Characteristics of patients in the MTX monotherapy arm (PL+MTX) and the RTX plus MTX combination arm (RTX+MTX) at 1 year according to their 1 year disease activity state (mean±SD)
| SDAI≤11 | 11<SDAI≤26 | SDAI>26 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| PL+MTX | RTX+MTX | p | PL+MTX | RTX+MTX | p | PL+MTX | RTX+MTX | p | |
| N | 85 | 126 | NA | 59 | 61 | NA | 44 | 17 | NA |
| Swollen joint count (0–28) | 0.7±1.2 | 0.9±1.4 | NS | 3.5±2.4 | 4.2±3.2 | NS | 11.1±5.9 | 7.8±6.1 | NS |
| Tender joint count (0–28) | 1.5±1.7 | 0.9±1.3 | <0.01 | 5.9±3.4 | 7.4±3.6 | <0.05 | 16.0±5.7 | 17.9±7.5 | NS |
| Patient global (0–100 mm) | 13.9±13.7 | 12.6±13.3 | NS | 38.9±21.8 | 30.3±21.2 | <0.05 | 52.6±21.4 | 55.4±21.5 | NS |
| Evaluator global (0–100 mm) | 10.9±9.1 | 8.0±7.7 | <0.05 | 31.4±15.5 | 27.1±14.3 | NS | 52.0±19.9 | 38.4±13.0 | <0.05 |
| Pain (0–100 mm) | 12.5±11.7 | 11.7±11.8 | NS | 33.6±20.6 | 26.8±19.7 | NS | 49.6±23.0 | 47.5±21.6 | NS |
| C-reactive protein (mg/dl) | 0.8±0.9 | 0.4±0.5 | NS | 1.8±2.2 | 0.7±0.8 | <0.001 | 1.9±2.2 | 1.6±4.0 | <0.05 |
| Erythrocyte sedimentation rate (mm/h) | 29.9±20.6 | 22.8±16.6 | NS | 45.1±28.1 | 27.7±20.0 | <0.001 | 48.1±27.8 | 20.0±15.5 | <0.001 |
| Disease Activity score 28 | 3.0±0.8 | 2.7±0.8 | <0.001 | 4.8±0.7 | 4.5±0.8 | NS | 6.4±0.8 | 5.7±1.0 | <0.05 |
| SDAI | 5.6±3.2 | 4.3±2.9 | <0.01 | 18.3±4.5 | 18.0±4.0 | NS | 39.4±11.4 | 36.8±11.0 | NS |
| Clinical Disease Activity Index | 4.8±3 | 3.9±2.9 | <0.05 | 16.5±4.5 | 17.3±3.9 | NS | 37.6±10.8 | 35.1±12.1 | NS |
| Health Assessment Questionnaire | 0.6±0.6 | 0.5±0.5 | NS | 1.0±0.6 | 0.8±0.6 | NS | 1.54±0.7 | 1.4±0.5 | NS |
| TGSS | 5.4±7.8 | 7.0±11.0 | NS | 9.3±11.3 | 8.7±12.1 | NS | 13.3±13.7 | 5.3±6.8 | NS |
| Change in TGSS | 0.4±0.9 | 0.4±1.0 | NS | 1.0±1.7 | 0.4±1.3 | <0.01 | 1.3±3.0 | −0.1±0.4 | NS |
MTX, methotrexate; NS, not significant (p≥0.05); NA, not applicable; RTX, rituximab; PL, placebo; SDAI, simplified disease activity index; TGSS, Genant modified total Sharp score.