Омализумаб - первый препарат генно-инженерной биологической терапии: новые ожидания и актуальность применения при бронхиальной астме

Признание того факта, что астма является сложным, многофакторным расстройством, привело к более серьезному фокусу на пациенте и на тех нарушениях его состояния, которые способствуют более или менее общей клинической выраженности заболевания. В патогенезе бронхиальной астмы определяются Т2- и не-Т2-эндотипы. Эндотип - это субтип болезни, определяемый уникальным или отличительным функциональным или патофизиологическим механизмом. Один эндотип бронхиальной астмы может лежать в основе нескольких фенотипов, так как является молекулярной основой фенотипов. Наиболее распространенным и очевидным фенотипом бронхиальной астмы является аллергический, или атопический. Открытие IgE стало новой эрой в понимании механизмов формирования аллергических заболеваний, в том числе бронхиальной астмы. Логично, что первым таргетным (целевым) препаратом для пациентов с тяжелой аллергической бронхиальной астмой стал омализумаб (анти-IgE-терапия). Клинические исследования убедительно продемонстрировали, что у пациентов с астмой, требующей терапии высокими дозами ингаляционных и (или) системных глюкокортикоидов, анти-IgE-терапия снижает частоту обострений, уменьшает степень тяжести астмы, а также позволяет отменять или значительно снижать дозы системных препаратов. Омализумаб уменьшает эозинофильную инфильтрацию подслизистого слоя бронхов, эозинофилию в мокроте, что коррелирует со снижением фракции выдыхаемого оксида азота. Его применение модифицирует тяжелое течение аллергической астмы у детей и взрослых, снижает толщину стенки бронхов, увеличивает их просвет, что клинически проявляется увеличением объема форсированного выдоха за 1-ю секунду. Также доказан противовоспалительный эффект омализумаба.

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