medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/2079-701X-2015-18-74-79medsovet-457Research ArticleДЕМИЕЛИНИЗИРУЮЩИЕ ЗАБОЛЕВАНИЯDEMYELINATING DISEASESДиметилфумарат: новый таблетированный препарат для лечения рассеянного склерозаDimethyl fumarate: the new tableted preparation for the treatment of multiple sclerosisПоповаЕ. В.PopovaE. V.MoscowХачановаН. В.KhachanovaN. V.MoscowЛащН. Ю.LaschN. Y.MoscowОрловаЕ. В.OrlovaЕ. V.MoscowБойкоА. Н.BoykoA. N.MoscowГородская клиническая больница №24; Российский национальный исследовательский медицинский университет им. Н.И. ПироговаРоссияCity clinical hospital No.24; Russian National Research Medical University named after N.I. PirogovRussian FederationРоссийский национальный исследовательский медицинский университет им. Н.И. ПироговаРоссияRussian National Research Medical University named after N.I. PirogovRussian FederationООО «Джонсон & Джонсон»РоссияJohnson & JohnsonRussian Federation2015301220150187479Copyright © Попова Е.В., Хачанова Н.В., Лащ Н.Ю., Орлова Е.В., Бойко А.Н., 20152015Попова Е.В., Хачанова Н.В., Лащ Н.Ю., Орлова Е.В., Бойко А.Н.Popova E.V., Khachanova N.V., Lasch N.Y., Orlova Е.V., Boyko A.N.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/457

Диметилфумарат (ДМФ) - диметиловый эфир фумаровой кислоты, молекулы естественного происхождения, которая играет ключевую роль в окислительно-восстановительных процессах тканевого дыхания. Результаты исследований на моделях лабораторных животных свидетельствуют о том, что препарат оказывает противовоспалительное и цитопротективное действие. Противовоспалительные эффекты ДМФ предположительно опосредуются несколькими механизмами, включая подавление транскрипции в клетках, зависимой от ядерного фактора каппа В, а также угнетение экспрессии цито-кинов и молекул адгезии. Через 2 года после начала лечения ДМФ значительно повышал относительное количество пациентов с отсутствием активного заболевания по клиническим, радиологическим и общим критериям в сравнении с группой плацебо. По данным исследования DEFINE, доля больных без определяемой активности заболевания в группе ДМФ два раза в сутки составила 28% (vs placebo, p = 0,012), по данным исследования CONFIRM - 18% (vs placebo, p < 0,0001). ДМФ продемонстрировал сходную эффективность в различных подгруппах пациентов, сформированных по исходным характеристикам заболевания, включая частоту рецидивов в прошлом, предшествующее лечение, степень инвалидизации, а также тип и объем очагов поражения. По профилю безопасности ДМФ был сходен с ГА и плацебо. Нежелательные явления со стороны желудочно-кишечного тракта на фоне ДМФ были легкой или средней степени тяжести, носили преходящий характер и поддавались коррекции. Применение ДМФ не приводило к повышению риска инфекций и злокачественных новообразований.

Dimethyl fumarate (DMF) is dimethyl ester of fumaric acid, a naturally occurring molecule that plays a key role in redox processes of tissue respiration. Results of studies on animal models demonstrate that the drug has an anti-inflammatory and cytoprotective action. Anti-inflammatory effects of DMF could be mediated by several mechanisms, including inhibition of nuclear factor-kappaB-dependent transcription and suppression of cytokine production and cell adhesion molecule expression. 2 years after start of treatment DMF significantly increased the relative number of patients without active disease by clinical, radiological and general criteria in comparison with the placebo group. According to the DEFINE trial, the proportion of patients without active disease in twice daily DMF group was 28% (vs placebo, p = 0,012), and 18% (vs placebo, p < 0, 0001) according to the CONFIRM trial. DMF demonstrated similar efficacy in various subgroups of patients classified according to baseline characteristics of the disease, including frequency of relapses in the past, pre-treatment, level of disability, as well as type and extent of the lesions. In terms of safety profile, DMF was similar to GA and placebo. Adverse effects on the gastrointestinal tract against the background of DMF were mild or moderate, transient and treatable. Administration of DMF did not increase the risk of infections and malignancies.

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