Rheumatoid Arthritis

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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 Care & Research, 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

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Abstract

Objective

To investigate the effectiveness of 4 different treatment strategies for recent-onset rheumatoid arthritis (RA) on 2-year patient-reported outcomes, including functioning and quality of life.

Methods

A total of 508 patients with recent-onset RA were randomly assigned to 1) sequential monotherapy, 2) step-up combination therapy, both starting with methotrexate, 3) initial combination therapy, including a tapered high-dose prednisone, or 4) initial combination therapy with methotrexate and infliximab. Treatment was adjusted every 3 months if the Disease Activity Score (DAS) remained >2.4. The McMaster Toronto Arthritis Patient Preference Disability Questionnaire, the Short Form 36 (SF-36), and scores for pain, global health, and disease activity measured on a 100-mm visual analog scale (VAS) were compared between groups at baseline and every 3 months thereafter for 2 years.

Results

After 2 years, all patient-reported outcomes had improved significantly from baseline, irrespective of the treatment strategy. SF-36 subscale scores approached population norms for 3 physical components, and achieved population norms (P > 0.05) for bodily pain and 4 mental components. Improvement in functioning, VAS scores, and physical items of the SF-36 occurred significantly earlier in patients treated with initial combination therapies (all comparisons after 3 months: overall P < 0.001; P < 0.05 for groups 1 and 2 versus groups 3 and 4).

Conclusion

All 4 DAS-driven treatment strategies resulted in substantial improvements in functional ability, quality of life, and self-assessed VAS scores after 2 years. Initial combination therapy led to significantly faster improvement in all patient-reported measures.

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