Эффективность и безопасность биоаналога ритуксимаба (Ацеллбия®) при ревматоидном артрите в качестве «первого» генно-инженерного биологического препарата: результаты клинического исследования III фазы (ALTERRA)

Российской биотехнологической компанией «БИОКАД» разработан препарат химерных моноклональных антител к CD20 (BCD-020, Ацеллбия®) являющийся биоаналогом препарата ритуксимаб (РТМ; Мабтера®, Ф. Хоффманн-Ля Рош Лтд., Швейцария). В последние годы получены данные о возможности применения РТМ в более низких дозах, чем в стандартных рекомендациях и инструкциях, касающихся применения данного препарата. Это послужило основанием для проведения исследования BCD-020-4/ALTERRA (ALTErnative Rituximab regimen in Rheumatoid Arthritis), целью которого явилось изучение эффективности и безопасности применения Ацеллбия® (в дозе 600 мг дважды с интервалом 2 нед) в качестве «первого» ГИБП для лечения активного ревматоидного артрита (РА), резистентного к терапии метотрексатом (МТ). В исследование было включено 159 пациентов в возрасте от 18 до 80 лет с активным РА. Через 24 нед число больных, достигших 20% улучшения по критериям Американской коллегии ревматологов (ACR), составило в группе Ацеллбия® + МТ 65,7%, а в группе плацебо (ПЛ) + МТ – 29,4% (р<0,0001). Различия в частоте эффекта ACR20 в группе исследуемой терапии и в группе сравнения составила 36,3% с 95% ДИ 19,27–53,28%. Получены достоверные различия между группами в частоте достижения эффекта ACR50: 28,4% в группе исследуемого препарата и 5,9% в группе сравнения (р=0,001) и ACR70 – 12,8% и лишь 2,0 % больных в группе сравнения соответственно (р=0,036). Анализ данных о безопасности (частота всех зарегистрированных нежелательных явлений – НЯ) свидетельствует об отсутствии достоверных различий между пациентами основной и контрольной групп и демонстрирует соответствие данным о безопасности препарата РТМ (Мабтера®), все НЯ были ожидаемыми. Отмечено, что наличие антител к РТМ со связывающей и нейтрализующей активностью не оказало влияния на эффективность и безопасность терапии.

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