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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">10.14412/1996-7012-2021-3-35-42</article-id><article-id custom-type="elpub" pub-id-type="custom">mrj-1145</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>Сравнительная эффективность тофацитиниба и адалимумаба у пациентов с псориатическим артритом в реальной клинической практике. Данные Общероссийского регистра пациентов с псориатическим артритом</article-title><trans-title-group xml:lang="en"><trans-title>Comparative efficacy of tofacitinib and adalimumab in patients with psoriatic arthritis in real clinical practice. Data from the Russian nationwide register of patients with psoriatic arthritis</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-6875-4552</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Логинова</surname><given-names>Е. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Loginova</surname><given-names>E. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Елена Юрьевна Логинова</p><p>Россия, 115522, Москва, Каширское шоссе, 34А</p></bio><bio xml:lang="en"><p>Elena Yurievna Loginiva</p><p>34A, Kashirskoe Shosse, Moscow 115522, Russia</p></bio><email xlink:type="simple">eyloginova@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/0000-0003-0579-1131</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Коротаева</surname><given-names>Т. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Korotaeva</surname><given-names>T. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Россия, 115522, Москва, Каширское шоссе, 34А</p></bio><bio xml:lang="en"><p>34A, Kashirskoe Shosse, Moscow 115522, Russia</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/0000-0001-5015-7143</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Губарь</surname><given-names>Е. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Gubar</surname><given-names>E. E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Россия, 115522, Москва, Каширское шоссе, 34А</p></bio><bio xml:lang="en"><p>34A, Kashirskoe Shosse, Moscow 115522, Russia</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/0000-0001-5968-2403</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Корсакова</surname><given-names>Ю. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Korsakova</surname><given-names>Yu. L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Россия, 115522, Москва, Каширское шоссе, 34А</p></bio><bio xml:lang="en"><p>34A, Kashirskoe Shosse, Moscow 115522, Russia</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/0000-0002-4285-0869</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Глухова</surname><given-names>С. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Glukhova</surname><given-names>S. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Россия, 115522, Москва, Каширское шоссе, 34А</p></bio><bio xml:lang="en"><p>34A, Kashirskoe Shosse, Moscow 115522, Russia</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/0000-0003-2153-5429</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Василенко</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Vasilenko</surname><given-names>E. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Россия, 191015, Санкт-Петербург, ул. Кирочная, 41</p></bio><bio xml:lang="en"><p>41, Kirochnaya st., St. Petersburg 191015, Russia</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/0000-0002-5486-2576</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Василенко</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Vasilenko</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>173008, Россия, Великий Новгород, ул. Павла Левитта, 14</p></bio><bio xml:lang="en"><p>14, Pavla Levitta st., Veliky Novgorod 173008, Russia</p></bio><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-4972-7716</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кузнецова</surname><given-names>Н. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Kuznetsova</surname><given-names>N. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>620102, Екатеринбург, ул. Волгоградская, 189</p></bio><bio xml:lang="en"><p>189, Volgogradskaya st., Ekaterinburg 620102, Russia</p></bio><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-0530-0080</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Патрикеева</surname><given-names>И. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Patrikeyeva</surname><given-names>I. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>625023, Тюмень, ул. Котовского, 55</p></bio><bio xml:lang="en"><p>55, Kotovskogo st., Tyumen 625023, Russia</p></bio><xref ref-type="aff" rid="aff-5"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1598-8360</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Насонов</surname><given-names>Е. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Nasonov</surname><given-names>E. L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Россия, 115522, Москва, Каширское шоссе, 34А</p><p>119991, Москва, ул. Трубецкая, 8, стр.2</p></bio><bio xml:lang="en"><p>34A, Kashirskoe Shosse, Moscow 115522, Russia</p><p>8, Trubetskaya St., Build. 2, Moscow 119991, Russia</p></bio><xref ref-type="aff" rid="aff-6"/></contrib></contrib-group><aff-alternatives id="aff-1"><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-2"><aff xml:lang="ru"><institution>ФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>North-Western State Medical University named after I.I. Mechnikov</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>ГОБУЗ «Новгородская областная клиническая больница»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Novgorod Regional Clinical Hospital</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>МАУЗ «Городская клиническая больница №40»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>City Clinical Hospital №40</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-5"><aff xml:lang="ru"><institution>ГБУЗ Тюменской области «Областная клиническая больница №1»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Regional Clinical Hospital №1</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-6"><aff xml:lang="ru"><institution>ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»; 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>V.A. Nasonova Research Institute of Rheumatology; I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University)</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2021</year></pub-date><pub-date pub-type="epub"><day>23</day><month>06</month><year>2021</year></pub-date><volume>15</volume><issue>3</issue><elocation-id>35–42</elocation-id><permissions><copyright-statement>Copyright &amp;#x00A9; Логинова Е.Ю., Коротаева Т.В., Губарь Е.Е., Корсакова Ю.Л., Глухова С.И., Василенко Е.А., Василенко А.А., Кузнецова Н.А., Патрикеева И.М., Насонов Е.Л., 2021</copyright-statement><copyright-year>2021</copyright-year><copyright-holder xml:lang="ru">Логинова Е.Ю., Коротаева Т.В., Губарь Е.Е., Корсакова Ю.Л., Глухова С.И., Василенко Е.А., Василенко А.А., Кузнецова Н.А., Патрикеева И.М., Насонов Е.Л.</copyright-holder><copyright-holder xml:lang="en">Loginova E.Y., Korotaeva T.V., Gubar E.E., Korsakova Y.L., Glukhova S.I., Vasilenko E.A., Vasilenko A.A., Kuznetsova N.A., Patrikeyeva I.M., Nasonov E.L.</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/1145">https://mrj.ima-press.net/mrj/article/view/1145</self-uri><abstract><p>Цель исследования – сравнение клинической эффективности таргетного синтетического базисного противовоспалительного препарата (тсБПВП) тофацитиниба (ТОФА) и генно-инженерного биологического препарата (ГИБП), ингибитора фактора некроза опухоли α (иФНОα) адалимумаба (АДА) у больных псориатическим артритом (ПсА) в реальной клинической практике по данным Общероссийского регистра пациентов с ПсА.</p><sec><title>Пациенты и методы</title><p>Пациенты и методы. В исследование включено 77 больных ПсА (43 мужчины и 34 женщины), соответствовавших критериям CASPAR и наблюдавшихся в Общероссийском регистре. Пациенты были разделены на две группы в зависимости от проводимого лечения. В 1-ю группу, в которой назначали таблетированный ТОФА по 5 мг 2 раза в день, вошел 41 пациент: 24 (58,5%) мужчины и 17 (41,5%) женщин, медиана возраста – 41 [34; 50] год, медиана длительности ПсА – 72 [35; 120] мес. Ко 2-й группе, в которой использовали АДА по 40 мг/2 нед подкожно, отнесены 36 больных: 19 (52,8%) мужчин и 17 (47,2%) женщин, медиана возраста – 44 [34; 51] года, медиана длительности ПсА – 59 [22; 102] мес. Комбинированную терапию, включавшую метотрексат (МТ), получали 80,5% пациентов группы ТОФА и 52,8% пациента группы АДА. У всех пациентов в начале исследования и каждые 6 мес оценивали активность и эффективность терапии ПсА по DAPSA и критериям минимальной активности болезни – MAБ (число болезненных суставов ≤1, число припухших суставов ≤1, PASI ≤1 или BSA ≤3, оценка боли ≤15, общая оценка активности болезни больным ≤20 мм по визуальной аналоговой шкале, HAQ ≤0,5, энтези- ты ≤1), динамику BASDAI и BSA. Определяли число больных, достигших ремиссии (DAPSA ≤4) или МАБ (5 критериев из 7) на фоне терапии ТОФА и АДА.</p></sec><sec><title>Результаты и обсуждение</title><p>Результаты и обсуждение. До начала терапии в 1-й группе медиана DAPSA составляла 44,2 [37,8; 55,3]: умеренная активность ПсА была у 5 (12,2%), высокая – у 36 (87,8%) больных. Во 2-й группе медиана DAPSA равнялась 35,8 [21,1; 52]: низкая активность выявлена у 3 (8,6%), умеренная – у 11 (31,4%), высокая – у 21 (60%) больного (доступны данные 35 пациентов). Через 6 мес после начала лечения у пациентов 1-й и 2-й групп произошло значимое снижение всех показателей активности ПсА по сравнению с исходными. Мeдиана DAPSA составила соответственно 11 [4,3; 17,3] и 9,1 [6; 19,6]; ремиссии по DAPSA достигли соответственно 11 (26,8%) и 6 (20,8%) больных, низкой активности – 15 (36,6%) и 13 (44,8%), МАБ – 16 (40%) и 9 (30%). Число пациентов с дактилитом значимо уменьшилось: с 22 (53,7%) до 5 (13,2%) и с 13 (36,1%) до 6 (20%) соответственно в 1-й и 2-й группах. Мeдиана HAQ снизилась с 1 [0,625; 1,5] дo 0,5 [0; 0,875] и с 0,875 [0,5; 1,38] дo 0,5 [0; 0,875]; мeдиана BASDAI – с 6 [4,2; 7] дo 1,4 [0,6; 3,2] и с 4,4 [1,9; 5,8] дo 3 [0,8; 4,5] соответственно. В 1-й группе число пациентов с BSA &gt;3% сократилось с 16 (39%) до 8 (26,7%; p&lt;0,225), а во 2-й группе из-за недостаточного объема данных (5 пациентов) динамику BSA оценить не удалось.</p></sec><sec><title>Заключение</title><p>Заключение. Показана сопоставимая эффективность ТОФА и АДА в реальной клинической практике в отношении всех клинических проявлений ПсА: через 6 мес терапии у большинства пациентов с ПсА отмечено достижение МАБ, низкой активности болезни и ремиссии по DAPSA и BASDAI.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Objective</title><p>Objective: to compare the clinical efficacy in real clinical practice of the targeted synthetic disease-modifying antirheumatic drug (sDMARD) tofacitinib (TOFA) and the biologic DMARD (bDMARD), an inhibitor of tumor necrosis factor alpha (TNFα), adalimumab (ADA) in patients with psoriatic arthritis (PsA), included in the Russian nationwide register of patients with PsA.</p></sec><sec><title>Patients and methods</title><p>Patients and methods. The study included 77 patients with PsA (43 men and 34 women) who met the CASPAR criteria and were observed in the Russian nationwide register. Patients were divided into two groups depending on the treatment. Group 1, in which oral TOFA was prescribed, 5 mg 2 times a day, included 41 patients: 24 (58.5%) men and 17 (41.5%) women, the median age was 41 [34; 50] years, the median duration of PsA was 72 [35; 120] months. Group 2, in which subcutaneous ADA was used, 40 mg every 2 weeks, included 36 patients: 19 (52.8%) men and 17 (47.2%) women, the median age was 44 [34; 51] years, the median duration of PsA was 59 [22; 102] months. Combination therapy, including methotrexate (MT), received 80.5% of patients in the TOFA group and 52.8% of patients in the ADA group. At the beginning of the study and every 6 months further, the activity and efficacy of PsA therapy were assessed in all patients according to DAPSA and criteria for minimal disease activity – MDA (number of painful joints ≤1, number of swollen joints ≤1, PASI ≤1 or BSA ≤3 , pain score ≤15, patient's general assessment of disease activity ≤20 mm on a visual analogue scale, HAQ ≤0.5, enthesitis ≤1), dynamics of BASDAI and BSA were also assessed. The number of patients who achieved remission (DAPSA ≤4) or MDA (5 criteria out of 7) during therapy with TOFA and ADA was determined.</p></sec><sec><title>Results and discussion</title><p>Results and discussion. Before the start of the therapy in the 1st group, the median DAPSA was 44.2 [37.8; 55.3]: moderate PsA activity was in 5 (12.2%) patients, high in 36 (87.8%) patients. In group 2, the median DAPSA was 35.8 [21.1; 52]: low activity was detected in 3 (8.6%), moderate – in 11 (31.4%), high – in 21 (60%) patients (data from 35 patients was available). 6 months after the start of treatment in patients of the 1st and the 2nd group, there was a significant decrease in all indicators of PsA activity compared to the baseline. The median DAPSA was 11 [4.3; 17.3] and 9.1 [6; 19.6]; remissions according to DAPSA reached 11 (26.8%) and 6 (20.8%) patients, respectively, low activity – 15 (36.6%) and 13 (44.8%), MDA – 16 (40%) and 9 (30%). The number of patients with dactylitis in the 1st and in the 2nd group significantly decreased: from 22 (53.7%) to 5 (13.2%) and from 13 (36.1%) to 6 (20%), respectively. Median HAQ decreased from 1 [0.625; 1.5] to 0.5 [0; 0.875] and from 0.875 [0.5; 1.38] to 0.5 [0; 0.875]; median BASDAI – from 6 [4.2; 7] to 1.4 [0.6; 3.2] and from 4.4 [1.9; 5.8] to 3 [0.8; 4.5], respectively. In group 1, the number of patients with BSA&gt; 3% decreased from 16 (39%) to 8 (26.7%; p&lt;0.225), and in group 2, due to insufficient data (5 patients), we failed to evaluate BSA dynamics.</p></sec><sec><title>Conclusion</title><p>Conclusion. In real clinical practice TOFA and ADA both had comparable efficacy on all clinical manifestations of PsA: after 6 months of therapy, most patients with PsA achieved MDA, low disease activity and remission according to DAPSA and BASDAI.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>псориатический артрит</kwd><kwd>тофацитиниб</kwd><kwd>адалимумаб</kwd><kwd>генно-инженерные биологические препараты</kwd><kwd>таргетные синтетические базисные противовоспалительные препараты</kwd><kwd>ремиссия</kwd><kwd>минимальная активность болезни</kwd></kwd-group><kwd-group xml:lang="en"><kwd>psoriatic arthritis</kwd><kwd>tofacitinib</kwd><kwd>adalimumab</kwd><kwd>biologic disease-modifying antirheumatic drug</kwd><kwd>targeted synthetic disease-modifying antirheumatic drug</kwd><kwd>remission</kwd><kwd>minimal disease activity</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">Gladman DD, Antoni C, Mease P, et al. 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Ann Rheum Dis. 2020;79:1162.</mixed-citation></citation-alternatives></ref><ref id="cit25"><label>25</label><citation-alternatives><mixed-citation xml:lang="ru">www.pfizer.com/news/press-release/press-release-detail/pfizer-shares-co-primary-endpoint-results-post-marketing</mixed-citation><mixed-citation xml:lang="en">www.pfizer.com/news/press-release/press-release-detail/pfizer-shares-co-primary-endpoint-results-post-marketing</mixed-citation></citation-alternatives></ref><ref id="cit26"><label>26</label><citation-alternatives><mixed-citation xml:lang="ru">Инструкция по медицинскому применению препарата тофацитиниб (Яквинус) № ЛП-002026-200820.</mixed-citation><mixed-citation xml:lang="en">Instructions for the medical use of the tofacitinib (Yaquinus) № LP-002026-200820.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
