medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/2079-701X-2019-9-64-71medsovet-3036Research ArticleДЕМИЕЛИНИЗИРУЮЩИЕ ЗАБОЛЕВАНИЯDEMYELINATING DISEASESДолгосрочные результаты терапии рассеянного склероза окрелизумабом: клиническая и МРТ-эффективность и профиль безопасностиOcrelizumab therapy and long-term outcomes in multiple sclerosis: clinical and MRI-efficacyand safety profileКлабуковаД. Л.KlabukovaD. L.

к.б.н., ведущий научный сотрудник отдела лекарственного обеспечения и фармакоэкономического анализа Государственного бюджетного учреждения города Москвы «Научно-практический центр клинических исследований и оценки медицинских технологий Департамента здравоохранения города Москвы».

Cand. of Sci. (Med.), Leading Researcher, Department of Drug Provision and Pharmacoeconomic Analysis, State Budgetary Institution of the city of Moscow «Scientific and Practical Center for Clinical Research and Medical Technology Assessment of Moscow Healthcare Department».

daria.klabukova@gmail.comДавыдовскаяМ. В.DavydovskayaM. V.

заместитель директора по научной работе Государственного бюджетного учреждения города Москвы «Научно-практический центр клинических исследований и оценки медицинских технологий Департамента здравоохранения города Москвы»; д.м.н., профессор кафедры неврологии, нейрохирургии и медицинской генетики Федерального государственного бюджетного образовательного учреждения высшего образования «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Министерства здравоохранения Российской Федерации.

Deputy Director for Research, State Budgetary Institution of the city of Moscow «Scientific and Practical Center for Clinical Research and Medical Technology Assessment of Moscow Healthcare Department»; Dr. of Sci. (Med.), Professor of the Chair for Neurology, Neurosurgery and Medical Genetics, Federal State Budgetary Educational Institution of Higher Education «Pirogov Russian National Research Medical University» of the Ministry of Health of the Russian Federation.

mdavydovskaya@gmail.comГосударственное бюджетное учреждение города Москвы «Научно-практический центр клинических исследований и оценки медицинских технологий Департамента здравоохранения города Москвы».РоссияState Budgetary Institution of the city of Moscow «Scientific and Practical Center for Clinical Research and Medical Technology Assessment of Moscow Healthcare Department».Russian FederationГосударственное бюджетное учреждение города Москвы «Научно-практический центр клинических исследований и оценки медицинских технологий Департамента здравоохранения города Москвы»; Федеральное государственное бюджетное образовательное учреждение высшего образования «Российский национальный исследовательский медицинский университет имени Н.И. Пирогова» Министерства здравоохранения Российской Федерации.РоссияState Budgetary Institution of the city of Moscow «Scientific and Practical Center for Clinical Research and Medical Technology Assessment of Moscow Healthcare Department»; Federal State Budgetary Educational Institution of Higher Education Russian National Research Medical University named after N.I. Pirogov of the Ministry of Health of the Russian Federation.Russian Federation201911062019096471Copyright © Клабукова Д.Л., Давыдовская М.В., 20192019Клабукова Д.Л., Давыдовская М.В.Klabukova D.L., Davydovskaya M.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/3036

Окрелизумаб (Окревус®) представляет собой гуманизированное моноклональное антитело против CD20, одобренное для лечения взрослых с рецидивирующим рассеянным склерозом (РРС) и первично-прогрессирующим рассеянным склерозом (ППРС). В статье представлены данные о клинической и МРТ-эффективности и профиле безопасности препарата окрелизумаб при долгосрочном применении у пациентов с РС различных форм течения. Проведен поиск, систематизация и анализ накопленных данных клинических исследований и реальной клинической практики. По результатам пятилетнего наблюдения при терапии окрелизумабом продемонстрировано значительное и клинически значимое преимущество в снижении прогрессирования заболевания у пациентов с ППРС. У пациентов с РРС после 5 лет лечения окрелизумабом отмечено снижение доли больных с прогрессированием заболевания и степени атрофии головного мозга, а также более частое достижение статуса отсутствия активности заболевания (NEDA) по сравнению с пациентами с отсроченным на 2 года началом лечения окрелизумабом. Профиль безопасности препарата соответствует результатам, полученным в контролируемых периодах клинических исследований.

Ocrelizumab (Ocrevus®) is a humanized anti-CD20 monoclonal antibody approved for the treatment of adults with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The article presents data on the clinical and MRI efficacy and safety profile of ocrelizumab for the long-term use in patients with MS of various forms of the course. The authors performed the search, systematization and analysis of the pooled data of clinical studies and real clinical practice. Five-year follow-upof ocrelizumab therapy showed a compelling and clinical ly significant advantage in reducing the disease progression in patients with PPMS. After five-year ocrelizumab therapy in patients with PPMS, the study showed a reduction of the proportion of patients with disease progression and degree of brain atrophy, and more frequent achievement of the disease inactivity status (NEDA) as compared to patients with two- year delayed initiation of ocrelizumab therapy. The safety profile of the drug corresponds to the results obtained in the controlled periods of clinical trials.

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