ASPIRE (DMARD naïve) | ATTRACT (background MTX) | ||||
---|---|---|---|---|---|
Variable | NOR-DMARD | MTX | MTX + IFX* | PLC | IFX* |
Patient (n) | 1129 | 242 | 579 | 68 | 262 |
Age (years) | 55.3±26.9 | 49.6±12.7 | 49.5±12.8 | 50.8±11.5 | 52.7±11.4 |
Female (%) | 73.3 | 74.2 | 70.3 | 81.3 | 76.9 |
Rheumatoid factor positivity (%) | 67.8 | 58.5 | 51.7 | 77.3 | 70.5 |
Disease activity score 28 | 4.97±1.36 | 6.20±1.02 | 6.17±1.04 | 6.55±1.02 | 6.7±1.0 |
Duration of RA (years) | 8.2±9.6 | 0.8±0.7 | 0.8±0.7 | 10.4±8.3 | 10.2±8.0 |
Health assessment questionnaire (0-3) | 0.7±0.5† | 1.5±0.6 | 1.5±0.7 | 1.7±0.6 | 1.7±0.6 |
Simplified disease activity index | 26.9±13.9 | 38.1±11.7 | 38.2±12.2 | 45.1±14.7 | 46.9±14.7 |
Clinical disease activity index | 24.6±13.1 | 35.5±10.5 | 35.2±11.1 | 41.7±13.8 | 43.2±13.4 |
Swollen joint count (0-28) | 7.1±5.6 | 8.9±4.2 | 9.2±4.4 | 15.0±6.3 | 14.9±6.3 |
Tender joint count (0-28) | 8.2±6.8 | 14.2±6.2 | 13.4±6.3 | 14.6±7.7 | 16.2±7.3 |
C-reactive protein (mg/dl) | 2.26±2.77 | 2.54±2.95 | 2.90±3.31 | 3.81±3.69 | 3.70±3.78 |
Erythrocyte sedimentation rate (mm/h) | 28.7±22.7 | 44.4±27.2 | 45.6±29.2 | 48.2±23.7 | 49.4±24.0 |
Patient global assessment (mm) | 52.2±24.1 | 60.4±25.1 | 61.1±24.7 | 59.2±24.9 | 61.1±22.7 |
Evaluator global assessment (mm) | 40.6±19.0 | 65.2±17.2 | 65.8±18.6 | 62.2±17.4 | 60.0±17.9 |
Radiographic score | - | 11.4±16.2 | 11.1±14.8 | 80.9±79.4 | 69.6±64.7 |
↵* The two infliximab doses from ASPIRE were pooled, and the four different doses (or dosing intervals) from ATTRACT were also pooled.
↵† Physical disability measured by the modified Health assessment.
NOR-DMARD, Norwegian disease modifying antirheumatic drug prescription dataset; IFX, infliximab; MTX, methotrexate; RA, rheumatoid arthritis; PLC, placebo.