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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">rsp</journal-id><journal-title-group><journal-title xml:lang="ru">Научно-практическая ревматология</journal-title><trans-title-group xml:lang="en"><trans-title>Rheumatology Science and Practice</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">1995-4484</issn><issn pub-type="epub">1995-4492</issn><publisher><publisher-name>IMA-PRESS, LLC</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.47360/1995-4484-2023-25-33</article-id><article-id custom-type="elpub" pub-id-type="custom">rsp-3274</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>ПРОБЛЕМЫ РЕВМАТОЛОГИИ В ПЕРИОД ПАНДЕМИИ КОРОНОВИРУСНОЙ БОЛЕЗНИ 2019</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>PROBLEMS OF RHEUMATOLOGY DURING THE 2019 CORONAVIRUS PANDEMIC</subject></subj-group></article-categories><title-group><article-title>Результаты 12-недельного открытого неинтервенционного исследования эффективности и безопасности терапии препаратом олокизумаб у пациентов с ревматоидным артритом после переключения с анти-B-клеточной терапии в условиях пандемии SARS-CoV-2</article-title><trans-title-group xml:lang="en"><trans-title>Results of a 12-week open-label, non-interventional study of the efficacy and safety of olokizumab therapy in patients with rheumatoid arthritis after switching from anti-B-cell therapy during the SARS-CoV-2 pandemic</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-1099-3256</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Акимова</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Akimova</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Акимова Анна Александровна</p><p>630060, Российская Федерация, Новосибирск, ул. Тимакова, 2 </p></bio><bio xml:lang="en"><p>630060, Russian Federation, Novosibirsk, Timakova str., 2 </p></bio><email xlink:type="simple">anya-zemtsova@mail.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/0000-0003-0900-1600</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Банщикова</surname><given-names>Н. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Banshchikova</surname><given-names>N. E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>630060, Российская Федерация, Новосибирск, ул. Тимакова, 2 </p></bio><bio xml:lang="en"><p>630060, Russian Federation, Novosibirsk, Timakova str., 2 </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/0000-0002-7213-7482</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сизиков</surname><given-names>А. Э.</given-names></name><name name-style="western" xml:lang="en"><surname>Sizikov</surname><given-names>A. E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>630099, Российская Федерация, Новосибирск, ул. Ядринцевская, 14 </p></bio><bio xml:lang="en"><p>630099, Russian Federation, Novosibirsk, Yadrintsevskaya str., 14 </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/0000-0002-5213-5658</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Муллагалиев</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Mullagaliev</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>630060, Российская Федерация, Новосибирск, ул. Тимакова, 2 </p></bio><bio xml:lang="en"><p>630060, Russian Federation, Novosibirsk, Timakova str., 2 </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/0000-0002-6275-2924</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Летягина</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Letyagina</surname><given-names>E. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>630060, Российская Федерация, Новосибирск, ул. Тимакова, 2 </p></bio><bio xml:lang="en"><p>630060, Russian Federation, Novosibirsk, Timakova str., 2 </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/0000-0002-8633-0662</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ильина</surname><given-names>Н. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Ilina</surname><given-names>N. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>630099, Российская Федерация, Новосибирск, ул. Ядринцевская, 14 </p></bio><bio xml:lang="en"><p>630099, Russian Federation, Novosibirsk, Yadrintsevskaya str., 14 </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/0000-0002-7080-777X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Курочкина</surname><given-names>Ю. Д.</given-names></name><name name-style="western" xml:lang="en"><surname>Kurochkina</surname><given-names>Yu. D.</given-names></name></name-alternatives><bio xml:lang="ru"><p>630060, Российская Федерация, Новосибирск, ул. Тимакова, 2 </p></bio><bio xml:lang="en"><p>630060, Russian Federation, Novosibirsk, Timakova str., 2 </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/0000-0001-6330-1044</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Убшаева</surname><given-names>Ю. Б.</given-names></name><name name-style="western" xml:lang="en"><surname>Ubshaeva</surname><given-names>Yu. B.</given-names></name></name-alternatives><bio xml:lang="ru"><p>630060, Российская Федерация, Новосибирск, ул. Тимакова, 2 </p></bio><bio xml:lang="en"><p>630060, Russian Federation, Novosibirsk, Timakova str., 2 </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/0000-0001-6606-7185</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Омельченко</surname><given-names>В. О.</given-names></name><name name-style="western" xml:lang="en"><surname>Omelchenko</surname><given-names>V. O.</given-names></name></name-alternatives><bio xml:lang="ru"><p>630060, Российская Федерация, Новосибирск, ул. Тимакова, 2 </p></bio><bio xml:lang="en"><p>630060, Russian Federation, Novosibirsk, Timakova str., 2 </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/0000-0003-3797-6392</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Чумасова</surname><given-names>О. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Chumasova</surname><given-names>O. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>630099, Российская Федерация, Новосибирск, ул. Ядринцевская, 14 </p></bio><bio xml:lang="en"><p>630099, Russian Federation, Novosibirsk, Yadrintsevskaya str., 14 </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/0000-0001-7676-6166</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шкаруба</surname><given-names>Н. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Shkaruba</surname><given-names>N. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>630099, Российская Федерация, Новосибирск, ул. Ядринцевская, 14 </p></bio><bio xml:lang="en"><p>630099, Russian Federation, Novosibirsk, Yadrintsevskaya str., 14</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/0000-0002-4890-0847</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Королев</surname><given-names>М. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Korolev</surname><given-names>M. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>630060, Российская Федерация, Новосибирск, ул. Тимакова, 2 </p></bio><bio xml:lang="en"><p>630060, Russian Federation, Novosibirsk, Timakova str., 2 </p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Научно-исследовательский институт клинической и экспериментальной лимфологии – филиал ФГБНУ «Федеральный исследовательский центр Институт цитологии и генетики Сибирского отделения  Российской академии наук»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Research Institute of Clinical and Experimental Lymрhology – Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ФГБНУ «Научно-исследовательский институт фундаментальной и клинической иммунологии»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Research Institute of Fundamental and Clinical Immunology</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2023</year></pub-date><pub-date pub-type="epub"><day>02</day><month>03</month><year>2023</year></pub-date><volume>61</volume><issue>1</issue><elocation-id>25–33</elocation-id><permissions><copyright-statement>Copyright &amp;#x00A9; Акимова А.А., Банщикова Н.Е., Сизиков А.Э., Муллагалиев А.А., Летягина Е.А., Ильина Н.А., Курочкина Ю.Д., Убшаева Ю.Б., Омельченко В.О., Чумасова О.А., Шкаруба Н.С., Королев М.А., 2023</copyright-statement><copyright-year>2023</copyright-year><copyright-holder xml:lang="ru">Акимова А.А., Банщикова Н.Е., Сизиков А.Э., Муллагалиев А.А., Летягина Е.А., Ильина Н.А., Курочкина Ю.Д., Убшаева Ю.Б., Омельченко В.О., Чумасова О.А., Шкаруба Н.С., Королев М.А.</copyright-holder><copyright-holder xml:lang="en">Akimova A.A., Banshchikova N.E., Sizikov A.E., Mullagaliev A.A., Letyagina E.A., Ilina N.A., Kurochkina Y.D., Ubshaeva Y.B., Omelchenko V.O., Chumasova O.A., Shkaruba N.S., Korolev M.A.</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://rsp.mediar-press.net/rsp/article/view/3274">https://rsp.mediar-press.net/rsp/article/view/3274</self-uri><abstract><p>Актуальность. Пандемия новой коронавирусной инфекции (COVID-19, coronavirus disease 2019) значительно изменила представления о профиле безопасности терапии иммуновоспалительных ревматических заболеваний (ИВРЗ). Это в первую очередь связано с негативным влиянием некоторых базисных противовоспалительных препаратов (БПВП) и генно-инженерных биологических препаратов (ГИБП) на течение и исходы новой коронавирусной инфекции. В ряде исследований показано, что анти-В-клеточная терапия ритуксимабом (РТМ) была ассоциирована со статистически значимым увеличением риска тяжелого течения COVID-19 и ростом летальности. Данные реальной клинической практики продиктовали необходимость введения ряда ограничений для использования некоторых классов ГИБП и поиска альтернативных программ терапии для сохранения контроля над активностью заболевания.Цель исследования – оценить эффективность и безопасность препарата олокизумаб (Артлегиа®; раствор для подкожного введения, 160 мг/мл – 0,4 мл; производство АО «Р-Фарм», Россия) для лечения пациентов с ревматоидным артритом (РА) в условиях реальной клинической практики после переключения с ритуксимаба в условиях пандемии COVID-19.Материалы и методы. В исследование включено 14 больных с подтвержденным диагнозом РА, получивших не менее одного курса терапии РТМ в дозе 1000–500 мг дважды с интервалом в 2 недели не менее 6 месяцев назад. По мере роста активности РА пациенты переключались на олокизумаб на фоне продолжения терапии синтетическим БПВП. На 0-й, 4-й, 8-й, 12-й неделях после переключения была проведена оценка выраженности боли по визуальной аналоговой шкале, числа болезненных (ЧБС) и припухших (ЧПС) суставов из 28, уровня острофазовых маркеров воспаления, индексов активности заболевания DAS28-СОЭ (Disease Activity Score 28 с определением скорости оседания эритроцитов), DAS28-СРБ (DAS28 с определением уровня C-реактивного белка), CDAI (Clinical Disease Activity Index), индекса HAQ (Health Assessment Questionnaire), а также профиля безопасности терапии.Результаты. Через 8 и 12 недель на фоне введения олокизумаба отмечено статистически значимое снижение ЧБС (в обоих случаях медиана уменьшилась с 10 до 4 ; p&lt;0,05), а через 4, 8 и 12 недель – статистически значимое снижение ЧПС (p&lt;0,05). Анализ динамики лабораторных маркеров воспаления продемонстрировал снижение уровня СРБ и СОЭ через 4, 8 и 12 недель терапии. Медиана СРБ уменьшилась с 21 до 1 мг/л, 1 мг/л и 0 мг/л соответственно (р&lt;0,05); медиана СОЭ – с 31 до 7 мм/ч, 4 мм/ч и 5 мм/ч соответственно (р&lt;0,05). Вне зависимости от исходных значений уровень СРБ уже к 4-й неделе достигал нормальных показателей. Все индексы активности РА продемонстрировали положительную динамику начиная с 4-й недели в каждом оценочном периоде по сравнению с исходными результатами. Медиана DAS28-СОЭ после 4, 8 и 12 недель уменьшилась с 5,52 до 3,59, 3,33 и 3,22 соответственно (p&lt;0,05); медиана DAS28-СРБ – с 5,39 до 3,71, 3,35 и 3,45 соответственно (p&lt;0,05); медиана CDAI – с 28,5 до 18,0, 16,5 и 16,0 соответственно (p&lt;0,05). У всех пациентов было зафиксировано уменьшение боли к 8-й неделе наблюдения. Через 12 недель отмечалось улучшение функционального статуса пациентов; медиана индекса HAQ уменьшилась с 1,62 до 1,31 (p&lt;0,05).Заключение. Исследование продемонстрировало, что немедицинское переключение с РТМ на олокизумаб оказалось эффективным и безопасным в условиях пандемии COVID-19.</p></abstract><trans-abstract xml:lang="en"><p>The COVID-19 pandemic has significantly changed the understanding of the safety profile of therapies for immunoinflammatory rheumatic diseases (IRDs). This is primarily due to the negative impact of a number of basic anti-inflammatory drugs (DMARDs) and biological DMARDs on the course and outcomes of a new coronavirus infection. A number of studies have shown that anti-B-cell therapy (rituximab) gave a statistically significant increase in the risk of severe COVID-19 and an increase in mortality. At the same time, the analysis of real clinical practice data dictated the need to establish a number of restrictions on the use of certain classes of biological DMARDs and to search for alternative therapy programs to maintain control over disease activity.Purpose of the study – to evaluate the efficacy and safety of the drug Artlegia® (olokizumab), solution for subcuta neous injection, 160 mg/ml – 0.4 ml, manufactured by R-Pharm JSC, Russia) for the treatment of patients with rheuma toid arthritis in real clinical practice after switching with rituximab during the COVID-19 pandemic.Materials and methods. The study included 14 patients with a confirmed diagnosis of rheumatoid arthritis (RA), who were previously on rituximab therapy at a dose of 1000–500 mg twice with an interval of 2 weeks, who received at least one course of therapy with this drug. As RA worsened, patients were switched to olokizumab against the background of standard DMARDs. At 4, 8, 12 weeks after the switch, the severity of pain was assessed on the VAS scale, the number of painful and swollen joints (TJC28 and TSC28), the level of acute phase markers of inflammation, the DAS28 disease activity index calculated using ESR and CRP, and the CDAI (clinical activity index), functional state index HAQ, as well as assessment of the safety profile of therapy.Results. Data analysis was performed using median values (Me) were used for data analysis. A significant decrease of TJC28 was after the injection of olokizumab (Artlegia®) in 8 and 12 weeks (Me baseline = 10; Me 8 weeks = 4; Me 12 weeks = 4; p&lt;0.05) and a decrease of TSC28 in 4, 8 and 12 weeks (Me baseline = 9; Me 4 weeks = 3.5; Me 8 weeks = 2.5; Me 12 weeks = 2.0; p&lt;0.05). Laboratory markers of inflammation showed a decrease in CRP and ESR levels after 4 weeks of treatment (CRP: Me baseline = 21, Me 4 weeks = 1 (p&lt;0.05); ESR: Me baseline = 31, Me 4 weeks = 7 (p&lt;0.05)). Positive dynamics persisted at 8 and 12 weeks (CRP: Me 8 weeks = 1, Me 12 weeks = 0; ESR: Me 8 weeks = 4, Me 12 weeks = 5). The level of CRP by the fourth week 4 became within the normal range, regardless of the initial values. All activity indices improved from the fourth week in each evaluation period compared to baseline: DAS28-ESR: Me baseline = 5.52, Me 4 weeks = 3.59, Me 8 weeks = 3.33, Me 12 weeks = 3.22 (p&lt;0.05); DAS28-CRP: Me baseline = 5.39, Me 4 weeks = 3.71, Me 8 weeks = 3.35, Me 12 weeks = 3.45 (p&lt;0.05); CDAI: Me baseline = 28.5, Me 4 weeks = 18.0, Me 8 weeks = 16.5, Me 12 weeks = 16.0 (p&lt;0.05). All patients showed a reduction in pain (VAS scale) by week 8. The functional status of patients, according to the HAQ index, showed a significant decrease only by the 12th week of the study: Me baseline = 1.62, Me 12 weeks = 1.31 (p&lt;0.05).Conclusion. The study found that switching from rituximab to olokizumab was effective and safe during the COVID-19 pandemic.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>ревматоидный артрит</kwd><kwd>COVID-19</kwd><kwd>олокизумаб</kwd><kwd>ритуксимаб</kwd></kwd-group><kwd-group xml:lang="en"><kwd>rheumatoid arthritis</kwd><kwd>COVID-19</kwd><kwd>olokizumab</kwd><kwd>rituximab</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена в рамках государственного задания НИИКЭЛ – филиала ИЦиГ СО РАН (проект № FWNR-2022- 0009).</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">Белов БС, Лила АМ. COVID-19 и ревматология: год спустя. Научно-практическая ревматология. 2021;59(1):31-36. doi: 10.47360/1995-4484-2021-31-36</mixed-citation><mixed-citation xml:lang="en">Belov BS, Lila AM. COVID-19 and rheumatology: A year later. 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