medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/ms2024-195medsovet-8334Research ArticleХРОНИЧЕСКИЕ ЗАБОЛЕВАНИЯ ЛЕГКИХCHRONIC PULMONARY DISEASESПрямое сравнительное исследование эффективности анти-IgE- и анти-IL4Rα-терапии у пациентов с тяжелой аллергической и смешанной бронхиальной астмойDirect comparative study of anti-IgE and anti-IL4Rα therapy effectiveness in patients with severe allergic and mixed bronchial asthmahttps://orcid.org/0000-0002-3028-2657НаумоваВ. В.NaumovaV. V.

Наумова Вероника Викторовна - к.м.н., доцент кафедры факультетской терапии, эндокринологии, аллергологии и иммунологии.

620028, Екатеринбург, ул. Репина, д. 3

Veronika V. Naumova - Cand. Sci. (Med.), Assistant Professor of the Department of Faculty Therapy, Endocrinology, Allergology and Immunology, Ural State Medical University.

3, Repin St., Ekaterinburg, 620028

nika.naumova@gmail.comhttps://orcid.org/0000-0003-2485-2243БельтюковЕ. К.BeltyukovE. К.

Бельтюков Евгений Кронидович - чл.-корр. РАН, д.м.н., профессор, профессор кафедры факультетской терапии, эндокринологии, аллергологии и иммунологии.

620028, Екатеринбург, ул. Репина, д. 3

Evgeny K. Beltyukov - Corr. Member RAS, Dr. Sci. (Med.), Professor, Professor of the Department of Faculty Therapy, Endocrinology, Allergology and Immunology, Ural State Medical University.

3, Repin St., Ekaterinburg, 620028

asthma@mail.ruhttps://orcid.org/0000-0002-5250-7351КовтунО. П.KovtunО. P.

Ковтун Ольга Петровна - акад. РАН, д.м.н., профессор, ректор.

620028, Екатеринбург, ул. Репина, д. 3

Olga P. Kovtun - Acad. RAS, Dr. Sci. (Med.), Professor, Rector, Ural State Medical University.

3, Repin St., Ekaterinburg, 620028

usma@usma.ruhttps://orcid.org/0000-0003-0823-4605БыковаГ. A.BykovaG. A.

Быкова Галина Александровна - к.м.н., ассистент кафедры факультетской терапии, эндокринологии, аллергологии и иммунологии.

620028, Екатеринбург, ул.Репина, д.3

Galina A. Bykova - Cand. Sci. (Med.), Assistant of the Department of Faculty Therapy, Endocrinology, Allergology and Immunology, Ural State Medical University.

3, Repin St., Ekaterinburg, 620028

Center-ao@yandex.ruhttps://orcid.org/0009-0009-9902-3766ТрошинаВ. И.TroshinaV. I.

Трошина Виктория Игоревна – студент.

620028, Екатеринбург, ул. Репина, д. 3

Viktoriia I. Troshina - Student, Ural State Medical University.

3, Repin St., Ekaterinburg, 620028

viktorytrosh@mail.ruhttps://orcid.org/0009-0001-6446-407XМинееваА. Н.MineevaA. N.

Минеева Алена Николаевна – студент.

620028, Екатеринбург, ул. Репина, д. 3

Alyona N. Mineeva - Student, Ural State Medical University.

3, Repin St., Ekaterinburg, 620028

mineeva.med@gmail.comУральский государственный медицинский университетРоссияUral State Medical UniversityRussian Federation202406062024097486Copyright © Наумова В.В., Бельтюков Е.К., Ковтун О.П., Быкова Г.A., Трошина В.И., Минеева А.Н., 20242024Наумова В.В., Бельтюков Е.К., Ковтун О.П., Быкова Г.A., Трошина В.И., Минеева А.Н.Naumova V.V., Beltyukov E.К., Kovtun О.P., Bykova G.A., Troshina V.I., Mineeva A.N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/8334Введение

Введение. В научных базах данных встречается недостаточное количество прямых сравнительных исследований генно-инженерных биологических препаратов (ГИБП) для лечения тяжелой бронхиальной астмы (ТБА).

Цель

Цель. Сравнить эффективность омализумаба и дупилумаба у пациентов с аллергической и смешанной ТБА в реальной клинической практике.

Материалы и методы

Материалы и методы. В прямое сравнительное исследование вошли больные ТБА с аллергическим компонентом из регионального регистра Свердловской области. Проанализированы данные пациентов с аллергической (n = 68) и смешанной (n = 27) ТБА, получавших омализумаб (n = 62) и дупилумаб (n = 33). Определялась эффективность терапии в течение 12 мес. в общей группе 1, группе аллергической астмы 2 и группе смешанной астмы 3 по показателям: контроль ТБА по АСТ- опроснику (Asthma Control Test), доля пациентов с неконтролируемой астмой, потребность в системных глюкокортикостероидах (СГКС) и быстродействующих бронхолитиках (БДБЛ), объем базисной терапии, количество обострений, вызовов СМП (скорой медицинской помощи) и госпитализаций, объем форсированного выдоха за первую секунду (ОФВ ), оценка качества жизни по опросникам AQLQ (Asthma Quality of Life Questionnaire) и SNOT-22 (Sino-Nasal Outcome Test). Контрольные оценочные визиты проводились до начала терапии, через 4 и 12 мес. приема ГИБП.

Результаты

Результаты. В целом за 12 мес. таргетной терапии у пациентов, получавших омализумаб, статистически значимая положительная динамика наблюдалась по 12 оцениваемым показателям из 13; у пациентов, получавших дупилумаб, – по 9 показателям. При анализе таких показателей, как АСТ, прием СГКС, обострения БА (бронхиальной астмы), ОФВ , выявлена статистически значимая положительная динамика по всем 4 показателям у пациентов, получавших омализумаб в группе 2, и у пациентов, получавших дупилумаб в группе 3.

Выводы

Выводы. Пациенты с аллергическим компонентом ТБА одинаково хорошо отвечают на терапию омализумабом и дупилумабом. При этом выявлена тенденция к преимущественной эффективности таргетной терапии омализумабом у пациентов с аллергической астмой, дупилумабом – у пациентов со смешанным фенотипом заболевания.

Introduction

Introduction. There is insufficiency of direct comparative studies of genetically engineered biological drugs (GEBD) for severe bronchial asthma (SA) treatment in scientific databases.

Aim

Aim. To compare omalizumab and dupilumab effectiveness in patients with allergic and mixed SA in real clinical practice.

Materials and methods

Materials and methods. The direct comparative study included SA patients with an allergic component from regional registry of Sverdlovsk region. The data of patients with allergic (n = 68) and mixed (n = 27) SA treated with omalizumab (n = 62) and dupilumab (n = 33) were analyzed. Therapy effectiveness was determined for 12 months in general group No. 1, allergic asthma group No. 2 and mixed asthma group No. 3 according to the following indicators: asthma control level (ACT), proportion of patients with uncontrolled asthma, need for systemic glucocorticosteroids (SGCS) and short‐acting beta agonists (SABA), basic therapy volume, asthma exacerbations number, emergency calls and hospitalizations, forced expiratory volume in the first second (FEV ), assessment of life quality (AQLQ and SNOT-22). Control evaluation visits were conducted before therapy start, after 4 and 12 months of biologics taking.

Results

Results. In general, during the 12 months of targeted therapy in patients receiving omalizumab statistically significant positive dynamics was observed in 12 of the 13 evaluated indicators; in patients receiving dupilumab – in 9 indicators. When analyzing such indicators as, ACT, taking SGCS, exacerbations of SA, FEV , statistically significant positive dynamics was revealed for all 4 indicators in patients receiving omalizumab in group No. 2 and in patients receiving dupilumab in group No. 3.

Conclusions

Conclusions. Patients with allergic component of SA respond equally well to therapy with omalizumab and dupilumab. At the same time, a tendency towards the advantage of omalizumab in patients with allergic asthma, and dupilumab in patients with a mixed phenotype of the disease was revealed.

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