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Efficacy of benralizumab in severe eosinophilic asthma: results of a real clinical practice prospective study BEST in Russia

https://doi.org/10.18093/0869-0189-2024-34-3-441-453

Abstract

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.

About the Authors

D. S. Fomina
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”, Moscow Department of Health; Non-profit Joint Stock Company “Astana Medical University”, Ministry of Health of the Republic of Kazakhstan
Russian Federation

Daria S. Fomina, Candidate of Medicine, Associate Professor, Allergist-immunologist, Associate Professor, Department of Clinical Allergology аnd Immunology; Head of Moscow City Scientific and Practical Center of Allergology and Immunology

ul. Trubetskaya 8, build. 2, Moscow, 119991

ul. Pekhotnaya 3, Moscow, 123182

ul. Beibitshilik 49a, Astana, 010000

tel.: (499) 196-19-54


Competing Interests:

The authors declare no conflict of interest



G. L. Ignatova
Federal State Budgetary Educational Institution of Higher Education “South Ural State Medical University”, Ministry of Healthcare of Russian Federation
Russian Federation

Galina L. Ignatova, Doctor of Medicine, Professor, Head of Department of Therapy, Institute of Postgraduate Physician Training

ul. Vorovskogo 64, Chelyabinsk, 454092

tel.: (951) 238-20-71


Competing Interests:

The authors declare no conflict of interest



T. G. Kabanova
State Budgetary Health Institution of the Moscow Region “Moscow Regional Research Clinical Institute named after M.F.Vladimirsky”
Russian Federation

Tatiana G. Kabanova, Candidate of Medicine, Head of Multidisciplinary Day Hospital

ul. Shchepkina 61/2, Moscow, 129110

tel.: (903) 273-18-88


Competing Interests:

The authors declare no conflict of interest



A. A. Kameleva
State Budgetary Healthcare Institution of the City of Moscow “City Clinical Hospital named after D.D.Pletnev of Moscow Department of Health”
Russian Federation

Anastasia A. Kameleva, Candidate of Medicine, Allergologist-Immunologist

ul. Odinnadtsataya Parkovaya 32, Moscow, 105077

tel.: (916) 854-53-93


Competing Interests:

The authors declare no conflict of interest



L. S. Kozyreva
Federal State Budgetary Educational Institution of Higher Education “Bashkir State Medical University”, Ministry of Healthcare of Russian Federation
Russian Federation

Liliya S. Kozyreva, Candidate of Medicine, Associate Professor, Department of Therapy and General Medical Practice with a Geriatrics Course, Institute of Additional Professional Education, Head of the Department of Pulmonology at the Clinic; Chief Freelance Pulmonologist

ul. Lenina 3, Ufa, 450000, Republic of Bashkortostan

тел.: (917) 414-22-96


Competing Interests:

The authors declare no conflict of interest



N. I. Kosyakova
Federal State Budgetary Institution of Science, Federal Research Center “Pushchino Scientific Center for Biological Research of the Russian Academy of Sciences”, Ministry of Science and Higher Education of the Russian Federation
Russian Federation

Ninel I. Kosyakova, Doctor of Medicine, Deputy Chief Physician for Science, Head of the Department of Immunology and Allergology of the Hospital

Prospekt Nauki 3, Moscow Region, Pushchino, 142290

tel.: (916) 469-69-19


Competing Interests:

The authors declare no conflict of interest



L. M. Kudelya
Federal State Budgetary Educational Institution of Higher Education “Novosibirsk State Medical University”, Ministry of Healthcare of Russian Federation
Russian Federation

Lyubov M. Kudelya, Doctor of Medicine, Professor, Department of Internal Diseases named after Academician L.D.Sidorova; Chief Pulmonologist of the Novosibirsk region

Krasnyy Prospekt 52, Novosibirsk, 630091

тел.: (383) 315-97-07


Competing Interests:

The authors declare no conflict of interest



N. A. Kuzubova
Federal State Budgetary Educational Institution of Higher Education “Academician I.P.Pavlov First St. Petersburg State Medical University” of the Ministry of Healthcare of Russian Federation
Russian Federation

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

ul. L`va Tolstogo 6 – 8, Saint-Petersburg, 197022

tel.: (812) 338-66-16


Competing Interests:

The authors declare no conflict of interest



I. V. Leshсhenko
Federal State Budget Educational Institution of Higher Education “Ural State Medical University” of the Ministry of Health of the Russian Federation; Ural Research Institute of Phthisiopulmonology – a Branch of National Medical Research Center for Phthisiology, Pulmonology and Infectious Diseases, Healthcare Ministry of Russia; Limited Liability Company “Novaya bol’nitsa” Clinical Association
Russian Federation

Igor V. Leshсhenko, Doctor of Medicine, Professor, Department of Phthisiology
and Pulmonology; Chief Researcher; Scientific Director

ul. Repina 3, Ekaterinburg, 620028

ul. 22-go Parts’ezda 50, Ekaterinburg, 620039

ul. Zavodskaya 29, Ekaterinburg, 620109

tel.: (343) 246-44-75


Competing Interests:

The authors declare no conflict of interest



L. V. Shulzhenko
Federal State Budgetary Educational Institution of Higher Education “Kuban State Medical University” of the Ministry of Health of the Russian Federation; Federal Budgetary Healthcare Institution “Research Institute – Regional Hospital No.1. Named after S.V.Ochapovskiy”
Russian Federation

Larisa V. Shulzhenko, Doctor of Medicine, Professor, Head of Department of Pulmonology, Faculty of Postgraduate Physician Training; Head of the Department of Pulmonology

ul. Mitrofana Sedina 4, Krasnodar, 350063

ul. Pervogo Maya 167, Krasnodar, 360086

tel.: (861) 252-73-38


Competing Interests:

The authors declare no conflict of interest



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For citations:


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. Efficacy of benralizumab in severe eosinophilic asthma: results of a real clinical practice prospective study BEST in Russia. PULMONOLOGIYA. 2024;34(3):441-453. (In Russ.) https://doi.org/10.18093/0869-0189-2024-34-3-441-453

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ISSN 0869-0189 (Print)
ISSN 2541-9617 (Online)