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Efficacy of the first and subsequent treatment lines with adalimumab in patients with rheumatoid arthritis: data analysis from the Czech National Registry ATTRA


Authors: R. Horváth 1;  J. Hurňáková 2;  R. Janková 1;  T. Philipp 3;  L. Szczuková 4;  K. Hejduk 4 ;  K. Pavelka 2
Authors place of work: Oddělení revmatologie dětí a dospělých, FN Motol, Praha 1;  Revmatologický ústav, Praha 2;  Revmatologické a rehabilitační oddělení, Thomayerova nemocnice, Praha 3;  Institut biostatistiky a analýz, Lékařská fakulta, Masarykova univerzita, Brno 4
Published in the journal: Čes. Revmatol., 24, 2016, No. 3, p. 78-91.
Category: Original Papers

Summary

Introduction:
Therapy with TNFα inhibitors is highly effective, particularly when used in the first line treatment of the patients with rheumatoid arthritis (RA). Satisfactory clinical responses can be achieved in up to 70 % of the subjects during the first year of the administration. Still, a significant percentage of the patients do not respond well, thus alternative treatments need to be searched for. Switching to another TNFα blocker is the most common strategy, supported by the results from different randomized clinical trials which have known limitations. Valuable data regarding the efficacy and safety of individual medications are brought to us from large clinical registries which best reflect a real clinical practice.

Aims:
The aim of our study was to analyse the efficacy of the first and subsequent treatment lines with TNFα blocker adalimumab within the rheumatoid arthritis patient registry ATTRA.

Patients:
In the evaluated period, there were total of 1245 RA patients analysed in the complete data file within the ATTRA-RA registry based on the evaluation criteria. 986 patients were treated in the first line and 259 subjects in the subsequent line.

Results:
After 24 months, the DAS 28 score in the group treated in the first line with adalimumab reached a mean of 2,8 ± 1,1 (n = 387) vs. 3,0 ± 1,0 (n = 85) for subsequent line (p = 0,020). After two years of treatment, a good response according to the EULAR criteria was achieved in 68,7 % (n = 266) of patients treated in the first line vs. 56,5 % (n = 48) of patients treated in the subsequent line (p = 0,042). After two years of treatment, the remission criteria were achieved in 45,2 % (n = 175) of patients in the first line and in 32,9 % (n = 28) of patients in subsequent line (p = 0,040). After one year of treatment with adalimumab, remission or low disease activity was attained by 41,7 % (n = 20) of patients switching for the reason of ineffectiveness, by 66,7 % (n = 12) of patients switching due to loss of efficacy and by 53,7 % (n = 22) of patients switching due to an adverse events.

Conclusion:
Based on the results from the Czech National Registry ATTRA we can conclude that the efficacy of the first and subsequent treatment line with adalimumab is satisfactory and highly effective treatment strategy in clinical practice. The first line treatment was significantly better than the subsequent treatment line in the majority of the evaluated parameters. The subsequent line was highly effective, particularly when the rationale for switching to adalimumab was a secondary failure or a presence of adverse event to the previous TNFα blocker.

Key words:
Rheumatoid arthritis, biological therapy, TNFα inhibitors, adalimumab, subsequent treatment line


Zdroje

1. Navarro-Sarabia F, Ariza-Ariza R, Hernandez-Cruz B, Villanueva I. Adalimumab for treating rheumatoid arthritis. Cochrane Database Syst Rev 2005(3): CD005113.

2. Genovese MC, Bathon JM, Fleischmann RM, Moreland LW, et al. Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol 2005; 32(7): 1232–42.

3. Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, 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. Arthritis Rheum 2004; 50(5): 1400–11.

4. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, 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. Arthritis Rheum 2006; 54(1): 26–37.

5. Smolen JS, Weinblatt ME. When patients with rheumatoid arthritis fail tumour necrosis factor inhibitors: what is the next step? Ann Rheum Dis 2008; 67(11): 1497–8.

6. Smolen JS, Breedveld FC, Burmester GR, Bykerk V, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Ann Rheum Dis 2015; XXXX ????.

7. Keystone EC: Switching tumor necrosis factor inhibitors: an opinion. Nat Clin Pract Rheumatol 2006; 2(11): 576–7.

8. Bombardieri S, Ruiz AA, Fardellone P, Geusens P, et al. Effectiveness of adalimumab for rheumatoid arthritis in patients with a history of TNF-antagonist therapy in clinical practice. Rheumatology (Oxford) 2007; 46(7): 1191–9.

9. Furst DE, Gaylis N, Bray V, Olech E, et al. Open-label, pilot protocol of patients with rheumatoid arthritis who switch to infliximab after an incomplete response to etanercept: the opposite study. Ann Rheum Dis 2007; 66(7): 893–9.

10. Bingham CO, 3rd, Ince A, Haraoui B, Keystone EC, et al. Effectiveness and safety of etanercept in subjects with RA who have failed infliximab therapy: 16-week, open-label, observational study. Curr Med Res Opin 2009; 25(5): 1131–42.

11. van Vollenhoven R, Harju A, Brannemark S, Klareskog L. Treatment with infliximab (Remicade) when etanercept (Enbrel) has failed or vice versa: data from the STURE registry showing that switching tumour necrosis factor alpha blockers can make sense. Ann Rheum Dis 2003; 62(12): 1195–98.

12. Karlsson JA, Kristensen LE, Kapetanovic MC, Gulfe A, et al. Treatment response to a second or third TNF-inhibitor in RA: results from the South Swedish Arthritis Treatment Group Register. Rheumatology (Oxford) 2008; 47(4): 507–13.

13. Pavlik T, Janousova E, Pospisil Z, Muzik J, et al. Estimation of current cumulative incidence of leukaemia-free patients and current leukaemia-free survival in chronic myeloid leukaemia in the era of modern pharmacotherapy. BMC Med Res Methodol 2011; 11: 140.

14. Klein JP, Logan B, Harhoff M, Andersen PK: Analyzing survival curves at a fixed point in time. Stat Med 2007; 26(24): 4505–19.

15. Donahue KE, Gartlehner G, Jonas DE, Lux LJ, et al. Systematic review: comparative effectiveness and harms of disease-modifying medications for rheumatoid arthritis. Ann Intern Med 2008; 148(2): 124– 34.

16. Hochberg MC, Lebwohl MG, Plevy SE, Hobbs KF, et al. The benefit/risk profile of TNF-blocking agents: findings of a consensus panel. Semin Arthritis Rheum 2005; 34(6): 819–836.

17. Virkki LM, Valleala H, Takakubo Y, Vuotila J, et al. Outcomes of switching anti-TNF drugs in rheumatoid arthritis--a study based on observational data from the Finnish Register of Biological Treatment (ROB-FIN). Clin Rheumatol 2011; 30(11): 1447–54.

18. Scrivo R, Conti F, Spinelli FR, Truglia S, et al. Switching between TNFalpha antagonists in rheumatoid arthritis: personal experience and review of the literature. Reumatismo 2009; 61(2): 107–17.

19. Remy A, Avouac J, Gossec L, Combe B: Clinical relevance of switching to a second tumour necrosis factor-alpha inhibitor after discontinuation of a first tumour necrosis factor-alpha inhibitor in rheumatoid arthritis: a systematic literature review and meta-analysis. Clin Exp Rheumatol 2011; 29(1): 96–103.

20. Greenberg JD, Reed G, Decktor D, Harrold L, et al. A comparative effectiveness study of adalimumab, etanercept and infliximab in biologically naive and switched rheumatoid arthritis patients: results from the US CORRONA registry. Ann Rheum Dis 2012; 71(7): 1134–42.

21. van Vollenhoven RF, Emery P, Bingham CO, 3rd, Keystone EC, 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): 1496–1502.

22. Kremer JM, Genant HK, Moreland LW, Russell AS, et al. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med 2006; 144(12): 865–76.

23. Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, et al. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet 2008; 371(9617): 987–97.

Štítky
Dermatology & STDs Paediatric rheumatology Rheumatology
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