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. FominaRussian 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
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
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
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
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
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
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
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
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
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