Characteristics of patients in the MTX monotherapy arm and the RTX plus MTX arm, at baseline and after 1 year (mean±SD, unless indicated otherwise)
| Baseline | 1 year | |||||
|---|---|---|---|---|---|---|
| PL+MTX | RTX+MTX | p | PL+MTX | RTX+MTX | p | |
| N | 188 | 204 | NS | 188 | 204 | NA |
| Age (years) | 47.5±12.6 | 47.3±13.3 | NS | – | – | NA |
| Disease duration (years) | 0.9±1.0 | 1.0±1.3 | NS | – | – | NA |
| Rheumatoid factor (% pos.) | 88.3 | 87.3 | NS | – | – | NA |
| Swollen joint count (0–28) | 13.8±6.3 | 14.9±6.6 | NS | 4.0±5.2 | 2.46±3.5 | <0.1 |
| Tender joint count (0–28) | 17.9±7.4 | 18.7±7 | NS | 6.3±6.7 | 4.27±5.9 | <0.001 |
| Patient global (0–100 mm) | 96.1±20.4 | 68.2±22.7 | NS | 30.8±24.5 | 21.4±21.1 | <0.001 |
| Evaluator global (0–100 mm) | 69.2±17.5 | 68.4±17.3 | NS | 27.0±21.8 | 16.3±15.1 | <0.001 |
| Pain (0–100 mm) | 64.2±22.9 | 63.5±23 | NS | 27.7±23.3 | 19.2±18.9 | <0.001 |
| C-reactive protein (mg/dl) | 3.0±2.6 | 3.0±2.8 | NS | 1.4±1.8 | 0.6±1.3 | <0.001 |
| Erythrocyte sedimentation rate (mm/h) | 62.0±28.2 | 58.7±31.3 | NS | 38.9±26.1 | 24.0±17.7 | <0.001 |
| Disease Activity score 28 | 7.1±1.0 | 7.1±1.0 | NS | 4.4±1.6 | 3.5±1.4 | <0.001 |
| Simplified Disease Activity Index | 48.5±15.3 | 50.2±15.0 | NS | 17.5±14.8 | 11.1±10.9 | <0.001 |
| Clinical Disease Activity Index | 45.5±14.6 | 47.2±14.2 | NS | 16.1±14.3 | 10.5±10.6 | <0.001 |
| Health Assessment Questionnaire | 1.86±0.6 | 1.76±0.7 | NS | 0.95±0.7 | 0.66±0.6 | <0.001 |
| TGSS | 7.4±10.5 | 6.7±10.8 | NS | 8.2±10.9 | 7.3±11.1 | NS |
| Change in TGSS | – | – | NA | 0.81±1.9 | 0.35±1.1 | <0.001 |
MTX, methotrexate; NS, not significant (p≥0.05); NA, not applicable; RTX, rituximab; PL, placebo; TGSS, Genant modified total Sharp score.