Rheumatoid Arthritis

You have full text access to this OnlineOpen article

Patient-reported outcomes in a randomized trial comparing four different treatment strategies in recent-onset rheumatoid arthritis†

  1. S. M. van der Kooij1,‡,*,
  2. J. K. de Vries-Bouwstra2,§,
  3. Y. P. M. Goekoop-Ruiterman1,
  4. J. A. P. M. Ewals3,
  5. K. H. Han4,
  6. J. M. W. Hazes5,¶,
  7. P. J. S. M. Kerstens6,
  8. A. J. Peeters7,
  9. D. van Zeben8,
  10. F. C. Breedveld1,‖,
  11. T. W. J. Huizinga1,
  12. B. A. C. Dijkmans2,††,
  13. C. F. Allaart1,‡‡

Article first published online: 30 DEC 2008

DOI: 10.1002/art.24367

Issue

Arthritis Care & Research

Arthritis Care & Research

Volume 61, Issue 1, pages 4–12, 15 January 2009

Additional Information

How to Cite

van der Kooij, S. M., de Vries-Bouwstra, J. K., Goekoop-Ruiterman, Y. P. M., Ewals, J. A. P. M., Han, K. H., Hazes, J. M. W., Kerstens, P. J. S. M., Peeters, A. J., van Zeben, D., Breedveld, F. C., Huizinga, T. W. J., Dijkmans, B. A. C. and Allaart, C. F. (2009), Patient-reported outcomes in a randomized trial comparing four different treatment strategies in recent-onset rheumatoid arthritis. Arthritis & Rheumatism, 61: 4–12. doi: 10.1002/art.24367

Author Information

  1. 1

    Leiden University Medical Center, Leiden, The Netherlands

  2. 2

    VU University Medical Center, Amsterdam, The Netherlands

  3. 3

    Haga Hospital, The Hague, The Netherlands

  4. 4

    Rijnmond-Zuid Medical Center, Rotterdam, The Netherlands

  5. 5

    Erasmus University Medical Center, Rotterdam, The Netherlands

  6. 6

    Jan van Breemen Institute, Amsterdam, The Netherlands

  7. 7

    Reinier de Graaf Gasthuis, Delft, The Netherlands

  8. 8

    Sint Franciscus Gasthuis, Rotterdam, The Netherlands

  1. ‡

    Dr. van der Kooij has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Schering-Plough.

  2. §

    Dr. de Vries-Bouwstra has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Schering-Plough.

  3. Dr. Hazes has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from UCB, Roche, Schering-Plough, and Wyeth.

  4. ‖

    Dr. Breedveld has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Wyeth, Schering-Plough, and Roche.

  5. ††

    Dr. Dijkmans has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Schering-Plough, Abbott, and Wyeth.

  6. ‡‡

    Dr. Allaart has received speaking fees (less than $10,000) from Schering-Plough.

*Department of Rheumatology C-01-R, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands

  1. †

    ISRCTN: 32675862.

Publication History

  1. Issue published online: 30 DEC 2008
  2. Article first published online: 30 DEC 2008
  3. Manuscript Accepted: 12 SEP 2008
  4. Manuscript Received: 28 MAR 2008

Funded by

  • Dutch College of Health Insurances
  • Centocor, Inc.
  • Schering-Plough BV

SEARCH

SEARCH BY CITATION

ARTICLE TOOLS

View Full Article (HTML) Get PDF (204K)

REFERENCES

  • 1
    American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum 2002; 46: 328–46.
    Direct Link:
  • 2
    Lubeck DP. Patient-reported outcomes and their role in the assessment of rheumatoid arthritis. Pharmacoeconomics 2004; 22(2 Suppl 1 ): 27–38.
  • 3
    Wolfe F, Michaud K, Gefeller O, Choi HK. Predicting mortality in patients with rheumatoid arthritis. Arthritis Rheum 2003; 48: 1530–42.
    Direct Link:
  • 4
    Cohen SB, Strand V, Aguilar D, Ofman JJ. Patient- versus physician-reported outcomes in rheumatoid arthritis patients treated with recombinant interleukin-1 receptor antagonist (anakinra) therapy. Rheumatology (Oxford) 2004; 43: 704–11.
  • 5
    Pincus T, Strand V, Koch G, Amara I, Crawford B, Wolfe F, et al. An index of the three core data set patient questionnaire measures distinguishes efficacy of active treatment from that of placebo as effectively as the American College of Rheumatology 20% response criteria (ACR20) or the Disease Activity Score (DAS) in a rheumatoid arthritis clinical trial. Arthritis Rheum 2003; 48: 625–30.
    Direct Link:
  • 6
    Strand V, Cohen S, Crawford B, Smolen JS, Scott DL. Patient-reported outcomes better discriminate active treatment from placebo in randomized controlled trials in rheumatoid arthritis. Rheumatology (Oxford) 2004; 43: 640–7.
  • 7
    Emery P, Kosinski M, Li T, Martin M, Williams GR, Becker JC, et al. Treatment of rheumatoid arthritis patients with abatacept and methotrexate significantly improved health-related quality of life. J Rheumatol 2006; 33: 681–9.
  • 8
    Kimel M, Cifaldi M, Chen N, Revicki D. Adalimumab plus methotrexate improved SF-36 scores and reduced the effect of rheumatoid arthritis (RA) on work activity for patients with early RA. J Rheumatol 2008; 35: 206–15.
  • 9
    Kosinski M, Kujawski SC, Martin R, Wanke LA, Buatti MC, Ware JE Jr, et al. Health-related quality of life in early rheumatoid arthritis: impact of disease and treatment response. Am J Manag Care 2002; 8: 231–40.
  • 10
    Mease PJ, Revicki DA, Szechinski J, Greenwald M, Kivitz A, Barile-Fabris L, et al. Improved health-related quality of life for patients with active rheumatoid arthritis receiving rituximab: results of the Dose-Ranging Assessment: International Clinical Evaluation of Rituximab in Rheumatoid Arthritis (DANCER) Trial. J Rheumatol 2008; 35: 20–30.
  • 11
    Strand V, Scott DL, Emery P, Kalden JR, Smolen JS, Cannon GW, et al. Physical function and health related quality of life: analysis of 2-year data from randomized, controlled studies of leflunomide, sulfasalazine, or methotrexate in patients with active rheumatoid arthritis. J Rheumatol 2005; 32: 590–601.
  • 12
    Van der Heijde D, Klareskog L, Singh A, Tornero J, Melo-Gomes J, Codreanu C, et al. Patient reported outcomes in a trial of combination therapy with etanercept and methotrexate for rheumatoid arthritis: the TEMPO trial. Ann Rheum Dis 2006; 65: 328–34.
  • 13
    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.
  • 14
    Verstappen SM, Jacobs JW, van der Veen MJ, Heurkens AH, Schenk Y, ter Borg EJ, et al, and the Utrecht Rheumatoid Arthritis Cohort Study Group. Intensive treatment with methotrexate in early rheumatoid arthritis: aiming for remission. Computer Assisted Management in Early Rheumatoid Arthritis (CAMERA, an open-label strategy trial). Ann Rheum Dis 2007; 66: 1443–9.
  • 15
    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.
    Direct Link:
  • 16
    Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, van Zeben D, Kerstens PJ, Hazes JM, et al. Comparison of treatment strategies in early rheumatoid arthritis: a randomized trial. Ann Intern Med 2007; 146: 406–15.
  • 17
    Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988; 31: 315–24.
    Direct Link:
  • 18
    Van der Heijde DM, van 't Hof M, van Riel PL, van de Putte LB. Development of a disease activity score based on judgment in clinical practice by rheumatologists. J Rheumatol 1993; 20: 579–81.
  • 19
    Tugwell P, Bombardier C, Buchanan WW, Goldsmith CH, Grace E, Hanna B. The MACTAR Patient Preference Disability Questionnaire: an individualized functional priority approach for assessing improvement in physical disability in clinical trials in rheumatoid arthritis. J Rheumatol 1987; 14: 446–51.
  • 20
    Verhoeven AC, Boers M, van der Liden S. Validity of the MACTAR questionnaire as a functional index in a rheumatoid arthritis clinical trial. J Rheumatol 2000; 27: 2801–9.
  • 21
    Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 30: 473–83.
  • 22
    Ware JE Jr, Kosinski M, Keller SD. SF-36 health survey manual and interpretation guide. Boston: The Health Institute; 1994.
  • 23
    Kosinski M, Zhao SZ, Dedhiya S, Osterhaus JT, Ware JE Jr. Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum 2000; 43: 1478–87.
    Direct Link:
  • 24
    Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sanderman R, et al. Translation, validation, and norming of the Dutch language version of the SF-36 health survey in community and chronic disease populations. J Clin Epidemiol 1998; 51: 1055–68.
  • 25
    Pham B, Cranney A, Boers M, Verhoeven AC, Wells G, Tugwell P. Validity of area-under-the-curve analysis to summarize effect in rheumatoid arthritis clinical trials. J Rheumatol 1999; 26: 712–6.
  • 26
    Puolakka K, Kautiainen H, Mottonen T, Hannonen P, Korpela M, Hakala M, et al. 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.
    Direct Link:
  • 27
    Van den Hout WB, Goekoop-Ruiterman YP, Allaart CF, de Vries-Bouwstra JK, Hazes JM, Kerstens PJ, et al. Cost-utility analysis of treatment strategies in patients with recent-onset rheumatoid arthritis. Arthritis Rheum. In press.
  • 28
    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.
    Direct Link:
  • 29
    Goekoop-Ruiterman YP, Vries-Bouwstra JK, Allaart CF, Kerstens PJ, Grillet BA, de Jager MH, et al. Patient preferences for treatment: report from a randomised comparison of treatment strategies in early rheumatoid arthritis (BeSt trial). Ann Rheum Dis 2007; 66: 1227–32.
  • 30
    Welsing PM, van Gestel AM, Swinkels HL, Kiemeney LA, van Riel PL. The relationship between disease activity, joint destruction, and functional capacity over the course of rheumatoid arthritis. Arthritis Rheum 2001; 44: 2009–17.
    Direct Link:
  • 31
    Combe B, Landewe R, Lukas C, Bolosiu HD, Breedveld F, Dougados M, et al. EULAR recommendations for the manage- ment of early arthritis: report of a task force of the European Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis 2007; 66: 34–45.
  • 32
    Van der Kooij SM, Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Peeters AJ, van Krugten MV, Breedveld FC, et al. Probability of continued low disease activity in patients with recent onset rheumatoid arthritis treated according to the disease activity score. Ann Rheum Dis 2008; 67: 266–9.
View Full Article (HTML) Get PDF (204K)