Clinical experience with infliximab administration in patients with rheumatoid arthritis by Russian register data


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Aim. To analyse the data on infliximab administration (efficacy, tolerance, toxicity) in patients with rheumatoid arthritis (RA) in Russia by clinical evidence provided by the multicenter observation trial.
Material and methods. The register included 297 patients with a documented diagnosis of RA who had for the first time treated with infliximab. The efficacy of the drug was evaluated by EULAR criteria based on the dynamics of DAS28 index.
Results. The results of infliximab treatment show good response of RA patients to standard courses of infliximab. A good/satisfactory effect by EULAR criteria was achieved in 80% patients to week 22 of therapy and in 85% to week 46. After 6-month (22 week) infliximab treatment a good effect was achieved in 15.7% patients, satisfactory - in 64.7%; 19.6% patients did not respond. Remission (DAS28 < 2.6 units) was achieved in 7% patients. Infliximab tolerance was satisfactory. Non-severe infusion reactions were most frequent unwanted effects. To treatment week 22, ten patients developed serious side effects causing the drug discontinuation.
Conclusion. The results of the Russian register confirm a high therapeutic potential and satisfactory tolerance of infliximab observed in real rheumatological practice of the treatment of severe RA. These results agree with those of European registers of infliximab.

References

  1. Насонов Е. Л. Лечение ревматоидного артрита: современное состояние проблемы. Рус. мед. журн., 2006; 8: 573- 577.
  2. Насонов Е. Л. Фактор некроза опухоли-α - новая мишень для противовоспалительной терапии ревматоидного артрита. Рус. мед. журн. 2000; 17: 718-722.
  3. Лукина Г. В., Сигидин Я. А., Чичасова Н. В. и др. Применение моноклональных антител к фактору некроза опухоли (Ремикейд) при ревматоидном артрите: предварительные результаты. Тер. арх., 2003; 5: 9-12.
  4. Zink A., Askling J., Dixon W. G. et al. European biologies registers - methodology, selected results, and perspectives. Ann. Rheum. Dis. 22 June, on line. Doc. 10.1136/ard 2008 09 1926.
  5. Arnett F. C., Edworth S. M., Bloch D. A. et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthr. and Rneum. 1988; 31: 315-324.
  6. Fransen J., Stucki G., van Riel P. L. C. M. Rheumatoid arthritis measures. Arthr. and Rheum. 2003; 49: S214-S224.
  7. Listing J., Strangfeld A., Rau R. et al. Clinical and functional remission: even though biologies are superior to conventional DMARDs overall success rates remain low: results from RABBIT, the German biologies register. Arthr. Res. Ther. 2006; 8: R66.
  8. Hyrich K. L., Watson K. D., Silman A. J., Symmons D. P. Predictors of response to anti-TNF-a therapy among patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologies Register. Rheumatology (Oxford). 2006; 45: 1558-1565.
  9. Hyrich K. L., Symmons D. P. M., Watson K. D. et al. Comparison of the response to infliximab or etanercept monotherapy with response to cotherapy with methotrexate or another disrase-modifying anti-rheumatic drug in patients with rheumatoid arthritis. Results from the British Society for Rheumatology Biologies Register. Arthr. and Rheum. 2006; 54: 1786-1794.
  10. Mancarella L., Bobbio-Pallaviccini F., Ceccarelli F. et al. Good clinical response, remission, and predictors of remission in rheumatoid arthritis patients treated with tumor necrosis factor-α blockers: the GISEA study. J. Rhematol. 2007; 34: 1670- 1673.
  11. Potter C., Hyrich K. L., Tracey A. et al. Association of rheumatoid factor and anti-cyclic citrullinated peptide positivity, but not carriage of shared epitope or PTPN22 susceptibility variants, with anti-tumor necrosis factor response in rheumatoid arthritis. Ann. Rheum. Dis. 2009; 68: 69-74.
  12. Kristensen L., Kapetanovic M. C., Guelfe A. et al. Predictors of response to anti-TNF therapy according to ACR and EULAR criteria in patients with established RA: results from the South Swedish Arthritis Treatment Group. Register. Rheumatology (Oxford) 2008; March 3; on line. doi: 10.1093/rheumatology/ken002.
  13. Lipsky P., Heijde van der D., St. Clair E. et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N. Engl. J. Med. 2000; 343: 1594-1602.
  14. Maini R., St. Clair E. W., Breedveld F. et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomized phase III trial. ATTRACT Study Group. Lancet 1999; 354: 1932-1939.
  15. Westhovens R., Yocum D., Han J. et al. For the START Study Group. The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: a randomized, placebo-controlled trial. Arthr. and Rheum. 2006; 54: 1075-1086.
  16. St. Clair E. W., van der Heijde D. M. F. M., Smolen J. S. et al. Combination of infliximab with methotrexate therapy for early rheumatoid arthritis. Arthr. and Rheum. 2004; 50: 3432-3443.
  17. Brumenauer B., Judd M., Cranney A. et al. Infliximab for the treatment of rheumatoid arthritis. (Cochrane Review). Cochrane Library 2004; 2.
  18. Chen Y.-F., Jobanputra P., Barton P. et al. A systemic review of the effectiveness of adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis in adults and economic evaluation of their cost-effectiveness. Hlth Technol Assessment 2006; 10 (42): 248.
  19. Nixon R., Bansback N., Brennan A. The efficacy of inhibiting tumor necrosis factor a in patients with rheumatoid arthritis: a meta-analysis and adjusted indirect comparisons Rheumatology (Oxford) 2007; on line 46: 1140-1147.
  20. Alonso-Ruiz A., Ignacio Pijoan J., Ansuategui E. et al. Tumor necrosis factor alpha drugs in rheumatoid arthritis: a systemic review and metaanalysis of efficacy and safety. BMC Musculoskelet. Disord. 2008; 9: 52.
  21. National Institute for Health and Clinical Excellence. Adalimumab. Etanercept and infliximab for the treatment of rheumatoid arthritis 2007. www.NICE.Оrg.uk/guidance/TA130/cost.Template/pdf/English.
  22. Zinraras E., Dahabren I. J., Giannouli S. et al. Infliximab ana methotrexate in the treatment of rheumatoid arthritis: a systemic review and meta-analysis of dosage regimens. Clin. Ther. 2008; 30: 1939-1955.
  23. Figueiredo I. T., Morel J., Sany J., Combe B. Maintenance and tolerability of infliximab in a cohоrt of 152 patients with rheumatoid arthritis. Clin. Exp. Rheumatol. 2008; 26: 18-23.
  24. Douglos M. M., Gossec L., Ruyssen-Witrand A. et al. Retention rates of tumor necrosis factor blockers in daily practice in 770 rheumatic patients. J. Rheumatol 2006; 33: 2433-2438.
  25. Cruyssen B. V., van Loooy S., Wyns B. et al. Four-year follow-up of infliximab therapy in rheumatoid arthritis patients with long-standing refractory disease: attrition and long-term evalution of disease activity. Arthr. Res. Ther. 2006; 8: R112.
  26. Buch M. H., Bingham S. J., Bryer D., Emery P. Long-term infliximab treatment in rheumatoid arthritis: subsequent outcome of initial responders. Rheumatology (Oxford) 2007; 46: 1153-1156.
  27. Zink A., Strangfeld A., Schneider M. et al. Effectiveness of tumor necrosis factor inhibitors in rheumatoid arthritis in an observational cohort study. Comparison of patients according to their eligibility for major randomized clinical trials. Arthr. and Rheum. 2008; 54: 3399-3407.
  28. Agarwal S., Glass R. J., Shadick N. A. et al. Predictors of discontinuation of tumor necrosis factor inhibitors in patients with rheumatoid arthritis. J. Rheumatol. 2008; 35: 1-9.
  29. Cohen S. B., Emery P., Greenwald M. W. et al. for the REFLEX Trial Group. Rituximab for theumatoid arthritis refractory to anti-tumor necrosis factor therapy. Results of multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthr. and Rheum. 2006; 54: 2793-2806.
  30. Насонов Е. Л., Лукина Г. В., Сигидин Я. А. и др. Применение моноклональных антител к В-лимфоцитам (ритуксимаб) при ревматоидном артрите в России (Предварительные результаты Российского Регистра). Тер. арх. 2008; 8: 57-63.
  31. Bukhari M., Lunt M., Harrison B. J. et al. Rheumatoid factor is the major predictor of increasing severity of radiographic erosions in rheumatoid arthritis. Results from Norfolk Arthritis Register Study, a large cohort. Arthr. and Rheum. 2002; 46: 906-912.
  32. Nell V. P. K., Machold K. P., Stamm Т. А. et al. Autoantibody profiling as early diagnostic and prognostic tool for rheumatoid arthritis. Ann. Rheum. Dis. 2005; 64: 1731-1736.
  33. Keystone E., Freundlich В., Schiff M. et al. Patients with moderate rheumatoid arthritis (RA) achieve better disease activity states with etanercept treatment than patients with severe RA. J. Rheumatol. 2009; 36: 522-531.
  34. Козлов Р. С., Якушин С. Б., Насонов Е. Л. Инфекционные осложнения терапии блокаторами фактора некроза опухоли: предупрежден - значит вооружен. Клин. микробиол. и антимикроб. химиотер. 2006; 8: 314-324.

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