омализумабом у пациентов с аллергической ТБА наблюдалось значимое уменьшение числа обострений и использования РЗО, улучшение качества жизни и контроля над астмой, снижение потребности в КДБ и СГКС, улучшение функции внешнего дыхания. У пациентов, получавших омализумаб два года, наблюдалось дальнейшее улучшение или стабилизация основных показателей эффективности терапии.

Introduction

Introduction. The study of omalizumab efficacy in patients with severe bronchial asthma (SA) in randomized clinical trials is limited to 52 weeks. In real clinical practice, patients can receive the drug for much longer.

Aim

Aim. Evaluate the one-year and two-year efficacy of omalizumab in patients with SA in Sverdlovsk region.

Material and methods

Material and methods. The study included patients (n = 54) with allergic and mixed SA from the registry of Sverdlovsk region. Omalizumab efficacy was assessed over 12 and 24 months of therapy by dynamics of asthma exacerbations frequency, the use of health care resources, the need for short-acting beta-agonists (SABA) and systemic glucocorticosteroids (SGCS), the level of asthma control according to ACT, and the quality of life according to AQLQ, FEV1 levels and peripheral blood eosinophils.

Results

Results. During 12 months of omalizumab therapy, the reduction in asthma exacerbation rate was 63.7% (from 2.01 ± 1.51 per patient per year to 0.73 ± 1.03) (p < 0.001), which was accompanied by a decrease in emergency calls and hospitalizations rates by 92.4 and 84.1%, respectively (p < 0.001). Improved asthma control (by ACT) from 9 (Q1-Q3: 7–13) to 20 points (Q1-Q3: 16–23); the proportion of patients with uncontrolled SA decreased from 97.4 to 48.7% (p < 0.001). The need for SABA decreased to 92.9% (p < 0.001). The proportion of patients on SGCS decreased from 60.5% to 15.8% (p < 0.001). The quality of life (AQLQ) significantly improved, FEV1 increased (p < 0.001), the number of eosinophils in peripheral blood decreased (p = 0.015). By the end of the second year of therapy, the trend of improvement in indicators of efficacy continued.

Conclusions

Conclusions. During 1 year of therapy with omalizumab, patients with allergic SA experienced a significant decrease in the number of exacerbations and use of health care resources, improved quality of life and asthma control, reduced need for SABA and SGCS, and improved respiratory function. In patients treated with omalizumab for 2 years, there was a further improvement or stabilization of efficacy indicators.

астмааллергияконтрольтаргетная терапиягенно-инженерные биологические препаратыомализумабasthmaallergycontroltargeted therapygenetically engineered biological drugsomalizumabReferencesBush A., Zar H.J. WHO universal definition of severe asthma. Curr Opin Allergy Clin Immunol. 2011;11(2):115–121. https://doi.org/10.1097/ACI.0B013E32834487AE.Bush A., Zar H.J. WHO universal definition of severe asthma. Curr Opin Allergy Clin Immunol. 2011;11(2):115–121. https://doi.org/10.1097/ACI.0B013E32834487AE.To T., Stanojevic S., Moores G., Gershon A.S., Bateman E.D., Cruz A.A. et al. Global asthma prevalence in adults: Findings from the cross-sectional world health survey. BMC Public Health. 2012;12(1):1–8. https://doi.org/10.1186/1471-2458-12-204/TABLES/3.To T., Stanojevic S., Moores G., Gershon A.S., Bateman E.D., Cruz A.A. et al. Global asthma prevalence in adults: Findings from the cross-sectional world health survey. BMC Public Health. 2012;12(1):1–8. https://doi.org/10.1186/1471-2458-12-204/TABLES/3.Viegi G., Maio S., Fasola S., Baldacci S. Global Burden of Chronic Respiratory Diseases. J Aerosol Med Pulm Drug Deliv. 2020;33(4):171177. https://doi.org/10.1089/jamp.2019.1576.Viegi G., Maio S., Fasola S., Baldacci S. Global Burden of Chronic Respiratory Diseases. J Aerosol Med Pulm Drug Deliv. 2020;33(4):171177. https://doi.org/10.1089/jamp.2019.1576.Tan L., Reibman J., Ambrose C., Chung Y., Desai P., Llanos Ackert J.P. et al. Clinical and economic burden of uncontrolled severe noneosinophilic asthma. Am J Manag Care. 2022;28(6):E212–220. https://doi.org/10.37765/AJMC.2022.89159.Tan L., Reibman J., Ambrose C., Chung Y., Desai P., Llanos Ackert J.P. et al. Clinical and economic burden of uncontrolled severe noneosinophilic asthma. Am J Manag Care. 2022;28(6):E212–220. https://doi.org/10.37765/AJMC.2022.89159.Nunes C., Pereira A.M., Morais-Almeida M. Asthma costs and social impact. Asthma Res Pract. 2017;3:1. https://doi.org/10.1186/S40733-016-0029-3.Nunes C., Pereira A.M., Morais-Almeida M. Asthma costs and social impact. Asthma Res Pract. 2017;3:1. https://doi.org/10.1186/S40733-016-0029-3.Ivanova J.I., Bergman R., Birnbaum H.G., Colice G.L., Silverman R.A., McLaurin K. Effect of asthma exacerbations on health care costs among asthmatic patients with moderate and severe persistent asthma. J Allergy Clin Immunol. 2012;129(5):1229–1235. https://doi.org/10.1016/J.JACI.2012.01.039.Ivanova J.I., Bergman R., Birnbaum H.G., Colice G.L., Silverman R.A., McLaurin K. Effect of asthma exacerbations on health care costs among asthmatic patients with moderate and severe persistent asthma. J Allergy Clin Immunol. 2012;129(5):1229–1235. https://doi.org/10.1016/J.JACI.2012.01.039.Bourdin A., Fabry-Vendrand C., Ostinelli J., Ait-Yahia M., Darnal E., Bouee S. et al. The Burden of Severe Asthma in France: A Case-Control Study Using a Medical Claims Database. J Allergy Clin Immunol Pract. 2019;7(5):1477–1487. https://doi.org/10.1016/J.JAIP.2018.12.029.Bourdin A., Fabry-Vendrand C., Ostinelli J., Ait-Yahia M., Darnal E., Bouee S. et al. The Burden of Severe Asthma in France: A Case-Control Study Using a Medical Claims Database. J Allergy Clin Immunol Pract. 2019;7(5):1477–1487. https://doi.org/10.1016/J.JAIP.2018.12.029.Humbert M., Beasley R., Ayres J., Slavin R., Hébert J., Bousquet J. et al. 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(3):309–316. https://doi.org/10.1111/J.1398-9995.2004.00772.X.Humbert M., Beasley R., Ayres J., Slavin R., Hébert J., Bousquet J. et al. 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(3):309–316. https://doi.org/10.1111/J.1398-9995.2004.00772.X.Brown R., Turk F., Dale P., Bousquet J. Cost-effectiveness of omalizumab in patients with severe persistent allergic asthma. Allergy. 2007;62(2):149–153. https://doi.org/10.1111/J.1398-9995.2006.01310.X.Brown R., Turk F., Dale P., Bousquet J. Cost-effectiveness of omalizumab in patients with severe persistent allergic asthma. Allergy. 2007;62(2):149–153. https://doi.org/10.1111/J.1398-9995.2006.01310.X.Vignola A.M., Humbert M., Bousquet J., Boulet L.P., Hedgecock S., Blogg M. et al. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with concomitant allergic asthma and persistent allergic rhinitis: SOLAR. Allergy. 2004;59(7):709–717. https://doi.org/10.1111/J.1398-9995.2004.00550.X.Vignola A.M., Humbert M., Bousquet J., Boulet L.P., Hedgecock S., Blogg M. et al. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with concomitant allergic asthma and persistent allergic rhinitis: SOLAR. Allergy. 2004;59(7):709–717. https://doi.org/10.1111/J.1398-9995.2004.00550.X.Buhl R., Solèr M., Matz J., Townley R., O’Brien J., Noga O. et al. Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma. Eur Respir J. 2002;20(1):73–78. https://doi.org/10.1183/09031936.02.00278102.Buhl R., Solèr M., Matz J., Townley R., O’Brien J., Noga O. et al. Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma. Eur Respir J. 2002;20(1):73–78. https://doi.org/10.1183/09031936.02.00278102.Ayres J.G., Higgins B., Chilvers E.R., 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. https://doi.org/10.1111/J.1398-9995.2004.00533.X.Ayres J.G., Higgins B., Chilvers E.R., 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. https://doi.org/10.1111/J.1398-9995.2004.00533.X.Hanania N.A., Alpan O., Hamilos D.L., Condemi J.J., Reyes-Rivera I., Zhu J. et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011;154(9):573–582. https://doi.org/10.7326/0003-4819-154-9-201105030-00002.Hanania N.A., Alpan O., Hamilos D.L., Condemi J.J., Reyes-Rivera I., Zhu J. et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011;154(9):573–582. https://doi.org/10.7326/0003-4819-154-9-201105030-00002.Ohta K., Miyamoto T., Amagasaki T., Yamamoto M. Efficacy and safety of omalizumab in an Asian population with moderate-to-severe persistent asthma. Respirology (Carlton, Vic). 2009;14(8):1156–1165. https://doi.org/10.1111/-J.1440-1843.2009.01633.X.Ohta K., Miyamoto T., Amagasaki T., Yamamoto M. Efficacy and safety of omalizumab in an Asian population with moderate-to-severe persistent asthma. Respirology (Carlton, Vic). 2009;14(8):1156–1165. https://doi.org/10.1111/-J.1440-1843.2009.01633.X.Holgate S.T., Chuchalin A.G., Hébert J., Lötvall J., Persson G.B., Chung K.F. et al. Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy. 2004;34(4):632–638. https://doi.org/10.1111/J.1365-2222.2004.1916.X.Holgate S.T., Chuchalin A.G., Hébert J., Lötvall J., Persson G.B., Chung K.F. et al. Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy. 2004;34(4):632–638. https://doi.org/10.1111/J.1365-2222.2004.1916.X.Bousquet J., Siergiejko Z., Świebocka E., Humbert M., Rabe K.F., Smith N. et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy. 2011;66(5):671–678. https://doi.org/10.1111/-J.1398-9995.2010.02522.X.Bousquet J., Siergiejko Z., Świebocka E., Humbert M., Rabe K.F., Smith N. et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy. 2011;66(5):671–678. https://doi.org/10.1111/-J.1398-9995.2010.02522.X.Finn A., Gross G., Van Bavel J., Lee T., Windom H., Everhard F. et al. Omalizumab improves asthma-related quality of life in patients with severe allergic asthma. J Allergy Clin Immunol. 2003;111(2):278–284. https://doi.org/10.1067/mai.2003.54.Finn A., Gross G., Van Bavel J., Lee T., Windom H., Everhard F. et al. Omalizumab improves asthma-related quality of life in patients with severe allergic asthma. J Allergy Clin Immunol. 2003;111(2):278–284. https://doi.org/10.1067/mai.2003.54.Niven R., Chung K.F., Panahloo Z., Blogg M., Ayre G. Effectiveness of omalizumab in patients with inadequately controlled severe persistent allergic asthma: an open-label study. Respir Med. 2008;102(10):1371–1378. https://doi.org/10.1016/J.RMED.2008.06.002.Niven R., Chung K.F., Panahloo Z., Blogg M., Ayre G. Effectiveness of omalizumab in patients with inadequately controlled severe persistent allergic asthma: an open-label study. Respir Med. 2008;102(10):1371–1378. https://doi.org/10.1016/J.RMED.2008.06.002.Deniz Y.M., Gupta N. Safety and tolerability of omalizumab (Xolair), a recombinant humanized monoclonal anti-IgE antibody. Clin Rev Allergy Immunol. 2005;29(1):31–48. https://doi.org/10.1385/CRIAI:29:1:031.Deniz Y.M., Gupta N. Safety and tolerability of omalizumab (Xolair), a recombinant humanized monoclonal anti-IgE antibody. Clin Rev Allergy Immunol. 2005;29(1):31–48. https://doi.org/10.1385/CRIAI:29:1:031.Ke X., Kavati A., Wertz D., Huang Q., Wang L., Willey V.J. et al. Real-world Clinical Characteristics, Treatment Patterns, and Exacerbations in US Patients With Asthma Newly Treated With Omalizumab. Clin Ther. 2018;40(7):1140–1158.e4. https://doi.org/10.1016/J.CLINTHERA.2018.05.014.Ke X., Kavati A., Wertz D., Huang Q., Wang L., Willey V.J. et al. Real-world Clinical Characteristics, Treatment Patterns, and Exacerbations in US Patients With Asthma Newly Treated With Omalizumab. Clin Ther. 2018;40(7):1140–1158.e4. https://doi.org/10.1016/J.CLINTHERA.2018.05.014.Lee J.K., Amin S., Erdmann M., Kukaswadia A., Ivanovic J., Fischer A. et al. Real-world observational study on the characteristics and treatment patterns of allergic asthma patients receiving omalizumab in Canada. Patient Prefer Adherence. 2020;14:725–735. https://doi.org/10.2147/PPA.S248324.Lee J.K., Amin S., Erdmann M., Kukaswadia A., Ivanovic J., Fischer A. et al. Real-world observational study on the characteristics and treatment patterns of allergic asthma patients receiving omalizumab in Canada. Patient Prefer Adherence. 2020;14:725–735. https://doi.org/10.2147/PPA.S248324.Ильяина Н.И., Курбачева О.М., Павлова К.С., Польнер С.А. Аллергический ринит: клинические рекомендации. 2018. Режим доступа: https://cr.minzdrav.gov.ru/recomend/261_1.Ilyaina N.I., Kurbacheva O.M., Pavlova K.S., Polner S.A. Allergic rhinitis: clinical guidelines. 2018. (In Russ.). Available at: https://cr.minzdrav.gov.ru/recomend/261_1.Астафьева Н.Г., Баранов А.А., Вишнева Е.А., Дайхес Н.А., Жестков А.В., Ильина Н.И. и др. Аллергический ринит: клинические рекомендации. 2020. Режим доступа: https://nrcii.ru/docs/2.allergic_rhinitis.pdf.Astafeva N.G., Baranov A.A., Vishneva E.A., Daykhes N.A., Zhestkov A.V., Ilina N.I. et al. Allergic rhinitis: clinical guidelines. 2020. (In Russ.). Available at: https://nrcii.ru/docs/2.allergic_rhinitis.pdf.Fokkens W.J., Lund V.J., Mullol J., Bachert C., Alobid I., Baroody F. et al. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012;50(1):1–12. https://doi.org/10.4193/RHINO12.000.Fokkens W.J., Lund V.J., Mullol J., Bachert C., Alobid I., Baroody F. et al. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012;50(1):1–12. https://doi.org/10.4193/RHINO12.000.Bachert C., Pawankar R., Zhang L., Bunnag C., Fokkens W.J., Hamilos D.L. et al. ICON: chronic rhinosinusitis. World Allergy Organ J. 2014;7(1). https://doi.org/10.1186/1939-4551-7-25.Bachert C., Pawankar R., Zhang L., Bunnag C., Fokkens W.J., Hamilos D.L. et al. ICON: chronic rhinosinusitis. World Allergy Organ J. 2014;7(1). https://doi.org/10.1186/1939-4551-7-25.Bachert C., Han J.K., Wagenmann M., Hosemann W., Lee S.E., Backer V. et al. EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management. J Allergy Clin Immunol. 2021;147(1):29–36. https://doi.org/10.1016/J.JACI.2020.11.013.Bachert C., Han J.K., Wagenmann M., Hosemann W., Lee S.E., Backer V. et al. EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management. J Allergy Clin Immunol. 2021;147(1):29–36. https://doi.org/10.1016/J.JACI.2020.11.013.Molimard M., Buhl R., Niven R., Le Gros V., Thielen A., Thirlwell J. et al. Omalizumab reduces oral corticosteroid use in patients with severe allergic asthma: real-life data. Respir Med. 2010;104(9):1381–1385. https://doi.org/10.1016/J.RMED.2010.06.001.Molimard M., Buhl R., Niven R., Le Gros V., Thielen A., Thirlwell J. et al. Omalizumab reduces oral corticosteroid use in patients with severe allergic asthma: real-life data. Respir Med. 2010;104(9):1381–1385. https://doi.org/10.1016/J.RMED.2010.06.001.Schumann C., Kropf C., Wibmer T., Rüdiger S., Stoiber K.M., Thielen A. et al. Omalizumab in patients with severe asthma: the XCLUSIVE study. Clin Respir J. 2012;6(4):215–227. https://doi.org/10.1111/J.1752-699X.2011.00263.X.Schumann C., Kropf C., Wibmer T., Rüdiger S., Stoiber K.M., Thielen A. et al. Omalizumab in patients with severe asthma: the XCLUSIVE study. Clin Respir J. 2012;6(4):215–227. https://doi.org/10.1111/J.1752-699X.2011.00263.X.Tzortzaki E.G., Georgiou A., Kampas D., Lemessios M., Markatos M., Adamidi T. et al. Long-term omalizumab treatment in severe allergic asthma: the South-Eastern Mediterranean “real-life” experience. Pulm Pharmacol Ther. 2012;25(1):77–82. https://doi.org/10.1016/J.PUPT.2011.11.004.Tzortzaki E.G., Georgiou A., Kampas D., Lemessios M., Markatos M., Adamidi T. et al. Long-term omalizumab treatment in severe allergic asthma: the South-Eastern Mediterranean “real-life” experience. Pulm Pharmacol Ther. 2012;25(1):77–82. https://doi.org/10.1016/J.PUPT.2011.11.004.Gemıcıoğlu B., Çalişkaner Öztürk B., Duman B. Comparison of allergic asthma patients treated with omalizumab and non-allergic patients treated with continuous oral corticosteroids: results of five year follow-up therapies. Tuberk Toraks. 2016;64(2):97–104. https://doi.org/10.5578/tt.22074.Gemıcıoğlu B., Çalişkaner Öztürk B., Duman B. Comparison of allergic asthma patients treated with omalizumab and non-allergic patients treated with continuous oral corticosteroids: results of five year follow-up therapies. Tuberk Toraks. 2016;64(2):97–104. https://doi.org/10.5578/tt.22074.Van Dijk B.C.P., Svedsater H., Heddini A., Nelsen L., Balradj J.S., Alleman C. Relationship between the Asthma Control Test (ACT) and other outcomes: A targeted literature review. BMC Pulm Med. 2020;20(1):1–9. https://doi.org/10.1186/S12890-020-1090-5/TABLES/1.Van Dijk B.C.P., Svedsater H., Heddini A., Nelsen L., Balradj J.S., Alleman C. Relationship between the Asthma Control Test (ACT) and other outcomes: A targeted literature review. BMC Pulm Med. 2020;20(1):1–9. https://doi.org/10.1186/S12890-020-1090-5/TABLES/1.Eisner M.D., Zazzali J.L., Miller M.K., Bradley M.S., Schatz M. Longitudinal changes in asthma control with omalizumab: 2-year interim data from the EXCELS Study. J Asthma. 2012;49(6):642–648. https://doi.org/10.3109/02770903.2012.690477.Eisner M.D., Zazzali J.L., Miller M.K., Bradley M.S., Schatz M. Longitudinal changes in asthma control with omalizumab: 2-year interim data from the EXCELS Study. J Asthma. 2012;49(6):642–648. https://doi.org/10.3109/02770903.2012.690477.Papaioannou A.I., Mplizou M., Porpodis K., Fouka E., Zervas E., Samitas K. et al. Long-term efficacy and safety of omalizumab in patients with allergic asthma: A real-life study. Allergy Asthma Proc. 2021;42(3):235–242. https://doi.org/10.2500/AAP.2021.42.210014.Papaioannou A.I., Mplizou M., Porpodis K., Fouka E., Zervas E., Samitas K. et al. Long-term efficacy and safety of omalizumab in patients with allergic asthma: A real-life study. Allergy Asthma Proc. 2021;42(3):235–242. https://doi.org/10.2500/AAP.2021.42.210014.Mansur A.H., Srivastava S., Mitchell V., Sullivan J., Kasujee I. Longterm clinical outcomes of omalizumab therapy in severe allergic asthma: Study of efficacy and safety. Respir Med. 2017;124:36–43. https://doi.org/10.1016/j.rmed.2017.01.008.Mansur A.H., Srivastava S., Mitchell V., Sullivan J., Kasujee I. Longterm clinical outcomes of omalizumab therapy in severe allergic asthma: Study of efficacy and safety. Respir Med. 2017;124:36–43. https://doi.org/10.1016/j.rmed.2017.01.008.Braunstahl G.J., Chen C.W., Maykut R., Georgiou P., Peachey G., Bruce J. The eXpeRience registry: the “real-world” effectiveness of omalizumab in allergic asthma. Respir Med. 2013;107(8):1141–1151. https://doi.org/10.1016/J.RMED.2013.04.017.Braunstahl G.J., Chen C.W., Maykut R., Georgiou P., Peachey G., Bruce J. The eXpeRience registry: the “real-world” effectiveness of omalizumab in allergic asthma. Respir Med. 2013;107(8):1141–1151. https://doi.org/10.1016/J.RMED.2013.04.017.Al-Ahmad M., Arifhodzic N., Nurkic J., Maher A., Rodriguez-Bouza T., Al-Ahmed N. et al. “Real-life” Efficacy and Safety Aspects of 4-Year Omalizumab Treatment for Asthma. Med Princ Pract. 2018;27(3):260–266. https://doi.org/10.1159/000487482Al-Ahmad M., Arifhodzic N., Nurkic J., Maher A., Rodriguez-Bouza T., Al-Ahmed N. et al. “Real-life” Efficacy and Safety Aspects of 4-Year Omalizumab Treatment for Asthma. Med Princ Pract. 2018;27(3):260–266. https://doi.org/10.1159/000487482Canonica G.W., Colombo G.L., Rogliani P., Santus P., Pitotti C., Di Matteo S. et al. Omalizumab for Severe Allergic Asthma Treatment in Italy: A Cost-Effectiveness Analysis from PROXIMA Study. Risk Manag Healthc Policy. 2020;13:43–53. https://doi.org/10.2147/RMHP.S211321.Canonica G.W., Colombo G.L., Rogliani P., Santus P., Pitotti C., Di Matteo S. et al. Omalizumab for Severe Allergic Asthma Treatment in Italy: A Cost-Effectiveness Analysis from PROXIMA Study. Risk Manag Healthc Policy. 2020;13:43–53. https://doi.org/10.2147/RMHP.S211321.Caminati M., Senna G., Guerriero M., Dama A.R., Chieco-Bianchi F., Stefanizzi G. et al. Omalizumab for severe allergic asthma in clinical trials and real-life studies: what we know and what we should address. Pulm Pharmacol Ther. 2015;31:28–35. https://doi.org/10.1016/J.PUPT.2015.01.006.Caminati M., Senna G., Guerriero M., Dama A.R., Chieco-Bianchi F., Stefanizzi G. et al. Omalizumab for severe allergic asthma in clinical trials and real-life studies: what we know and what we should address. Pulm Pharmacol Ther. 2015;31:28–35. https://doi.org/10.1016/J.PUPT.2015.01.006.

The authors declare that there are no conflicts of interest present.