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

Автор: Кусевич Д.А., Авдеева А.С.

Журнал: Научно-практическая ревматология @journal-rsp

Статья в выпуске: 4 т.55, 2017 года.

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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 генноинженерными биологическими препаратами, после неэффективного лечения ингибиторами фактора некроза опухоли а (ФНОа). 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 ФНОа, 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.

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Ревматоидный артрит, активность заболевания, ритуксимаб, эффективность терапии, безопасность терапии

Короткий адрес: https://sciup.org/14945842

IDR: 14945842 | DOI: 10.14412/1995-4484-2017-420-428

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

Насонов ЕЛ, Каратеев ДЕ. Ревматоидный артрит. В кн.: Насонов ЕЛ, Насонова ВА, редакторы. Ревматология. Национальное руководство. Москва: ГЭОТАР-Медиа; 2008
Насонов ЕЛ, редактор. Генно-инженерные биологические препараты в лечении ревматоидного артрита. Москва: ИМА-ПРЕСС; 2013
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
Насонов ЕЛ, редактор. Анти-В-клеточная терапия в ревматологии: фокус на ритуксимаб. Москва: ИМА-ПРЕСС; 2012
Насонов ЕЛ. Фармакотерапия ревматоидного артрита -взгляд в 21 век. Клиническая медицина. 2005;(6):8-12
Leandro MJ, Cooper N, Cambridge G, et al. Bone-marrow В-lineage cells in patients with rheumatoid arthritis following rituximab therapy. Rheumatology (Oxford). 2007;46(1):29-36 DOI: 10.1093/rheumatology/kel148
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
Nakou M, Katsikas G, Sidiropoulos P, et al. Rituximab therapy reduces activated В cells in both the peripheral blood and bone marrow of patients with rheumatoid arthritis: depletion of memory В cells correlates with clinical response. Arthritis Res Ther. 2009;11:R131 DOI: 10.1186/ar2798
Roll P, Palanichamy A, Kneitz C, et al. Regeneration of В cell subsets after transient depletion using anti-CD20 antibodies in rheumatoid arthritis. Arthritis Rheum. 2006;54(8):2377-86 DOI: 10.1002/art.22019
Vital EM, Rawstron AC, Dass S, et al. Reduced-dose rituximab in rheumatoid arthritis: efficacy depends on degree of В cell depletion. Arthritis Rheum. 2011;63(3):603-8 DOI: 10.1002/art.30152
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
Edwards JC, Szcezepanski L, Szechinski J, et al. Efficacy of В-cell targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004;350(25):2572-81 DOI: 10.1056/NEJMoa032534
Насонов ЕЛ. Фармакотерапия ревматоидного артрита в XXI веке: фокус на ритуксимаб. Современная ревматология. 2009;3(4):67-75
Cohen MD, Keystone E. Rituximab for rheumatoid arthritis. Rheumatol Ther. 2015;2:99-111 DOI: 10.1007/s40744-015-0016-9
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- DOI: 10.1016/S0140-6736(16)00380-9
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
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 second-line 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
Keyser FD, Hoffman I, Durez P, et al. Longterm followup of rit-uximab 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
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
Wendler J, Burmester G R, Sörensen 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
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
Ferraccioli G, Tolusso В, 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
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
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
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
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
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
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.
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
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
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. April 11, 2016 DOI: 10.1371/journal.pone.0153217
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
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
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
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
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
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
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
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
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
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
Young NS, Brown KE. Parvovirus B19. N Engl J Med. 2004;350(6):586-97 DOI: 10.1056/NEJMra030840
Brown KE, Young NS. Parvoviruses and bone marrow failure. Stem Cells Dayt Ohio. 1996;14:151-63 DOI: 10.1002/stem.140151
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.
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
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
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
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
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
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
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
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
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
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 . Arthritis Rheum. 2016;68 Suppl 10. Available from: http://acrabstracts.org/abstract/a-single-infusion-of-rituximab-delays-the-onset-of-arthritis-in-subjects-at-high-risk-of-developing-ra/. Accessed May 20, 2017.
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

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