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

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

Автор: Насонов Е.Л., Мазуров В.И., Зонова Е.В., Князева Л.А., Марусенко И.М., Несмеянова О.Б., Плаксина Т.В., Шаповалова Ю.С., Иливанова Е.П., Кречикова Д.Г., Петроченкова Н.А., Решетько О.В., Денисов Л.Н., Гордеев И.Г., Давыдова А.Ф., Еремина Н.А., Земерова Е.В., Иванова Т.Б., Кастанаян А.А., Покровская Т.Г., Смакотина С.А., Смолярчук Е.А., Артемьева А.В., Иванов Р.А., Усачева Ю.В., Черняева Е.В.

Журнал: Научно-практическая ревматология @journal-rsp

Рубрика: Оригинальные исследования

Статья в выпуске: 4 т.55, 2017 года.

Бесплатный доступ

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

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Ревматоидный артрит, ритуксимаб, ацеллбия®, мабтера

Короткий адрес: https://sciup.org/14945833

IDR: 14945833   |   DOI: 10.14412/1995-4484-2017-351-359

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

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