medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/ms2023-206medsovet-7723Research ArticleРЕВМАТОЛОГИЯRHEUMATOLOGYТофацитиниб в лечении ревматоидного артрита – данные реальной практики и рандомизированных клинических исследованийTofacitinib in the treatment of rheumatoid arthritis: real-life practice and randomized clinical trial datahttps://orcid.org/0000-0001-8051-8659ЧичасоваН. В.ChichasovaN. V.

Чичасова Наталья Владимировна - доктор медицинских наук, старший преподаватель учебно-методического отдела, НИИР имени В.А. Насоновой; профессор кафедры ревматологии, РМАНПО.

115522, Москва, Каширское шоссе, д. 34а; 125993, Москва, ул. Баррикадная, д. 2/1, стр. 1

Natalia V. Chichasova - Dr. Sci. (Med.), Senior Lecturer of the Educational and Methodological Department, Nasonova RIR; Professor of the Department of Rheumatology, RMACPE.

34а, Kashirskoe Shosse, Moscow, 115522; 2/1, Bldg. 1, Barrikadnaya St., Moscow, 125993

kafedrarheum@yandex.ruhttps://orcid.org/0000-0002-6068-3080ЛилаА. М.LilaA. M.

Лила Александр Михайлович - доктор медицинских наук, директор, НИИР имени В.А. Насоновой; заведующий кафедрой ревматологии, РМАНПО.

115522, Москва, Каширское шоссе, д. 34а; 125993, Москва, ул. Баррикадная, д. 2/1, стр. 1

Aleksander M. Lila - Dr. Sci. (Med.), Director, Nasonova RIR; Head of the Department of Rheumatology, RMACPE.

34а, Kashirskoe Shosse, Moscow, 115522; 2/1, Bldg. 1, Barrikadnaya St., Moscow, 125993

sokrat@irramn.ruНаучно-исследовательский институт ревматологии имени В.А. Насоновой; Российская медицинская академия непрерывного профессионального образованияРоссияNasonova Research Institute of Rheumatology; Russian Medical Academy of Continuous Professional EducationRussian Federation202319082023013147154Copyright © Чичасова Н.В., Лила А.М., 20232023Чичасова Н.В., Лила А.М.Chichasova N.V., Lila A.M.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/7723

В статье приведено обоснование необходимости наличия большого арсенала лекарственных препаратов для лечения многолетнего ревматоидного артрита. Представлены данные рандомизированных контролируемых исследований, свидетельствующих о высокой эффективности тофацитиниба в разных дозах в виде монотерапии, или комбинации с метотрексатом, или другими классическими синтетическими базисными противовоспалительными препаратами в отношении подавления активности и прогрессирования заболевания в различных группах больных, как не ответивших на метотрексат, так и не ответивших на терапию ингибиторами фактора некроза опухоли альфа. Данные продленных фаз рандомизированных клинических исследований показали устойчивость эффективности тофацитиниба в течение до 9,5 лет. Представлены данные реальной клинической практики, подтвердившие высокую эффективность препарата и отметившие быстроту развития эффекта и его высокую анальгетическую активность. Обсуждаются вопросы безопасности тофацитиниба с акцентом на сердечно-сосудистую безопасность препарата, учитывая добавления в последние рекомендации Европейской антиревматической лиги 2022 г. о необходимости учитывать факторы риска развития сердечно-сосудистых нежелательных явлений при планировании терапии ингибиторами янус-киназ. Отмечается, что некоторое увеличение риска таких нежелательных явлений при назначении тофацитиниба, по сравнению с ингибиторами фактора некроза опухоли альфа, отмечено у лиц старшего возраста, имеющих хотя бы один фактор риска развития сердечно-сосудистых событий. Данные по безопасности тофацитиниба представлены по данным метаанализов, систематических обзоров, сведениям из национальных регистров, открытых наблюдательных исследований, а также по результатам использования препарата в реальной клинической практике. Отмечено появление в РФ отечественного дженерика оригинального препарата.

The article justifies the need for a large arsenal of drugs to treat perennial rheumatoid arthritis. The authors present randomized controlled trial data showing high efficacy of tofacitinib at different doses as monotherapy, or in combination with methotrexate, or other conventional synthetic disease-modifying anti-inflammatory drugs in suppressing the activity and progression of the disease in various groups of patients, both non-responders to methotrexate, and non-responders to tumour necrosis factor-alpha inhibitors. Extension-phase data of randomized clinical trials demonstrated sustained efficacy of tofacitinib for up to 9.5 years. The authors presented the real-world evidence confirming high efficiency of the drug and noted the rapidity of onset of the effect and its high analgesic activity. The safety issues of tofacitinib with an emphasis on the cardiovascular safety of the drug, taking into account updates to the latest 2022 EULAR Recommendations on the need to consider risk factors for the development of cardiovascular adverse events when planning therapy with Janus kinase inhibitors are discussed. It is reported that slightly increased risk of such adverse events during use of tofacitinib, as compared with inhibitors of tumour necrosis factor alpha, was observed in elderly patients who have at least one risk factor for the development of cardiovascular events. Tofacitinib safety data were obtained from meta-analyses, systematic reviews, national registries, open observational studies, as well as outcomes of the use of the drug in real clinical practice. The launch of a domestic generic of the original drug was noted in the Russian Federation.

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