Patient-reported outcomes in a randomized trial comparing four different treatment strategies in recent-onset rheumatoid arthritis
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.
|Keywords||Short Form 36, adult, aged, article, clinical trial, combination chemotherapy, controlled clinical trial, controlled study, cyclosporin A, disease activity, drug dose reduction, female, functional assessment, human, hydroxychloroquine, infliximab, leflunomide, major clinical study, male, methotrexate, monotherapy, quality of life, prednisone, randomized controlled trial, rheumatoid arthritis, salazosulfapyridine, self report, single blind procedure, treatment outcome, unspecified side effect, visual analog scale|
|Persistent URL||dx.doi.org/10.1002/art.24367, hdl.handle.net/1765/15044|
|Journal||Arthritis Care & Research|
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, … 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(1), 4–12. doi:10.1002/art.24367