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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">mrj</journal-id><journal-title-group><journal-title xml:lang="ru">Современная ревматология</journal-title><trans-title-group xml:lang="en"><trans-title>Modern Rheumatology Journal</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">1996-7012</issn><issn pub-type="epub">2310-158X</issn><publisher><publisher-name>IMA-PRESS, LLC</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.14412/1996-7012-2025-5-41-51</article-id><article-id custom-type="elpub" pub-id-type="custom">mrj-1839</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>ОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ORIGINAL INVESTIGATIONS</subject></subj-group></article-categories><title-group><article-title>Замедление прогрессирования анкилозирующего спондилита на фоне долгосрочной терапии нетакимабом: результаты международного многоцентрового рандомизированного двойного слепого клинического исследования III фазы BCD-085-5/ASTERA</article-title><trans-title-group xml:lang="en"><trans-title>Slowing the progression of ankylosing spondylitis during long-term therapy with netakimab: results of the international multicenter randomized double-blind phase III clinical trial BCD-085-5/ASTERA</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0797-2051</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мазуров</surname><given-names>В. 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Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Lin’kova</surname><given-names>Yu. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>198515, Санкт-Петербург, поселок Стрельна, ул. Связи, 38, стр. 1 </p></bio><bio xml:lang="en"><p>38, Svyazi Street, Build. 1, Strelna, St. Petersburg 198515</p></bio><xref ref-type="aff" rid="aff-24"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-8499-2232</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Зинкина-Орихан</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Zinkina-Orikhan</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>198515, Санкт-Петербург, поселок Стрельна, ул. Связи, 38, стр. 1 </p></bio><bio xml:lang="en"><p>38, Svyazi Street, Build. 1, Strelna, St. Petersburg 198515</p></bio><xref ref-type="aff" rid="aff-24"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2680-1909</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Фокина</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Fokina</surname><given-names>E. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>198515, Санкт-Петербург, поселок Стрельна, ул. Связи, 38, стр. 1 </p></bio><bio xml:lang="en"><p>38, Svyazi Street, Build. 1, Strelna, St. Petersburg 198515</p></bio><xref ref-type="aff" rid="aff-24"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1267-0074</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Еремеева</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Eremeeva</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>198515, Санкт-Петербург, поселок Стрельна, ул. Связи, 38, стр. 1 </p></bio><bio xml:lang="en"><p>38, Svyazi Street, Build. 1, Strelna, St. Petersburg 198515</p></bio><xref ref-type="aff" rid="aff-24"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9790-8207</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Пухтинская</surname><given-names>П. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Pukhtinskaia</surname><given-names>P. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>198515, Санкт-Петербург, поселок Стрельна, ул. Связи, 38, стр. 1 </p></bio><bio xml:lang="en"><p>38, Svyazi Street, Build. 1, Strelna, St. Petersburg 198515</p></bio><xref ref-type="aff" rid="aff-24"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>North-Western State Medical University named after I.I. Mechnikov, Ministry of Health of Russia</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой» ; ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>V.A. Nasonova Research Institute of Rheumatology ; Russian Medical Academy of Continuing Professional Education, Ministry of Health of Russia</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>V.A. Nasonova Research Institute of Rheumatology</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России ; Санкт-Петербургское ГБУЗ «Клиническая ревматологическая больница № 25»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>North-Western State Medical University named after I.I. Mechnikov, Ministry of Health of Russia ; Clinical Rheumatology Hospital №25</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-5"><aff xml:lang="ru"><institution>ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой» ; ФГБУ «Федеральный научно-клинический центр&#13;
специализированных видов медицинской помощи и медицинских технологий Федерального медико-биологического агентства»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>V.A. Nasonova Research Institute of Rheumatology ; Federal Research and Clinical Center of Specialized Medical Care and Medical Technologies, FMBA</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-6"><aff xml:lang="ru"><institution>Учреждение здравоохранения «1-я городская клиническая больница»</institution><country>Беларусь</country></aff><aff xml:lang="en"><institution>First City Clinical Hospital</institution><country>Belarus</country></aff></aff-alternatives><aff-alternatives id="aff-7"><aff xml:lang="ru"><institution>ГУ «Минский научно-практический центр хирургии, трансплантологии и гематологии»</institution><country>Беларусь</country></aff><aff xml:lang="en"><institution>Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology</institution><country>Belarus</country></aff></aff-alternatives><aff-alternatives id="aff-8"><aff xml:lang="ru"><institution>ФГБОУ ВО «Ростовский государственный медицинский университет» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Rostov State Medical University, Ministry of Health of Russia</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-9"><aff xml:lang="ru"><institution>ЧУЗ «Клиническая больница «РЖД-Медицина» города Саратов»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Clinical Hospital «RZD-Meditsina»</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-10"><aff xml:lang="ru"><institution>ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава России ; Санкт-Петербургское ГБУЗ «Городская поликлиника №38»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>North-Western State Medical University named after I.I. Mechnikov, Ministry of Health of Russia ; City Polyclinic №38</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-11"><aff xml:lang="ru"><institution>ГБУЗ Нижегородской области «Нижегородская областная клиническая больница им. Н.А. Семашко»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>N.A. Semashko Nizhny Novgorod Regional Clinical Hospital</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-12"><aff xml:lang="ru"><institution>ФГБОУ ВО «Красноярский государственный медицинский университет им. проф. В.Ф. Войно-Ясенецкого» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky, Ministry of Health of Russia</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-13"><aff xml:lang="ru"><institution>БУЗ Омской области «Областная клиническая больница»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Regional Clinical Hospital</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-14"><aff xml:lang="ru"><institution>ОГБУЗ «Иркутская городская клиническая больница №1»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Irkutsk City Clinical Hospital №1</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-15"><aff xml:lang="ru"><institution>ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский университет)</institution><country>Россия</country></aff><aff xml:lang="en"><institution>I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-16"><aff xml:lang="ru"><institution>КГБУЗ «Городская больница № 4 им. Н.П. Гулла, города Барнаул»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>City Hospital №4 named after N.P. Gull</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-17"><aff xml:lang="ru"><institution>ФГБОУ ВО «Казанский государственный медицинский университет» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Kazan State Medical University, Ministry of Health of Russia</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-18"><aff xml:lang="ru"><institution>ЧУЗ «Клиническая больница «РЖД-Медицина» города Смоленск»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Clinical Hospital «RZD-Meditsina»</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-19"><aff xml:lang="ru"><institution>ГБУЗ «Городская клиническая больница №15 им. О.М. Филатова» Департамента здравоохранения города Москвы»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>City Clinical Hospital №15 named after O.M. Filatov</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-20"><aff xml:lang="ru"><institution>ГБУЗ «Челябинская областная клиническая больница»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Chelyabinsk Regional Clinical Hospital</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-21"><aff xml:lang="ru"><institution>ГБУЗ «Ленинградская областная клиническая больница»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Leningrad Regional Clinical Hospital</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-22"><aff xml:lang="ru"><institution>ГБУЗ АО «Первая городская клиническая больница им. Е.Е. Волосевич»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>E.E. Volosevich First City Clinical Hospital</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-23"><aff xml:lang="ru"><institution>ФГБВОУ ВО «Военно-медицинская академия им. С.М. Кирова» Минобороны России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Military medical academy named after S.M. Kirov</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-24"><aff xml:lang="ru"><institution>АО «БИОКАД»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>JSC BIOCAD</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>18</day><month>10</month><year>2025</year></pub-date><volume>19</volume><issue>5</issue><fpage>41</fpage><lpage>51</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Мазуров В.И., Лила А.М., Эрдес Ш.Ф., Гайдукова И.З., Дубинина Т.В., Смирнов А.В., Пристром А.М., Кундер Е.В., Сорока Н.Ф., Кастанаян А.А., Поварова Т.В., Жугрова Е.С., Самигуллина Р.Р., Плаксина Т.В., Шестерня П.А., Кропотина Т.В., Антипова О.В., Смолярчук Е.А., Цюпа О.А., Абдулганиева Д.И., Лапшина С.А., Кречикова Д.Г., Гордеев И.Г., Несмеянова О.Б., Иливанова Е.П., Стрелкова А.В., Тыренко В.В., Линькова Ю.Н., Зинкина-Орихан А.В., Фокина Е.А., Еремеева А.В., Пухтинская П.С., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Мазуров В.И., Лила А.М., Эрдес Ш.Ф., Гайдукова И.З., Дубинина Т.В., Смирнов А.В., Пристром А.М., Кундер Е.В., Сорока Н.Ф., Кастанаян А.А., Поварова Т.В., Жугрова Е.С., Самигуллина Р.Р., Плаксина Т.В., Шестерня П.А., Кропотина Т.В., Антипова О.В., Смолярчук Е.А., Цюпа О.А., Абдулганиева Д.И., Лапшина С.А., Кречикова Д.Г., Гордеев И.Г., Несмеянова О.Б., Иливанова Е.П., Стрелкова А.В., Тыренко В.В., Линькова Ю.Н., Зинкина-Орихан А.В., Фокина Е.А., Еремеева А.В., Пухтинская П.С.</copyright-holder><copyright-holder xml:lang="en">Mazurov V.I., Lila A.M., Erdes S.F., Gaydukova I.Z., Dubinina T.V., Smirnov A.V., Pristrom A.M., Kunder E.V., Soroka N.F., Kastanayan A.A., Povarova T.V., Zhugrova E.S., Samigullina R.R., Plaksina T.V., Shesternya P.A., Kropotina T.V., Antipova O.V., Smolyarchuk E.A., Tsyupa O.A., Abdulganieva D.I., Lapshina S.A., Krechikova D.G., Gordeev I.G., Nesmeyanova O.B., Ilivanova E.P., Strelkova A.V., Tyrenko V.V., Lin’kova Y.N., Zinkina-Orikhan A.V., Fokina E.A., Eremeeva A.V., Pukhtinskaia P.S.</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://mrj.ima-press.net/mrj/article/view/1839">https://mrj.ima-press.net/mrj/article/view/1839</self-uri><abstract><p>Цель – оценить действие долгосрочной терапии препаратом нетакимаб (НТК) на рентгенологическое прогрессирование и снижение выраженности воспалительных изменений по данным магнитно-резонансной томографии (МРТ) у пациентов с анкилозирующим спондилитом (АС), а также выявить факторы, влияющие на достижение ответа.Материал и методы. Проведен апостериорный анализ эффективности лечения НТК 228 пациентов с активным АС в течение 156 нед в рамках рандомизированного клинического исследования BCD-085-5/ASTERA. Определено относительное количество пациентов с отсутствием признаков рентгенологического прогрессирования, у которых увеличение индекса mSASSS на неделе 156 терапии составило &lt;2 баллов по сравнению с исходным уровнем. Дополнительно установлено относительное количество пациентов с отсутствием увеличения индекса mSASSS на неделе 156 по сравнению с исходным уровнем. Оценено относительное количество пациентов без увеличения индексов ASspi-MRI-а и SPARCC, а также с положительной динамикой этих индексов – достижением значений 0 баллов или снижения показателей на ≥50% от исходного уровня на неделях 52, 104 и 156 терапии. Анализ влияния исходных клинико-демографических факторов на достижение ответа по индексам mSASSS, ASspi-MRI-а и SPARCC проведен с использованием одномерных и многомерных моделей логистической Результаты и обсуждение. Из 228 пациентов в течение 156 нед терапии НТК у 66% наблюдалось отсутствие рентгенологического прогрессирования, а у 63% – отсутствие увеличения индекса mSASSS по сравнению с исходным уровнем. Продемонстрирована положительная динамика индексов ASspi-MRI-а и SPARCC на протяжении 2 лет терапии НТК с сохранением эффекта к неделе 156 лечения. В одномерной модели логистической регрессии показана меньшая частота рентгенологического прогрессирования по индексу mSASSS у пациентов более молодого возраста (р=0,013) и пациентов, не имевших синдесмофитов и анкилозов позвоночника на момент назначения терапии (р&lt;0,01). С помощью многомерной модели не выявлено значимого влияния исходных клинико-демографических факторов и факторов анамнеза на эффект терапии НТК.Заключение. Результаты исследования показали, что долгосрочная терапия НТК обеспечивает отсутствие рентгенологического прогрессирования и снижение выраженности активных воспалительных изменений по данным МРТ у большинства пациентов с АС независимо от исходных клинико-демографических характеристик и предшествующего лечения ингибиторами фактора некроза опухоли α.</p></abstract><trans-abstract xml:lang="en"><p>Objective. To evaluate the effect of long-term therapy with netakimab (NTK) on radiographic progression and reduction of inflammatory changes assessed by magnetic resonance imaging (MRI) in patients with ankylosing spondylitis (AS), and to identify factors influencing treatment response.Material and methods. A post hoc analysis was performed on 228 patients with active AS who received NTK for 156 weeks in the randomized clinical trial BCD-085-5/ASTERA. The proportion of patients without radiographic progression was determined, defined as an increase in the mSASSS (modified Stoke Ankylosing Spondylitis Spinal Score) of &lt;2 points from baseline to week 156. Additionally, the proportion of patients without any increase in mSASSS by week 156 was calculated. The proportions of patients without increases in the ASspi-MRI-a (Ankylosing Spondylitis spine MRI activity index) and SPARCC (Spondyloarthritis Research Consortium of Canada index), as well as with positive dynamics of these indices (reaching 0 or a ≥50% reduction from baseline at weeks 52, 104 and 156), were also assessed. The influence of baseline clinical and demographic factors on achieving a response by mSASSS, ASspi-MRI-a, and SPARCC was analyzed using univariate and multivariate logistic regression models.Results and discussion. Among 228 patients, 66% showed no radiographic progression and 63% had no increase in mSASSS at week 156 compared with baseline. Positive dynamics in ASspi-MRI-a and SPARCC indices were demonstrated during two years of NTK therapy, with sustained effect through week 156. In univariate logistic regression, younger age (p=0.013) and absence of syndesmophytes or spinal ankylosis at baseline (p&lt;0.01) were associated with lower rates of radiographic progression by mSASSS. Multivariate analysis did not reveal significant influence of baseline clinical-demographic or disease-history factors on NTK treatment response.Conclusion. Long-term therapy with NTK prevents radiographic progression and reduces active inflammatory changes by MRI in the majority of AS patients, regardless of baseline clinical and demographic characteristics or prior tumor necrosis factor α inhibitor therapy.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>нетакимаб</kwd><kwd>блокада интерлейкина 17А</kwd><kwd>рентгенологический аксиальный спондилоартрит</kwd><kwd>анкилозирующий спондилит</kwd></kwd-group><kwd-group xml:lang="en"><kwd>netakimab</kwd><kwd>interleukin-17A blockade</kwd><kwd>radiographic axial spondyloarthritis</kwd><kwd>ankylosing spondylitis</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Статья спонсируется АО «БИОКАД».</funding-statement><funding-statement xml:lang="en">The article is sponsored by JSC BIOCAD.</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Navarro-Compan V, Sepriano A, El-Zorkany B, van der Heijde D. 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