Efficacy of benralizumab in severe eosinophilic asthma: results of a real clinical practice prospective study BEST in Russia
Эффективность бенрализумаба при тяжелой эозинофильной бронхиальной астме: результаты проспективного исследования BEST в условиях реальной клинической практики в России
Fomina D.S. Ignatova G.L. Kabanova T.G. Kameleva A.A. Kozyreva L.S. Kosyakova N.I. Kudelya L.M. Kuzubova N.A. Leshсhenko I.V. Shulzhenko L.V.
2024Pulmonology LLC
Pulmonologiya
2024#34Issue 3441 - 453 pp.
The study of the efficacy of biological therapy in patients with severe bronchial asthma in real world settings is a relevant task since observational research programs allow answering questions that fall out of focus with a strict selection of patients in RCT. Multicenter studies are prioritized because they allow combining and systematizing additional previously undescribed data in a wider population. The aim of the BEST study (Real World Evidence of Benralizumab in Eosinophilic Severe AsThma in Russia) was to confirm the clinical effectiveness of benralizumab regarding change of disease control and quality of life (QoL) level associated with respiratory status in patients with eosinophilic phenotype of uncontrolled severe asthma in real clinical practice in Russia. Methods. An open-label non-randomised multicenter study was conducted involving 59 adult patients with severe eosinophilic asthma. Benralizumab was prescribed according to indications used in routine practice in addition to maintenance therapy. The duration of follow-up was 56 weeks. Disease control level was assessed using the Asthma Control Questionnaire-5 (ACQ-5), and QoL associated with respiratory status was assessed using the St. George’s Respiratory Questionnaire (SGRQ). Patients’ Global Impression of Change (PGIC) and Patients’ Global Impression of Severity (PGIS) were used for subjective assessments of the well-being of patients. The frequency of exacerbations, usage of systemic corticosteroids (SCS), and functional parameters were also evaluated. Results. The use of benralizumab led to a clinically significant improvement in ACQ-5 and SGRQ scores, a significant decrease in the frequency of exacerbations and a significant increase in pre- and post-bronchodilation FEV1 and FVC. There was an improvement in the well-being of patients according to the PGIC and PGIS scales. The SCS dose did not change. The therapeutic effect of benralizumab occurred quickly and persisted throughout the whole study, demonstrating the most significant changes in effectiveness values by the 56th week of treatment. Conclusion. The use of benralizumab in real clinical practice significantly improved the control of severe eosinophilic asthma and QoL of patients and was associated with a favorable safety profile.
benralizumab , biological agents , severe eosinophilic asthma (SEA)
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Federal State Autonomous Educational Institution of Higher Education I.M.Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), ul. Trubetskaya 8, build. 2, Moscow, 119991, Russian Federation
State Budgetary Healthcare Institution of Moscow City “Moscow City Clinical Hospital 52”, Moscow Department of Health, ul. Pekhotnaya 3, Moscow, 123182, Russian Federation
Non-profit Joint Stock Company “Astana Medical University”, Ministry of Health of the Republic of Kazakhstan, ul. Beibitshilik 49a, Astana, 010000, Kazakhstan
Federal State Budgetary Educational Institution of Higher Education “South Ural State Medical University”, Ministry of Healthcare of Russian Federation, ul. Vorovskogo 64, Chelyabinsk, 454092, Russian Federation
State Budgetary Health Institution of the Moscow Region “Moscow Regional Research Clinical Institute named after M.F.Vladimirsky”, ul. Shchepkina 61/2, Moscow, 129110, Russian Federation
State Budgetary Healthcare Institution, the City of Moscow “City Clinical Hospital named after D.D.Pletnev of Moscow Department of Health”, ul. Odinnadtsataya Parkovaya 32, Moscow, 105077, Russian Federation
Federal State Budgetary Educational Institution of Higher Education “Bashkir State Medical University”, Ministry of Healthcare of Russian Federation, ul. Lenina 3, Republic of Bashkortostan, Ufa, 450000, Russian Federation
Federal State Budgetary Institution of Science, Federal Research Center “Pushchino Scientific Center for Biological Research, the Russian Academy of Sciences”, Ministry of Science and Higher Education of the Russian Federation, Prospekt Nauki 3, Moscow Region, Pushchino, 142290, Russian Federation
Federal State Budgetary Educational Institution of Higher Education “Novosibirsk State Medical University”, Ministry of Healthcare of Russian Federation, Krasnyy Prospekt 52, Novosibirsk, 630091, Russian Federation
Federal State Budgetary Educational Institution of Higher Education “Academician I.P.Pavlov First St. Petersburg State Medical University”, the Ministry of Healthcare of Russian Federation, ul. L`va Tolstogo 6 – 8, Saint-Petersburg, 197022, Russian Federation
Federal State Budget Educational Institution of Higher Education “Ural State Medical University”, the Ministry of Health of the Russian Federation, ul. Repina 3, Ekaterinburg, 620028, Russian Federation
Ural Research Institute of Phthisiopulmonology – a Branch of National Medical Research Center for Phthisiology, Pulmonology and Infectious Diseases, Healthcare Ministry of Russia, ul. 22-go Parts’ezda 50, Ekaterinburg, 620039, Russian Federation
Limited Liability Company “Novaya bol’nitsa” Clinical Association, ul. Zavodskaya 29, Ekaterinburg, 620109, Russian Federation
Federal State Budgetary Educational Institution of Higher Education “Kuban State Medical University”, the Ministry of Health of the Russian Federation, ul. Mitrofana Sedina 4, Krasnodar, 350063, Russian Federation
Federal Budgetary Healthcare Institution “Research Institute, Regional Hospital No.1. Named after S.V.Ochapovskiy”, ul. Pervogo Maya 167, Krasnodar, 360086, Russian Federation
Federal State Autonomous Educational Institution of Higher Education I.M.Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
State Budgetary Healthcare Institution of Moscow City “Moscow City Clinical Hospital 52”
Non-profit Joint Stock Company “Astana Medical University”
Federal State Budgetary Educational Institution of Higher Education “South Ural State Medical University”
State Budgetary Health Institution of the Moscow Region “Moscow Regional Research Clinical Institute named after M.F.Vladimirsky”
State Budgetary Healthcare Institution
Federal State Budgetary Educational Institution of Higher Education “Bashkir State Medical University”
Federal State Budgetary Institution of Science
Federal State Budgetary Educational Institution of Higher Education “Novosibirsk State Medical University”
Federal State Budgetary Educational Institution of Higher Education “Academician I.P.Pavlov First St. Petersburg State Medical University”
Federal State Budget Educational Institution of Higher Education “Ural State Medical University”
Ural Research Institute of Phthisiopulmonology – a Branch of National Medical Research Center for Phthisiology
Limited Liability Company “Novaya bol’nitsa” Clinical Association
Federal State Budgetary Educational Institution of Higher Education “Kuban State Medical University”
Federal Budgetary Healthcare Institution “Research Institute
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