rspНаучно-практическая ревматологияRheumatology Science and Practice1995-44841995-4492IMA-PRESS, LLC10.14412/1995-4484-2019-274-279rsp-2725Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL RESEARCHОценка терапии ритуксимабом в реальной клинической практике (по данным регистра больных ревматоидным артритом ОРЕЛ)Evaluation of rituximab therapy in real clinical practice (according to the OREL registry of patients with rheumatoid arthritisАвдееваА. С.AvdeevaA. S.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

9056249400@mail.ruСатыбалдыевА. М.SatybaldyevA. M.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

ДемидоваН. В.DemidovaN. V.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

НикишинаН. Ю.NikishinaN. Yu.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

ГерасимоваЕ. В.GerasimovaE. V.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

МуравьеваН. В.MuravyevaN. V.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

ГридневаГ. И.GridnevaG. I.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

РумянцеваО. А.RumyantsevaO. A.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

КасумоваК. А.KasumovaK. A.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

АлексееваА. В.AlekseevaA. V.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

ЧичасоваН. В.ChichasovaN. V.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

КусевичД. А.KusevichD. A.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

РыбаковаВ. В.RybakovaV. V.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

КошкароваE. А.KoshkarovaE. A.

119049, Москва, Крымский Вал, 3, стр. 2.

3, Krymsky Val, Build. 2, Moscow 119049.

ЛилаА. М.LilaA. M.

115522, Москва, Каширское шоссе, 34А.

34A, Kashirskoe Shosse, Moscow 11552.

НасоновE. Л.NasonovE. L.ФГБНУ «Научно-исследовательский институт ревматологии им В.А. Насоновой»РоссияV.A. Nasonova Research Institute of RheumatologyRussian FederationАстон КонсалтингРоссияAston ConsultingRussian FederationФГБНУ «Научно-исследовательский институт ревматологии им В.А. Насоновой»; ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет)РоссияV.A. Nasonova Research Institute of Rheumatology; I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University).Russian Federation201909072019573274279Copyright © Авдеева А.С., Сатыбалдыев А.М., Демидова Н.В., Никишина Н.Ю., Герасимова Е.В., Муравьева Н.В., Гриднева Г.И., Румянцева О.А., Касумова К.А., Алексеева А.В., Чичасова Н.В., Кусевич Д.А., Рыбакова В.В., Кошкарова E.А., Лила А.М., Насонов E.Л., 20192019Авдеева А.С., Сатыбалдыев А.М., Демидова Н.В., Никишина Н.Ю., Герасимова Е.В., Муравьева Н.В., Гриднева Г.И., Румянцева О.А., Касумова К.А., Алексеева А.В., Чичасова Н.В., Кусевич Д.А., Рыбакова В.В., Кошкарова E.А., Лила А.М., Насонов E.Л.Avdeeva A.S., Satybaldyev A.M., Demidova N.V., Nikishina N.Y., Gerasimova E.V., Muravyeva N.V., Gridneva G.I., Rumyantseva O.A., Kasumova K.A., Alekseeva A.V., Chichasova N.V., Kusevich D.A., Rybakova V.V., Koshkarova E.A., Lila A.M., Nasonov E.L.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://rsp.mediar-press.net/rsp/article/view/2725

Цель  – проанализировать терапию генно-инженерным биологическим препаратом (ГИБП) ритуксимабом (РТМ) в реальной клинической практике (по данным регистра больных ревматоидным артритом ОРЕЛ).

Материал и методы

Материал и методы. В анализ было включено 349 пациентов. Все больные получали терапию РТМ: 340 – оригинальный препарат (Мабтера®) и 9 – биоаналог (Ацеллбия®). РТМ в комбинации с базисными противовоспалительными препаратами (БПВП) получали 263 пациента (75,4%), в виде монотерапии – 86 (24,6%).

Результаты и обсуждение

Результаты и обсуждение. Из 349 пациентов, включенных в анализ, у 272 (77,9%) РТМ был первым назначенным ГИБП (263 пациента получали оригинальный препарат и 9 – биоаналог) и 77 (22,1%) пациентов уже получали ранее ГИБП. Большинство пациентов – 205 (58,7%) – получили три курса терапии РТМ и более, один курс РТМ был проведен 109 (31,2%) больных, два курса получили 35 (10%) пациентов. Применение РТМ сопровождалось достоверным снижением активности заболевания уже после первого курса терапии, уровней острофазовых показателей (СРБ и СОЭ), после 5-го курса терапии концентрация СРБ снизилась в 1,4 раза и составила 7 [1,2; 17,9] мг/л, а СОЭ – в 1,8 раза и составила 10 [5; 20] мм/ч (p<0,05).

Заключение

Заключение. Анализ терапии РТМ больных РА в реальной клинической практике продемонстрировал, что РТМ в большинстве случаев назначался как первый ГИБП, в комбинации с БПВП, основным из которых был метотрексат. Применение РТМ сопровождалось достоверным снижением активности заболевания, уровней острофазовых показателей и содержания аутоантител в сыворотке крови.

Objective

Objective: to analyze therapy with rituximab (RTM) in real clinical practice according to the data available in OREL registry of patients with active rheumatoid arthritis (RA).

Subjects and methods

Subjects and methods. The analysis included 349 patients. All the patients received RTM: 340 – the original drug (MabThera®) and 9 – the biosimilar Acellbia®. 263 patients (75.4%) received RTM in combination with disease-modifying anti-rheumatic drugs (DMARDs) and 86 (24.6%) – RTM as monotherapy.

Results and discussion

Results and discussion. Of the 349 patients included in the analysis, 272 (77.9%) patients received RTM as the first biologic agent (BA) (263 patients were treated with the original drug and 9 – with the biosimilar) and 77 (22.1%) patients had previously used the BA. The majority of patients (n=205 (58.7%)) received three or more; 109 (31.2%) patients – one, and 35 (10%) – two RTM courses of RTM therapy. RTM caused a significant reduction in disease activity just after the first therapy course and in the levels of acute-phase reactants (C-reactive protein (CRP) and ESR); after the fifth therapy course, median CRP concentration decreased by 1.4 times and amounted to 7 [1.2; 17.9] mg/l and that of ESR reduced by 1.8 times and was 10 [5; 20] mm/hr (p<0.05).

Conclusion

Conclusion. The analysis of RTM therapy in RA patients in real clinical practice demonstrated that in most cases RTM was given as the first BA, in combination with DMARDs, the main agent of which was methotrexate. The use of RTM was accompanied by a significant reduction in disease activity and in the serum levels of acute-phase reactants and autoantibodies.

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The authors declare that there are no conflicts of interest present.