The role of etanercept in the treatment of patients with severe rheumatoid arthritis
https://doi.org/10.21518/2079-701X-2013-12-97-105
Abstract
The article is devoted to the use of a tumor-necrosis-factor-alpha inhibitor etanercept in patients with severe rheumatoid arthritis. The author examines various aspects of therapy with genetically engineered biologic drugs (GEBD), in particular the issues of efficiency and safety, the possibility of monotherapy, antidestructive effect of the drug, etc.
About the Author
N. V. Chichasova
Research Institute of Rheumatology named after V.A. Nasonova RAMS
Russian Federation
Russian Federation
References
1. Генно-инженерные препараты в лечении ревматоидного артрита / под ред. академика РАМН Е.Л. Насонова. М.: ИМАПРЕСС, 2013.
2. Korth-Bradley J.M., Rubin A.S., Hanna R.K. et al. The pharmacokinetics of etanercept in healthy volunteers // Ann. Pharmacother. 2000. No103. Р. 161-164.
3. Ariza-Ariza R., Navarro-Sarabia F., Hernandez-Cruz B. et al. Dose escalation of the anti-TNF-а agents in patients with rheumatoid arthritis. A systematic review // Rheumatology (Oxford). 2007. No46. Р. 529-532.
4. Van der Heijde D., Klareskog L., Rodrigues-Valvelde V. et al. Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis. Two-year clinical and radiographic results from the TEMPO study, a double-blind, randomized trial // Arthr. Rheum. 2006. No54. Р. 1063-1074.
5. Emery P., Breedveld F.C., Hall S. et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active early, moderate to severe rheumatoid arthritis (COMET): a randomized, double-blind, parallel treatment trial // Lancet. 2008. No372. Р. 375-382.
6. Felson D.T., Anderson J.J., Boers M. et al. American College of rheumatology preliminary definition of improvement in rheumatoid arthritis // Arthr. Rheum. 1995. No38. Р. 727-735.
7. Sharp J.T. Radiologic assessment as an outcome measure in rheumatoid arthritis // Arthr. Rheum. 1989. No41. Р. 221-229.
8. Van der Heijde D., Burmester G., Melo-Gomes J. et al. The safety and efficacy of adding etanercept to methotrexate or methotrexate to etanercept in moderately active rheumatoid arthritis patients previously treated with monotherapy // Ann. Rheum. Dis. 2008. No67. Р. 182-188.
9. Klareskog L., Moreland L.W., Cohen S.B. et al. Safety and efficacy of over 10 years of continuous etanercept therapy in patients with rheumatoid arthritis in North America and Europe // Ann. Rheum. Dis. 2008. No67 (Suppl. II). Р. 175.
10. Hetland M.L., Christensen J., 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 // Arthr. Rheum. 2010. No62. Р. 22-32.
11. Van Gestel A.M., Prevoo M.L., van t'Hof M.A. et al. Development and validation of the European League Against Rheumatism response kriteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organisation/International League against Rheumatism // Arthr. Rheum. 1996. No39. Р. 34-40.
12. Hochberg M.C., Tracy J.K., Hawkins-Holt M., Flores R.H. Comparison of the efficacy of the tumour necrosis factor alpha blocking agents adalimumab, etanercept, and infliximab when added to methotrexate in patients with active rheumatoid arthritis // Ann. Rheum. Dis. 2003. No62 (Suppl. 2). Р. 13-16.
13. Reynolds A., Bacon P.A. The efficacy of etanercept and infliximab in patients with rheumatoid arthritis who have failed treatment with DMARDs: a meta-analysis // Arthr. Rheum. 2002. No46. Р. 332.
14. Reynolds A., Bacon P.A. The efficacy of etanercept and adalimumab in patients with rheumatoid arthritis who have failed treatment with DMARDs: a meta-analysis // Rheumatology. 2003. No42. Р. 91.
15. Moots R.J., Haraoui B., Matucci-Cerinic M. et al. Difference in biologic dose-escalation, non-biologic and steroid intensification among three anti-TNF agents: evidence from clinical practice // Clin. Exp. Rheum. 2011. No29. Р. 26-34.
16. Ferdinand C. Breedveld, Michael H. Weisman, Arthur F. Kavanaugh et al. The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment // Arthr. Rheum. 2006. No54. Р. 26-37.
17. St Clair E.W., van der Heijde D., Smolen J. et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis // Arthr. Rheum. 2004. No50. Р. 3432-3443.
18. Maini R., CtClair E.W., Breedveld F. et al. Infliximab (chimeric anti-timour necrosis factor monoclonal antibody versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial // Lancet. 1999. No354. Р. 1932-1939.
19. Keystone E.C. et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52 week trial // Arthr. Rheum. 2004. No50. Р. 1400-1411.
20. Kremer J., Fleischmann R., Brzezicki J. et al. Tocilizumab inhibits structural joint damage, improves physical function, and increases DAS28 remission rates in RA patients who respond inadequately to methotrexate: the LITHE study // Ann. Rheum. Dis. 2009. No68 (Suppl. 3). Р. 122.
21. Cohen S.B., Emery P., Greenwald M.W. et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy. Results of multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety of twenty-four weeks // Arthr. Rheum. 2006. No54. Р. 2793–2806.
22. Van Vollenhoven R.F., Keystone W.C., Furst D.E. et al. Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study // Ann. Rheum. Dis. 2005. No64 (suppl.). S432.
23. Genant H.K., Peterfy C.G., Westhovens R. et al. Abatacept inhibits structural damage progression in rheumatoid arthritis: results from the long-term extension of the AIM trial // Ann. Rheum. Dis. 2008. No67. Р. 1084–1089.
24. Singh J.A., Wells G.A., Cristensen R. et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview (Review) // The Cochrane Library. 2011. Iss. 2 (http://www.thecochranelibrary.com)
25. Bathon J.M., Martin R.W., Fleschmann R.M. et al. Comparison of etanercept and methotrexate in patients with early rheumatoid arthritis // N. Engl. J. Med. 2000. No343. Р. 1586–1593.
26. Van Vollenchoven R.F., Ernestam S., Geborek P. et al. Addition of infliximab compared with addition of sulfasalazine and hydrochloroquine to methotrexate in patients with early rheumatoid arthritis (SWEFOT trial): 1-year results of a randomized trial // Lancet. 2009. No374. Р. 459–466.
27. Thompson A.E., Rieder S.W., Pope J.E. Tumor necrosis factor therapy and the risk of serious infection and malignancy in patients with early rheumatoid arthritis // Arthr. Rheum. 2011. No63. Р. 1479–1485.
28. Насонов Е.Л., Козлов Р.С., Якушин С.Б. Инфекционные осложнения терапии блокаторами фактора некроза опухоли: предупрежден – значит, вооружен // Клин. Микробиол. Антимикробн. Химиотер. 2006. №8. С. 1–11.
29. Tubach F., Salmon D., Ravaud P. et al. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The tree-year prospective french research axed tolerance of biotherapy registry // Arthr. Rheum. 2009. No60. Р. 1884–1894.
30. Favalli E.G., Desiati F., Atzeni F. et al. Serious infections during anti-TNFα treatment in rheumatoid arthritis patients // Autoimm. Rev. 2009. No8. Р. 266–273.
31. Gomez- Reino J.J., Carmona L., Descalzo M.A. Tumor necrosis factor antagonists due to incomplete prevention of reactivation of latent infection // Arthr. Rheum. (Arthritis Care & Research). 2007. No57. Р. 756–761.
32. Dixon W.G., Hyrich K.L., Watson K.D. et al. Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy : results from British Society for Rheumatology Biologic Register (BSRB) // Ann. Rheum. Dis. 2010. No69. Р. 522–528.
33. Schiff M.H., Burmester G.R., Kent J.D. et al. Safety analysis of adalimumab (Humira) in global clinical trials and US post marketing surveillance of patients with rheumatoid arthritis // Ann. Rheum. Dis. 2006. No65. Р. 889–894.
34. Bongartz T., Sutton A.J., Sweeting M.J.et al. Anti-TNF antibody terapy in rheumatoid arthritis and the risk of serious infections and malignancies. Systematic review and meta-analysis of rare harmful effects in randomized controlled trials // JAMA. 2006. No295. Р. 2275–2285.
35. Dixon W., Silman A. Is there an association between anti-TNF monoclonal antibody therapy in rheumatoid arthritis and risk of malignancy and serious infection? Commentary on the meta-analysis by Bongartz et al. // Arthritis. Res. Ther. 2006. No8. Р. 111.
36. Wolfe F., Michaud K. Biologic treatment of the rheumatoid arthritis and the risk of malignancy // Arthr. Rheum. 2007. No56. Р. 2886–2895.
37. Askling J., Fored C.M., Drandt L.et al. Risks of solid cancers in patients with rheumatoid arthritis and after treatment with timour nacrosis factor antagonists // Ann. Rheum. Dis. 2005. No64. Р. 1421–1426.
38. Geborek P., Bladstrom A., Turesson C., et al. Tumour nacrosis factor blokers do not increase overall tumour risk in patients with rheumatoid arthritis, but may be associated with an increased risk of lymphomas // Ann. Rheum. Dis. 2005. No64. Р. 699–703.
39. Weinblatt M.E., Genovese M.C., Kremer J.M. et al. Safety and efficacy of Etanercept (Enbrel) treatment in North American patients with earle and long-standing rheumatoid arthritis : 1 year of clinical experience // ACR presentation, 2008.
40. 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. No54. Р. 692–701.
41. Askling J., Fored C.M., Drandt L. et al. Risks of solid cancers in patients with rheumatoid arthritis and after treatment with timour nacrosis factor antagonists // Ann. Rheum. Dis. 2005. No64. Р. 1421–1426.
42. Jamnitsli A., Bartelds G.M., Nurmohamed M.T. et al. The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept // Ann. Rheum. Dis. 2011. No70. Р. 284–288.
43. Jamnitski et al. Beneficial effect of one year Etanercept treatment on the lipid profile in patients with rheumatoid arthritis – ETRA study // EULAR, 2010. THU0173.
44. DeNoon D. Survey: the lies we tell our doctors: 45% of WebMD readers don’t tell their doctors the (whole) truth. 21 Sept. 2004. http:/www.medicinet.com/script/main/art.asp?articlekey=46985 (accessed 1 Feb 2013).
45. Choquette D., Arundine M., Thomas O.C. Large discrepancy between exprcted and observed ratios of biologic treated rheumatoid arthritis patients also compliant on DMARDS // Ann. Rheum. Dis. 2011. No70. Р. 197.
46. Choquette D., Thomas O., Arundine M. Lower expected levels of DMARD acquisition immediately pre and post biologic initiation in rheumatoid arthritis patients // Arthr. Rheum. 2012. No64. S783.
47. Emery P., Sebba A., Huizinga T.W.J. Biologic and oral disease-modifying antirheumatic drug monotherapy in rheumatoid arthritis // Ann. Rheum. Dis. 2013. No10. Р. 1–8.
48. Combe B., Codreanu C., Fiocco U. Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a double-blind comparison // Ann. Rheum. Dis. 2006. No65. Р. 1357–1362.
49. Genovese M.C., Bathon J.M., Fleischmann R.M. et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes // Arthr. Rheum. 2002. No46. Р. 1443–1450.
50. Kameda H., Kanbe K., Sato E. et al. Continuation of methotrexate resulted in better clinical and radiographic outcome than discontinuation upon starting etanercept in patients with rheumatoid arthritis: 52-week results from JESRM study // J. Rheum. 2011. No38. Р. 1585–1592.
51. Van Riel P.L.C.M., Taggart A.J., Sany J., et al. Efficacy and safety of combination etanercept and methotrexate versus etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: the ADORE study // Ann. Rheum. Dis. 2006. No65. Р. 1478–1483.
52. Kristensen L.E., Saxne T., Nilsson J.-A. et al. Impact of concomitant DMARD therapy on adherence to treatment etanercept and infliximab in rheumatoid arthritis. Results from a six-year observation study in southern Sweden // Arthr. Rs. Ther. 2006. No8. R174.
53. Koike T., Harigai M., Inokuma S. et al. Safety and effectiveness of 6 months’ Etanercept monotherapy and combination therapy in Japanese patients with rheumatoid arthritis: effect of concomitant disease-modifying antirheumatic drugs // J. Rheum. 2013. No40. Р. 1658–1668.
54. Fleischmann R., Koenig A.S., Pedersen R. et al. Treatment outcomes based on methotrexate dose range in patients with rheumatoid arthritis receiving etanercept plus methotrexate versus methotrexate alone // Arthr. Rheum. 2011. No63 (Suppl. 10). Р. 441.
Review
For citations:
Chichasova NV. The role of etanercept in the treatment of patients with severe rheumatoid arthritis. Meditsinskiy sovet = Medical Council. 2013;(12):97-105. (In Russ.) https://doi.org/10.21518/2079-701X-2013-12-97-105
Views:
408
Email this article 