Information de reference pour ce titreAccession Number: | 00000889-200805000-00014.
|
Author: | Saunders, S. A. 1; Capell, H. A. 2; Stirling, A. 1; Vallance, R. 1; Kincaid, W. 1; McMahon, A. D. 3; Porter, D. R. 1
|
Institution: | (1)S. A. Saunders, MB ChB, MRCP, A. Stirling, RGN, R. Vallance, MB ChB, FRCR(Glas), FRCR, DMRD, W. Kincaid, MB ChB, FRCR, D. R. Porter, MA, BM BCh: Gartnavel General Hospital, Glasgow, UK; (2)H. A. Capell, MB BCh, MD, FRCP: Glasgow Royal Infirmary, Glasgow, UK; (3)A. D. McMahon, PhD: University of Glasgow, Glasgow, UK.
|
Title: | |
Source: | Arthritis & Rheumatism. 58(5):1310-1317, May 2008.
|
Abstract: | Objective: The Tight Control of Rheumatoid Arthritis study previously demonstrated that an intensive step-up disease-modifying antirheumatic drug (DMARD) treatment strategy targeting persistent disease activity was superior to routine care in the management of early rheumatoid arthritis (RA). We undertook this study to test the hypothesis that early parallel triple therapy achieves better outcomes than step-up therapy within an intensive disease management regimen.
Methods: Ninety-six patients with early RA (mean disease duration 11.5 months) were randomized to receive step-up therapy (sulfasalazine [SSZ] monotherapy, then after 3 months, methotrexate [MTX] was added, and when the maximum tolerated dosage of MTX was reached, hydroxychloroquine [HCQ] was added) or parallel triple therapy (SSZ/MTX/HCQ). All patients were assessed monthly for 12 months. If their disease activity score in 28 joints (DAS28) was >=3.2, the dosage of DMARDs was increased according to protocol, and swollen joints were injected with triamcinolone acetonide (maximum dosage 80 mg per month). A metrologist who was blinded to the treatment allocation performed assessments every 3 months. The primary outcome measure was the mean decrease in the DAS28 score at 12 months.
Results: Both groups showed substantial improvements in disease activity and functional outcome. At 12 months, the mean decrease in the DAS28 score was -4.0 (step-up therapy group) versus -3.3 (parallel therapy group) (P = 0.163). No significant differences in the percentages of patients with DAS28 remission (step-up therapy group 45% versus parallel triple therapy group 33%), DAS28 good response (60% versus 41%, respectively), or American College of Rheumatology criteria for 20% improvement (ACR20) (77% versus 76%, respectively), ACR50 (60% versus 51%, respectively), or ACR70 (30% versus 20%, respectively) responses were seen. Radiologic progression was similar in both groups.
Conclusion: This study confirms that highly effective control of disease activity can be achieved using conventional DMARDs as part of an intensive disease management strategy. Within this setting, step-up therapy is at least as effective as parallel triple therapy.
(C) 2008, American College of Rheumatology
|
References: | 1. O'Dell JR, Haire CE, Erikson N, Drymalski W, Palmer W, Eckhoff PJ, et al. Treatment of rheumatoid arthritis with methotrexate alone, sulfasalazine and hydroxychloroquine, or a combination of all three medications. N Engl J Med 1996;334:1287-91.
2. O'Dell JR, Leff R, Paulsen G, Haire C, Mallek J, Eckhoff PJ, et al. Treatment of rheumatoid arthritis with methotrexate and hydroxychloroquine, methotrexate and sulfasalazine, or a combination of the three medications: results of a two-year, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2002;46:1164-70.
3. Mottonen T, Hannonen P, Leirisalo-Repo M, Nissila M, Kautiainen H, Korpela M, et al, for the FIN-RACo Trial Group. Comparison of combination therapy with single-drug therapy in early rheumatoid arthritis: a randomised trial. Lancet 1999;353:1568-73.
4. Boers M, Verhoeven AC, Markusse HM, van de Laar MA, Westhovens R, van Denderen JC, et al. Randomised comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis [published erratum appears in Lancet 1998;351:220]. Lancet 1997;350:309-18.
5. Grigor C, Capell H, Stirling A, McMahon AD, Lock P, Vallance R, et al. Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet 2004;364:263-9.
6. Van der Heijde DM, van 't Hof MA, van Riel PL, Theunisse LM, Lubberts EW, van Leeuwen MA, et al. Judging disease activity in clinical practice in rheumatoid arthritis: first step in the development of a disease activity score. Ann Rheum Dis 1990;49:916-20.
7. Prevoo ML, van't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts: development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44-8.
8. Boers M, Tugwell P, Felson DT, van Riel PL, Kirwan JR, Edmonds JP, et al. World Health Organization and International League of Associations for Rheumatology core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. J Rheumatol Suppl 1994;41:86-9.
9. Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137-45.
10. Ware JE, Kosinski M, Keller SD. A 12-item Short Form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996;34:220-33.
11. Van der Heijde D. How to read radiographs according to the Sharp/van der Heijde method [corrected and republished in J Rheumatol 2000;27:261-3]. J Rheumatol 1999;26:743-5.
12. Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis [published erratum appears in N Engl J Med 2001;344:76,240]. N Engl J Med 2000;343:1586-93.
13. St Clair EW, van der Heijde DM, Smolen JS, Maini RN, Bathon JM, Emery P, et al, for the Active-Controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset Study Group. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum 2004;50:3432-43.
14. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al, for the PREMIER Investigators. 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;54:26-37.
15. Korpela M, Laasonen L, Hannonen P, Kautiainen H, Leirisalo-Repo M, Hakala M, et al, for the FIN-RACo Trial Group. Retardation of joint damage in patients with early rheumatoid arthritis by initial aggressive treatment with disease-modifying antirheumatic drugs: five-year experience from the FIN-RACo study group. Arthritis Rheum 2004;50:2072-81.
16. Puolakka K, Kautiainen H, Mottonen T, Hannonen P, Korpela M, Hakala M, et al, for the FIN-RACo Trial Group. Early suppression of disease activity is essential for maintenance of work capacity in patients with recent-onset rheumatoid arthritis: five-year experience from the FIN-RACo trial. Arthritis Rheum 2005;52:36-41.
17. Landewe RB, Boers M, Verhoeven AC, Westhovens R, van de Laar MA, Markusse HM, et al. COBRA combination therapy in patients with early rheumatoid arthritis: long-term structural benefits of a brief intervention. Arthritis Rheum 2002;46:347-56.
18. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJ, Hazes JM, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum 2005;52:3381-90.
19. Landewe R, van der Heijde D, Klareskog L, van Vollenhoven R, Fatenejad S. Disconnect between inflammation and joint destruction after treatment with etanercept plus methotrexate: results from the trial of etanercept and methotrexate with radiographic and patient outcomes. Arthritis Rheum 2006;54:3119-25.
20. Irvine S, Munro R, Porter D. Early referral, diagnosis, and treatment of rheumatoid arthritis: evidence for changing medical practice. Ann Rheum Dis 1999;58:510-3.
|
Language: | English.
|
Document Type: | Rheumatoid Arthritis Clinical Study.
|
Journal Subset: | Clinical Medicine.
|
ISSN: | 0004-3591
|
NLM Journal Code: | 0370605, 90m
|
Annotation(s) | |
|
|