Факторы, определяющие длительный успех терапии генно-инженерными биологическими препаратами при ревматоидном артрите
Аннотация
Необходимость достижения клинической ремиссии или низкой активности болезни у каждого пациента с ревматоидным артритом подчеркивает важность комбинированной терапии с включением метотрексата и генно-инженерных биологических препаратов в случаях резистентности к обычным базисным противовоспалительным препаратам. Современные требования подразумевают не только достижение результата, но и его длительное (многолетнее) сохранение. Возможность достижения стабильных результатов лечения определяется сочетанием многих факторов, таких как клиническая эффективность, безопасность, низкая иммуногенность, возможность длительного применения и экономическая целесообразность. Анализ данных литературы за последние 5 лет позволяет сделать вывод, что ингибитор фактора некроза опухоли этанерцепт обладает оптимальным сочетанием этих параметров.
Об авторе
Дмитрий Евгеньевич Каратеев
ФГБНУ Научно-исследовательский институт ревматологии им. В.А. Насоновой
Россия
115522, Москва, Каширское шоссе, 34А
Россия
115522, Москва, Каширское шоссе, 34А
Литература
1. Smolen J, Aletaha D, Bijlsma JW, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010 Apr;69(4):631–7. doi: 10.1136/ard.2009.123919. Epub 2010 Mar 9.
2. Smolen JS, Breedveld FC, Burmester GR, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Ann Rheum Dis. 2015 May 12. pii: annrheumdis-2015-207524. doi: 10.1136/annrheumdis-2015-207524. [Epub ahead of print].
3. Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014 Mar;73(3):492–509. doi: 10.1136/annrheumdis-2013-204573. Epub 2013 Oct 25.
4. Насонов ЕЛ, Мазуров ВИ, Каратеев ДЕ и др. Проект рекомендаций по лечению ревматоидного артрита Общероссийской общественной организации «Ассоциация ревматологов России»-2014 (часть 1). Научно-практическая ревматология 2014;52(5):477–94. [Nasonov EL, Mazurov VI, Karateev DE, et al. Project: Recommendations on treatment of rheumatoid arthritis developed by All-Russian Public Organization «Asspciation of Rheumatologists of Russia»-2014 (Part 1). Nauchno-prakticheskaya revmatologiya = Rheumatology Science and Practice. 2014;52(5):477–94. (In. Russ.)]. DOI: http://dx.doi.org/10.14412/1995-4484-2014-477-4
5. Stoffer MA, Schoels MM, Smolen JS, et al. Evidence for treating rheumatoid arthritis to target: results of a systematic literature search update. Ann Rheum Dis. 2015 May 19. pii: annrheumdis-2015-207526. doi: 10.1136/annrheumdis-2015-207526. [Epub ahead of print]
6. Каратеев ДЕ, Лучихина ЕЛ, Муравьев ЮВ и др. Первое российское стратегическое исследование фармакотерапии ревматоидного артрита (РЕМАРКА). Научно-практическая ревматология. 2013;51(2):117–25. [Karateev DE, Luchikhina EL, Muravyev Yu, et al. The first Russian strategic study of pharmacotherapy for rheumatoid arthritis (REMARCA). Nauchno-practicheskaya revmatologiya = Rheumatology Science and Practice. 2013;51(2):117–25. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1995-4484-2013-637
7. Насонов ЕЛ. Новые подходы к фармакотерапии ревматоидного артрита: тофацитиниб. Научно-практическая ревматология. 2014;52(2):209–21. [Nasonov EL. New approaches to pharmacotherapy of rheumatoid arthritis: Tofacitinib. Nauchnopracticheskaya revmatologiya = Rheumatology Science and Practice. 2014;52(2):209–21. (In Russ.)]. DOI: http://dx.doi.org/10.14412/ 1995-4484-2014-209-221
8. Каратеев Д.Е. Новое направление в патогенетической терапии ревматоидного артрита: первый ингибитор Янус-киназ-тофацитиниб. Современная ревматология. 2014; 8(1):39–44. [Karateev DE. A new trend in pathogenetic treatment of rheumatoid arthritis: tofacitinib, the first inhibitor of Janus kinase. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2014; 8(1):39–44. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1996-7012-2014-1-39-44
9. Насонов ЕЛ, Каратеев ДЕ, Чичасова НВ. Новые рекомендации по лечению ревматоидного артрита (EULAR, 2013): место метотрексата. Научно-практическая ревматология. 2014;52(1):8–27. [Nasonov EL, Karateev DE, Chichasova NV. New recommendations for the management of rheumatoid arthritis (EULAR, 2013): the role of Methotrexate. Nauchno-practicheskaya revmatologiya = Rheumatology Science and Practice. 2014;52(1):8–27. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1995-4484-2014-8-26
10. Каратеев ДЕ, Лучихина ЕЛ, Демидова НВ и др. Первое российское стратегическое исследование фармакотерапии ревматоидного артрита (РЕМАРКА): результаты лечения 130 больных в течение 12 месяцев. Научно-практическая ревматология. 2014; 52(6):607–14. [Karateev DE, Luchikhina EL, Demidova NV, et al. The first russian strategic study of pharmacotherapy for rheumatoid arthritis (REMARCA trial): results of 12-month treatment in 130 patients. Nauchno-practicheskaya revmatologiya = Rheumatology Science and Practice. 2014;.52(6):607–14. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1995-4484-2014-607-614
11. Smolen JS, Aletaha D. Rheumatoid arthritis therapy reappraisal: strategies, opportunities and challenges. Nat Rev Rheumatol. 2015 May;11(5):276–89. doi:10.1038/nrrheum.2015.8.
12. Moreland LW, O'Dell JR, Paulus HE, et al. A randomized comparative effectivenessstudy of oral triple therapy versus etanercept plus methotrexate in early aggressive rheumatoid arthritis: the treatment of Early Aggressive Rheumatoid Arthritis Trial. Arthritis Rheum. 2012;64(9):2824–35. DOI: 10.1002/art.34498.
13. O'Dell JR, Curtis JR, Mikuls TR, et al. Validation of the methotrexate-first strategy in patients with early, poor-prognosis rheumatoid arthritis: results from a two-year randomized, double-blind trial. Arthritis Rheum. 2013;65(8):1985–94. DOI: 10.1002/art.38012.
14. Van Vollenhoven RF, Ernestam S, Geborek P, et al. Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in patients with early rheumatoid arthritis (Swefot trial): 1-year results of a randomised trial. Lancet. 2009;374(9688):459–66. DOI: 10.1016/S0140-6736(09)60944-2.
15. Van Vollenhoven RF, Geborek P, Forslind K, et al. Conventional combination treatment versus biological treatment in methotrexate refractory early rheumatoid arthritis: 2 year follow-up of the randomised, non-blinded, parallel-group Swefot trial. Lancet. 2012;379(9827):1712–20. DOI:10.1016/S0140-6736(12)60027-0.
16. Лучихина ЕЛ. Прогнозирование и длительное поддержание низкой активности заболевания на фоне терапии генно-инженерными биологическими препаратами при ревматоидном артрите. Современная ревматология. 2014;8(2):66–70. [Luchikhina EL. The prediction and longterm maintenance of low disease activity during therapy with disease modifying antiinflammatory drugs for rheumatoid arthritis. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2014;8(2):66–70. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1996-7012-2014-2-66-70
17. Nam JL, Ramiro S, Gaujoux-Viala C, et al. Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2014;73(3):516–28. doi: 10.1136/annrheumdis-2013-204577.
18. Weinblatt ME, Schiff M, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum. 2013 Jan;65(1):28–38. doi: 10.1002/art.37711.
19. Albert DA. Are all biologics the same? Optimal treatment strategies for patients with early rheumatoid arthritis: systematic review and indirect pairwise meta-analysis. J Clin Rheumatol. 2015 Jul 29. [Epub ahead of print].
20. Dixon WG, Watson K, Lunt M, et al. Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving antitumor necrosis factor therapy. Arthritis Rheum. 2006 Aug;54(8):2368–76.
21. Dixon WG, Symmons DP, Lunt M, et al. Serious infection following anti-tumor necrosis factor-therapy in patients with rheumatoid arthritis. Arthritis Rheum. 2007 Sep;56(9):2896–904.
22. Alonso-Ruiz A, Pijoan JI, Ansuategui E, et al. Tumor necrosis factor alpha drugs in rheumatoid arthritis: systematic review and metaanalysis of efficacy and safety. BMC Musculoskelet Disord. 2008 Apr 17;9:52. doi: 10.1186/1471-2474-9-52.
23. Leombruno JP, Einarson TR, Keystone EC. The safety of anti-tumour necrosis factor treatments in rheumatoid arthritis: meta and exposure-adjusted pooled analyses of serious adverse events. Ann Rheum Dis. 2009 Jul;68(7):1136–45. doi: 10.1136/ard.2008.091025. Epub 2008 Aug 27.
24. 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 Mar;42(3):372–8. doi: 10.3899/jrheum.140853.
25. Lethaby A, Lopez-Olivo MA, Maxwell L, et al. Etanercept for the treatment of rheumatoid arthritis. Cochrane Database Syst Rev. 2013 May 31;5:CD004525. doi: 10.1002/14651858.CD004525.pub2.
26. Tubach F, Salmon D, Ravaud P, et al. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy han with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance off Biotherapies registry. Arthritis Rheum. 2009;60(7):1884–94. doi: 10.1002/art.24632
27. Cantini F, Niccoli L, Goletti D. Adalimumab, etanercept, infliximab, and the risk of tuberculosis: data from clinical trials, national registries, and postmarketing surveillance. J Rheumatol Suppl. 2014;91:47–55. doi: 10.3899/jrheum.140102.
28. Jung SM, Ju JH, Park MS, Kwok SK, et al. Risk of tuberculosis in patients treated with anti-tumor necrosis factor therapy: a nationwide study in South Korea, a country with an intermediate tuberculosis burden. Int J Rheum Dis. 2015;18(3):323–30. doi: 10.1111/1756-185X.12530..
29. Salmon-Ceron D, Tubach F, Lortholary O, et al. Drug-specific risk of non-tuberculosis opportunistic infections in patients receiving anti-TNF therapy reported to the 3-year rospective French RATIO registry. Ann Rheum Dis. 2011 Apr;70(4):616–23. doi: 10.1136/ard.2010.137422.
30. Wolbink GJ, Vis M, Lems WF, et al. Development of anti-infliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum. 2006;54(3):711–5. http://dx.doi.org/10.1002/art.21671
31. Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007;66(7):921–6. DOI: http://dx.doi.org/10.1136/ard.200
32. Каратеев ДЕ. Вопросы иммуногенности биологических препаратов: теория и практика. Современная ревматология. 2009;3(1):67–72. [Karateev DE. The problems of the immunogenicity of biologicals: theory and practice. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2009;3(1):67–72. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1996-7012-2009-527
33. Александрова ЕН, Новиков АА, Насонов ЕЛ. Роль лабораторных биомаркеров в мониторинге и прогнозировании эффективности терапии ревматических заболеваний генно-инженерными биологическими препаратами. Современная ревматология. 2014;8(1):5–13. [Aleksandrova EN, Novikov AA, Nasonov EL. Role of laboratory biomarkers in monitoring and prediction of the effectiveness of treatment of rheumatic diseases using genetically engineered drugs. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2014;8(1):5–13. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1996-7012-2014-1-5-13
34. Каратеев ДЕ, Лучихина ЕЛ. Актуальные вопросы применения ингибиторов фактора некроза опухоли при ревматоидном артрите. Современная ревматология. 2008;2(4):46–51. [Karateev DE, Luchikhina EL. Use of tumor necrosis factora inhibitors in rheumatoid arthritis: topical aspects. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2008;2(4):46–51. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1996-7012-2008-507
35. Каратеев ДЕ. Насколько реально длительное сохранение лечебного эффекта ингибиторов фактора некроза опухоли Фокус на иммуногенность. Современная ревматология. 2014;8(2):35–40. [Karateev DE. How real is the long-lasting effect of tumor necrosis factor α inhibitors? Focus on immunogenicity. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2014;8(2):35–40. (In Russ.)]. DOI: http://dx.doi.org/10.14412/1996-7012-2014-2-35-40
36. Thomas SS, Borazan N, Barroso N, et al. Comparative Immunogenicity of TNF Inhibitors: Impact on Clinical Efficacy and Tolerability in the Management of Autoimmune Diseases. A Systematic Review and Meta-Analysis. BioDrugs. 2015;29(4):241–58. doi: 10.1007/s40259-015-0134-5.
37. Stoner KL, Harder H, Fallowfield LJ, Jenkins VA. Intravenous versus Subcutaneous Drug Administration. Which Do Patients Prefer? A Systematic Review. Patient. 2014 Jul 12. [Epub ahead of print].
38. Sylwestrzak G, Liu J, Stephenson JJ, et al. Considering patient preferences when selecting anti-tumor necrosis factor therapeutic options. Am Health Drug Benefits. 2014 Apr;7(2):71–81.
39. Chilton F, Collett RA. Treatment choices, preferences and decision-making by patients with rheumatoid arthritis. Musculoskeletal Care. 2008 Mar;6(1):1–14.
40. Tang B, Rahman M, Waters HC, Callegari P. Treatment persistence with adalimumab, etanercept, or infliximab in combination with methotrexate and the effects on health care costs in patients with rheumatoid arthritis. Clin Ther. 2008 Jul;30(7):1375–84.
41. Degli Esposti L, Sangiorgi D, Perrone V, et al. Adherence and resource use among patients treated with biologic drugs: findings from BEETLE study. Clinicoecon Outcomes Res. 2014 18;6:401–7. doi: 10.2147/CEOR.S66338.
42. Neubauer S, Cifaldi M, Mittendorf T, et al. Biologic TNF inhibiting agents for treatment of rheumatoid arthritis: persistence and dosing patterns in Germany. Health Econ Rev. 2014;4(1):32. doi: 10.1186/s13561-014-0032-4.
43. Cho SK, Sung YK, Choi CB, Bae SC. Impact of comorbidities on TNF inhibitor persistence in rheumatoid arthritis patients: an analysis of Korean National Health Insurance claims data. Rheumatol Int. 2012;32(12):3851–6. doi: 10.1007/s00296-011-2312-1.
44. Markenson JA, Gibofsky A, Palmer WR, et al. Persistence with anti-tumor necrosis factor therapies in patients with rheumatoid arthritis: observations from the RADIUS registry. J Rheumatol. 2011;38(7):1273–81. doi: 10.3899/jrheum.101142.
45. Hetland ML, Christensen IJ, Tarp U, et al. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum. 2010;62(1):22–32. doi: 10.1002/art.27227.
46. Jobanputra P, Maggs F, Deeming A, et al. A randomised efficacy and discontinuation study of etanercept versus adalimumab (RED SEA) for rheumatoid arthritis: a pragmatic, unblinded, non-inferiority study of first TNF inhibitor use: outcomes over 2 years. BMJ Open. 2012 12;2(6). doi: 10.1136/bmjopen-2012-001395.
47. Scirе CA, Caporali R, Sarzi-Puttini P, et al. Drug survival of the first course of antiTNF agents in patients with rheumatoid arthritis and seronegative spondyloarthritis: analysis from the MonitorNet database. Clin Exp Rheumatol. 2013 NovDec;31(6):857–63. Epub 2013 Aug 26.
48. Arora A, Mahajan A, Spurden D, et al. Long-Term Drug Survival of TNF Inhibitor Therapy in RA Patients: A Systematic Review of European National Drug Registers. Int J Rheumatol. 2013;2013:764518. doi: 10.1155/2013/764518.
49. Fisher A, Bassett K, Wright JM, et al. Comparative persistence of the TNF antagonists in rheumatoid arthritis – a populationbased cohort study. PLoS One. 2014 Aug 20;9(8):e105193. doi: 10.1371/journal.pone.0105193.
50. Howe A, Eyck LT, Dufour R, Shah N, Harrison DJ. Treatment patterns and annual drug costs of biologic therapies across indications from the Humana commercial database. J Manag Care Spec Pharm. 2014 Dec;20(12):1236–44.
51. Schabert VF, Watson C, Gandra SR, et al. Annual costs of tumor necrosis factor inhibitors using real-world data in a commercially insured population in the United States. J Med Econ. 2012;15(2):264–75. doi: 10.3111/13696998.2011.644645
52. Bonafede MM, Gandra SR, Watson C, et al. Cost per treated patient for etanercept, adalimumab, and infliximab across adult indications: a claims analysis. Adv Ther. 2012, 29(3):234–48. doi: 10.1007/s12325-012-0007-y.
53. Bonafede M, Joseph GJ, Shah N, et al. Cost of tumor necrosis factor blockers per patient with rheumatoid arthritis in a multistate Medicaid population. Clinicoecon Outcomes Res. 2014 Sep 15;6:381–8. doi: 10.2147/CEOR.S61445. eCollection 2014.
54. Ollendorf DA, Klingman D, Hazard E, Ray S. Differences in annual medication costs and rates of dosage increase between tumor necrosis factor-antagonist therapies for rheumatoid arthritis in a managed care population. Clin Ther. 2009;31(4):825–35. doi: 10.1016/j.clinthera.2009.04.002.
55. Wu N, Bhurke S, Shah N, Harrison DJ. Application of a validated algorithm to estimate the effectiveness and cost of biologics for rheumatoid arthritis in the US pharmacy benefit manager context. Clinicoecon Outcomes Res. 2015 May 13;7:257–66. doi: 10.2147/CEOR.S83932. eCollection 2015.
56. Benucci M, Li Gobbi F, Sabadini L, et al. The economic burden of biological therapy in rheumatoid arthritis in clinical practice: costeffectiveness analysis of sub-cutaneous antiTNFalpha treatment in Italian patients. Int J Immunopathol Pharmacol. 2009;22(4):1147–52.
57. Carswell EA, Old LJ, Kassel RL, et al. An endotoxin-induced serum factor that causes necrosis of tumors. Proc Natl Acad Sci USA. 1975;72(9):3666–70.
58. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000262/human_med_000764.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125
Для цитирования:
Каратеев Д.Е. Факторы, определяющие длительный успех терапии генно-инженерными биологическими препаратами при ревматоидном артрите. Современная ревматология. 2015;9(3):54-60. https://doi.org/10.14412/1996-7012-2015-3-54-60
For citation:
Karateev D.E. Factors determining long-term success of biologic therapy in rheumatoid arthritis. Modern Rheumatology Journal. 2015;9(3):54-60. (In Russ.) https://doi.org/10.14412/1996-7012-2015-3-54-60
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