rspНаучно-практическая ревматологияRheumatology Science and Practice1995-44841995-4492IMA-PRESS, LLC10.14412/1995-4484-2017-351-359rsp-2407Research ArticleОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯORIGINAL RESEARCHЭффективность и безопасность биоаналога ритуксимаба (Ацеллбия®) при ревматоидном артрите в качестве «первого» генно-инженерного биологического препарата: результаты клинического исследования III фазы (ALTERRA)THE EFFICACY AND SAFETY OF RITUXIMAB BIOSIMILAR (ACELLBIA®) IN RHEUMATOID ARTHRITIS AS THE FIRST BIOLOGICAL AGENT: RESULTS OF PHASE III (ALTERRA) CLINICAL TRIALНасоновЕ. Л.NasonovE. L.

115522 Москва, Каширское шоссе, 34А

кафедра ревматологии Института профессионального образования

119991 Москва, ул. Трубецкая, 8, стр. 2

34A, Kashirskoe Shosse, Moscow 115522

Department of Rheumatology, Institute of Professional Education

8, Trubetskaya St., Build. 2, Moscow 119991

nasonov@irramn.ruМазуровВ. И.MazurovV. I.

191015 Санкт-Петербург, ул. Кирочная, 41

41, Kirochnaya St., Saint Petersburg 191015

ЗоноваЕ. В.ZonovaE. V.

630099 Новосибирск, ул. Серебренниковская, 42

42, Serebrennikovskaya St., Novosibirsk 630099

КнязеваЛ. А.KnyazevaL. A.

305007 Курск, ул. Сумская, 45а 

45a, Sumskaya St., Kursk 305007

МарусенкоИ. М.MarusenkoI. M.

185000 Петрозаводск, ул. Пирогова, 3

3, Pirogov St., Petrozavodsk 185000

НесмеяноваО. Б.NesmeyanovaO. B.

454076 Челябинск, ул. Воровского, 70

70, Vorovsky St., Chelyabinsk 454076

ПлаксинаТ. В.PlaksinaT. V.

603126 Нижний Новгород, ул. Родионова, 190

190, Rodionov St., Nizhny Novgorod 603126

ШаповаловаЮ. С.ShapovalovaYu. S.

454000 Челябинск, ул. Цвиллинга, 41

841, Tsvilling St., Chelyabinsk 454000

ИливановаЕ. П.IlivanovaE. P.

194291 Санкт-Петербург, пр. Луначарского, 45-49

45-49, Lunacharsky Pr., Saint Petersburg 194291

КречиковаД. Г.KrechikovaD. G.

214025 Смоленск, 1-й Краснофлотский переулок, 15

15, First Krasnoflotsky Lane, Smolensk 214025

ПетроченковаН. А.PetrochenkovaN. A.

214019 Смоленск, ул. Крупской, 28

28, Krupskaya St., Smolensk 214019

РешетькоО. В.ReshetkoO. V.

410053 Саратов, Смирновское ущелье, 1

1, Smirnovskoe Ushchelye, Saratov 410053

ДенисовЛ. Н.DenisovL. N.

115522 Москва, Каширское шоссе, 34А

V.A. Nasonova Research Institute of Rheumatology

ГордеевИ. Г.GordeevI. G.

111539 Москва, ул. Вешняковская, 23

Moscow Healthcare Department

23, Veshnyakovskaya St., Moscow 111539

ДавыдоваА. Ф.DavydovaA. F.

350086 Краснодар, ул. 1 Мая, 167

167, First May St., Krasnodar 350086

ЕреминаН. А.EreminaN. A.

603140 Нижний Новгород, пр. Ленина, 18

18, Lenin Pr., Nizhny Novgorod 603140

ЗемероваЕ. В.ZemerovaE. V.

628012 Ханты-Мансийск, ул. Калинина, 40

40, Kalinin St., Khanty-Mansiysk 628012

ИвановаТ. Б.IvanovaT. B.

121374 Москва, Можайское шоссе, 14, к. 6

 Moscow Healthcare Department

14, Mozhaiskoe Shosse, Build. 6, Moscow 121374

КастанаянА. А.KastanayanA. A.

344022 Ростов-на-Дону, пер. Нахичеванский, 29

29, Nakhichevansky Lane, Rostov-on-Don 344022

ПокровскаяТ. Г.PokrovskayaT. G.

308015 Белгород, ул. Победы, 85

85, Pobeda St., Belgorod 308015

СмакотинаС. А.SmakotinaS. A.

650029 Кемерово, ул. Ворошилова, 22а

22a, Voroshilov St., Kemerovo 650029

СмолярчукЕ. А.SmolyarchukE. A.

119991 Москва, ул. Трубецкая, 8, стр. 2;

8, Trubetskaya St., Build. 2, Moscow 119991

АртемьеваА. В.ArtemyevaA. V.

198515 Санкт-Петербург, пос. Стрельна, ул. Связи, 34А

34A, Svyaz St., Strelnya, Saint Petersburg 198515

ИвановР. А.IvanovR. A.

198515 Санкт-Петербург, пос. Стрельна, ул. Связи, 34А

34A, Svyaz St., Strelnya, Saint Petersburg 198515

УсачеваЮ. В.UsachevaYu. V.

198515 Санкт-Петербург, пос. Стрельна, ул. Связи, 34А

34A, Svyaz St., Strelnya, Saint Petersburg 198515

ЧерняеваЕ. В.ChernyaevaE. V.

198515 Санкт-Петербург, пос. Стрельна, ул. Связи, 34А

34A, Svyaz St., Strelnya, Saint Petersburg 198515

ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой» ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава РоссииРоссияV.A. Nasonova Research Institute of Rheumatology I.M. Sechenov First Moscow State Medical University, Ministry of Health of RussiaRussian FederationФГБОУ ВО «Северо-Западный государственный медицинский университет им. И.И. Мечникова» Минздрава РоссииРоссияI.I. Mechnikov North-Western State Medical University, Ministry of Health of RussiaRussian FederationГАУЗ НСО «Городская клиническая поликлиника № 1»РоссияCity Polyclinic OneRussian FederationБМУ «Курская областная клиническая больница»РоссияKursk Regional Clinical HospitalRussian FederationГБУЗ РК «Республиканская больница им. В.А. Баранова» Минздрава Республики КарелияРоссияV.A. Baranov Republican Hospital, Ministry of Health of the Republic of KareliaRussian FederationГБУЗ «Челябинская областная клиническая больница»РоссияChelyabinsk Regional Clinical HospitalRussian FederationГБУЗ НО «Нижегородская областная клиническая больница им. Н.А. Семашко»РоссияN.A. Semashko Nizhny Novgorod Regional Clinical HospitalRussian FederationНУЗ «Дорожная клиническая больница на ст. Челябинск ОАО “РЖД”»РоссияRailway Clinical Hospital at the Chelyabinsk Station, OAO «RZhD»Russian FederationГУЗ «Ленинградская областная клиническая больница»РоссияLeningrad Regional Clinical HospitalRussian FederationНУЗ «Отделенческая больница на ст. Смоленск ОАО “РЖД”»РоссияDepartmental Hospital at the Smolensk Station, OAO «RZhD»Russian FederationФГБОУ ВПО «Смоленский государственный медицинский университет» Минздрава РоссииРоссияSmolensk State Medical University, Ministry of Health of RussiaRussian FederationГУЗ «Областная клиническая больница»РоссияRegional Clinical HospitalRussian FederationФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»РоссияV.A. Nasonova Research Institute of RheumatologyRussian FederationГУЗ г. Москвы «Городская клиническая больница №15 им. О.М. Филатова» ДЗ г. МосквыРоссияO.M. Filatov City Clinical Hospital FifteenRussian FederationГБУЗ «Краевая клиническая больница №1 им. профессора С.В. Очаповского»РоссияProfessor S.V. Ochapovsky Territorial Clinical Hospital OneRussian FederationНУЗ «Дорожная клиническая больница на станции Горький ОАО “РЖД”»РоссияRailway Clinical Hospital at the Gorky Station, OAO «RZhD»Russian FederationБУЗ ХМАО-Югры «Окружная клиническая больница»РоссияDistrict Clinical HospitalRussian FederationГУЗ г. Москвы «Городская клиническая больница №71 ДЗ г. Москвы»РоссияCity Clinical Hospital Seventy-OneRussian FederationГБОУ ВПО «Ростовский государственный медицинский университет» Минздрава РоссииРоссияRostov State Medical University, Ministry of Health of RussiaRussian FederationФГАОУ ВПО «Белгородский государственный национальный исследовательский университет»РоссияBelgorod State National Research UniversityRussian FederationГБОУ ВПО «Кемеровская государственная медицинская академия» Минздрава РоссииРоссияKemerovo State Medical Academy, Ministry of Health of RussiaRussian FederationФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава РоссииРоссияI.M. Sechenov First Moscow State Medical University, Ministry of Health of RussiaRussian FederationЗАО «БИОКАД»РоссияJSC «BIOCAD»Russian Federation201728092017554351359Copyright © Насонов Е.Л., Мазуров В.И., Зонова Е.В., Князева Л.А., Марусенко И.М., Несмеянова О.Б., Плаксина Т.В., Шаповалова Ю.С., Иливанова Е.П., Кречикова Д.Г., Петроченкова Н.А., Решетько О.В., Денисов Л.Н., Гордеев И.Г., Давыдова А.Ф., Еремина Н.А., Земерова Е.В., Иванова Т.Б., Кастанаян А.А., Покровская Т.Г., Смакотина С.А., Смолярчук Е.А., Артемьева А.В., Иванов Р.А., Усачева Ю.В., Черняева Е.В., 20172017Насонов Е.Л., Мазуров В.И., Зонова Е.В., Князева Л.А., Марусенко И.М., Несмеянова О.Б., Плаксина Т.В., Шаповалова Ю.С., Иливанова Е.П., Кречикова Д.Г., Петроченкова Н.А., Решетько О.В., Денисов Л.Н., Гордеев И.Г., Давыдова А.Ф., Еремина Н.А., Земерова Е.В., Иванова Т.Б., Кастанаян А.А., Покровская Т.Г., Смакотина С.А., Смолярчук Е.А., Артемьева А.В., Иванов Р.А., Усачева Ю.В., Черняева Е.В.Nasonov E.L., Mazurov V.I., Zonova E.V., Knyazeva L.A., Marusenko I.M., Nesmeyanova O.B., Plaksina T.V., Shapovalova Y.S., Ilivanova E.P., Krechikova D.G., Petrochenkova N.A., Reshetko O.V., Denisov L.N., Gordeev I.G., Davydova A.F., Eremina N.A., Zemerova E.V., Ivanova T.B., Kastanayan A.A., Pokrovskaya T.G., Smakotina S.A., Smolyarchuk E.A., Artemyeva A.V., Ivanov R.A., Usacheva Y.V., Chernyaeva E.V.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/2407

Российской биотехнологической компанией «БИОКАД» разработан препарат химерных моноклональных антител к CD20 (BCD-020, Ацеллбия®) являющийся биоаналогом препарата ритуксимаб (РТМ; Мабтера®, Ф. Хоффманн-Ля Рош Лтд., Швейцария). В последние годы получены данные о возможности применения РТМ в более низких дозах, чем в стандартных рекомендациях и инструкциях, касающихся применения данного препарата. Это послужило основанием для проведения исследования BCD-020-4/ALTERRA (ALTErnative Rituximab regimen in Rheumatoid Arthritis), целью которого явилось изучение эффективности и безопасности применения Ацеллбия® (в дозе 600 мг дважды с интервалом 2 нед) в качестве «первого» ГИБП для лечения активного ревматоидного артрита (РА), резистентного к терапии метотрексатом (МТ). В исследование было включено 159 пациентов в возрасте от 18 до 80 лет с активным РА. Через 24 нед число больных, достигших 20% улучшения по критериям Американской коллегии ревматологов (ACR), составило в группе Ацеллбия® + МТ 65,7%, а в группе плацебо (ПЛ) + МТ – 29,4% (р<0,0001). Различия в частоте эффекта ACR20 в группе исследуемой терапии и в группе сравнения составила 36,3% с 95% ДИ 19,27–53,28%. Получены достоверные различия между группами в частоте достижения эффекта ACR50: 28,4% в группе исследуемого препарата и 5,9% в группе сравнения (р=0,001) и ACR70 – 12,8% и лишь 2,0 % больных в группе сравнения соответственно (р=0,036). Анализ данных о безопасности (частота всех зарегистрированных нежелательных явлений – НЯ) свидетельствует об отсутствии достоверных различий между пациентами основной и контрольной групп и демонстрирует соответствие данным о безопасности препарата РТМ (Мабтера®), все НЯ были ожидаемыми. Отмечено, что наличие антител к РТМ со связывающей и нейтрализующей активностью не оказало влияния на эффективность и безопасность терапии.

The Russian biotechnological company «BIOCAD» has designed a chimeric monoclonal antibody against CD20 (BCD-020, Acellbia®) that is a biosimilar of rituximab (RTM; MabThera®, F. Hoffmann-La Roche Ltd., Switzerland). In recent years, there has been evidence that RTM can be used at lower doses than those given in the standard recommendations and instructions for the use of this drug. This serves as the basis for the BCD-020-4/ALTERRA (ALTErnative Rituximab regimen in Rheumatoid Arthritis) trial, the objective of which was to investigate the efficiency and safety of using Acellbia® (at a dose of 600 mg twice at a 2-week interval) as the first biological agent (BA) for methotrexate (MTX)-resistant active rheumatoid arthritis (RA). The investigation enrolled 159 patients aged 18 to 80 years with active RA. After 24 weeks 65.7 and 29.4% of patients achieved 20% improvement by the American College of Rheumatology (ACR) criteria in the Acellbia® + MTX and placebo (PL) + MTX groups, respectively (p<0.0001). The differences in the ACR20 response rate in the two groups were 36.3% (95% CI, 19.27–53.28%). There were significant differences between the groups in the ACR50 response rates: 28.4% and 5.9% (p=0.001) and in the ACR70 ones: 12.8% and only 2.0%, respectively (p=0.036). Analysis of all recorded adverse events (AE) frequency showed no significant differences between the patients in the study and control groups and demonstrates its equivalence with that of RTM (MabThera®); all the AE were expectable. It is noted that antibodies to RTM with binding and neutralizing activities had no impact on the efficiency and safety of therapy.

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