Отечественный препарат от артрита прошел глобальные клинические исследования
15 сентября 2020
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№200, сентябрь 2020
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Отечественный препарат от артрита прошел глобальные клинические исследования
Российский препарат для терапии ревматоидного артрита олокизумаб успешно прошел третью фазу международных клинических испытаний, которые могут стать основанием для регистрации ЛС за рубежом. Об этом сообщает пресс-служба производителя препарата группы компаний «Р-Фарм».
Олокизумаб, зарегистрированный в России под торговым наименованием «Артлегиа», является моноклональным антителом, которое ингибирует интерлейкин-6 (ИЛ-6) для терапии ревматоидного артрита.
В третьей фазе исследований под названием CREDO3 приняло участие 2444 пациента из 19 стран мира. Целью испытаний было изучение эффективности и безопасности олокизумаба в сочетании с метотрексатом среди людей с ревматоидным артритом, плохо контролируемым терапией ингибиторами ФНО-альфа (адалимумабом, инфликсимабом, этанерцептом и др.).
Участники получали ЛС в двух режимах дозирования — один раз в месяц и два раза в месяц. В каждой группе препарат по своим результатам превзошел плацебо как при достижении первичной конечной точки (20 % улучшения индекса ACR), так и по доле пациентов, достигших низкой активности заболевания согласно DAS28 (CRP).
Следующим этапом станет исследование CREDO4, которое продлится до 2022 года и основной целью которого станет подтверждение долговременной безопасности препарата. Однако результаты третьей фазы уже являются достаточным основанием для подачи заявки на регистрацию в США, Европе, Азии и Латинской Америке.
Напомним, что олокизумаб включен в рекомендации Минздрава по лечению коронавируса COVID-19 для упреждающей противовоспалительной терапии. Кроме этого, в апреле в России начались клинические исследования возможности препарата напрямую бороться с коронавирусной инфекцией.
Катрен Стиль
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