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Научно-практическая ревматология

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Эффективность и безопасность применения ритуксимаба при ревматоидном артрите (новые данные)

https://doi.org/10.14412/1995-4484-2017-420-428

Аннотация

Ревматоидный артрит (РА) – аутоиммунное ревматическое заболевание, характеризующееся хроническим эрозивным артритом (синовитом) и системным воспалительным поражением внутренних органов, приводящим к ранней инвалидизации и ухудшению качества жизни пациентов. Накопленные данные об эффективности, безопасности и экономической эффективности применения анти-В-клеточной терапии позволяют выделить ритуксимаб (РТМ) как чрезвычайно важный препарат первой или второй линии терапии генно-инженерными биологическими препаратами, после неэффективного лечения ингибиторами фактора некроза опухоли α (ФНОα). В связи с этим по-прежнему актуальной остается проблема персонифицированного выбора схемы лечения в каждом конкретном случае. Опыт применения РТМ в клинической практике свидетельствует о его высокой эффективности в отношении как клинических проявлений, так и влияния на качество жизни пациентов при развернутом РА, характеризующемся лекарственной резистентностью к базисным противовоспалительным препаратам и ингибиторам ФНОα, а также при раннем РА. В настоящее время в литературе представлено большое количество данных, посвященных роли предшествующей терапии, влиянию стадии РА при назначении и различных курсовых доз РТМ в эффективности терапии РА, часть из которых будет обсуждена в данном обзоре.

Об авторах

Д. А. Кусевич
ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России
Россия

аспирант 1-го года кафедры ревматологии Института профессионального образования ФГАОУ ВО «Первый  Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России

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



А. С. Авдеева
ФГБНУ «Научно- исследовательский институт ревматологии им. В.А. Насоновой»
Россия

научный сотрудник лаборатории стандартизации терапии ревматических заболеваний ФГБНУ НИИР им. В.А. Насоновой, канд. мед. наук

115522 Москва, Каширское шоссе, 34А



Список литературы

1. Насонов ЕЛ, Каратеев ДЕ. Ревматоидный артрит. В кн.: Насонов ЕЛ, Насонова ВА, редакторы. Ревматология. Национальное руководство. Москва: ГЭОТАР-Медиа; 2008 [Nasonov EL, Karateev DE. Rheumatoid arthritis. In: Nasonov EL, Nasonova VA, editors. Revmatologiya. Natsional'noe rukovodstvo [Rheumatology. National guidelance]. Moscow: GEOTAR-Media; 2008].

2. Насонов ЕЛ, редактор. Генно-инженерные биологические препараты в лечении ревматоидного артрита. Москва: ИМА- ПРЕСС; 2013 [Nasonov EL, editor. Genno- inzhenernye biologicheskie preparaty v lechenii revmatoidnogo artrita [Genetically engineered biological agents in the treatment of rheumatoid arthritis]. Moscow: IMA- PRESS; 2013].

3. Smolen JS, Aletaha D, Koeller M, et al. New therapies for treatment of rheumatoid arthritis. Lancet. 2007;370:1861-71. doi: 10.1016/S0140-6736(07)60784-3

4. Насонов ЕЛ, редактор. Анти-В-клеточная терапия в ревматологии: фокуc на ритуксимаб. Москва: ИМА-ПРЕСС; 2012 [Nasonov EL, editor. Anti-B-kletochnaya terapiya v revmatologii: fokuc na rituksimab [Anti-B-cell therapy in rheumatology: focus on rituximab]. Moscow: IMA-PRESS; 2012].

5. Насонов ЕЛ. Фармакотерапия ревматоидного артрита – взгляд в 21 век. Клиническая медицина. 2005;(6):8-12 [Nasonov EL. Pharmacotherapy of rheumatoid arthritis – a look into the 21st century. Klinicheskaya Meditsina = Clinical Medicine. 2005;(6):8-12 (In Russ.)].

6. Leandro MJ, Cooper N, Cambridge G, et al. Bone-marrow B-lineage cells in patients with rheumatoid arthritis following rituximab therapy. Rheumatology (Oxford). 2007;46(1):29- 36. doi: 10.1093/rheumatology/kel148

7. Pescovitz MD. Rituximab, an anti-CD20 monoclonal antibody: history and mechanism of action. Am J Transplant. 2006;6(5 Pt 1):859-66. doi: 10.1111/j.1600-6143.2006.01288.x

8. Nakou M, Katsikas G, Sidiropoulos P, et al. Rituximab therapy reduces activated B cells in both the peripheral blood and bone marrow of patients with rheumatoid arthritis: depletion of memory B cells correlates with clinical response. Arthritis Res Ther. 2009;11:R131. doi: 10.1186/ar2798

9. Roll P, Palanichamy A, Kneitz C, et al. Regeneration of B cell subsets after transient depletion using anti-CD20 antibodies in rheumatoid arthritis. Arthritis Rheum. 2006;54(8):2377-86. doi: 10.1002/art.22019

10. Vital EM, Rawstron AC, Dass S, et al. Reduced-dose rituximab in rheumatoid arthritis: efficacy depends on degree of B cell depletion. Arthritis Rheum. 2011;63(3):603-8. doi: 10.1002/art.30152

11. Thurlings RM, Vos K, Wijbrandts CA, et al. Synovial tissue response to rituximab; mechanisms of action and identification of biomarkers of response. Ann Rheum Dis. 2008;67(7):917-25. doi: 10.1136/ard.2007.080960

12. Edwards JC, Szcezepanski L, Szechinski J, et al. Efficacy of B-cell targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004;350(25):2572-81. doi: 10.1056/NEJMoa032534

13. Насонов ЕЛ. Фармакотерапия ревматоидного артрита в XXI веке: фокус на ритуксимаб. Современная ревматология. 2009;3(4):67-75 [Nasonov E.L. Pharmacotherapy for rheumatoid arthritis in the 21st century: Focus on rituximab. Sovremennaya Revmatologiya = Modern Rheumatology Journal. 2009;3(4):67-75 (In Russ.)]. doi: 10.14412/1996-7012-2009-576

14. Cohen MD, Keystone E. Rituximab for rheumatoid arthritis. Rheumatol Ther. 2015;2:99-111. doi: 10.1007/s40744-015-0016-9

15. Porter D, Melckebeke J, Dale J, et al. Tumour necrosis factor inhibition versus rituximab for patients with rheumatoid arthritis who require biological treatment (ORBIT): an open- label, randomised controlled, non-inferiority, trial. Lancet. 2016;388:239- 47. doi: 10.1016/S0140-6736(16)00380-9

16. Emery P, Gottenberg JE, Rubbert-Roth A, et al. Rituximab versus an alternative TNF inhibitor in patients with rheumatoid arthritis who failed to respond to a single previous TNF inhibitor: SWITCH-RA, a global, observational, comparative effectiveness study. Ann Rheum Dis. 2015;74:979-84. doi: 10.1136/annrheumdis-2013-203993

17. Torrente-Segarra V, Acosta Pereira A, Morla R, et al. VARIAR Study: Assessment of short- term efficacy and safety of rituximab compared to an tumor necrosis factor alpha antagonists as secondline drug therapy in patients with rheumatoid arthritis refractory to a first tumor necrosis factor alpha antagonist. Reumatol Clin. 2016;12(6):319-22. doi: 10.1016/j.reuma.2015.11.019

18. Keyser FD, Hoffman I, Durez P, et al. Longterm followup of rituximab therapy in patients with rheumatoid arthritis: Results from the Belgian MabThera in Rheumatoid Arthritis Registry. J Rheumatol. 2014;41;1761-5. doi: 10.3899/jrheum.131279

19. Harrold LR, Reed GW, Shewade A, et al. Effectiveness of rituximab for the treatment of rheumatoid arthritis in patients with prior exposure to anti-TNF: results from the CORRONA registry. J Rheumatol. 2015;42:1090-8. doi: 10.3899/jrheum.141043

20. Wendler J, Burmester G R, Sö rensen H, et al. Rituximab in patients with rheumatoid arthritis in routine practice (GERINIS): six-year results from a prospective, multicentre, non- interventional study in 2,484 patients Arthritis Res Ther. 2014,16:R80. doi: 10.1186/ar4521

21. Chatzidionysiou K, Lie E, Nasonov E, et al. Effectiveness of two different doses of rituximab for the treatment of rheumatoid arthritis in an international cohort: data from the CERERRA collaboration. Arthritis Res Ther. 2016;18:50. doi: 10.1186/s13075-016-0951-z

22. Ferraccioli G, Tolusso B, Gremese E. Could we use a lower dose of rituximab to treat rheumatoid arthritis in clinical practice: pros and cons? Arthritis Res Ther. 2016;18:126. doi: 10.1186/s13075-016-1022-1

23. Mariette X, Rouanet S, Sibilia J, et al. Evaluation of low-dose rituximab for the retreatment of patients with active rheumatoid arthritis: a non-inferiority randomized controlled trial. Ann Rheum Dis. 2014;73(8):1508-14. doi: 10.1136/annrheumdis-2013-203480

24. Tvete IF, Natvig B, Gasemyr J, et al. Comparing effects of biologic agents in treating patients with rheumatoid arthritis: A multiple treatment comparison regression analysis. PLoS ONE. 2015;10(9):e0137258. doi: 10.1371/journal.pone.0137258

25. Bredemeier M, Campos GG, de Oliveira FK. Updated systematic review and meta- analysis of randomized controlled trials comparing low-versus high-dose rituximab for rheumatoid arthritis. Clin Rheumatol. 2015;34(10);1801-5. doi: 10.1007/s10067-015-2977-z

26. Van Vollenhoven RF, Emery P, Bingham CO, et al. Long-term safety of rituximab in rheumatoid arthritis: 9.5 year follow-up of the global clinical trial programme with a focus on adverse events of interest in RA patients. Ann Rheum Dis. 2013;72(9):1496-502. doi: 10.1136/annrheumdis-2012-201956

27. Van Vollenhoven RF, Fleischmann RM, Furst DE, et al. Longterm safety of Rituximab: final report of the Rheumatoid Arthritis Global Clinical Trial program over 11 years. J Rheumatol. 2015;42:1761-6. doi: 10.3899/jrheum.150051

28. Vassilopoulos D, Delicha EM, Settas L, et al. Safety profile of repeated rituximab cycles in unselected rheumatoid arthritis patients: a long-term, prospective real-life study Clin Exper Rheumatol. 2016;34:893-900.

29. Aaltonen KJ, Joensuu JT, Virkki L, et al. Rates of serious infections and malignancies among patients with rheumatoid arthritis receiving either tumor necrosis factor inhibitor or rituximab therapy. J Rheumatol. 2015;42;372-8. doi: 10.3899/jrheum.140853

30. Harrold LR, Reed GW, Karki C, et al. Risk of infection associated with subsequent biologic agent use after rituximab: Results from a National Rheumatoid Arthritis Patient Registry. Arthritis Care Res. 2016;68(12):1888-93. doi: 10.1002/acr.22912

31. Tsai-Ling Liao, Ching-Heng Lin, Yi-Ming Chen, et al. Different risk of tuberculosis and efficacy of isoniazid prophylaxis in rheumatoid arthritis patients with biologic therapy: A nationwide retrospective cohort study in Taiwan PLOS ONE. doi: 10.1371/journal.pone.0153217. April 11, 2016

32. Silva-Fernandez L, Lunt M, Kearsley-Fleet L, et al, on behalf of the British Society for Rheumatology Biologics Register (BSRBR) Control Centre Consortium. The incidence of cancer in patients with rheumatoid arthritis and a prior malignancy who receive TNF inhibitors or rituximab: results from the British Society for Rheumatology Biologics Register-Rheumatoid. Arthritis Rheum. 2016;55:20332039. doi: 10.1093/rheumatology/kew314

33. Solomon DH, Kremer JM, Fisher M, et al. Comparative cancer risk associated with methotrexate, other non-biologic and biologic disease-modifying anti-rheumatic dugs. Semin Arthritis Rheum. 2014;43(4):489-97. doi: 10.1016/j.semarthrit.2013.08.003

34. Baecklund E, Iliadou A, Askling J, et al. Association of chronic inflammation, not its treatment, with increased lymphoma risk in rheumatoid arthritis. Arthritis Rheum. 2006;54:692-701. doi: 10.1002/art.21675

35. Smedby KE, Baecklund E, Askling J. Malignant lymphomas in autoimmunity and inflammation: a review of risks, risk factors, and lymphoma characteristics. Cancer Epidemiol Biomarkers Prev. 2006;15:2069-77. doi: 10.1158/1055-9965.EPI-06-0300

36. Salmon JH, Cacoub P, Combe B, et al. Late-onset neutropenia after treatment with rituximab for rheumatoid arthritis and other autoimmune diseases: data from the AutoImmunity and Rituximab registry. RMD Open. 2015;1:e000034. doi: 10.1136/rmdopen-2014-000034

37. Stamatopoulos K, Papadaki T, Pontikoglou C, et al. Lymphocyte subpopulation imbalances, bone marrow hematopoiesis and histopathology in rituximab-treated lymphoma patients with lateonset neutropenia. Leukemia. 2008;22:1446-9. doi: 10.1038/sj.leu.2405077

38. Dunleavy K, Hakim F, Kim HK, et al. B-cell recovery following rituximab-based therapy is associated with perturbations in stromal derived factor-1 and granulocyte homeostasis. Blood. 2005;106:795-802. doi: 10.1182/blood-2004-08-3198

39. Marotte H, Paintaud G, Watier H, Miossec P. Rituximab-related late-onset neutropenia in a patient with severe rheumatoid arthritis. Ann Rheum Dis. 2008;67:893-4. doi: 10.1136/ard.2007.081166

40. Giraud C, Tatar Z, Soubrier M. Agranulocytosis under biotherapy in rheumatoid arthritis: three cases hypothesis of parvovirus B19 involvement in agranulocytosis observed under tocilizumab and rituximab for the treatment of rheumatoid arthritis Clin Rheumatol. 2016;35:2615-8. doi: 10.1007/s10067-016-3379-6

41. Herzog-Tzarfati K, Shiloah E, Koren-Michowitz M, et al. Successful treatment of prolonged agranulocytosis caused by acute parvovirus B19 infection with intravenous immunoglobulins. Eur J Intern Med. 2006;17:439-40. doi: 10.1016/j.ejim.2006.02.014

42. Young NS, Brown KE. Parvovirus B19. N Engl J Med. 2004;350(6):586-97. doi: 10.1056/NEJMra030840

43. Brown KE, Young NS. Parvoviruses and bone marrow failure. Stem Cells Dayt Ohio. 1996;14:151-63. doi: 10.1002/stem.140151

44. Pham T, Fautrel B, Gottenberg JE, et al. Rituximab (MabThera) therapy and safety management. Clinical tool guide. Joint Bone Spine. 2008;75 Suppl 1:S1-99.

45. Pritchard CH, Greenwald M, Kremer JM, et al. Safety of infusing rituximab at a more rapid rate in patients with rheumatoid arthritis: results from the RATE-RA study. BMC Musculoskelat Disord. 2014;15:177-81. doi: 10.1186/1471-2474-15-177

46. Can M, Alibaz-Oner F, Yimaz-Oner S, et al. Accelerated infusion rates of rituximab are well-tolerated and safe in rheumatology practice: a single-center experience. Clin Rheumatol. 2013;32(1):87-90. doi: 10.1007/s10067-012-2094-1

47. Larsen JL, Jacobsen S. Rapid infusion with rituximab: short term safety in systemic autoimmune diseases. Rheumatol Int. 2013;33(2):529-33. doi: 10.1007/s00296-011-2208-0

48. Manders SHM, Kievit W, Adang E, et al. Cost-effectiveness of abatacept, rituximab, and TNFi treatment after previous failure with TNFi treatment in rheumatoid arthritis: a pragmatic multicentre randomised trial. Arthritis Res Ther. 2015;17:134. doi: 10.1186/s13075-015-0630-5

49. Malottki K, Barton P, Tsourapas A, et al. Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a tumour necrosis factor inhibitor: a systematic review and economic evaluation. Health Technol Assess. 2011;15:1-278. doi: 10.3310/hta15140

50. Hallinen TA, Soini EJ, Eklund K, Puolakka K. Cost-utility of different treatment strategies after the failure of tumour necrosis factor inhibitor in rheumatoid arthritis in the Finnish setting. Rheumatology. 2010;49:767-77. doi: 10.1093/rheumatology/kep425

51. Quartuccio L, Di Bidino R, Ruggeri M, et al. Cost-effectiveness analysis of two rituximab retreatment regimens for longstanding rheumatoid arthritis Arthritis Care Res. 2015;67(7):947-55. doi: 10.1002/acr.22534

52. Cohen S, Emery P, Greenwald M, et al. A phase I pharmacokinetics trial comparing PF- 05280586 (a potential biosimilar) and rituximab in patients with active rheumatoid arthritis. Br J Clin Pharmacol. 2016;82:129-38. doi: 10.1111/bcp.12916

53. Насонов ЕЛ, Зонова ЕВ, Иванова ОН и др. Результаты сравнительного клинического исследования III фазы препаратов ритуксимаба (Ацеллбия® и Мабтера®) при ревматоидном артрите (исследование BIORA). Научно-практическая ревматология. 2016;54(5):510-9 [Nasonov EL, Zonova EV, Ivanova ON, et al. The results of a phase III comparative clinical trial of rituximab (Acellbia® and Mabthera®) in rheumatoid arthritis (the BIORA study). Nauchno-Prakticheskaya Revmatologiya = Rheumatology Science and Practice. 2016;54(5):510-519 (In Russ.)]. doi: 10.14412/1995-4484-2016-510-519

54. Gerlag DM, Safy M, Maijer KI, et al. A Single Infusion of Rituximab Delays the Onset of Arthritis in Subjects at High Risk of Developing RA [abstract]. Arthritis Rheum. 2016;68 Suppl 10. Available from: http://acrabstracts.org/abstract/a-single-infusionof-rituximab- delays-the-onset-of-arthritis-in-subjects-at-highrisk-of-developing-ra/. Accessed May 20, 2017.

55. Lopez-Olivo MA, Amezaga Urruela M, McGahan L, et al. Rituximab for rheumatoid arthritis. Cochrane Database Syst Rev. 2015 Jan 20;1:CD007356. doi: 10.1002/14651858


Рецензия

Для цитирования:


Кусевич Д.А., Авдеева А.С. Эффективность и безопасность применения ритуксимаба при ревматоидном артрите (новые данные). Научно-практическая ревматология. 2017;55(4):420-428. https://doi.org/10.14412/1995-4484-2017-420-428

For citation:


Kusevich D.A., Avdeeva A.S. THE EFFICACY AND SAFETY OF RITUXIMAB IN RHEUMATOID ARTHRITIS: NEW EVIDENCE. Rheumatology Science and Practice. 2017;55(4):420-428. (In Russ.) https://doi.org/10.14412/1995-4484-2017-420-428

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ISSN 1995-4484 (Print)
ISSN 1995-4492 (Online)