Table 3.
Baseline patient demographic and disease characteristics: pooled data from five phase III trials of SC golimumab in RA, PsA and AS
| Characteristic | Placebo±MTX | Golimumab 50 mg±MTX | Golimumab 100 mg±MTX | Total |
|---|---|---|---|---|
| Randomised patients, N | 639 | 685 | 979 | 2303 |
| Women, n (%) | 442 (69.2) | 413 (60.3) | 660 (67.4) | 1515 (65.8) |
| Race, n (%) | ||||
| Asian | 67 (10.5) | 83 (12.1) | 135 (13.8) | 285 (12.4) |
| Black | 18 (2.8) | 12 (1.8) | 17 (1.7) | 47 (2.0) |
| White | 515 (80.6) | 563 (82.2) | 781 (79.8) | 1859 (80.7) |
| Other | 39 (6.1) | 27 (3.9) | 46 (4.7) | 112 (4.9) |
| Age, years | ||||
| Mean±SD | 49.4±13.03 | 48.0±12.52 | 48.4±12.50 | 48.6±12.66 |
| Median (IQR) | 50.0 (41.0, 58.0) | 48.0 (40.0, 57.0) | 49.0 (40.0, 57.0) | 49.0 (40.0, 57.0) |
| Disease duration, years | ||||
| Mean±SD | 8.2±8.73 | 7.7±8.12 | 7.2±7.75 | 7.6±8.15 |
| Median (IQR) | 4.8 (1.6, 11.6) | 4.9 (1.4, 11.1) | 4.5 (1.4, 10.1) | 4.7 (1.4, 10.9) |
| CRP, mg/dL | ||||
| Mean±SD | 1.9±2.73 | 2.0±2.62 | 2.1±2.86 | 2.0±2.76 |
| Median (IQR) | 1.0 (0.3, 2.3) | 0.9 (0.3, 2.4) | 0.9 (0.3, 2.6) | 0.9 (0.3, 2.4) |
| HAQ-DI in RA and PsA, 0–3*, N | 559 | 542 | 831 | 1932 |
| Mean±SD | 1.4±0.67 | 1.4±0.70 | 1.4±0.68 | 1.4±0.68 |
| Median (IQR) | 1.4 (1.0, 1.9) | 1.4 (0.9, 1.9) | 1.4 (0.9, 1.9) | 1.4 (0.9, 1.9) |
| DAS28-CRP in RA pts only, N | 448 | 398 | 688 | 1534 |
| Mean±SD | 5.6±1.04 | 5.8±1.09 | 5.6±1.03 | 5.7±1.05 |
| Median (IQR) | 5.6 (4.8, 6.3) | 5.8 (5.0, 6.5) | 5.6 (4.9, 6.4) | 5.7 (4.9, 6.4) |
| BASDAI >4 in AS pts, n/N (%) | 75/78 (96.2) | 130/138 (94.2) | 135/140 (96.4) | 340/356 (95.5) |
| MTX use in RA and PsA† | ||||
| Number of MTX-treated patients | 156 | 174 | 169 | 499 |
| Mean dose±SD (mg) | 16.0±5.01 | 16.0±5.30 | 16.3±5.33 | 16.1±5.21 |
| Median dose (IQR) (mg) | 15.0 (12.5, 20.0) | 15.0 (12.5, 20.0) | 15.0 (12.5, 20.0) | 15.0 (12.5, 20.0) |
| Oral corticosteroid use in RA and PsA† | ||||
| Number of corticosteroid-treated patients | 270 | 260 | 413 | 943 |
| Mean dose±SD (mg) | 6.6±2.59 | 6.8±2.70 | 6.8±2.60 | 6.8±2.62 |
| Median dose (IQR) (mg) | 5.0 (5.0, 10.0) | 6.0 (5.0, 10.0) | 5.0 (5.0, 10.0) | 5.0 (5.0, 10.0) |
*HAQ-DI data were not collected in the GO-RAISE golimumab trial conducted in patients with AS.
†MTX use at baseline was not allowed in the GO-BEFORE golimumab trial in MTX-naïve patients with RA; MTX and oral corticosteroid use was very limited in patients with AS and are thus summarised only for patients with RA and PsA.
AS, ankylosing spondylitis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CRP, C-reactive protein; DAS28-CRP, 28-joint Disease Activity Score using CRP; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; PsA, psoriatic arthritis; RA, rheumatoid arthritis; SC, subcutaneous.