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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">nogr</journal-id><journal-title-group><journal-title xml:lang="ru">Экспериментальная и клиническая гастроэнтерология</journal-title><trans-title-group xml:lang="en"><trans-title>Experimental and Clinical Gastroenterology</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">1682-8658</issn><publisher><publisher-name>«Global Media Technologies»</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.31146/1682-8658-ecg-195-11-35-41</article-id><article-id custom-type="elpub" pub-id-type="custom">nogr-1780</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>КЛИНИЧЕСКАЯ ГАСТРОЭНТЕРОЛОГИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>CLINICAL GASTROENTEROLOGY</subject></subj-group></article-categories><title-group><article-title>Эффективность и безопасность перехода с терапии оригинальными препаратами на биосимиляры при лечении воспалительных заболеваний кишечника</article-title><trans-title-group xml:lang="en"><trans-title>The effectiveness and safety of switching therapy with an original drug to biosimilars in treatment of inflammatory bowel diseases</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7778-8049</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Педа</surname><given-names>Е. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Peda</surname><given-names>E. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Педа Екатерина Сергеевна, врач-гастроэнтеролог отделения гастроэнтерологии</p><p>ул. Саляма Адиля, д. 2, г. Москва, 123423</p></bio><bio xml:lang="en"><p>Ekaterina S. Peda, gastroenterologist of the gastroenterology department</p><p>Salyama Adilya Str., 2, Moscow, 123423</p></bio><email xlink:type="simple">peda.katya@yandex.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/0000-0002-8803-7566</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>Alexandrov</surname><given-names>T. L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Александров Тимофей Леонидович, младший научный сотрудник отделения гастроэнтерологии</p><p>ул. Саляма Адиля, д. 2, г. Москва, 123423</p></bio><bio xml:lang="en"><p>Timofey L. Alexandrov, junior researcher of the department of gastroenterology</p><p>Salyama Adilya Str., 2, Moscow, 123423</p></bio><xref ref-type="aff" rid="aff-1"/></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>Баранова Татьяна Алексеевна, врач-гастроэнтеролог отделения гастроэнтерологии</p><p>ул. Саляма Адиля, д. 2, г. Москва, 123423</p></bio><bio xml:lang="en"><p>Tatyana A. Baranova, gastroenterologist of the gastroenterology department</p><p>Salyama Adilya Str., 2, Moscow, 123423</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-1180-0524</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белоус</surname><given-names>С. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Belous</surname><given-names>S. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Белоус София Сергеевна, к. м. н., заведующая дневным стационаром</p><p>ул. Саляма Адиля, д. 2, г. Москва, 123423</p></bio><bio xml:lang="en"><p>Sofia S. Belous, Candidate of Medical Sciences, Head of the day hospital</p><p>Salyama Adilya Str., 2, Moscow, 123423</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2323-1883</contrib-id><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>Тишаева Ирина Алексеевна, младший научный сотрудник отделения гастроэнтерологии</p><p>ул. Саляма Адиля, д. 2, г. Москва, 123423</p></bio><bio xml:lang="en"><p>Irina A. Tishaeva, junior researcher of the department of gastroenterology</p><p>Salyama Adilya Str., 2, Moscow, 123423</p></bio><xref ref-type="aff" rid="aff-1"/></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>Нанаева Бэлла Александровна, к. м. н., зав. отделением гастроэнтерологии</p><p>ул. Саляма Адиля, д. 2, г. Москва, 123423</p></bio><bio xml:lang="en"><p>Bella A. Nanaeva, Candidate of Medical Sciences, Head of the department of gastroenterology</p><p>Salyama Adilya Str., 2, Moscow, 123423</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-1172-6221</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шапина</surname><given-names>М. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Shapina</surname><given-names>M. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Шапина Марина Владимировна, к. м. н. руководитель отдела гастроэнтерологии</p><p>ул. Саляма Адиля, д. 2, г. Москва, 123423</p></bio><bio xml:lang="en"><p>Marina V. Shapina, Candidate of Medical Sciences, Head of the department of gastroenterology</p><p>Salyama Adilya Str., 2, Moscow, 123423</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><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>Князев Олег Владимирович, д. м. н., зав. отделением воспалительных заболеваний кишечника</p><p>ул. Шоссе Энтузиастов, д. 86, г. Москва 111123</p></bio><bio xml:lang="en"><p>Oleg V. Knyazev, MD, Head of department of inflammatory bowel diseases</p><p>Shosse Entuziastov Str.,86, 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/0000-0001-9885-6824</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Елигулашвили</surname><given-names>Р. Р.</given-names></name><name name-style="western" xml:lang="en"><surname>Eligulashvili</surname><given-names>R. R.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Елигулашвили Реваз Рамазович, к. м. н., старший научный сотрудник отделения рентгенодиагностики</p><p>ул. Саляма Адиля, д. 2, г. Москва, 123423</p></bio><bio xml:lang="en"><p>Revaz R. Yeligulashvili, Candidate of Medical Sciences, senior researcher of the department of X-ray Diagnostics</p><p>Salyama Adilya Str., 2, Moscow, 123423</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-5873-1074</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белинская</surname><given-names>В. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Belinskaya</surname><given-names>V. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Белинская Виктория Александровна, врач-гастроэнтеролог консультативной поликлиники</p><p>ул. Саляма Адиля, д. 2, г. Москва, 123423</p></bio><bio xml:lang="en"><p>Victoria A. Belinskaya, gastroenterologist of the consultative polyclinic</p><p>Salyama Adilya Str., 2, Moscow, 123423</p></bio><xref ref-type="aff" rid="aff-1"/></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>Подольская Дарья Владимировна, врач-гастроэнтеролог консультативной поликлиники</p><p>ул. Саляма Адиля, д. 2, г. Москва, 123423</p></bio><bio xml:lang="en"><p>Darya V Podolskaya, gastroenterologist of the consultative polyclinic</p><p>Salyama Adilya Str., 2, Moscow, 123423</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБУ «Национальный Медицинский Исследовательский Центр колопроктологии имени А. Н. Рыжих» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Ryzhikh Natianal Medical Research Centre for Coloproctology of the Ministry of Health of the Russia</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ГБУЗ «Московский клинический научно-практический центр имени А. С. Логинова» ДЗМ</institution><country>Россия</country></aff><aff xml:lang="en"><institution>GBUZ Moscow Clinical Scientific Center named after Loginov MHD</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2021</year></pub-date><pub-date pub-type="epub"><day>02</day><month>01</month><year>2022</year></pub-date><volume>0</volume><issue>11</issue><fpage>35</fpage><lpage>41</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Педа Е.С., Александров Т.Л., Баранова Т.А., Белоус С.С., Тишаева И.А., Нанаева Б.А., Шапина М.В., Князев О.В., Елигулашвили Р.Р., Белинская В.А., Подольская Д.В., 2022</copyright-statement><copyright-year>2022</copyright-year><copyright-holder xml:lang="ru">Педа Е.С., Александров Т.Л., Баранова Т.А., Белоус С.С., Тишаева И.А., Нанаева Б.А., Шапина М.В., Князев О.В., Елигулашвили Р.Р., Белинская В.А., Подольская Д.В.</copyright-holder><copyright-holder xml:lang="en">Peda E.S., Alexandrov T.L., Baranova T.A., Belous S.S., Tishaeva I.A., Nanaeva B.A., Shapina M.V., Knyazev O.V., Eligulashvili R.R., Belinskaya V.A., Podolskaya D.V.</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.nogr.org/jour/article/view/1780">https://www.nogr.org/jour/article/view/1780</self-uri><abstract><sec><title>Введение</title><p>Введение. Воспалительные заболевания кишечника (ВЗК) — это группа хронических иммунноопосредованных заболеваний неизвестной этиологии. Этиотропной терапии ВЗК не существует, все препараты, используемые для лечения, оказывают патогенетическое действие. В терапии ВЗК активно используются генно-инженерные биологические препараты (ГИБП). Первой зарегистрированной и активно применяемой в настоящее время группой ГИБП стали препараты анти-ФНО-α. Однако, по истечении срока действия соответствующих патентов, на рынке появляются биосимиляры оригинальных препаратов — их биоаналоги, сопоставимые по своим качествам с уже утвержденным эталонным продуктом.</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. На базе ФГБУ «НМИЦ Колопроктологии им. А. Н. Рыжих» МЗ РФ проведено ретроспективное исследование, в которое было включено 46 пациентов, перешедших с терапии оригинальным инфликсимабом или адалимумабом на терапию биосимиляром.</p></sec><sec><title>Обсуждение</title><p>Обсуждение. Данное исследование показало, что при возникновении необходимости переключения терапии с оригинальных препаратов инфликсимаб и адалимумаб на Инфликсимаб Биокад и Далибру эффективность терапии достоверно не снижается. Однако выявлено статистически значимое снижение эффективности при переходе с терапии оригинальным Инфликсимабом на Фламмэгис.</p><p>Учитывая, что использование биосимиляров позволяет снизить стоимость лечения и снизить нагрузку на бюджет здравоохранения, необходимо продолжить данное исследование с целью получения более долгосрочных результатов.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. Inflammatory bowel diseases are a group of chronic, immune-mediated diseases of unknown etiology. Etiotropic therapy of IBD does not exist, all drugs used to treat IBD have a pathogenetic effect. In the treatment of IBD biologic therapy is used. The most previously registered group of biologics are anti-TNF-α. But, after the expiration of the relevant patents, biosimilars appeared on the market (analogs, comparable in quality to the already approved reference product).</p></sec><sec><title>Materials and methods</title><p>Materials and methods. A retrospective study was conducted on the basis of the Ryzhikh Natianal Medical Research Centre for Coloproctology of the Ministry of Health of the Russia, which included 46 patients who switched from therapy with the original inﬂiximab or adalimumab to biosimilar therapy.</p></sec><sec><title>Discussion</title><p>Discussion. This study showed that when switching therapy with the original drugs infliximab and adalimumab to biosimilars, the effectiveness of therapy does not significantly decrease with the use of biosimilars Infliximab BIOCAD and Dalibra. However, a statistically significant decrease in efficacy was revealed when switching from therapy with the original Infliximab to Flammegis. Considering that the use of biosimilars can reduce the cost of treatment and reduce the burden on the health budget, it is necessary to continue this study in order to obtain longer-term results.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>воспалительные заболевания кишечника</kwd><kwd>генно-инженерная биологическая терапия</kwd><kwd>биосимиляры</kwd><kwd>инфликсимаб</kwd></kwd-group><kwd-group xml:lang="en"><kwd>inflammatory bowel diseases</kwd><kwd>biologic therapy</kwd><kwd>biosimilars</kwd><kwd>infliximab</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">Каграманова А. В., Парфенов А. И., Князев О. В. Актуальные проблемы диагностики и терапии воспалительных заболеваний кишечника. Эффективная фармакотерапия. Гастроэнтерология. 2018;2(16): 28–36.</mixed-citation><mixed-citation xml:lang="en">Kagramanova A. V., Parfyonov A. I., Knyazev O. V. 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