Анализ эффективности и безопасности применения абатацепта при ревматоидном артрите: результаты 12-месячного наблюдения
Анализ эффективности и безопасности применения абатацепта при ревматоидном артрите: результаты 12-месячного наблюдения
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Аннотация
Цель. Обобщить результаты 12-месячного наблюдения пациентов с ревматоидным артритом (РА), находящихся на терапии абатацептом (АБЦ).
Материалы и методы. В исследование включен 91 пациент с высокой активностью РА (DAS28=5,1±1,0), неэффективностью базисной терапии (в основном метотрексат, 70,3%) и генно-инженерной биологической терапии (в основном ингибиторы фактора некроза опухоли-α, 93%). Большинство пациентов среднего возраста (49±13,5 года), позитивные по ревматоидному фактору (РФ; 72,5%) и антителам к циклическому цитруллинированному пептиду (АЦЦП; 77%), с умеренным нарушением функционального статуса – HAQ 1,4 (0,9–2). АБЦ назначали внутривенно в дозе 10 мг/кг по стандартной схеме. Оценку эффективности терапии проводили по критериям EULAR/ACR 2011 г., индексам SDAI, CDAI и HAQ с использованием принципа «intention-to-treat».
Результаты. Лечение АБЦ привело к достоверному (p<0,05) снижению активности РА, начиная с 3 мес терапии. Клиническое улучшение по критериям EULAR после 6 мес лечения зарегистрировано у 70,9%, после 12 мес – у 63% пациентов. Почти 1/3 (28,7%) больных достигли хорошего ответа после 3 мес терапии, через 6 и 12 мес лечения отмечали дальнейшее увеличение количества таких пациентов (39,2 и 39% соответственно). Процент удержания терапии АБЦ после 6 мес составлял 77%, после 12 мес – 60%. При оценке эффективности терапии между группами «биологически-наивных» больных и пациентов с неэффективностью одного, двух и более генно-инженерных биологических препаратов (ГИБП) достоверных различий не выявлено. После 12 мес наблюдения хорошего ответа в этих группах достигли 38, 38 и 43% соответственно, но наименьшее количество «неответчиков» отмечено в группе пациентов, которые получали ≥2 ГИБП – 40, 40 и 28,5%. В последней отмечали исходно более высокую концентрацию С-реактивного белка (СРБ) и большую длительность РА. Функциональное состояние на фоне терапии АБЦ достоверно улучшалось, после 12 мес выраженное и умеренное улучшение по индексу HAQ отмечали у 39 и 21% пациентов соответственно. Нежелательные реакции (НР) зарегистрированы у 22 пациентов, самыми частыми являлись острые респираторные заболевания, которые отмечались у 11 (12%) пациентов.
Заключение. Назначение АБЦ приводит к достоверному снижению активности РА и улучшению функционального статуса пациентов вне зависимости от количества предшествующих ГИБП и длительности РА. АБЦ имеет хороший профиль безопасности, НР зарегистрированы у небольшого количества пациентов.
Ключевые слова: ревматоидный артрит, генно-инженерная биологическая терапия, абатацепт, удерживание терапии, «биологически-наивные» пациенты.
Materials and methods: Patients (n=91) with high RA activity (DAS28 = 5.1 ± 1.0) and an inadequate response on synthetic DMARDs (mainly methotrexate, 70.3%) and biologics (mainly TNF-α inhibitors, 93%) were included in the study. The majority of patients were middle-aged (49 ± 13.5) womens, RF (72.5%) and ACPA (77%) positive, with moderate functional impairment – HAQ = 1.4 (0.9-2). ABA were administered IV, 10 mg/kg according to the standard scheme. The evaluation of the effectiveness of the therapy was carried out according to the EULAR / ACR 2011 criteria using SDAI, CDAI, HAQ and the intention to treat approach.
Results: ABA led to a significant (p <0.05) decrease activity of RA. Clinical improvement according to EULAR criteria after 6 months of treatment was registered in 70.9%, after 12 months 63%. Almost a third of patients (28.7%) achieved a good response after 3 months of therapy, 39,2% – after 6 months and 39% – after 12 months. The retention rate of ABA therapy after 6 months was 77%, after 12 months – 60%. There were no significant differences between "bio-naive", 1 Bio and ≥2 Bio groups in achieving EULAR response. A good response was achieved in 38%, 38% and 43%, respectively, but the lowest number of non-responders was registered in ≥2 Bio – 38%, 36% and 43%. ABA significantly improved functional status of patients, after 12 months a marked and moderate improvement in the HAQ was achieved in 39% and 21% of patients, respectively. Adverse events (AE) were registered in 22 patients. The most frequent AE were upper respiratory tract infections – 11 (12%) patients.
Conclusion: Abatacept was effective in the overall population, and in all subgroups of patients. It has shown significant improvement of clinical and functional status in patients who had an inadequate response to previous therapy. ABA has a good safety profile. AE were registered only in a small number of patients.
Keywords: rheumatoid arthritis, biologics, abatacept, retention rate, “biologic-naive” pts.
Материалы и методы. В исследование включен 91 пациент с высокой активностью РА (DAS28=5,1±1,0), неэффективностью базисной терапии (в основном метотрексат, 70,3%) и генно-инженерной биологической терапии (в основном ингибиторы фактора некроза опухоли-α, 93%). Большинство пациентов среднего возраста (49±13,5 года), позитивные по ревматоидному фактору (РФ; 72,5%) и антителам к циклическому цитруллинированному пептиду (АЦЦП; 77%), с умеренным нарушением функционального статуса – HAQ 1,4 (0,9–2). АБЦ назначали внутривенно в дозе 10 мг/кг по стандартной схеме. Оценку эффективности терапии проводили по критериям EULAR/ACR 2011 г., индексам SDAI, CDAI и HAQ с использованием принципа «intention-to-treat».
Результаты. Лечение АБЦ привело к достоверному (p<0,05) снижению активности РА, начиная с 3 мес терапии. Клиническое улучшение по критериям EULAR после 6 мес лечения зарегистрировано у 70,9%, после 12 мес – у 63% пациентов. Почти 1/3 (28,7%) больных достигли хорошего ответа после 3 мес терапии, через 6 и 12 мес лечения отмечали дальнейшее увеличение количества таких пациентов (39,2 и 39% соответственно). Процент удержания терапии АБЦ после 6 мес составлял 77%, после 12 мес – 60%. При оценке эффективности терапии между группами «биологически-наивных» больных и пациентов с неэффективностью одного, двух и более генно-инженерных биологических препаратов (ГИБП) достоверных различий не выявлено. После 12 мес наблюдения хорошего ответа в этих группах достигли 38, 38 и 43% соответственно, но наименьшее количество «неответчиков» отмечено в группе пациентов, которые получали ≥2 ГИБП – 40, 40 и 28,5%. В последней отмечали исходно более высокую концентрацию С-реактивного белка (СРБ) и большую длительность РА. Функциональное состояние на фоне терапии АБЦ достоверно улучшалось, после 12 мес выраженное и умеренное улучшение по индексу HAQ отмечали у 39 и 21% пациентов соответственно. Нежелательные реакции (НР) зарегистрированы у 22 пациентов, самыми частыми являлись острые респираторные заболевания, которые отмечались у 11 (12%) пациентов.
Заключение. Назначение АБЦ приводит к достоверному снижению активности РА и улучшению функционального статуса пациентов вне зависимости от количества предшествующих ГИБП и длительности РА. АБЦ имеет хороший профиль безопасности, НР зарегистрированы у небольшого количества пациентов.
Ключевые слова: ревматоидный артрит, генно-инженерная биологическая терапия, абатацепт, удерживание терапии, «биологически-наивные» пациенты.
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Materials and methods: Patients (n=91) with high RA activity (DAS28 = 5.1 ± 1.0) and an inadequate response on synthetic DMARDs (mainly methotrexate, 70.3%) and biologics (mainly TNF-α inhibitors, 93%) were included in the study. The majority of patients were middle-aged (49 ± 13.5) womens, RF (72.5%) and ACPA (77%) positive, with moderate functional impairment – HAQ = 1.4 (0.9-2). ABA were administered IV, 10 mg/kg according to the standard scheme. The evaluation of the effectiveness of the therapy was carried out according to the EULAR / ACR 2011 criteria using SDAI, CDAI, HAQ and the intention to treat approach.
Results: ABA led to a significant (p <0.05) decrease activity of RA. Clinical improvement according to EULAR criteria after 6 months of treatment was registered in 70.9%, after 12 months 63%. Almost a third of patients (28.7%) achieved a good response after 3 months of therapy, 39,2% – after 6 months and 39% – after 12 months. The retention rate of ABA therapy after 6 months was 77%, after 12 months – 60%. There were no significant differences between "bio-naive", 1 Bio and ≥2 Bio groups in achieving EULAR response. A good response was achieved in 38%, 38% and 43%, respectively, but the lowest number of non-responders was registered in ≥2 Bio – 38%, 36% and 43%. ABA significantly improved functional status of patients, after 12 months a marked and moderate improvement in the HAQ was achieved in 39% and 21% of patients, respectively. Adverse events (AE) were registered in 22 patients. The most frequent AE were upper respiratory tract infections – 11 (12%) patients.
Conclusion: Abatacept was effective in the overall population, and in all subgroups of patients. It has shown significant improvement of clinical and functional status in patients who had an inadequate response to previous therapy. ABA has a good safety profile. AE were registered only in a small number of patients.
Keywords: rheumatoid arthritis, biologics, abatacept, retention rate, “biologic-naive” pts.
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35. Rintelen B, Sautner J, Haindl PM et al. Comparison of three rheumatoid arthritis disease activity scores in clinical routine. Scand J Rheumatol. 2009;38(5):336-41. doi: 10.1080/03009740902932835.
36. Medeiros, Marta Maria das Chagas, Oliveira, Brenda Maria Gurgel Barreto de, Cerqueira, João Victor Medeiros de, Quixadá, Raquel Telles de Souza, & Oliveira, Ídila Mont’Alverne Xavier de. (2015). Correlation of rheumatoid arthritis activity indexes (Disease Activity Score 28 measured with ESR and CRP, Simplified Disease Activity Index and Clinical Disease Activity Index) and agreement of disease activity states with various cut-off points in a Northeastern Brazilian population. Revista Brasileira de Reumatologia. 2014;55(6): 477-484. https://dx.doi.org/10.1016/j.rbr.2014.12.005
37. Leeb BF, Andel I, Sautner J et al. Disease activity measurement of rheumatoid arthritis: Comparison of the simplified disease activity index (SDAI) and the disease activity score including 28 joints (DAS28) in daily routine. Arthritis Rheum. 2005 Feb 15;53(1):56-60.
2. [Nasonov EL, Karateev DE. Primenenie blokatora ko-stimulyacii T-limfocitov abatacepta pri revmatoidnom artrite. Rheum science and practice. 2010; 4, пр.2:9-27. (In Russ.)].
3. [Nasonov EL, editor. Genno-inzhenernye biologicheskie preparaty v lechenii revmatoidnogo artrita [Genetically engineered biological preparations in treatment of rheumatoid arthritis]. Moscow: IMA-PRESS; 2013: 16. (In Russ.)].
4. [Nasonov EL, editor. Abatacept. In: Genno-inzhenernye biologicheskie preparaty v lechenii revmatoidnogo artrita [Abatacept. In: Genetically engineered biological preparations in treatment of rheumatoid arthritis]. Moscow: IMA-PRESS; 2013: 221. (In Russ.)].
5. Choy EH. Selective modulation of T-cell co-stimulation: a novel mode of action for the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2009;27(3):510-8.
6. Kempis J, Dudler J, Hasler P, et al. Use of abatacept in rheumatoid arthritis. Swiss Med Wkly. 2012 May 11;142:w13581. doi: 10.4414/ smw.2012.13581. PMID: 22581564
7. [Alexandrova EN, Novikov AA, Nasonov EL. Rol T-kletok v patogenese revmatoidnogo artrita. Rheum science and practice. 2010; 4, пр.2:3-9. (In Russ.)].
8. Nam JL, Winthrop KL, van Vollenhoven RF et al. Current evidence for the management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of RA. Ann Rheum Dis. 2010 Jun;69(6):976-86. doi: 10.1136/ard.2009.126573
9. Gaujoux-Viala C, Smolen JS, Landewé R et al. Current evidence for the management of rheumatoid arthritis with synthetic disease-modifying antirheumatic drugs: a sys- tematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2010 Jun;69(6):1004-9. doi: 10.1136/ard.2009
10. Kremer JM, Genant HK, Moreland LW et al. Results of a two-year follow up study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexate. Arthritis Rheum. 2008 Apr; 58(4):953-963. doi: 10.1002/art.23397
11. Schiff M, Keiserman M, Codding C et al. Clinical response and tolerability to abatacept in patients with rheumatoid arthritis previously treated with infliximab or abatacept: open-label extension of the ATTEST Study. Ann Rheum Dis. 2011 Nov; 70(11):2003-7. doi: 10.1136/ annrheumdis-2011-200316.
12. Genovese MC, Becker JC, Schiff M et al. Abatacept for Rheumatoid Arthritis Refractory to Tumor Necrosis Factor α Inhibition. N Engl J Med 2005; 353:1114-1123 Sept 15, 2005. doi: 10.1056/NEJMoa050524.
13. Weinblatt M, Combe B, Covucci A et al. Safety of the Selective Costimulation Modulator Abatacept in Rheumatoid Arthritis Patients Receiving Background Biologic and Nonbiologic Disease-Modifying Antirheumatic Drugs. A One-Year Randomized, Placebo-Controlled Study. Arthritis Rheum. 2006 Sep; 54(9): 2807-2816. doi: 10.1002/ art.22070
14. Schiff M, Pritchard C, Huffstutter JE et al. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. Ann Rheum Dis. 2009 Nov;68(11):1708-14. doi: 10.1136/ard.2008.099218
15. Wells AF, Westhovens R, Reed DM et al. Abatacept plus methotrexate provides incremental clinical benefits versus methotrexate alone in methotrexate-naive patients with early rheumatoid arthritis who achieve radiographic nonprogression. J Rheumatol. 2011 Nov;38(11):2362-8. doi: 10.3899/jrheum.110054
16. Emery P, Durez P, Dougados M et al. Impact of T-cell costimulation modulation in patients with undifferentiated infl ammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial). Ann Rheum Dis. 2010 Mar;69(3):510-6. doi: 10.1136/ard.2009.119016
17. Dudler J, Tuerk R, Handschin T et al. RAISE - rheumatoid arthritis independent Swiss treatment expectations and outcome: results for the abatacept subpopulation. Swiss Med Wkly. 2013 Dec 6;143:w13849. doi: 10.4414/smw.2013.13849
18. Nüßlein HG, Alten R, Galeazzi M et al. Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study. BMC Musculoskelet Disord. 2014 Jan 11;15:14. doi: 10.1186/1471-2474-15-14
19. Leffers HC, Østergaard M, Glintborg B et al. Efficacy of abatacept and tocilizumab in patients with rheumatoid arthritis treated in clinical practice: results from the nationwide Danish DANBIO registry. Annals of the Rheumatic Diseases. 2011;70:1216-1222.
20. Truchetet M-E, Poursac N, Barnetche T et al. Abatacept monotherapy compared with abatacept plus disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients: data from the ORA registry. Arthritis Research & Therapy. 2016;18:72. doi:10.1186/s13075-016-0956-7
21. Weinblatt ME, Moreland LW, Westhovens R et al. The Journal of Rheumatology, June 2013; 40 (6): 787-797. doi: https://doi.org/ 10.3899/jrheum.120906
22. Takahashi N, Kojima T, Kaneko A et al. Clinical efficacy of abatacept compared to adalimumab and tocilizumab in rheumatoid arthritis patients with high disease activity Clin Rheumatol. 2014; 33: 39. https://doi.org/10.1007/s10067-013-2392-2
23. Hirabara S, Takahashi N, Fukaya N et al. Clinical efficacy of abatacept, tocilizumab, and etanercept in Japanese rheumatoid arthritis patients with inadequate response to anti-TNF monoclonal antibodies. Clin Rheumatol. 2014;33:1247. https://doi.org/10.1007/s10067-014-2711-2
24. [Lukina GV, Sigidin IA, Mazurov VI. Predvaritelnye relutaty primenenia abatacepta v klinicheskoy praktike. In: Genno-inzhenernye biologicheskie preparaty v lechenii revmatoidnogo artrita [Preliminary results of abatacept treatment in routine practice. In: Genetically engineered biological preparations in treatment of rheumatoid arthritis. Moscow: IMA-PRESS; 2013: 386-387. (In Russ.)].
25. [ Mazurov VI, Dolgikh SV, Zhugrova ES, Shulman YB, Samigullina RR. Experience with abatacept used in the treatment of patients with rheumatoid arthritis. Rheumatology Science and Practice. 2011;49(6):14-16. (In Russ.)]. doi:10.14412/1995-4484-2011-513
26. [Borisova MA, Lukina GV, Sigidin YA, Luchikhina EL, Karateev DE, Aronova ES, Glukhova SI. Comparative evaluation of the efficacy and safety of abatacept in patients with different duration of rheumatoid arthritis. Rheumatology Science and Practice. 2016;54(6):667-673. (In Russ.)]. doi:10.14412/1995-4484-2016-667-673
27. Arnett FC, Edworth SM, Bloch DA et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthr Rheum. 1988;31:315-24. doi: 10.1002/art.1780310302
28. Aletaha D, Neogi T, Silman AJ. et al. 2010 Rheumatoid Arthritis Classification Criteria. Arthr Rheum. 2010;62:2569-2581. doi: 10.1002/ art.27584
29. [Karateev DE, Luchikhina EL, Muravyev YV, Demidova NV, Grineva GI, Novikova DS, Aleksandrova EN, Novikov AA, Smirnov AV, Volkov AV, Avdeyeva AS, Lopareva EV, Olyunin YA, Lukina GV, Popkova TV, Nasonov EL. Pervoe rossiiskoe strategicheskoe issledovanie farmakoterapii revmatoidnogo artrita (REMARKA). Rheumatology Science and Practice. 2013;51(2):117-125. (In Russ.)]. doi:10.14412/1995-4484-2013-637
30. [Karateev DE, Luchikhina EL, Demidova NV, Gridneva GS, Kanonirova MA, Muravyev YV, Lukina GV, Olyunin YA, Kasumova KA, Aleksandrova EN, Novikov AA, Avdeeva AA, Popkova TV, Novikova DS, Smirnov AV, Volkov AV, Nasonov EL. Pervoe rossiiskoe strategicheskoe issledovanie farmakoterapii revmatoidnogo artrita (REMARKA): resultati lecheniya 130 bolnih v techenie 12 mesyatcev. Rheumatology Science and Practice. 2015;53(5s):77-84. (In Russ.)]. doi:10.14412/1995-4484-2015-77-84
31. Fransen J, Stucki G, van Reil PLCM. Rheumatoid arthritis measures. Arthr Rheum. 2003;49:214-24. doi: 10.1002/art.11407
32. Aletaha D, Nell V, Stamm T et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthr Res Ther. 2005;7(4):796-806. doi: 10.1186/ar1740
33. Pincus T, Swearingen C, Wolfe F. Toward a multy-dimensional Health Assessment Questionnaire (MDHAQ) – assessment of advanced activities of daily living and psychological status in the patient-friendly health assessment questionnaire format. Arthr Rheum.1999;42:2220-30. doi: 10.1002/1529-0131(199910)42:10<2220::AID-ANR26>3.0. CO;2-5
34. Kosinski M, Zhao SZ, Dedhiya S et al. Determing minimally important changes in generic and disease-specific health-related quality of life questionaries in clinical trials of rheumatoid arthritis. Arthr Rheum. 2000;43(7):1478-87. doi: 1002/1529-0131(200007) 43:7%3C1478::AID-ANR10%3E3.0CO;2-M.
35. Rintelen B, Sautner J, Haindl PM et al. Comparison of three rheumatoid arthritis disease activity scores in clinical routine. Scand J Rheumatol. 2009;38(5):336-41. doi: 10.1080/03009740902932835.
36. Medeiros, Marta Maria das Chagas, Oliveira, Brenda Maria Gurgel Barreto de, Cerqueira, João Victor Medeiros de, Quixadá, Raquel Telles de Souza, & Oliveira, Ídila Mont’Alverne Xavier de. (2015). Correlation of rheumatoid arthritis activity indexes (Disease Activity Score 28 measured with ESR and CRP, Simplified Disease Activity Index and Clinical Disease Activity Index) and agreement of disease activity states with various cut-off points in a Northeastern Brazilian population. Revista Brasileira de Reumatologia. 2014;55(6): 477-484. https://dx.doi.org/10.1016/j.rbr.2014.12.005
37. Leeb BF, Andel I, Sautner J et al. Disease activity measurement of rheumatoid arthritis: Comparison of the simplified disease activity index (SDAI) and the disease activity score including 28 joints (DAS28) in daily routine. Arthritis Rheum. 2005 Feb 15;53(1):56-60.
2. Насонов Е.Л., Каратеев Д.Е. Применение блокатора ко-стимуляции Т-лимфоцитов абатацепта при ревматоидном артрите. Науч-практич ревматол. 2010; 4, пр.2:9-27. [Nasonov EL, Karateev DE. Primenenie blokatora ko-stimulyacii T-limfocitov abatacepta pri revmatoidnom artrite. Rheum science and practice. 2010; 4, пр.2:9-27. (In Russ.)].
3. Насонов Е.Л., редактор. Генно-инженерные биологические препараты в лечении ревматоидного артрита. Москва: ИМА-ПРЕСС; 2013: 16. [Nasonov EL, editor. Genno-inzhenernye biologicheskie preparaty v lechenii revmatoidnogo artrita [Genetically engineered biological preparations in treatment of rheumatoid arthritis]. Moscow: IMA-PRESS; 2013: 16. (In Russ.)].
4. Насонов Е.Л., редактор. Абатацепт. В кн.: Генно-инженерные биологические препараты в лечении ревматоидного артрита. Москва: ИМА-ПРЕСС; 2013: 221. [Nasonov EL, editor. Abatacept. In: Genno-inzhenernye biologicheskie preparaty v lechenii revmatoidnogo artrita [Abatacept. In: Genetically engineered biological preparations in treatment of rheumatoid arthritis]. Moscow: IMA-PRESS; 2013: 221. (In Russ.)].
5. Choy EH. Selective modulation of T-cell co-stimulation: a novel mode of action for the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2009;27(3):510-8.
6. Kempis J, Dudler J, Hasler P, et al. Use of abatacept in rheumatoid arthritis. Swiss Med Wkly. 2012 May 11;142:w13581. doi: 10.4414/ smw.2012.13581. PMID: 22581564
7. Александрова Е.Н., Новиков А.А., Насонов Е.Л. Роль Т-клеток в патогенезе ревматоидного артрита. Науч-практич ревматол. 2010; 4, пр.2:3-9. [Alexandrova EN, Novikov AA, Nasonov EL. Rol T-kletok v patogenese revmatoidnogo artrita. Rheum science and practice. 2010; 4, пр.2:3-9. (In Russ.)].
8. Nam JL, Winthrop KL, van Vollenhoven RF et al. Current evidence for the management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of RA. Ann Rheum Dis. 2010 Jun;69(6):976-86. doi: 10.1136/ard.2009.126573
9. Gaujoux-Viala C, Smolen JS, Landewé R et al. Current evidence for the management of rheumatoid arthritis with synthetic disease-modifying antirheumatic drugs: a sys- tematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2010 Jun;69(6):1004-9. doi: 10.1136/ard.2009
10. Kremer JM, Genant HK, Moreland LW et al. Results of a two-year follow up study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexate. Arthritis Rheum. 2008 Apr; 58(4):953-963. doi: 10.1002/art.23397
11. Schiff M, Keiserman M, Codding C et al. Clinical response and tolerability to abatacept in patients with rheumatoid arthritis previously treated with infliximab or abatacept: open-label extension of the ATTEST Study. Ann Rheum Dis. 2011 Nov; 70(11):2003-7. doi: 10.1136/ annrheumdis-2011-200316.
12. Genovese MC, Becker JC, Schiff M et al. Abatacept for Rheumatoid Arthritis Refractory to Tumor Necrosis Factor α Inhibition. N Engl J Med 2005; 353:1114-1123 Sept 15, 2005. doi: 10.1056/NEJMoa050524.
13. Weinblatt M, Combe B, Covucci A et al. Safety of the Selective Costimulation Modulator Abatacept in Rheumatoid Arthritis Patients Receiving Background Biologic and Nonbiologic Disease-Modifying Antirheumatic Drugs. A One-Year Randomized, Placebo-Controlled Study. Arthritis Rheum. 2006 Sep; 54(9): 2807-2816. doi: 10.1002/ art.22070
14. Schiff M, Pritchard C, Huffstutter JE et al. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. Ann Rheum Dis. 2009 Nov;68(11):1708-14. doi: 10.1136/ard.2008.099218
15. Wells AF, Westhovens R, Reed DM et al. Abatacept plus methotrexate provides incremental clinical benefits versus methotrexate alone in methotrexate-naive patients with early rheumatoid arthritis who achieve radiographic nonprogression. J Rheumatol. 2011 Nov;38(11):2362-8. doi: 10.3899/jrheum.110054
16. Emery P, Durez P, Dougados M et al. Impact of T-cell costimulation modulation in patients with undifferentiated infl ammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial). Ann Rheum Dis. 2010 Mar;69(3):510-6. doi: 10.1136/ard.2009.119016
17. Dudler J, Tuerk R, Handschin T et al. RAISE - rheumatoid arthritis independent Swiss treatment expectations and outcome: results for the abatacept subpopulation. Swiss Med Wkly. 2013 Dec 6;143:w13849. doi: 10.4414/smw.2013.13849
18. Nüßlein HG, Alten R, Galeazzi M et al. Real-world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6-month interim analysis of the 2-year, observational, prospective ACTION study. BMC Musculoskelet Disord. 2014 Jan 11;15:14. doi: 10.1186/1471-2474-15-14
19. Leffers HC, Østergaard M, Glintborg B et al. Efficacy of abatacept and tocilizumab in patients with rheumatoid arthritis treated in clinical practice: results from the nationwide Danish DANBIO registry. Annals of the Rheumatic Diseases. 2011;70:1216-1222.
20. Truchetet M-E, Poursac N, Barnetche T et al. Abatacept monotherapy compared with abatacept plus disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients: data from the ORA registry. Arthritis Research & Therapy. 2016;18:72. doi:10.1186/s13075-016-0956-7
21. Weinblatt ME, Moreland LW, Westhovens R et al. The Journal of Rheumatology, June 2013; 40 (6): 787-797. doi: https://doi.org/ 10.3899/jrheum.120906
22. Takahashi N, Kojima T, Kaneko A et al. Clinical efficacy of abatacept compared to adalimumab and tocilizumab in rheumatoid arthritis patients with high disease activity Clin Rheumatol. 2014; 33: 39. https://doi.org/10.1007/s10067-013-2392-2
23. Hirabara S, Takahashi N, Fukaya N et al. Clinical efficacy of abatacept, tocilizumab, and etanercept in Japanese rheumatoid arthritis patients with inadequate response to anti-TNF monoclonal antibodies. Clin Rheumatol. 2014;33:1247. https://doi.org/10.1007/s10067-014-2711-2
24. Лукина Г.В., Сигидин Я.А., Мазуров В.И. и др. Предварительные результаты применения абатацепта в клинической практике. В кн.: Генно-инженерные биологические препараты в лечении ревматоидного артрита. Под ред. Е.Л. Насонова. Москва: ИМА-ПРЕСС; 2013: 386-387. [Lukina GV, Sigidin IA, Mazurov VI. Predvaritelnye relutaty primenenia abatacepta v klinicheskoy praktike. In: Genno-inzhenernye biologicheskie preparaty v lechenii revmatoidnogo artrita [Preliminary results of abatacept treatment in routine practice. In: Genetically engineered biological preparations in treatment of rheumatoid arthritis. Moscow: IMA-PRESS; 2013: 386-387. (In Russ.)].
25. Мазуров В.И., Долгих С.В., Жугрова Е.С., Шульман Ю.Б., Самигуллина Р.Р. Опыт применения абатацепта в лечении больных ревматоидным артритом. Науч-практич ревматол. 2011;49(6):14-16. [ Mazurov VI, Dolgikh SV, Zhugrova ES, Shulman YB, Samigullina RR. Experience with abatacept used in the treatment of patients with rheumatoid arthritis. Rheumatology Science and Practice. 2011;49(6):14-16. (In Russ.)]. doi:10.14412/1995-4484-2011-513
26. Борисова М.А., Лукина Г.В., Сигидин Я.А., Лучихина Е.Л., Каратеев Д.Е., Аронова Е.С., Глухова С.И. Сравнительная оценка эффективности и безопасности абатацепта у пациентов с разной длительностью ревматоидного артрита. Науч-практич ревматол. 2016;54(6):667-673. [Borisova MA, Lukina GV, Sigidin YA, Luchikhina EL, Karateev DE, Aronova ES, Glukhova SI. Comparative evaluation of the efficacy and safety of abatacept in patients with different duration of rheumatoid arthritis. Rheumatology Science and Practice. 2016;54(6):667-673. (In Russ.)]. doi:10.14412/1995-4484-2016-667-673
27. Arnett FC, Edworth SM, Bloch DA et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthr Rheum. 1988;31:315-24. doi: 10.1002/art.1780310302
28. Aletaha D, Neogi T, Silman AJ. et al. 2010 Rheumatoid Arthritis Classification Criteria. Arthr Rheum. 2010;62:2569-2581. doi: 10.1002/ art.27584
29. Каратеев Д.Е., Лучихина Е.Л., Муравьев Ю.В., Демидова Н.В., Гринева Г.И., Новикова Д.С., Александрова Е.Н., Новиков А.А., Смирнов А.В., Волков А.В., Авдеева А.С., Лопарева Е.В., Олюнин Ю.А., Лукина Г.В., Попкова Т.В., Насонов Е.Л. Первое российское стратегическое исследование фармакотерапии ревматоидного артрита (РЕМАРКА). Науч-практич ревматол. 2013;51(2):117-125. [Karateev DE, Luchikhina EL, Muravyev YV, Demidova NV, Grineva GI, Novikova DS, Aleksandrova EN, Novikov AA, Smirnov AV, Volkov AV, Avdeyeva AS, Lopareva EV, Olyunin YA, Lukina GV, Popkova TV, Nasonov EL. Pervoe rossiiskoe strategicheskoe issledovanie farmakoterapii revmatoidnogo artrita (REMARKA). Rheumatology Science and Practice. 2013;51(2):117-125. (In Russ.)]. doi:10.14412/1995-4484-2013-637
30. Каратеев Д.Е., Лучихина Е.Л., Демидова Н.В., Гриднева Г.С., Канонирова М.А., Муравьев Ю.В., Лукина Г.В., Олюнин Ю.А., Касумова К.А., Александрова Е.Н., Новиков А.А., Авдеева А.С., Попкова Т.В., Новикова Д.С., Смирнов А.В., Волков А.В., Насонов Е.Л. Первое российское стратегическое исследование фармакотерапии ревматоидного артрита (РЕМАРКА): результаты лечения 130 больных в течение 12 месяцев. Науч-практич ревматол. 2015;53(5s):77-84. [Karateev DE, Luchikhina EL, Demidova NV, Gridneva GS, Kanonirova MA, Muravyev YV, Lukina GV, Olyunin YA, Kasumova KA, Aleksandrova EN, Novikov AA, Avdeeva AA, Popkova TV, Novikova DS, Smirnov AV, Volkov AV, Nasonov EL. Pervoe rossiiskoe strategicheskoe issledovanie farmakoterapii revmatoidnogo artrita (REMARKA): resultati lecheniya 130 bolnih v techenie 12 mesyatcev. Rheumatology Science and Practice. 2015;53(5s):77-84. (In Russ.)]. doi:10.14412/1995-4484-2015-77-84
31. Fransen J, Stucki G, van Reil PLCM. Rheumatoid arthritis measures. Arthr Rheum. 2003;49:214-24. doi: 10.1002/art.11407
32. Aletaha D, Nell V, Stamm T et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthr Res Ther. 2005;7(4):796-806. doi: 10.1186/ar1740
33. Pincus T, Swearingen C, Wolfe F. Toward a multy-dimensional Health Assessment Questionnaire (MDHAQ) – assessment of advanced activities of daily living and psychological status in the patient-friendly health assessment questionnaire format. Arthr Rheum.1999;42:2220-30. doi: 10.1002/1529-0131(199910)42:10<2220::AID-ANR26>3.0. CO;2-5
34. Kosinski M, Zhao SZ, Dedhiya S et al. Determing minimally important changes in generic and disease-specific health-related quality of life questionaries in clinical trials of rheumatoid arthritis. Arthr Rheum. 2000;43(7):1478-87. doi: 1002/1529-0131(200007) 43:7%3C1478::AID-ANR10%3E3.0CO;2-M.
35. Rintelen B, Sautner J, Haindl PM et al. Comparison of three rheumatoid arthritis disease activity scores in clinical routine. Scand J Rheumatol. 2009;38(5):336-41. doi: 10.1080/03009740902932835.
36. Medeiros, Marta Maria das Chagas, Oliveira, Brenda Maria Gurgel Barreto de, Cerqueira, João Victor Medeiros de, Quixadá, Raquel Telles de Souza, & Oliveira, Ídila Mont’Alverne Xavier de. (2015). Correlation of rheumatoid arthritis activity indexes (Disease Activity Score 28 measured with ESR and CRP, Simplified Disease Activity Index and Clinical Disease Activity Index) and agreement of disease activity states with various cut-off points in a Northeastern Brazilian population. Revista Brasileira de Reumatologia. 2014;55(6): 477-484. https://dx.doi.org/10.1016/j.rbr.2014.12.005
37. Leeb BF, Andel I, Sautner J et al. Disease activity measurement of rheumatoid arthritis: Comparison of the simplified disease activity index (SDAI) and the disease activity score including 28 joints (DAS28) in daily routine. Arthritis Rheum. 2005 Feb 15;53(1):56-60.
________________________________________________
2. [Nasonov EL, Karateev DE. Primenenie blokatora ko-stimulyacii T-limfocitov abatacepta pri revmatoidnom artrite. Rheum science and practice. 2010; 4, пр.2:9-27. (In Russ.)].
3. [Nasonov EL, editor. Genno-inzhenernye biologicheskie preparaty v lechenii revmatoidnogo artrita [Genetically engineered biological preparations in treatment of rheumatoid arthritis]. Moscow: IMA-PRESS; 2013: 16. (In Russ.)].
4. [Nasonov EL, editor. Abatacept. In: Genno-inzhenernye biologicheskie preparaty v lechenii revmatoidnogo artrita [Abatacept. In: Genetically engineered biological preparations in treatment of rheumatoid arthritis]. Moscow: IMA-PRESS; 2013: 221. (In Russ.)].
5. Choy EH. Selective modulation of T-cell co-stimulation: a novel mode of action for the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2009;27(3):510-8.
6. Kempis J, Dudler J, Hasler P, et al. Use of abatacept in rheumatoid arthritis. Swiss Med Wkly. 2012 May 11;142:w13581. doi: 10.4414/ smw.2012.13581. PMID: 22581564
7. [Alexandrova EN, Novikov AA, Nasonov EL. Rol T-kletok v patogenese revmatoidnogo artrita. Rheum science and practice. 2010; 4, пр.2:3-9. (In Russ.)].
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Авторы
М.А. БОРИСОВА 1, Г.В. ЛУКИНА 1,2, Я.А. СИГИДИН 1, Е.С. АРОНОВА 1, Е.Л. ЛУЧИХИНА 3, Д.Е. КАРАТЕЕВ 3, С.И. ГЛУХОВА 1, Е.Л. НАСОНОВ 1,4
1 ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой», Москва, Россия;
2 ГБУЗ «Московский клинический научно-практический центр им. А.С. Логинова Департамента здравоохранения Москвы», Москва, Россия;
3 Московский областной научно-исследовательский клинический институт им. М. Ф. Владимирского (МОНИКИ), Москва, Россия;
4 ГБОУ ВПО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России, Москва, Россия
1 V.A. Nasonova Research Institute of Rheumatology, laboratory of monitoring safety of antirheumatic treatment, Moscow, Russia;
2 Moscow Clinical Scientific Center named after Loginov A.S., Moscow, Russia;
3 Rheumatology, Moscow Regional Research and Clinical Institute (MONIKI), Moscow, Russia;
4 I.M. Sechenov First Moscow State Medical University, Moscow, Russia
1 ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой», Москва, Россия;
2 ГБУЗ «Московский клинический научно-практический центр им. А.С. Логинова Департамента здравоохранения Москвы», Москва, Россия;
3 Московский областной научно-исследовательский клинический институт им. М. Ф. Владимирского (МОНИКИ), Москва, Россия;
4 ГБОУ ВПО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России, Москва, Россия
________________________________________________
1 V.A. Nasonova Research Institute of Rheumatology, laboratory of monitoring safety of antirheumatic treatment, Moscow, Russia;
2 Moscow Clinical Scientific Center named after Loginov A.S., Moscow, Russia;
3 Rheumatology, Moscow Regional Research and Clinical Institute (MONIKI), Moscow, Russia;
4 I.M. Sechenov First Moscow State Medical University, Moscow, Russia
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