medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/ms2023-308medsovet-7881Research ArticleХРОНИЧЕСКИЕ ЗАБОЛЕВАНИЯ ЛЕГКИХCHRONIC PULMONARY DISEASESПрямое сравнительное исследование эффективности меполизумаба и дупилумаба у пациентов с тяжелой неаллергической эозинофильной бронхиальной астмойDirect comparative study of the effectiveness of mepolizumab and dupilumab in patients with severe non-allergic eosinophilic asthmahttps://orcid.org/0000-0002-3028-2657НаумоваВ. В.NaumovaV. V.

Наумова Вероника Викторовна, кандидат медицинских наук, 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

3, Repin St., Ekaterinburg, 620028

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

Бельтюков Евгений Кронидович, член корреспондент РАН, доктор медицинских наук, 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

3, Repin St., Ekaterinburg, 620028

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

Ковтун Ольга Петровна, академик РАН, доктор медицинских наук, профессор, ректор

620028, Екатеринбург, ул. Репина, д. 3

Olga P. Kovtun, Acad. RAS, Dr. Sci. (Med.), Professor, Rector

3, Repin St., Ekaterinburg, 620028

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

Быкова Галина Александровна, кандидат медицинских наук

620028, Екатеринбург, ул. Репина, д. 3

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

3, Repin St., Ekaterinburg, 620028

Center-ao@yandex.ruhttps://orcid.org/0000-0002-0705-6651СмоленскаяО. Г.SmolenskayaO. G.

Смоленская Ольга Георгиевна, доктор медицинских наук, профессор, заведующая кафедрой факультетской терапии, эндокринологии, аллергологии и иммунологии

620028, Екатеринбург, ул. Репина, д. 3

Оlga G. Smolenskaya, Dr. Sci. (Med.), Professor; Head of the Department of Faculty Therapy, Endocrinology, Allergology and Immunology

3, Repin St., Ekaterinburg, 620028

o.smolenskaya@mail.ruhttps://orcid.org/0000-0002-8104-0017ШтановаА. А.ShtanovaA. A.

Штанова Александра Александровна, студен

620028, Екатеринбург, ул. Репина, д. 3

Alexandra A. Shtanova, Student

3, Repin St., Ekaterinburg, 620028

alekshtanova@gmail.comhttps://orcid.org/0000-0001-5365-7792СтепинаД. А.StepinaD. A.

Степина Дарья Артемовна, студент

620028, Екатеринбург, ул. Репина, д. 3

Daria A. Stepina, Student

3, Repin St., Ekaterinburg, 620028

d.stepina37@gmail.comУральский государственный медицинский университетРоссияUrals State Medical UniversityRussian Federation2023151120230201827Copyright © Наумова В.В., Бельтюков Е.К., Ковтун О.П., Быкова Г.А., Смоленская О.Г., Штанова А.А., Степина Д.А., 20232023Наумова В.В., Бельтюков Е.К., Ковтун О.П., Быкова Г.А., Смоленская О.Г., Штанова А.А., Степина Д.А.Naumova V.V., Beltyukov E.K., Kovtun O.P., Bykova G.A., Smolenskaya O.G., Shtanova A.A., Stepina D.A.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/7881Введение

Введение. Генно-инженерные биологические препараты (ГИБП) для лечения тяжелой бронхиальной астмы (ТБА) достаточно широко используются в реальной клинической практике. Но прямых сравнительных исследований на данный момент крайне мало.

Цель

Цель. Сравнить эффективность меполизумаба и дупилумаба у пациентов с неаллергической эозинофильной ТБА в реальной клинической практике на примере территориального регистра Свердловской области.

Материалы и методы

Материалы и методы. Проанализированы данные пациентов с неаллергической эозинофильной ТБА, получавших дупилумаб (n = 23) и меполизумаб (n = 19). Определялась эффективность терапии по системе BARS и доле пациентов, достигших ремиссии ТБА, динамике АСТ-теста, опроснику AQLQ, уровню ОФВ1, эозинофилов крови, кратности применения короткодействующих бронходилататоров (КДБД) и потребности в системных глюкокортикостероидах (СГКС), частоте обострений БА и госпитализаций.

Результаты

Результаты. За 12 месяцев таргетной терапии хороший ответ на терапию по BARS выявлен у 77,8% пациентов на дупилумабе и у 82,4% пациентов на меполизумабе (р = 1,000). Ремиссии ТБА без учета ОФВ1 достигли 62,5% пациентов группы дупилумаба и 68,8% пациентов группы меполизумаба (р = 1,000). Ремиссия ТБА с учетом ОФВ1 достигнута у 43,8% пациентов на дупилумабе и у 56,2% пациентов на меполизумабе (р = 0,724). По всем отдельно анализируемым показателям установлены статистически значимые улучшения в каждой группе наблюдения. Статистически значимые различия через год терапии между группами зарегистрированы по уровню эозинофилов (р < 0,001) и по назальным симптомам, оцененным с помощью опросника SNOT-22 (р = 0,048) в пользу меполизумаба.

Выводы

Выводы. Пациенты с неаллергической эозинофильной ТБА одинаково хорошо отвечают на терапию дупилумабом и меполизумабом. Препараты в равной степени улучшают контроль над заболеванием, качество жизни, уменьшают потребность в КДБД и СГКС, показывают сходный уровень безопасности.

Introduction

Introduction. Biologics for severe asthma (SA) treatment are widely used in real clinical practice. But there are very few direct comparative studies at the moment.

Aim

Aim. To compare mepolizumab and dupilumab effectiveness in patients with non-allergic eosinophilic SA in real clinical practice using regional register of Sverdlovsk region.

Materials and methods

Materials and methods. The data of patients with non-allergic eosinophilic SA treated with dupilumab (n = 23) and mepolizumab (n = 19) were analyzed. Therapy effectiveness was determined according to BARS and patients’ proportion who achieved asthma remission, dynamics of ACT, AQLQ, FEV1, blood eosinophils, frequency of short-acting bronchodilators use and systemic glucocorticosteroids (SGCS) demand, frequency of asthma exacerbations and hospitalizations.

Results

Results. Within 12 months of targeted therapy a good response to biologics according to BARS in 77.8% of patients on dupilumab and in 82.4% of patients on mepolizumab (p = 1.000) was revealed. Remission of SA (without FEV1) was achieved in 62.5% of patients in dupilumab group and in 68.8% of patients in mepolizumab group (p = 1.000). Remission of SA (with FEV1) was achieved in 43.8% of patients on dupilumab and in 56.2% of patients on mepolizumab (p = 0.724). There were statistically significant improvements for all separately analyzed indicators in each observation group. Statistically significant differences after a year of therapy between groups were recorded in terms of eosinophil levels (p < 0.001) and nasal symptoms assessed using the SNOT-22 questionnaire (p = 0.048) in favour of mepolizumab.

Conclusions

Conclusions. Patients with non-allergic eosinophilic SA have good response to both dupilumab and mepolizumab. The drugs equally improve disease control, life quality, reduce the need for relievers and SGCS, show a similar safety level.

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