Table 1.
Summary of demographics and disease characteristics at baseline (randomised patients)
| Placebo+MTX | Golimumab 2 mg/kg+MTX | All patients | |
|---|---|---|---|
| Randomised patients (n) | 197 | 395 | 592 |
| Age (years) | |||
| Mean±SD | 51.4±11.26 | 51.9±12.55 | 51.8±12.13 |
| Median (range) | 52.0 (19, 78) | 53.0 (18, 83) | 52.0 (18, 83) |
| Women (n (%)) | 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 (IQ range) | 4.8 (1.9, 9.6) | 4.6 (1.8, 9.6) | 4.7 (1.9, 9.6) |
| Total vdH-S score (0–448) (n) | 193 | 391 | 584 |
| Mean±SD | 50.3 (59.85) | 47.6 (54.63) | 48.5 (56.37) |
| Median (IQ range) | 29.0 (8.5, 77.2) | 28.0 (9.0, 67.5) | 28.5 (9.0, 68.0) |
| Erosion score (0–168) | |||
| Mean±SD | 25.6 (32.38) | 23.9 (29.00) | 24.5 (30.15) |
| Median (IQ range) | 13.0 (4.0, 36.0) | 13.5 (4.0, 32.0) | 13.3 (4.0, 35.0) |
| JSN score (0–280) | |||
| Mean±SD | 24.6 (29.47) | 23.7 (28.26) | 24.0 (28.64) |
| Median (IQ range) | 12.5 (4.0, 37.5) | 13.00 (3.0, 35.5) | 13.0 (3.3, 36.0) |
| Swollen joint count (0–66) | |||
| Mean±SD | 14.8±8.54 | 15.0±8.23 | 14.9±8.33 |
| Median (IQ range) | 12.0 (8.0, 19.0) | 12.0 (9.0, 19.0) | 12.0 (9.0, 19.0) |
| Tender joint count (0–68) | |||
| Mean±SD | 25.9±14.13 | 26.4±13.93 | 26.3±13.99 |
| Median (IQ range) | 22.0 (14.0, 36.0) | 24.0 (15.0, 35.0) | 23.0 (15.0, 35.0) |
| CRP (normal ≤1.0 mg/dL) | |||
| Mean±SD | 2.2±1.88 | 2.8±2.86 | 2.6±2.59 |
| Median (IQ range) | 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 (IQ range) | 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±12.45 | 38.5±11.60 | 38.4±11.88 |
| Median (IQ range) | 38.0 (28.8, 47.1) | 37.0 (29.8, 45.7) | 37.3 (29.7, 45.9) |
| Disease activity (n (%)) | |||
| Low (>2.8 and <10) | 1 (0.5) | 0 | 1 (0.2) |
| Moderate (≥10 and <22) | 16 (8.1) | 17 (4.3) | 33 (5.6) |
| High (≥22) | 180 (91.4) | 378 (95.7) | 558 (94.3) |
| SDAI (0–86) | |||
| Mean±SD | 40.6±12.88 | 41.3±12.29 | 41.1±12.49 |
| Median (IQ range) | 40.0 (30.5, 50.2) | 39.8 (31.9, 49.3) | 39.8 (31.0, 49.6) |
| Disease activity (n (%)) | |||
| Low (>3.3 and <11) | 1 (0.5) | 0 | 1 (0.2) |
| Moderate (≥11 and <26) | 26 (13.2) | 26 (6.6) | 52 (8.8) |
| High (≥26) | 170 (86.3) | 369 (93.4) | 539 (91.0) |
| HAQ-DI (0–3) | |||
| Mean±SD | 1.6±0.62 | 1.6±0.67 | 1.6±0.65 |
| Median (IQ range) | 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-DI, Health Assessment Questionnaire-Disability Index; JSN, joint space narrowing; MTX, methotrexate; SDAI, Simplified Disease Activity Index; vdH-S, van der Heijde-Sharp.