Patient-Reported Outcomes in a Randomized Trial Comparing Four Different Treatment Strategies in Recent-Onset Rheumatoid Arthritis

S.M. van der Kooij, J.K. Bouwstra, Y.P. Goekoop-Ruiterman, J.A.P.M. Ewals, K.H. Han, JM Hazes, P.J.S.M. Kerstens, AJ Peeters, D. van Zeben, F.C. Breedveld, T.W. Huizinga, B.A.C. Dijkmans, C.F. Allaart

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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 WAS) 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 find 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
Original languageUndefined/Unknown
Pages (from-to)4-12
JournalArthritis & Rheumatism
Issue number1
Publication statusPublished - 2009

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