Baseline patient and disease characteristics: full analysis patient population*
| Group 1: Placebo+MTX | Group 2: Golimumab 50 mg+MTX | Group 3: Golimumab 100 mg+MTX | Combined Groups 2 and 3 | |
|---|---|---|---|---|
| Number of patients | 88 | 86 | 87 | 173 |
| Female patients, n (%) | 73 (83.0%) | 73 (84.9%) | 78 (89.7%) | 151 (87.3%) |
| Age (years) | 51.1 (11.6), 51.0 [24, 73] | 50.4 (9.9), 52.0 [25, 72] | 50.0 (12.2), 52.0 [21, 73] | 50.2 (11.1), 52.0 [21, 73] |
| Average duration of RA (years) | 8.7 (8.2), 6.4 [0.3, 46.1] | 8.8 (8.8), 6.4 [0.4, 36.8] | 8.1 (6.5), 6.4 [0.5, 32.4] | 8.4 (7.7), 6.4 [0.4, 36.8] |
| <1 year, n (%) | 9 (10.2%) | 8 (9.3%) | 5 (5.7%) | 13 (7.5%) |
| ≥1–<3 years, n (%) | 20 (22.7%) | 20 (23.3%) | 15 (17.2%) | 35 (20.2%) |
| ≥3–<5 years, n (%) | 13 (14.8%) | 10 (11.6%) | 14 (16.1%) | 24 (13.9%) |
| ≥5–<10 years, n (%) | 16 (18.2%) | 21 (24.4%) | 26 (29.9%) | 47 (27.2%) |
| ≥10 years, n (%) | 30 (34.1%) | 27 (31.4%) | 27 (31.0%) | 54 (31.2%) |
| Swollen joint count (0–66) | 11.4 (6.58), 9.0 [4, 36] | 11.8 (6.72), 10.0 [4, 33] | 11.5 (6.58), 9.0 [4, 32] | 11.6 (6.63), 9.0 [4, 33] |
| Tender joint count (0–68) | 13.2 (7.83), 11.0 [4, 45] | 13.1 (8.38), 11.0 [4, 40] | 12.9 (7.64), 11.0 [4, 39] | 13.0 (7.99), 11.0 [4, 40] |
| Patient's assessment of pain (VAS 0–100 mm) | 52.2 (22.86), 51.5 [2, 100] | 49.5 (23.80), 48.0 [3, 100] | 47.0 (23.88), 47.0 [6, 100] | 48.2 (23.80), 48.0 [3, 100] |
| Patient's global assessment of disease activity (VAS 0–100 mm) | 50.7 (22.63), 48.0 [2, 100] | 46.1 (23.07), 47.5 [1, 100] | 45.3 (22.90), 48.0 [4, 100] | 45.7 (22.92), 48.0 [1, 100] |
| Physician's global assessment of disease activity (VAS 0–100 mm) | 54.4 (17.97), 57.0 [22, 96] | 58.0 (18.77), 59.0 [12, 91] | 54.5 (17.81), 57.0 [14, 87] | 56.2 (18.32), 58.0 [12, 91] |
| HAQ-DI (0–3) | 1.0 (0.68), 0.9 [0.0, 2.8] | 1.0 (0.61), 1.0 [0.0, 2.4] | 0.9 (0.59), 0.9 [0.0, 3.0] | 0.9 (0.60), 0.9 [0.0, 3.0] |
| CRP (mg/dl) | 2.2 (2.44), 1.3 [0.0, 15.5] | 1.9 (2.63), 0.9 [0.0, 13.9] | 1.5 (1.68), 1.0 [0.0, 8.2] | 1.7 (2.21), 0.9 [0.0, 13.9] |
| DAS (ESR) | 5.6 (0.99), 5.6 [2.8, 8.0] | 5.5 (1.18), 5.6 [3.1, 8.8] | 5.5 (0.97), 5.4 [3.5, 8.2] | 5.5 (1.07), 5.5 [3.1, 8.8] |
| vdH-S score | ||||
| Total score | 54.2 (62.9), 32.3 [0.0, 289.2] | 58.0 (62.4), 35.0 [0.0, 300.5] | 53.2 (48.4), 43.0 [0.0, 215.0] | 55.6 (55.7), 37.5 [0.0, 300.5] |
| JSN score | 23.4 (27.4), 13.5 [0.0, 128.0] | 25.9 (29.4), 14.5 [0.0, 127.0] | 23.9 (24.5), 16.5 [0.0, 99.0] | 24.9 (27.0), 16.0 [0.0, 127.0] |
| Erosion score | 30.8 (37.1), 17.8 [0.0, 190.0] | 32.1 (34.7), 20.8 [0.0, 185.0] | 29.3 (26.3), 21.0 [0.0, 116.0] | 30.7 (30.7), 21.0 [0.0, 185.0] |
Values are mean (SD), median [range] unless otherwise specified.
↵* The full analysis patient population excluded patients who did not meet the study eligibility criteria, who did not receive study treatment and/or who had no efficacy data following randomisation.
CRP, C-reactive protein; DAS 28 (ESR), disease activity score using 28-joint count and erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; JSN, joint space narrowing; MTX, methotrexate; RA, rheumatoid arthritis; VAS, visual analogue scale; vdH-S, van der Heijde-modified Sharp score.