pulmoПульмонологияPULMONOLOGIYA0869-01892541-9617Scientific and Practical Journal “PULMONOLOGIYA” LLC10.18093/0869-0189-2021-31-5-628-634pulmo-2882Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL STUDIESЭффективность бенрализумаба при лечении эозинофильного фенотипа тяжелой бронхиальной астмы в условиях реальной клинической практикиThe effectiveness of benralizumab in the treatment of the eosinophilic phenotype of severe asthma in real clinical practicehttps://orcid.org/0000-0003-4678-3904ТитоваО. Н.TitovaOlga N.

Титова Ольга Николаевна – д. м. н., профессор, директор Научно-исследовательского института пульмонологии

SPIN-код: 4801-4985

197022, Санкт-Петербург, ул. Льва Толстого, 6–8

тел.: (812) 338-68-40

Olga N. Titova, Doctor of Medicine, Professor, Director of Research Institute of Pulmonology

SPIN-code: 4801-4985

ul. L’va Tolstogo 6 – 8, Saint-Petersburg, 197089

tel.: (812) 338-68-40

titova-on@mail.ruhttps://orcid.org/0000-0002-1166-9717КузубоваН. А.KuzubovaNatalia A.

Кузубова Наталия Анатольевна – д. м. н., заместитель директора по научной работе Научно-исследовательского института пульмонологии

SPIN-код: 4461-0180

197022, Санкт-Петербург, ул. Льва Толстого, 6–8

тел.: (812) 338-66-06

Nataliya A. Kuzubova, Doctor of Medicine, Deputy Director for Research, Research Institute of Pulmonology

ul. L’va Tolstogo 6 – 8, Saint-Petersburg, 197089

tel.: (812) 338-66-06

 

kuzubova@mail.ruhttps://orcid.org/0000-0001-7052-6903СкляроваД. Б.SklyarovaDaria B.

Склярова Дарья Борисовна – к. м. н., старший научный сотрудник Научно-исследовательского института пульмонологии

197022, Санкт-Петербург, ул. Льва Толстого, 6–8

тел.: (812) 417-36-97

Daria B. Sklyarova, Candidate of Medicine, Researcher of Research Institute of Pulmonology

ul. L’va Tolstogo 6 – 8, Saint-Petersburg, 197089

tel.: (812) 417-36-97

darya_sklyarova@mail.ruПетроваМ. А.PetrovaMaria A.

Петрова Мария Анатольевна – д. м. н., профессор, ведущий научный сотрудник Научно-исследовательского института пульмонологии

197022, Санкт-Петербург, ул. Льва Толстого, 6–8

тел.: (812) 417-36-92

Maria A. Petrova, Doctor of Medicine, Professor, Leading researcher of Research Institute of Pulmonology

ul. L’va Tolstogo 6 – 8, Saint-Petersburg, 197089

tel.: (812) 417-36-92

map1946@rambler.ruФедеральное государственное бюджетное образовательное учреждение высшего образования «Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова» Министерства здравоохраненияРоссияFederal State Budgetary Educational Institution of Higher Education “Academician I.P.Pavlov First St. Petersburg State Medical University”, Ministry of HealthcareRussian Federation202120102021315628634Copyright © Титова О.Н., Кузубова Н.А., Склярова Д.Б., Петрова М.А., 20212021Титова О.Н., Кузубова Н.А., Склярова Д.Б., Петрова М.А.Titova O.N., Kuzubova N.A., Sklyarova D.B., Petrova M.A.This work is licensed under a Creative Commons Attribution 4.0 License.https://journal.pulmonology.ru/pulm/article/view/2882

Целью исследования явилась оценка эффективности бенрализумаба у пациентов с эозинофильным фенотипом тяжелой бронхиальной астмы (ТБА) в условиях реальной клинической практики после 1 года терапии.

Материалы и методы

Материалы и методы. На фоне терапии бенрализумабом дважды обследованы больные (n = 13; средний возраст – 55,44 ± 7,18 года) эозинофильной ТБА – до начала лечения и через 1 год терапии бенрализумабом. Оценивались жалобы, анамнез, проводимая терапия, абсолютные значения содержания эозинофилов в крови, показатели спирометрии и опросника по контролю над бронхиальной астмой (БА) (Asthma Control Questionnaire – ACQ-5).

Результаты

Результаты. В анализе крови у всех пациентов исходно отмечена выраженная эозинофилия (577,5 ± 356,4 клеток / мкл). Через 1 год использования бенрализумаба количество эозинофилов снизилось на 96,15 %. На фоне терапии показатель ACQ-5 снизился с 1,63 ± 0,62 до 0,73 ± 0,41 балла, что соответствовало достижению контроля над БА. Объем форсированного выдоха за 1-ю секунду (ОФВ1) увеличился на 23 %. Число обострений снизилось на 58,09 %. До терапии бенрализумабом 12 (92,31 %) пациентов ежедневно принимали пероральные глюкокортикостероиды (оГКС) (10,00 ± 2,17 мг преднизолона). С течением времени у всех обследованных отмечено снижение ночных и дневных симптомов и использования оГКС. У 5 (38,46 %) пациентов удалось добиться полной отмены, у 7 (53,84 %) – снижения дозы оГКС.

Заключение

Заключение. При включении бенрализумаба в терапию эозинофильного фенотипа ТБА значительно снижается уровень эозинофилов в крови, что опосредует улучшение контроля над БА, увеличение ОФВ1, сокращение числа обострений и уменьшение потребности в использовании оГКС. У пациентов, получающих препарат, необходим тщательный контроль над развитием нежелательных явлений терапии в долгосрочном периоде.

To evaluate the effectiveness of benralizumab in patients with the eosinophilic phenotype of severe asthma in real clinical practice after a year of therapy.

Methods

Methods. During Benralizumab therapy, 13 patients with severe eosinophilic asthma (average age – 55.44 ± 7.18 years old) were examined twice: before the treatment and after 1 year of benralizumab therapy. The assessment included collection of complaints, medical history, current therapy, Asthma Control Questionnaire (ACQ-5) test, absolute blood count of eosinophils, spirometry.

Results

Results. All patients initially had pronounced eosinophilia of 577.5 ± 356.4 cells/μl. After 1 year of using benralizumab, the eosinophil count decreased by 96.15%. During therapy, the ACQ-5 index decreased from 1.63 ± 0.62 to 0.73 ± 0.41 in the study patients, which corresponded to the achievement of asthma control. The forced expiratory volume in 1 second (FEV1) increased by 23 %. The number of exacerbations decreased by 58.09%. 12 (92.31%) patients were on oral corticosteroids (OCS) (10 ± 2.17 mg of prednisolone daily) before benralizumab therapy. All subjects noted a decrease in night and day symptoms over time and were able to reduce the use of OCS. 5 (38.46%) patients achieved complete elimination of daily OCS use, 7 (53.84%) patients were able to reduce their daily OCS dose.

Conclusion

Conclusion. Benralizumab therapy as an add-on maintenance treatment in patients with eosinophilic phenotype of severe asthma contributes to a significant decrease in peripheral blood eosinophils, which mediates an improvement in asthma control, an increase in FEV1, a reduction in the number of exacerbations, and a decrease in the need for the OCS usage. Careful monitoring of long-term adverse events is necessary during treatment with benralizumab.

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