Patient-reported outcomes in a randomized trial comparing four different treatment strategies in recent-onset rheumatoid arthritis

Arthritis Rheum. 2009 Jan 15;61(1):4-12. doi: 10.1002/art.24367.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal / therapeutic use
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Rheumatoid / drug therapy*
  • Arthritis, Rheumatoid / physiopathology
  • Arthritis, Rheumatoid / psychology
  • Disability Evaluation
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Endpoint Determination
  • Female
  • Humans
  • Infliximab
  • Male
  • Methotrexate / therapeutic use
  • Middle Aged
  • Pain Measurement
  • Patients* / psychology
  • Prednisone / therapeutic use
  • Quality of Life* / psychology
  • Severity of Illness Index
  • Treatment Outcome*


  • Antibodies, Monoclonal
  • Antirheumatic Agents
  • Infliximab
  • Prednisone
  • Methotrexate