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Эффективность и безопасность иммунобиологических препаратов у пациентов с тяжелой бронхиальной астмой в реальной клинической практике - Журнал Терапевтический архив №3 Вопросы пульмонологии 2024
Эффективность и безопасность иммунобиологических препаратов у пациентов с тяжелой бронхиальной астмой в реальной клинической практике
Сергеева Г.Р., Емельянов А.В. Эффективность и безопасность иммунобиологических препаратов у пациентов с тяжелой бронхиальной астмой в реальной клинической практике. Терапевтический архив. 2024;96(3):240–245. DOI: 10.26442/00403660.2024.03.202626
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
DOI: 10.26442/00403660.2024.03.202626
© ООО «КОНСИЛИУМ МЕДИКУМ», 2024 г.
________________________________________________
DOI: 10.26442/00403660.2024.03.202626
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Аннотация
Цель. Провести оценку эффективности и безопасности препаратов моноклональных антител у пациентов с тяжелой бронхиальной астмой (ТБА) в пятилетнем проспективном наблюдении.
Материалы и методы. Всего 129 взрослых амбулаторных пациентов (мужчин 29%) с ТБА в возрасте от 18 до 81 года обследованы в течение 5 лет с интервалами 3–6 мес. Стандартную терапию (ингаляционные глюкокортикостероиды / длительно действующие b2-адреномиметики ± длительно действующие холинолитики ± монтелукаст ± системные глюкокортикостероиды) получали 85 больных, у 44 пациентов применялось дополнительное лечение иммунобиологическими препаратами (омализумабом – 9 человек, меполизумабом – 8, бенрализумабом – 11, дупилумабом – 16). Исследование функции легких выполняли методом спирометрии с оценкой обратимости обструкции (спирограф 2120 Vitalograph, Великобритания). Содержание эозинофилов в периферической крови определялось импедансным методом на автоматическом гемоанализаторе. Оксид азота выдыхаемого воздуха измерялся на хемилюминесцентном газоанализаторе LR4100, Logan Research (Великобритания). Контроль БА и качество жизни пациентов оценивались при помощи русскоязычных версий теста ACQ-5 и SGRQ (респираторного вопросника госпиталя Святого Георгия).
Результаты. Использование биологических препаратов приводило к более выраженному снижению числа обострений, поддерживающей дозы пероральных глюкокортикостероидов, улучшению контроля ТБА, показателей функции легких, качества жизни, уменьшению уровня эозинофилов в крови и оксида азота выдыхаемого воздуха, чем при стандартной терапии. При назначении моноклональных антител системных нежелательных явлений не зарегистрировано. Местные реакции (отек, гиперемия, зуд в месте инъекции) возникли у 14% пациентов.
Заключение. Длительное назначение биологических препаратов в дополнение к стандартной терапии у пациентов с ТБА характеризуется высокой эффективностью и благоприятным профилем безопасности.
Ключевые слова: тяжелая бронхиальная астма, биологическая терапия, реальная клиническая практика
Materials and methods. We recruited 129 adult outpatients (29% males) aged 18–81 yrs with severe asthma were followed up during 5 yrs and were examined for every 3–6 months. Eighty five patients were treated by conventional therapy (ICS/LABA ± tiotropium, montelukast, OCS) only and 44 pts additionally received biologicals (оmalizumab – 9 pts, мepolizumab – 8 pts, benralizumab – 11 pts, dupilumab – 16 pts). Pulmonary function tests were measured by dry spirometer (2120, Vitalograph Ltd., UK). Eosinophil count in blood was assessed by automatic haemoanalyser. Fraction of exhaled nitric oxide was measured by a chemiluminescence analyzer (LR4100; Logan Research, UK). Asthma control and quality of life were assessed by using Russian versions of ACQ-5 and SGRQ.
Results. The use of biologicals led to a more significant reduction of exacerbations and OCS use, improvement of lung function, asthma control and quality of life, decrease of eosinophil and fraction of exhaled nitric oxide than conventional therapy of severe asthma (p<0.05). Systemic side effects were not registered, frequency of local adverse reactions (edema, hyperemia and itching at injection site) was 14%.
Conclusion. Long-term use of biologicals added to conventional therapy in patients with severe asthma is characterized by high effectiveness and favorable safety profile.
Keywords: severe asthma, biological therapy, real clinical practice
Материалы и методы. Всего 129 взрослых амбулаторных пациентов (мужчин 29%) с ТБА в возрасте от 18 до 81 года обследованы в течение 5 лет с интервалами 3–6 мес. Стандартную терапию (ингаляционные глюкокортикостероиды / длительно действующие b2-адреномиметики ± длительно действующие холинолитики ± монтелукаст ± системные глюкокортикостероиды) получали 85 больных, у 44 пациентов применялось дополнительное лечение иммунобиологическими препаратами (омализумабом – 9 человек, меполизумабом – 8, бенрализумабом – 11, дупилумабом – 16). Исследование функции легких выполняли методом спирометрии с оценкой обратимости обструкции (спирограф 2120 Vitalograph, Великобритания). Содержание эозинофилов в периферической крови определялось импедансным методом на автоматическом гемоанализаторе. Оксид азота выдыхаемого воздуха измерялся на хемилюминесцентном газоанализаторе LR4100, Logan Research (Великобритания). Контроль БА и качество жизни пациентов оценивались при помощи русскоязычных версий теста ACQ-5 и SGRQ (респираторного вопросника госпиталя Святого Георгия).
Результаты. Использование биологических препаратов приводило к более выраженному снижению числа обострений, поддерживающей дозы пероральных глюкокортикостероидов, улучшению контроля ТБА, показателей функции легких, качества жизни, уменьшению уровня эозинофилов в крови и оксида азота выдыхаемого воздуха, чем при стандартной терапии. При назначении моноклональных антител системных нежелательных явлений не зарегистрировано. Местные реакции (отек, гиперемия, зуд в месте инъекции) возникли у 14% пациентов.
Заключение. Длительное назначение биологических препаратов в дополнение к стандартной терапии у пациентов с ТБА характеризуется высокой эффективностью и благоприятным профилем безопасности.
Ключевые слова: тяжелая бронхиальная астма, биологическая терапия, реальная клиническая практика
________________________________________________
Materials and methods. We recruited 129 adult outpatients (29% males) aged 18–81 yrs with severe asthma were followed up during 5 yrs and were examined for every 3–6 months. Eighty five patients were treated by conventional therapy (ICS/LABA ± tiotropium, montelukast, OCS) only and 44 pts additionally received biologicals (оmalizumab – 9 pts, мepolizumab – 8 pts, benralizumab – 11 pts, dupilumab – 16 pts). Pulmonary function tests were measured by dry spirometer (2120, Vitalograph Ltd., UK). Eosinophil count in blood was assessed by automatic haemoanalyser. Fraction of exhaled nitric oxide was measured by a chemiluminescence analyzer (LR4100; Logan Research, UK). Asthma control and quality of life were assessed by using Russian versions of ACQ-5 and SGRQ.
Results. The use of biologicals led to a more significant reduction of exacerbations and OCS use, improvement of lung function, asthma control and quality of life, decrease of eosinophil and fraction of exhaled nitric oxide than conventional therapy of severe asthma (p<0.05). Systemic side effects were not registered, frequency of local adverse reactions (edema, hyperemia and itching at injection site) was 14%.
Conclusion. Long-term use of biologicals added to conventional therapy in patients with severe asthma is characterized by high effectiveness and favorable safety profile.
Keywords: severe asthma, biological therapy, real clinical practice
Полный текст
Список литературы
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10. Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):651-9. DOI:10.1016/S0140-6736(12)60988-X
11. Ortega HG, Liu MC, Pavord ID, et al; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-207. DOI:10.1056/NEJMoa1403290
12. Castro M, Zangrilli J, Wechsler ME, 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;3(5):355-66. DOI:10.1016/S2213-2600(15)00042-9
13. Busse WW, Maspero JF, Rabe KF, et al. Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma. Adv Ther. 2018;35(5):737-48. DOI:10.1007/s12325-018-0702-4
14. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-27.
DOI:10.1016/S0140-6736(16)31324-1
15. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-41.
DOI:10.1016/S0140-6736(16)31322-8
16. Bel EH, Wenzel SE, Thompson PJ, et al; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189-97. DOI:10.1056/NEJMoa1403291
17. Nair P, Wenzel S, Rabe KF, et al; ZONDA Trial Investigators. Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017;376(25):2448-58. DOI:10.1056/NEJMoa1703501
18. Rabe KF, Nair P, Brusselle G, et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018;378(26):2475-85. DOI:10.1056/NEJMoa1804093
19. Menzies-Gow A, Gurnell M, Heaney LG, et al. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2022;10(1):47-58. DOI:10.1016/S2213-2600(21)00352-0
20. Khatri S, Moore W, Gibson PG, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019;143(5):1742-51.e7. DOI:10.1016/j.jaci.2018.09.033
21. Korn S, Bourdin A, Chupp G, et al. Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years. J Allergy Clin Immunol Pract. 2021;9(12):4381-92.e4. DOI:10.1016/j.jaip.2021.07.058
22. Wechsler ME, Ford LB, Maspero JF, et al. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2022;10(1):11-25. DOI:10.1016/S2213-2600(21)00322-2
23. Price D, Brusselle G, Roche N, et al. Real-world research and its importance in respiratory medicine. Breathe (Sheff). 2015;11(1):26-38. DOI:10.1183/20734735.015414
24. Bilò MB, Antonicelli L, Carone M, et al. Severe asthma management in the era of biologics: insights of the Italian Registry on Severe Asthma (IRSA). Eur Ann Allergy Clin Immunol. 2021;53(3):103-14. DOI:10.23822/EurAnnACI.1764-1489.196
25. Hardtstock F, Krieger J, Wilke T, et al. Use of Biologic Therapies in the Treatment of Asthma – A Comparative Real World Data Analysis on Healthcare Resource Utilization and Costs Before and After Therapy Initiation. J Asthma Allergy. 2022;15:407-18. DOI:10.2147/JAA.S354062
26. Nenasheva N, Belevsky A, Kravchenko N, et al. Preliminary analysis of the data of patients with severe bronchial asthma included in the Russian National Register of Severe Asthma (RSAR). Eur Respir J. 2019;54(Suppl. 63):PA4261. DOI:10.1183/13993003.congress-2019.PA4261
27. Wang E, Wechsler ME, Tran TN, et al. Characterization of Severe Asthma Worldwide: Data From the International Severe Asthma Registry. Chest. 2020;157(4):790-804. DOI:10.1016/j.chest.2019.10.053
28. Sweeney J, Patterson CC, Menzies-Gow A, et al; British Thoracic Society Difficult Asthma Network. Comorbidity in severe asthma requiring systemic corticosteroid therapy: cross-sectional data from the Optimum Patient Care Research Database and the British Thoracic Difficult Asthma Registry. Thorax. 2016;71(4):339-46. DOI:10.1136/thoraxjnl-2015-207630
2. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43(2):343-73. DOI:10.1183/09031936.00202013
3. Holguin F, Cardet JC, Chung KF, et al. Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2020;55(1):1900588. DOI:10.1183/13993003.00588-2019
4. Bronkhial'naia astma. Klinicheskie rekomendatsii. Rossiiskoe respiratornoe obshchestvo, Rossiiskaia assotsiatsiia allergologov i klinicheskikh immunologov, Soiuz pediatrov Rossii. 2021 (in Russian).
5. Emelyanov AV, Leshenkova EV, Sergeeva GR, Tsukanova IV. Modern treatment of bronchial asthma. Therapy. 2022;8(1):133-41 (in Russian). DOI:10.18565/therapy.2022.1.133-141
6. Dweik RA, Boggs PB, Erzurum SC, et al; American Thoracic Society Committee on Interpretation of Exhaled Nitric Oxide Levels (FENO) for Clinical Applications. An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications. Am J Respir Crit Care Med. 2011;184(5):602-15. DOI:10.1164/rccm.9120-11ST
7. Agache I, Beltran J, Akdis C, et al. Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines – recommendations on the use of biologicals in severe asthma. Allergy. 2020;75(5):1023-42. DOI:10.1111/all.14221
8. 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. DOI:10.1164/rccm.200312-1651OC
9. Brusselle G, Michils A, Louis R, et al. „Real-life“ effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study. Respir Med. 2009;103(11):1633-42. DOI:10.1016/j.rmed.2009.06.014
10. Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):651-9. DOI:10.1016/S0140-6736(12)60988-X
11. Ortega HG, Liu MC, Pavord ID, et al; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-207. DOI:10.1056/NEJMoa1403290
12. Castro M, Zangrilli J, Wechsler ME, 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;3(5):355-66. DOI:10.1016/S2213-2600(15)00042-9
13. Busse WW, Maspero JF, Rabe KF, et al. Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma. Adv Ther. 2018;35(5):737-48. DOI:10.1007/s12325-018-0702-4
14. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-27.
DOI:10.1016/S0140-6736(16)31324-1
15. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-41.
DOI:10.1016/S0140-6736(16)31322-8
16. Bel EH, Wenzel SE, Thompson PJ, et al; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189-97. DOI:10.1056/NEJMoa1403291
17. Nair P, Wenzel S, Rabe KF, et al; ZONDA Trial Investigators. Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017;376(25):2448-58. DOI:10.1056/NEJMoa1703501
18. Rabe KF, Nair P, Brusselle G, et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018;378(26):2475-85. DOI:10.1056/NEJMoa1804093
19. Menzies-Gow A, Gurnell M, Heaney LG, et al. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2022;10(1):47-58. DOI:10.1016/S2213-2600(21)00352-0
20. Khatri S, Moore W, Gibson PG, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019;143(5):1742-51.e7. DOI:10.1016/j.jaci.2018.09.033
21. Korn S, Bourdin A, Chupp G, et al. Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years. J Allergy Clin Immunol Pract. 2021;9(12):4381-92.e4. DOI:10.1016/j.jaip.2021.07.058
22. Wechsler ME, Ford LB, Maspero JF, et al. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2022;10(1):11-25. DOI:10.1016/S2213-2600(21)00322-2
23. Price D, Brusselle G, Roche N, et al. Real-world research and its importance in respiratory medicine. Breathe (Sheff). 2015;11(1):26-38. DOI:10.1183/20734735.015414
24. Bilò MB, Antonicelli L, Carone M, et al. Severe asthma management in the era of biologics: insights of the Italian Registry on Severe Asthma (IRSA). Eur Ann Allergy Clin Immunol. 2021;53(3):103-14. DOI:10.23822/EurAnnACI.1764-1489.196
25. Hardtstock F, Krieger J, Wilke T, et al. Use of Biologic Therapies in the Treatment of Asthma – A Comparative Real World Data Analysis on Healthcare Resource Utilization and Costs Before and After Therapy Initiation. J Asthma Allergy. 2022;15:407-18. DOI:10.2147/JAA.S354062
26. Nenasheva N, Belevsky A, Kravchenko N, et al. Preliminary analysis of the data of patients with severe bronchial asthma included in the Russian National Register of Severe Asthma (RSAR). Eur Respir J. 2019;54(Suppl. 63):PA4261. DOI:10.1183/13993003.congress-2019.PA4261
27. Wang E, Wechsler ME, Tran TN, et al. Characterization of Severe Asthma Worldwide: Data From the International Severe Asthma Registry. Chest. 2020;157(4):790-804. DOI:10.1016/j.chest.2019.10.053
28. Sweeney J, Patterson CC, Menzies-Gow A, et al; British Thoracic Society Difficult Asthma Network. Comorbidity in severe asthma requiring systemic corticosteroid therapy: cross-sectional data from the Optimum Patient Care Research Database and the British Thoracic Difficult Asthma Registry. Thorax. 2016;71(4):339-46. DOI:10.1136/thoraxjnl-2015-207630
2. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43(2):343-73. DOI:10.1183/09031936.00202013
3. Holguin F, Cardet JC, Chung KF, et al. Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2020;55(1):1900588. DOI:10.1183/13993003.00588-2019
4. Бронхиальная астма. Клинические рекомендации. Российское респираторное общество, Российская ассоциация аллергологов и клинических иммунологов, Союз педиатров России. 2021 [Bronkhial'naia astma. Klinicheskie rekomendatsii. Rossiiskoe respiratornoe obshchestvo, Rossiiskaia assotsiatsiia allergologov i klinicheskikh immunologov, Soiuz pediatrov Rossii. 2021 (in Russian)].
5. Емельянов А.В., Лешенкова Е.В., Сергеева Г.Р., Цуканова И.В. Актуальные вопросы лечения бронхиальной астмы. Терапия. 2022;8(1):133-41 [Emelyanov AV, Leshenkova EV, Sergeeva GR, Tsukanova IV. Modern treatment of bronchial asthma. Therapy. 2022;8(1):133-41 (in Russian)]. DOI:10.18565/therapy.2022.1.133-141
6. Dweik RA, Boggs PB, Erzurum SC, et al; American Thoracic Society Committee on Interpretation of Exhaled Nitric Oxide Levels (FENO) for Clinical Applications. An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications. Am J Respir Crit Care Med. 2011;184(5):602-15. DOI:10.1164/rccm.9120-11ST
7. Agache I, Beltran J, Akdis C, et al. Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines – recommendations on the use of biologicals in severe asthma. Allergy. 2020;75(5):1023-42. DOI:10.1111/all.14221
8. 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. DOI:10.1164/rccm.200312-1651OC
9. Brusselle G, Michils A, Louis R, et al. „Real-life“ effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study. Respir Med. 2009;103(11):1633-42. DOI:10.1016/j.rmed.2009.06.014
10. Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):651-9. DOI:10.1016/S0140-6736(12)60988-X
11. Ortega HG, Liu MC, Pavord ID, et al; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-207. DOI:10.1056/NEJMoa1403290
12. Castro M, Zangrilli J, Wechsler ME, 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;3(5):355-66. DOI:10.1016/S2213-2600(15)00042-9
13. Busse WW, Maspero JF, Rabe KF, et al. Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma. Adv Ther. 2018;35(5):737-48. DOI:10.1007/s12325-018-0702-4
14. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-27.
DOI:10.1016/S0140-6736(16)31324-1
15. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-41.
DOI:10.1016/S0140-6736(16)31322-8
16. Bel EH, Wenzel SE, Thompson PJ, et al; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189-97. DOI:10.1056/NEJMoa1403291
17. Nair P, Wenzel S, Rabe KF, et al; ZONDA Trial Investigators. Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017;376(25):2448-58. DOI:10.1056/NEJMoa1703501
18. Rabe KF, Nair P, Brusselle G, et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018;378(26):2475-85. DOI:10.1056/NEJMoa1804093
19. Menzies-Gow A, Gurnell M, Heaney LG, et al. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2022;10(1):47-58. DOI:10.1016/S2213-2600(21)00352-0
20. Khatri S, Moore W, Gibson PG, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019;143(5):1742-51.e7. DOI:10.1016/j.jaci.2018.09.033
21. Korn S, Bourdin A, Chupp G, et al. Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years. J Allergy Clin Immunol Pract. 2021;9(12):4381-92.e4. DOI:10.1016/j.jaip.2021.07.058
22. Wechsler ME, Ford LB, Maspero JF, et al. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2022;10(1):11-25. DOI:10.1016/S2213-2600(21)00322-2
23. Price D, Brusselle G, Roche N, et al. Real-world research and its importance in respiratory medicine. Breathe (Sheff). 2015;11(1):26-38. DOI:10.1183/20734735.015414
24. Bilò MB, Antonicelli L, Carone M, et al. Severe asthma management in the era of biologics: insights of the Italian Registry on Severe Asthma (IRSA). Eur Ann Allergy Clin Immunol. 2021;53(3):103-14. DOI:10.23822/EurAnnACI.1764-1489.196
25. Hardtstock F, Krieger J, Wilke T, et al. Use of Biologic Therapies in the Treatment of Asthma – A Comparative Real World Data Analysis on Healthcare Resource Utilization and Costs Before and After Therapy Initiation. J Asthma Allergy. 2022;15:407-18. DOI:10.2147/JAA.S354062
26. Nenasheva N, Belevsky A, Kravchenko N, et al. Preliminary analysis of the data of patients with severe bronchial asthma included in the Russian National Register of Severe Asthma (RSAR). Eur Respir J. 2019;54(Suppl. 63):PA4261. DOI:10.1183/13993003.congress-2019.PA4261
27. Wang E, Wechsler ME, Tran TN, et al. Characterization of Severe Asthma Worldwide: Data From the International Severe Asthma Registry. Chest. 2020;157(4):790-804. DOI:10.1016/j.chest.2019.10.053
28. Sweeney J, Patterson CC, Menzies-Gow A, et al; British Thoracic Society Difficult Asthma Network. Comorbidity in severe asthma requiring systemic corticosteroid therapy: cross-sectional data from the Optimum Patient Care Research Database and the British Thoracic Difficult Asthma Registry. Thorax. 2016;71(4):339-46. DOI:10.1136/thoraxjnl-2015-207630
________________________________________________
2. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43(2):343-73. DOI:10.1183/09031936.00202013
3. Holguin F, Cardet JC, Chung KF, et al. Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2020;55(1):1900588. DOI:10.1183/13993003.00588-2019
4. Bronkhial'naia astma. Klinicheskie rekomendatsii. Rossiiskoe respiratornoe obshchestvo, Rossiiskaia assotsiatsiia allergologov i klinicheskikh immunologov, Soiuz pediatrov Rossii. 2021 (in Russian).
5. Emelyanov AV, Leshenkova EV, Sergeeva GR, Tsukanova IV. Modern treatment of bronchial asthma. Therapy. 2022;8(1):133-41 (in Russian). DOI:10.18565/therapy.2022.1.133-141
6. Dweik RA, Boggs PB, Erzurum SC, et al; American Thoracic Society Committee on Interpretation of Exhaled Nitric Oxide Levels (FENO) for Clinical Applications. An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications. Am J Respir Crit Care Med. 2011;184(5):602-15. DOI:10.1164/rccm.9120-11ST
7. Agache I, Beltran J, Akdis C, et al. Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines – recommendations on the use of biologicals in severe asthma. Allergy. 2020;75(5):1023-42. DOI:10.1111/all.14221
8. 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. DOI:10.1164/rccm.200312-1651OC
9. Brusselle G, Michils A, Louis R, et al. „Real-life“ effectiveness of omalizumab in patients with severe persistent allergic asthma: The PERSIST study. Respir Med. 2009;103(11):1633-42. DOI:10.1016/j.rmed.2009.06.014
10. Pavord ID, Korn S, Howarth P, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):651-9. DOI:10.1016/S0140-6736(12)60988-X
11. Ortega HG, Liu MC, Pavord ID, et al; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-207. DOI:10.1056/NEJMoa1403290
12. Castro M, Zangrilli J, Wechsler ME, 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;3(5):355-66. DOI:10.1016/S2213-2600(15)00042-9
13. Busse WW, Maspero JF, Rabe KF, et al. Liberty Asthma QUEST: Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Dupilumab Efficacy/Safety in Patients with Uncontrolled, Moderate-to-Severe Asthma. Adv Ther. 2018;35(5):737-48. DOI:10.1007/s12325-018-0702-4
14. Bleecker ER, FitzGerald JM, Chanez P, et al; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2115-27.
DOI:10.1016/S0140-6736(16)31324-1
15. FitzGerald JM, Bleecker ER, Nair P, et al; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016;388(10056):2128-41.
DOI:10.1016/S0140-6736(16)31322-8
16. Bel EH, Wenzel SE, Thompson PJ, et al; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189-97. DOI:10.1056/NEJMoa1403291
17. Nair P, Wenzel S, Rabe KF, et al; ZONDA Trial Investigators. Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017;376(25):2448-58. DOI:10.1056/NEJMoa1703501
18. Rabe KF, Nair P, Brusselle G, et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018;378(26):2475-85. DOI:10.1056/NEJMoa1804093
19. Menzies-Gow A, Gurnell M, Heaney LG, et al. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2022;10(1):47-58. DOI:10.1016/S2213-2600(21)00352-0
20. Khatri S, Moore W, Gibson PG, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019;143(5):1742-51.e7. DOI:10.1016/j.jaci.2018.09.033
21. Korn S, Bourdin A, Chupp G, et al. Integrated Safety and Efficacy Among Patients Receiving Benralizumab for Up to 5 Years. J Allergy Clin Immunol Pract. 2021;9(12):4381-92.e4. DOI:10.1016/j.jaip.2021.07.058
22. Wechsler ME, Ford LB, Maspero JF, et al. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2022;10(1):11-25. DOI:10.1016/S2213-2600(21)00322-2
23. Price D, Brusselle G, Roche N, et al. Real-world research and its importance in respiratory medicine. Breathe (Sheff). 2015;11(1):26-38. DOI:10.1183/20734735.015414
24. Bilò MB, Antonicelli L, Carone M, et al. Severe asthma management in the era of biologics: insights of the Italian Registry on Severe Asthma (IRSA). Eur Ann Allergy Clin Immunol. 2021;53(3):103-14. DOI:10.23822/EurAnnACI.1764-1489.196
25. Hardtstock F, Krieger J, Wilke T, et al. Use of Biologic Therapies in the Treatment of Asthma – A Comparative Real World Data Analysis on Healthcare Resource Utilization and Costs Before and After Therapy Initiation. J Asthma Allergy. 2022;15:407-18. DOI:10.2147/JAA.S354062
26. Nenasheva N, Belevsky A, Kravchenko N, et al. Preliminary analysis of the data of patients with severe bronchial asthma included in the Russian National Register of Severe Asthma (RSAR). Eur Respir J. 2019;54(Suppl. 63):PA4261. DOI:10.1183/13993003.congress-2019.PA4261
27. Wang E, Wechsler ME, Tran TN, et al. Characterization of Severe Asthma Worldwide: Data From the International Severe Asthma Registry. Chest. 2020;157(4):790-804. DOI:10.1016/j.chest.2019.10.053
28. Sweeney J, Patterson CC, Menzies-Gow A, et al; British Thoracic Society Difficult Asthma Network. Comorbidity in severe asthma requiring systemic corticosteroid therapy: cross-sectional data from the Optimum Patient Care Research Database and the British Thoracic Difficult Asthma Registry. Thorax. 2016;71(4):339-46. DOI:10.1136/thoraxjnl-2015-207630
Авторы
Г.Р. Сергеева*, А.В. Емельянов
ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России, Санкт-Петербург, Россия
*sergeevagr@mail.ru
Mechnikov North-Western State Medical University, Saint Petersburg, Russia
*sergeevagr@mail.ru
ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России, Санкт-Петербург, Россия
*sergeevagr@mail.ru
________________________________________________
Mechnikov North-Western State Medical University, Saint Petersburg, Russia
*sergeevagr@mail.ru
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