Dr. van der Kooij has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Schering-Plough.
Patient-reported outcomes in a randomized trial comparing four different treatment strategies in recent-onset rheumatoid arthritis†
Article first published online: 30 DEC 2008
Copyright © 2008 by the American College of Rheumatology
Arthritis Care & Research
Volume 61, Issue 1, pages 4–12, 15 January 2009
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
- Issue published online: 30 DEC 2008
- Article first published online: 30 DEC 2008
- Manuscript Accepted: 12 SEP 2008
- Manuscript Received: 28 MAR 2008
- Dutch College of Health Insurances
- Centocor, Inc.
- Schering-Plough BV
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.
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.
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).
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.