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<article 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" xmlns:ali="http://www.niso.org/schemas/ali/1.0/" article-type="research-article" dtd-version="1.2" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">Therapy</journal-id><journal-title-group><journal-title xml:lang="en">Therapy</journal-title><trans-title-group xml:lang="ru"><trans-title>Терапия</trans-title></trans-title-group></journal-title-group><issn publication-format="print">2412-4036</issn><issn publication-format="electronic">2713-1823</issn><publisher><publisher-name xml:lang="en">Bionika Media</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">717586</article-id><article-id pub-id-type="doi">10.18565/therapy.2026.5.15-27</article-id><article-categories><subj-group subj-group-type="toc-heading" xml:lang="en"><subject>ORIGINAL STUDIES</subject></subj-group><subj-group subj-group-type="toc-heading" xml:lang="ru"><subject>ОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯ</subject></subj-group><subj-group subj-group-type="article-type"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title xml:lang="en">Evaluation of the efficacy and safety of the combined use of 5-aminosalicylic acid and genetically engineered biological drugs in patients with moderate ulcerative colitis</article-title><trans-title-group xml:lang="ru"><trans-title>Оценка эффективности и безопасности комбинированного применения препаратов 5-аминосалициловой кислоты и генно-инженерных биологических препаратов у пациентов со среднетяжелым язвенным колитом</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7250-0977</contrib-id><contrib-id contrib-id-type="spin">3268-0360</contrib-id><name-alternatives><name xml:lang="en"><surname>Knyazev</surname><given-names>Oleg V.</given-names></name><name xml:lang="ru"><surname>Князев</surname><given-names>Олег Владимирович</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>MD, Dr. Sci. (Medicine), head of the Department of intestinal pathology, head of the Moscow State Center of Gastroenterology</p></bio><bio xml:lang="ru"><p>д. м. н., заведующий отделом патологии кишечника, руководитель МГГЦ</p></bio><email>oleg7@bk.ru</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-4984-9526</contrib-id><contrib-id contrib-id-type="spin">3090-7083</contrib-id><name-alternatives><name xml:lang="en"><surname>Priymak</surname><given-names>Maxim A.</given-names></name><name xml:lang="ru"><surname>Приймак</surname><given-names>Максим Александрович</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>MD, deputy chief physician for medical affairs</p></bio><bio xml:lang="ru"><p>заместитель главного врача по медицинской части</p></bio><email>m.priymak@mknc.ru</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3818-6205</contrib-id><contrib-id contrib-id-type="spin">4086-6745</contrib-id><name-alternatives><name xml:lang="en"><surname>Kagramanova</surname><given-names>Anna V.</given-names></name><name xml:lang="ru"><surname>Каграманова</surname><given-names>Анна Валерьевна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>MD, PhD (Medicine), head of the Department of intestinal pathology</p></bio><bio xml:lang="ru"><p>к. м. н., заведующая отделением патологии кишечника</p></bio><email>a.kagramanova@mknc.ru</email><xref ref-type="aff" rid="aff1"/><xref ref-type="aff" rid="aff2"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7891-2702</contrib-id><contrib-id contrib-id-type="spin">9369-9674</contrib-id><name-alternatives><name xml:lang="en"><surname>Lishchinskaya</surname><given-names>Albina A.</given-names></name><name xml:lang="ru"><surname>Лищинская</surname><given-names>Альбина Александровна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>MD, PhD (Medicine), senior researcher at the Department of intestinal pathology</p></bio><bio xml:lang="ru"><p>к. м. н., старший научный сотрудник отдела патологии кишечника</p></bio><email>lalbina@inbox.ru</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0524-2514</contrib-id><contrib-id contrib-id-type="spin">6047-7590</contrib-id><name-alternatives><name xml:lang="en"><surname>Fadeeva</surname><given-names>Nina A.</given-names></name><name xml:lang="ru"><surname>Фадеева</surname><given-names>Нина Александровна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>MD, PhD (Medicine), head of the Department of gastroenterology, associate professor of the Department of gastroenterology, chief freelance gastroenterologist of the North-Western Administrative District (Department of Healthcare of Moscow)</p></bio><bio xml:lang="ru"><p>к. м. н., заведующая гастроэнтерологическим отделением, доцент кафедры гастроэнтерологии, главный внештатный специалист-гастроэнтеролог СЗАО ДЗМ</p></bio><email>n.fadeeva@mknc.ru</email><xref ref-type="aff" rid="aff1"/><xref ref-type="aff" rid="aff3"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0007-5952-6233</contrib-id><contrib-id contrib-id-type="spin">7199-3201</contrib-id><name-alternatives><name xml:lang="en"><surname>Demchenko</surname><given-names>Alexandra N.</given-names></name><name xml:lang="ru"><surname>Демченко</surname><given-names>Александра Николаевна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>gastroenterologist at the Department of intestinal pathology</p></bio><bio xml:lang="ru"><p>врач-гастроэнтеролог отделения патологии кишечника</p></bio><email>oleg7@bk.ru</email><xref ref-type="aff" rid="aff1"/></contrib></contrib-group><aff-alternatives id="aff1"><aff><institution xml:lang="en">A.S. Loginov Moscow Clinical Scientific Center</institution></aff><aff><institution xml:lang="ru">ГБУЗ «Московский клинический научный центр имени А.С. Логинова Департамента здравоохранения Москвы»</institution></aff></aff-alternatives><aff-alternatives id="aff2"><aff><institution xml:lang="en">Research Institute for Healthcare and Medical Management Organization</institution></aff><aff><institution xml:lang="ru">ГБУ «Научно-исследовательский институт организации здравоохранения и медицинского менеджмента Департамента здравоохранения города Москвы»</institution></aff></aff-alternatives><aff-alternatives id="aff3"><aff><institution xml:lang="en">Russian Medical Academy of Continuous Professional Education</institution></aff><aff><institution xml:lang="ru">ФГАОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России</institution></aff></aff-alternatives><pub-date date-type="pub" iso-8601-date="2026-08-29" publication-format="electronic"><day>29</day><month>08</month><year>2026</year></pub-date><volume>12</volume><issue>5</issue><issue-title xml:lang="en"/><issue-title xml:lang="ru"/><fpage>15</fpage><lpage>27</lpage><history><date date-type="received" iso-8601-date="2026-08-28"><day>28</day><month>08</month><year>2026</year></date><date date-type="accepted" iso-8601-date="2026-08-28"><day>28</day><month>08</month><year>2026</year></date></history><permissions><copyright-statement xml:lang="en">Copyright ©; 2026, “Bionika Media” LLC</copyright-statement><copyright-statement xml:lang="ru">Copyright ©; 2026, ООО «Бионика Медиа»</copyright-statement><copyright-year>2026</copyright-year><copyright-holder xml:lang="en">“Bionika Media” LLC</copyright-holder><copyright-holder xml:lang="ru">ООО «Бионика Медиа»</copyright-holder><license><ali:license_ref xmlns:ali="http://www.niso.org/schemas/ali/1.0/">https://journals.eco-vector.com/2412-4036/about/editorialPolicies</ali:license_ref></license></permissions><self-uri xlink:href="https://journals.eco-vector.com/2412-4036/article/view/717586">https://journals.eco-vector.com/2412-4036/article/view/717586</self-uri><abstract xml:lang="en"><p>Currently, there is no sufficient data to determine the indications for continuing 5-aminosalicylic acid (5-ASA) therapy in patients who have been prescribed genetically engineered biological drugs (GEBDs) due to their inefficiency. Currently, 60–80% of patients continue to receive 5-ASA concomitantly with GEBDs, despite previously documented inefficiency of 5-ASA monotherapy. Since the treatment of inflammatory bowel diseases is associated with high costs, there is a significant need to reduce unnecessary costs in the treatment of patients with ulcerative colitis (UC) and Crohn’s disease.</p> <p><bold>The aim:</bold> to study the efficacy and safety of the combined use of 5-ASA and GEBDs in patients with moderate UC.</p> <p><bold>Material and methods.</bold> For the study, four groups of patients were formed depending on the therapy administered: Group 1 – 68 (26.6%) biologic-naive patients with UC who received combination therapy with infliximab (INFL) and 5-ASA; Group 2 – 60 (23.4%) biologic-naive patients with UC who received monotherapy with INFL without 5-ASA; Group 3 included 73 (28.5%) patients with UC who had previously received GEBDs before receiving IFNL therapy and were continuing to use 5-ASA; Group 4 included 55 (21.5%) patients with UC who had used GEBDs before receiving IFNL therapy and were not receiving 5-ASA. The secondary endpoint was colonic mucosal (CM) healing with a Mayo score of 0.</p> <p><bold>Results.</bold> When comparing groups 1 and 4 of UC patients, we found that in bionaive and non-bionaive patients, the probability of CM healing with a combination of GEBDs (INFL) and 5-ASA drugs was higher than with therapy without 5-ASA (OR 9.402; 95% CI: 4.111–21.499; χ<sup>2</sup> = 31.389; p &lt; 0.001), as well as when comparing groups 2 and 4 (OR 5.281; 95% CI: 2.358–11.831; χ<sup>2</sup> = 17.325; p &lt; 0.001).</p> <p><bold>Conclusion. </bold>To achieve colonic mucosal healing (Mayo index = 0 points) in patients with UC previously treated with TNF-α inhibitors, a combination of biologic agents and 5-ASA preparations is advisable.</p></abstract><trans-abstract xml:lang="ru"><p>На сегодняшний день недостаточно данных, определяющих показания к продолжению приема препаратов 5-аминосалициловой кислоты (5-АСК) пациентами, у которых в связи с их неэффективностью назначены генно-инженерные биологические препараты (ГИБП). В настоящее время 60–80% больных одновременно c ГИБП продолжают получать 5-АСК, несмотря на зафиксированную ранее неэффективность монотерапии последними. Поскольку терапия воспалительных заболеваний кишечника сопряжена с высокими затратами, существует значительная потребность в снижении неоправданных расходов на лечение пациентов с язвенным колитом (ЯК) и болезнью Крона.</p> <p><bold>Цель</bold> – изучить эффективность и безопасность комбинированного применения препаратов 5-АСК и ГИБП у пациентов с ЯК средней степени тяжести.</p> <p><bold>Материал и методы.</bold> В рамках исследования в зависимости от проводившейся терапии были сформированы 4 группы пациентов: 1-я группа – 68 (26,6%) бионаивных пациентов с ЯК, которые получали комбинированную терапию препаратом инфликсимаба (ИНФЛ) и препаратами 5-АСК; 2-я группа – 60 (23,4%) бионаивных пациентов с ЯК, которые получали монотерапию препаратом ИНФЛ без 5-АСК; 3-я группа – 73 (28,5%) пациента с ЯК, которые ранее, до назначения терапии ИНФЛ, получали ГИБП и продолжают применять препараты 5-АСК; 4-я группа – 55 (21,5%) пациентов с ЯК, которые использовали ГИБП до назначения терапии ИНФЛ и не получают препараты 5-АСК. Конечной вторичной точкой являлось заживление слизистой оболочки толстой кишки (СОТК) по индексу Мейо 0 баллов.</p> <p><bold>Результаты. </bold>При сравнении 1-й и 4-й групп больных ЯК нами установлено, что у бионаивных и небионаивных пациентов вероятность заживления СОТК при сочетании ГИБП (ИНФЛ) с препаратами 5-АСК, выше, чем при применении терапии без 5-АСК (ОШ 9,402; 95% ДИ: 4,111–21,499; х<sup>2</sup> = 31,389; р &lt; 0,001), так же как и при сравнении 2-й и 4-й групп (ОШ 5,281; 95% ДИ: 2,358–11,831; х<sup>2</sup> = 17,325; р &lt; 0,001).</p> <p><bold>Заключение.</bold> Для достижения заживления СОТК (индекс Мейо = 0 баллов) у пациентов с ЯК, ранее получавших ингибиторы ФНО-α, целесообразно применение комбинации ГИБП и препаратов 5-АСК.</p></trans-abstract><kwd-group xml:lang="en"><kwd>ulcerative colitis</kwd><kwd>colonic mucosal healing</kwd><kwd>5-aminosalicylic acid preparations</kwd><kwd>genetically engineered biological drugs</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>язвенный колит</kwd><kwd>заживление слизистой оболочки толстой кишки</kwd><kwd>препараты 5-аминосалициловой кислоты</kwd><kwd>генно-инженерные биологические препараты</kwd></kwd-group><funding-group/></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><mixed-citation>Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. 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