Summary of demographics at baseline; randomised patients
| Placebo+MTX | Golimumab 2 mg/kg+MTX | Total | |
|---|---|---|---|
| Patients randomised | 197 | 395 | 592 |
| Age (years) | |||
| Mean±SD | 51.4±11.26 | 51.9±12.55 | 51.8±12.13 |
| Median | 52.0 | 53.0 | 52.0 |
| Range | (19, 78) | (18, 83) | (18, 83) |
| Sex, n (%) | |||
| Male | 40 (20.3) | 69 (17.5) | 109 (18.4) |
| Female | 157 (79.7) | 326 (82.5) | 483 (81.6) |
| Disease duration (years) | |||
| Mean±SD | 7.0±7.24 | 6.9±7.00 | 6.9±7.08 |
| Median (IQR) | 4.8 (1.9, 9.6) | 4.6 (1.8, 9.6) | 4.7 (1.9, 9.6) |
| Number of swollen joints (0–66) | |||
| Mean±SD | 14.8±8.54 | 15.0±8.23 | 14.9±8.33 |
| Median (IQR) | 12.0 (8.0, 19.0) | 12.0 (9.0, 19.0) | 12.0 (9.0, 19.0) |
| Number of tender joints (0–68) | |||
| Mean±SD | 25.9±14.13 | 26.4±13.93 | 26.3±13.99 |
| Median (IQR) | 22.0 (14.0, 36.0) | 24.0 (15.0, 35.0) | 23.0 (15.0, 35.0) |
| C-reactive protein (normal≤1.0 mg/dl) | |||
| Mean±SD | 2.2±1.88 | 2.8±2.86 | 2.6±2.59 |
| Median (IQR) | 1.7 (0.9, 3.0) | 2.0 (1.0, 3.4) | 1.9 (0.9, 3.3) |
| DAS28-CRP | |||
| Mean±SD | 5.9±0.93 | 6.0±0.82 | 5.9±0.86 |
| Median (IQR) | 6.0 (5.2, 6.6) | 5.9 (5.3, 6.5) | 5.9 (5.3, 6.5) |
| CDAI (0–76) | |||
| Mean±SD | 38.4±12.40 | 38.5±11.60 | 38.4±11.86 |
| Median (IQR) | 38.0 (28.8, 47.1) | 37.0 (29.8, 45.7) | 37.3 (29.7, 45.9) |
| SDAI (0–86) | |||
| Mean±SD | 40.6±12.85 | 41.3±12.29 | 41.1±12.47 |
| Median (IQR) | 40.0 (30.5, 50.2) | 39.8 (31.9, 49.3) | 39.8 (31.0, 49.6) |
| HAQ disability index (0–3) | |||
| Mean±SD | 1.6±0.62 | 1.6±0.67 | 1.6±0.65 |
| Median (IQR) | 1.6 (1.3, 2.0) | 1.6 (1.1, 2.0) | 1.6 (1.1, 2.0) |
CDAI, clinical disease activity index; CRP, C-reactive protein, DAS28, disease activity score employing 28 joints; HAQ, health assessment questionnaire; MTX, methotrexate; SDAI, simplified disease activity index.