References

mrj

Современная ревматология

Modern Rheumatology Journal

1996-70122310-158X

IMA-PRESS, LLC

10.14412/1996-7012-2014-4-76-85

mrj-579

Research Article

ОБЗОРЫ

REVIEWS

Ингибитор фактора некроза опухоли α голимумаб в лечении ревматоидного артрита

The tumor necrosis factor-α inhibitor golimumab in the treatment of rheumatoid arthritis

Чичасова

Наталия Владимировна

Chichasova

Natalia Vladimirovna

105043, Россия, Москва, ул. Б. Пироговская, д. 2, стр. 4

2, B. Pirogovskaya St., Build. 4, Moscow Russia 105043

kafedrarheum@yandex.ru

ГБОУ ВПО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава РоссииРоссияI.M. Sechenov First Moscow State Medical University, Ministry of Health of RussiaRussian Federation

2014

03122014

847685

2014

Чичасова Н.В.

Chichasova N.V.

Данная работа распространяется под лицензией Creative Commons Attribution 4.0.

This work is licensed under a Creative Commons Attribution 4.0 License.

https://mrj.ima-press.net/mrj/article/view/579

Для лечения ревматических заболеваний – ревматоидного артрита (РА), анкилозирующего спондилита, псориатического артрита – в 2012 г. в России зарегистрирован ингибитор фактора некроза опухоли (ФНО)α голимумаб (ГЛМ), который представляет собой полностью человеческое моноклональное антитело. Его отличительными чертами являются высокая аффинность к ФНО α, а также удобство применения: препарат вводится 1 раз в месяц подкожно в виде раствора, объемом 0,5 мл. Регистрации препарата предшествовало проведение массивной программы клинических исследований. Рандомизированные плацебоконтролируемые исследования GO-FORWARD, GO-BEFORE, GO-AFTER показали, что ГЛМ эффективен у пациентов с РА из различных подгрупп и обладает благоприятным профилем безопасности, соответствующим таковому всего класса генно-инженерных биологических препаратов. По данным этих исследований, ГЛМ оказывал позитивное влияние на функцию и качество жизни больных РА: отмечено достоверно большее снижение индекса HAQ как в ранние сроки лечения, так и на протяжении длительной открытой фазы (до 5 лет), достоверно большее уменьшение утомляемости, достоверно большее, чем в контрольной группе (р=0,032), улучшение физического и ментального состояния по опроснику SF-36, достоверное уменьшение времени нетрудоспособности.

The tumor necrosis factor-α (TNF-α) golimumab (GLM), that is a fully human monoclonal anti-body, was registered in Russia in 2012 to treat rheumatic diseases, such as rheumatoid arthritis (RA), ankylosing spondylitis, and psoriatic arthritis. Its distinguishing characteristics are a high affinity for TNF-α and easiness-to-use: the drug as a 0.5-ml solution is injected subcutaneously once monthly. The registration of the medication was followed by the implementation of a massive program of clinical trials. The randomized placebo-controlled GO-FORWARD, GO-BEFORE, and GO-AFTER studies have indicated that GLM is effective in patients with RA from different subgroups and has a favorable safety profile as compared to that of the entire class of biological agents. According to the data of these studies, GLM had a positive effect on the functional status and quality of life in patients with RA: there was a significantly greater decrease in HAQ scores in both the early and long open treatment phases (to 5 years) and in fatigability than in the control group (p=0.032), physical and mental health improvements, as shown by the SF-36 questionnaire, and a significant reduction in disability.

ревматоидный артритбазисные противовоспалительные препаратыгенно-инженерные биологические препаратыголимумаб

rheumatoid arthritisdisease-modifying antirheumatic drugsbiological agentsgolimumab

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The authors declare that there are no conflicts of interest present.