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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">medsovet</journal-id><journal-title-group><journal-title xml:lang="ru">Медицинский Совет</journal-title><trans-title-group xml:lang="en"><trans-title>Meditsinskiy sovet = Medical Council</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2079-701X</issn><issn pub-type="epub">2658-5790</issn><publisher><publisher-name>REMEDIUM GROUP Ltd.</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.21518/2079-701X-2021-15-20-29</article-id><article-id custom-type="elpub" pub-id-type="custom">medsovet-6415</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>Оригинальная статья</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>Original article</subject></subj-group></article-categories><title-group><article-title>Эффективность и безопасность тофацитиниба при язвенном колите средней и тяжелой степени в реальной клинической практике: три года наблюдения</article-title><trans-title-group xml:lang="en"><trans-title>Efficacy and safety of tofacitinib in moderate and severe ulcerative colitis in real clinical practice: three years of observation</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7250-0977</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Князев</surname><given-names>О. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Knyazev</surname><given-names>O. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>д.м.н., профессор, заведующий отделением лечения воспалительных заболеваний кишечника;  профессор научнообразовательного отдела; ведущий специалист организационно-методического отдела по колопроктологии</p><p>111123, Москва, Шоссе Энтузиастов, д. 86; 123423,  Москва,ул. Саляма Адиля, д. 2; 115088, Москва, ул. Большая Татарская, д. 30</p></bio><bio xml:lang="en"><p>Dr. Sci. (Med.), Professor, Head of the Department for the Treatment of Inflammatory Bowel Diseases; Professor of the Scientific and Educational Department; Leading Specialist of the Organizational and MethodologicalDepartment for coloproctology</p><p>86, Entuziastov Shosse, Moscow, 111123; Salyam Adil St., Moscow, 123423; 30, B. Tatarskaya St., Moscow, 115088</p></bio><email xlink:type="simple">oleg7@bk.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3818-6205</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Каграманова</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Kagramanova</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>111123, Москва, Шоссе Энтузиастов, д. 86</p></bio><bio xml:lang="en"><p>Cand. Sci. (Med.), Senior Researcher</p><p>86, Entuziastov Shosse, Moscow, 111123</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7891-2702</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Лищинская</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Lishchinskaya</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>111123, Москва, Шоссе Энтузиастов, д. 86</p></bio><bio xml:lang="en"><p> Cand. Sci. (Med.), Senior Researcher</p><p>86, Entuziastov Shosse, Moscow, 111123</p><p> </p></bio><email xlink:type="simple">lalbiba@inbox.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9508-7502</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ли</surname><given-names>И. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Li</surname><given-names>I. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>111123, Москва, Шоссе Энтузиастов, д. 86</p></bio><bio xml:lang="en"><p> Dr. Sci. (Med.), Chief Physician</p><p>86, Entuziastov Shosse, Moscow, 111123</p></bio><email xlink:type="simple">i.li@mknc.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-5694-1051</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Подольская</surname><given-names>Д. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Podolskaya</surname><given-names>D. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>123423,  Москва, ул. Саляма Адиля, д. 2</p></bio><bio xml:lang="en"><p>Junior Researcher, Department of Gastroenterology </p><p> 2, Salyam Adil St., Moscow, 123423</p></bio><email xlink:type="simple">dashamed2014@gmail.com</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7502-2437</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шкурко</surname><given-names>Т. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Shkurko</surname><given-names>T. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>123423,  Москва, ул. Саляма Адиля, д. 2; 115088, Москва, ул. Большая Татарская, д. 30</p></bio><bio xml:lang="en"><p>Cand. Sci. (Med.), Head of  the  Organizational and Methodological Department for  Coloproctology</p><p>2, Salyam Adil St., Moscow, 1234234 ; 30, B. Tatarskaya St., Moscow, 115088</p></bio><email xlink:type="simple">shkurkotania@yandex.ru</email><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-1697-4670</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Нанаева</surname><given-names>Б. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Nanaeva</surname><given-names>B. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>123423,  Москва, ул. Саляма Адиля, д. 2</p></bio><bio xml:lang="en"><p>Cand. Sci. (Med.), Head of the Department of Gastroenterology  </p><p>2, Salyam Adil St., Moscow, 123423</p></bio><email xlink:type="simple">nanaeva1987@mail.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-8803-7566</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Александров</surname><given-names>Т. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Aleksandrov</surname><given-names>T. L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>123423,  Москва, ул. Саляма Адиля, д. 2</p></bio><bio xml:lang="en"><p> Junior Researcher, Department of Gastroenterology</p><p>2, Salyam Adil St., Moscow, 123423</p></bio><email xlink:type="simple">alexandrov_tl@mail.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2013-8798</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Баранова</surname><given-names>Т. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Baranova</surname><given-names>T. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>123423,  Москва, ул. Саляма Адиля, д. 2</p></bio><bio xml:lang="en"><p>Junior Researcher, Department of Gastroenterology</p><p> 2, Salyam Adil St., Moscow, 123423</p></bio><email xlink:type="simple">tatya-ar@yandex.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Тишаева</surname><given-names>И. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Tishaeva</surname><given-names>I. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>123423,  Москва, ул. Саляма Адиля, д. 2</p></bio><bio xml:lang="en"><p> Junior Researcher, Department of Gastroenterology  </p><p> 2, Salyam Adil St., Moscow, 123423</p></bio><email xlink:type="simple">tishaeva.i@yandex.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7937-2346</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Звяглова</surname><given-names>М. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Zvyaglova</surname><given-names>M. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>111123, Москва, Шоссе Энтузиастов, д. 86</p></bio><bio xml:lang="en"><p>Junior Researcher, Department of Inflammatory Bowel Diseases</p><p>86, Entuziastov Shosse, Moscow, 111123</p></bio><email xlink:type="simple">zwmr306@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9782-4860</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Парфёнов</surname><given-names>А. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Parfenov</surname><given-names>A. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>111123, Москва, Шоссе Энтузиастов, д. 86</p></bio><bio xml:lang="en"><p> Dr. Sci. (Med.), Professor, Head of the Department of Intestinal Pathology </p><p>86, Entuziastov Shosse, Moscow, 111123</p></bio><email xlink:type="simple">asfold@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Московский клинический научно-практический центр имени А.С. Логинова; Национальный медицинский исследовательский центр колопроктологии имени А.Н. Рыжих;  Научно-исследовательский институт организации здравоохранения и медицинского менеджмента</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Loginov Moscow Clinical Scientific Center; Ryzhikh State Scientific Center of Coloproctology; Research Institute of Health Organization and Medical Management</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Московский клинический научно-практический центр имени А.С. Логинова</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Loginov Moscow Clinical Scientific Center</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Национальный медицинский исследовательский центр колопроктологии имени А.Н. Рыжих</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Ryzhikh State Scientific Center of Coloproctology</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>Национальный медицинский исследовательский центр колопроктологии имени А.Н. Рыжих;  Научно-исследовательский институт организации здравоохранения и медицинского менеджмента</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Ryzhikh State Scientific Center of Coloproctology;  Research Institute of Health Organization and Medical Management</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2021</year></pub-date><pub-date pub-type="epub"><day>16</day><month>10</month><year>2021</year></pub-date><volume>0</volume><issue>15</issue><fpage>20</fpage><lpage>29</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Князев О.В., Каграманова А.В., Лищинская А.А., Ли И.А., Подольская Д.В., Шкурко Т.В., Нанаева Б.А., Александров Т.Л., Баранова Т.А., Тишаева И.А., Звяглова М.Ю., Парфёнов А.И., 2021</copyright-statement><copyright-year>2021</copyright-year><copyright-holder xml:lang="ru">Князев О.В., Каграманова А.В., Лищинская А.А., Ли И.А., Подольская Д.В., Шкурко Т.В., Нанаева Б.А., Александров Т.Л., Баранова Т.А., Тишаева И.А., Звяглова М.Ю., Парфёнов А.И.</copyright-holder><copyright-holder xml:lang="en">Knyazev O.V., Kagramanova A.V., Lishchinskaya A.A., Li I.A., Podolskaya D.V., Shkurko T.V., Nanaeva B.A., Aleksandrov T.L., Baranova T.A., Tishaeva I.A., Zvyaglova M.Y., Parfenov A.I.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.med-sovet.pro/jour/article/view/6415">https://www.med-sovet.pro/jour/article/view/6415</self-uri><abstract><sec><title>Введение</title><p>Введение. Тофацитиниб (ТФЦБ) – первый представитель нового класса таргетных синтетических противовоспалительных препаратов для лечения язвенного колита (ЯК). В статье представлен трехлетний российский опыт применения ТФЦБ для лечения умеренного и тяжелого ЯК.</p></sec><sec><title>Цель</title><p>Цель. Оценить эффективность и безопасность терапии ТФЦБ в реальной клинической практике у больных ЯК средней и тяжелой степени в течение трех лет наблюдения.</p></sec><sec><title>Материалы и  методы</title><p>Материалы и  методы. В  исследование включены 56  пациентов с  ЯК, которые имели среднетяжелое (60,7%) и  тяжелое (35,8%) течение заболевания, у 67,8% диагностировано тотальное поражение, у 57,1% пациентов – внекишечные проявления. Оценивались раннее достижение клинического ответа, клинической и эндоскопической, бесстероидной ремиссии, безопасность.</p></sec><sec><title> Результаты</title><p> Результаты. Ранний ответ на терапию ТФЦБ получен у 47 (83,9%) пациентов. У 36 (64,3%) на 8-й неделе терапии была достигнута клиническая ремиссия, у 13 (23,2%) пациентов – клинический ответ. Большинство пациентов, достигших клинической ремиссии на 8-й и 12-й неделях, достигли заживления слизистой оболочки толстой кишки на 24-й неделе. Показатели клинической и  клинико-эндоскопической ремиссии через 24  нед.: 44  (78,6%) пациента, клинический ответ у  7  (12,5%) пациентов, 5 (8,9%) не ответили на терапию ТФЦБ. Бесстероидная ремиссия составила 77,6%. Через 2 года терапии ТФЦБ ремиссия ЯК сохранялась у 46 (82,1%). Через 36 мес. ремиссия ЯК сохранялась у 45 (80,3%) пациентов из 56, которым была начата терапия ТФЦБ. Кумулятивный эффект выживаемости при лечении ТФЦБ при ЯК составил 87,5% через 6 мес. и сохранялся в течение года, 82,1% – через 2 года, 80,3% – через 3 года.</p></sec><sec><title>Выводы</title><p>Выводы. Применение ТФЦБ при ЯК эффективно в отношении достижения быстрого клинического ответа, клинической ремиссии и заживления слизистой у больных, недостаточно отвечающих на биологическую терапию.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. Tofacitinib is the first member of a new class of targeted synthetic anti-inflammatory drugs for the treatment of ulcerative colitis (UC). The article presents a three-year Russian experience of tofacitinib use for the treatment of moderate and severe UC.</p></sec><sec><title>Aim of the study</title><p>Aim of the study. To evaluate the efficacy and safety of tofacitinib therapy in real clinical practice in moderate to severe UC patients during three years of follow-up.  </p></sec><sec><title>Methods</title><p>Methods. The study included 56 patients with UC who had moderate (60.7%) and severe (35.8%) states of disease, the total lesion was diagnosed in 67.8%, and extraintestinal manifestations in 57.1% of patients. Early achievement of clinical response, clinical and endoscopic, corticosteroid-free remission, and safety were evaluated.</p></sec><sec><title>Results</title><p>Results. Early response to tofacitinib therapy was obtained in 47 (83.9%) patients. Clinical remission was achieved in 36 (64.3%) at week 8 of therapy and clinical response was achieved in 13 (23.2%) patients. The majority of patients who achieved clinical remission at weeks 8 and 12 achieved healing of colon mucosa at week 24. Clinical and endoscopic remission rates after 24 weeks – 44 (78.6%) patients, clinical response in 7 (12.5%) patients, 5 (8.9%) did not respond to TFCB therapy. Corticosteroidfree remission was 77.6%. After 2 years of tofacitinib therapy, remission of UC was maintained in 46 (82.1%). After 36 months, remission of UC was maintained in 45 (80.3%) of the 56 patients who had been started on tofacitinib therapy. The cumulative effect of survival in the treatment of tofacitinib in UC was 87.5% after 6 months and persisted for one year, 82.1% after 2 years, and 80.3% after 3 years.</p></sec><sec><title>Conclusions</title><p>Conclusions. The administration of tofacitinib in UC is effective in achieving rapid clinical response, clinical remission, and mucosal healing in patients who do not respond well to biological therapy. </p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>воспалительные заболевания кишечника</kwd><kwd>генно-инженерные биологические препараты</kwd><kwd>ингибитор янус-киназ</kwd><kwd>тофацитиниб</kwd><kwd>язвенный колит</kwd></kwd-group><kwd-group xml:lang="en"><kwd>biological therapy</kwd><kwd>inflammatory bowel disease</kwd><kwd>Janus kinase [JAK] inhibitors</kwd><kwd>tofacitinib</kwd><kwd>ulcerative colitis</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Хатьков И.Е., Парфенов А.И., Князев О.В., Михайлянц Г.С., Атрощенко А.О., Ручкина И.Н. Воспалительные заболевания кишечника в практике терапевта и хирурга. 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