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Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): A randomized, controlled trial

  1. Y. P. M. Goekoop-Ruiterman1,†,*,
  2. J. K. De Vries-Bouwstra2,†,
  3. C. F. Allaart1,
  4. D. Van Zeben3,
  5. P. J. S. M. Kerstens4,
  6. J. M. W. Hazes5,
  7. A. H. Zwinderman6,
  8. H. K. Ronday7,
  9. K. H. Han8,
  10. M. L. Westedt9,
  11. A. H. Gerards10,
  12. J. H. L. M. Van Groenendael11,
  13. W. F. Lems12,
  14. M. V. Van Krugten13,
  15. F. C. Breedveld1,‡,
  16. B. A. C. Dijkmans14

Article first published online: 28 OCT 2005

DOI: 10.1002/art.21405

Issue

Arthritis & Rheumatism

Arthritis & Rheumatism

Volume 52, Issue 11, pages 3381–3390, November 2005

Additional Information

How to Cite

Goekoop-Ruiterman, Y. P. M., De Vries-Bouwstra, J. K., Allaart, C. F., Van Zeben, D., Kerstens, P. J. S. M., Hazes, J. M. W., Zwinderman, A. H., Ronday, H. K., Han, K. H., Westedt, M. L., Gerards, A. H., Van Groenendael, J. H. L. M., Lems, W. F., Van Krugten, M. V., Breedveld, F. C. and Dijkmans, B. A. C. (2005), Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): A randomized, controlled trial. Arthritis & Rheumatism, 52: 3381–3390. doi: 10.1002/art.21405

Author Information

  1. 1

    Leiden University Medical Center, Leiden, The Netherlands

  2. 2

    VU Medical Center, Amsterdam, The Netherlands

  3. 3

    Sint Franciscus Gasthuis, Rotterdam, The Netherlands

  4. 4

    Jan van Breemen Institute, Amsterdam, The Netherlands

  5. 5

    Erasmus Medical Center, Rotterdam, The Netherlands

  6. 6

    Academic Medical Center, Amsterdam, The Netherlands

  7. 7

    Haga Hospital, The Hague, The Netherlands

  8. 8

    Medical Center Rijnmond-Zuid, Rotterdam, The Netherlands

  9. 9

    Bronovo Hospital, The Hague, The Netherlands

  10. 10

    Vlietland Hospital, Schiedam, The Netherlands

  11. 11

    Franciscus Hospital, Roosendaal, The Netherlands

  12. 12

    Slotervaart Hospital, Amsterdam, The Netherlands

  13. 13

    Walcheren Hospital, Vlissingen, The Netherlands

  14. 14

    VU Medical Center, and Jan van Breemen Institute, Amsterdam, The Netherlands

  1. †

    Drs. Goekoop-Ruiterman and de Vries-Bouwstra contributed equally to this work.

  2. ‡

    Dr. Breedveld has received consultancy fees or honoraria (less than $10,000 per year) from Schering-Plough BV.

*Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands

Publication History

  1. Issue published online: 28 OCT 2005
  2. Article first published online: 28 OCT 2005
  3. Manuscript Accepted: 9 AUG 2005
  4. Manuscript Received: 14 MAR 2005

Funded by

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

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Abstract

Objective

Several treatment strategies have proven value in the amelioration of rheumatoid arthritis (RA), but the optimal strategy for preventing long-term joint damage and functional decline is unclear. We undertook this study to compare clinical and radiographic outcomes of 4 different treatment strategies, with intense monitoring in all patients.

Methods

In a multicenter, randomized clinical trial, 508 patients were allocated to 1 of 4 treatment strategies: sequential disease-modifying antirheumatic drug monotherapy (group 1), step-up combination therapy (group 2), initial combination therapy with tapered high-dose prednisone (group 3), and initial combination therapy with the tumor necrosis factor antagonist infliximab (group 4). Treatment adjustments were made every 3 months in an effort to obtain low disease activity (a Disease Activity Score in 44 joints of ≤2.4).

Results

Initial combination therapy including either prednisone (group 3) or infliximab (group 4) resulted in earlier functional improvement than did sequential monotherapy (group 1) and step-up combination therapy (group 2), with mean scores at 3 months on the Dutch version of the Health Assessment Questionnaire (D-HAQ) of 1.0 in groups 1 and 2 and 0.6 in groups 3 and 4 (P < 0.001). After 1 year, mean D-HAQ scores were 0.7 in groups 1 and 2 and 0.5 in groups 3 and 4 (P = 0.009). The median increases in total Sharp/Van der Heijde radiographic joint score were 2.0, 2.5, 1.0, and 0.5 in groups 1–4, respectively (P < 0.001). There were no significant differences in the number of adverse events and withdrawals between the groups.

Conclusion

In patients with early RA, initial combination therapy including either prednisone or infliximab resulted in earlier functional improvement and less radiographic damage after 1 year than did sequential monotherapy or step-up combination therapy.

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