Эффективность и безопасность моноклональных антител, применяемых в терапии болезни Альцгеймера
Авторы
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Юлия В. Коледова
ФГАУ НМИЦ нейрохирургии им. ак. Н.Н. Бурденко МЗ РФ
https://orcid.org/0000-0003-4185-7150
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Никита И. Бычковский
ФГАУ НМИЦ нейрохирургии им. ак. Н.Н. Бурденко МЗ РФ
https://orcid.org/0009-0009-3749-8408
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Владимир A. Митькевич
Институт молекулярной биологии им. В.А. Энгельгардта
https://orcid.org/0000-0002-1517-1983
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Александр A. Макаров
Институт молекулярной биологии им. В.А. Энгельгардта
https://orcid.org/0000-0001-6220-6969
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Юрий М. Полуэктов
Институт молекулярной биологии им. В.А. Энгельгардта
https://orcid.org/0000-0002-9710-7490
DOI:
https://doi.org/10.18413/rrpharmacology.11.842Аннотация
Введение: Достижения в области молекулярной биологии и биотехнологии способствовали разработке новых терапевтических стратегий лечения болезни Альцгеймера (БА). Значительный интерес среди них представляют моноклональные антитела. Данный класс препаратов привлекает внимание благодаря своей способности целенаправленно влиять на ключевые патологические процессы, а именно накопление амилоидных бляшек и тау-белка в головном мозге, что открывает перспективы для патогенетического подхода к терапии. Целью данного исследования является систематизация данных об эффективности, нежелательных явлениях и показателях смертности при применении моноклональных антител на основе результатов клинических испытаний в сопоставлении с традиционной терапией.
Материалы и методы: Для проведения анализа были найдены все зарегистрированные клинические исследования, посвященные применению моноклональных антител для терапии БА, в базе данных ClinicalTrials.gov. Данные о нежелательных явлениях были получены из публикаций, относящихся к клиническим исследованиям III фазы; в итоговый анализ вошла 21 статья. Сведения о традиционной терапии были получены из актуальных клинических рекомендаций по лечению БА.
Результаты: Проведенный анализ выявил, что частота серьезных нежелательных явлений и уровень смертности существенно варьируются в зависимости от конкретного моноклонального антитела. В большинстве случаев регистрируемые побочные эффекты не являются специфичными для применяемых препаратов. В связи с этим установить прямую причинно-следственную связь между приемом лекарственного средства и развитием определенных нежелательных явлений, а также провести адекватное сравнение профилей безопасности различных препаратов затруднительно ввиду различий в их механизмах действия и рекомендуемых дозировках. Магнитно-резонансная томография с оценкой амилоид-связанных аномалий визуализации (ARIA) по типу ARIA-E и ARIA-H представляется наиболее перспективным инструментом для сравнительной оценки антител, однако данный метод пока не обладает достаточной корреляцией с клинической симптоматикой. Кроме того, рекомендуется отдельно учитывать реакции, связанные с инфузией препаратов.
Заключение: Применение патогенетической терапии моноклональными антителами позволит в будущем повысить качество лечения БА. Однако на сегодняшний день не существует унифицированных протоколов для оценки эффективности препаратов и их сравнения. Оценка побочных эффектов и определение препарат-специфичных нежелательных реакций необходимы для повышения безопасности лечения пациентов с БА.
Графическая аннотация
Ключевые слова:
болезнь Альцгеймера, терапия болезни Альцгеймера, эффективность, безопасность, моноклональные антитела, ARIA-H, ARIA-EБиблиографические ссылки
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