Table 1.
Baseline demographics and disease characteristics for patients enrolled in studies of IV golimumab in RA, PsA, and AS*
| RA trial | PsA trial | AS trial | ||||
|---|---|---|---|---|---|---|
| Placebo | Golimumab | Placebo | Golimumab | Placebo | Golimumab | |
| Patients, N | 197 | 395 | 239 | 241 | 103 | 105 |
| Demographics and disease characteristics | ||||||
| Mean age, years (range) | 51.4 (19, 78) | 51.9 (18, 83) | 46.7 (18, 79) | 45.7 (19, 69) | 39.2 (20, 67) | 38.4 (19, 64) |
| Male, n (%) | 40 (20.3) | 69 (17.5) | 121 (50.6) | 128 (53.1) | 77 (74.8) | 86 (81.9) |
| BMI, kg/m2 | 27.0 (5.7) | 26.8 (5.5) | 28.9 (6.2) | 28.9 (6.4) | 26.8 (6.4) | 27.2 (5.9) |
| Disease duration, years | 7.0 (7.2) | 6.9 (7.0) | 5.3 (5.9) | 6.2 (6.0) | 5.5 (5.9) | 5.6 (6.6) |
| Swollen Joint count (0–66) | 14.8 (8.5) | 15.0 (8.2) | 14.1 (8.2) | 14.0 (8.4) | – | – |
| Tender joint count (0–68) | 25.9 (14.1) | 26.4 (13.9) | 26.1 (14.4) | 25.1 (13.8) | – | – |
| CRP, mg/dL | 2.2 (1.9) | 2.8 (2.9) | 2.0 (2.0) | 1.9 (2.5) | 1.9 (1.7) | 2.0 (1.8) |
| BASDAI, N | – | – | 53** | 56** | 103 | 105 |
| Score | – | – | 6.4 (1.9) | 6.5 (1.8) | 7.1 (1.2) | 7.0 (1.2) |
| Methotrexate, n (%) | 197 (100) | 395 (100) | 173 (72.4) | 163 (67.6) | 21 (20.4) | 16 (15.2) |
| Dose, mg/week | 16.6 (2.8) | 16.8 (2.9) | 14.9 (4.8) | 14.8 (4.7) | 13.7 (5.0) | 16.7 (4.9) |
| Oral corticosteroids, n (%) | 134 (68.0) | 251 (63.5) | 67 (28.0) | 66 (27.4) | 23 (22.3) | 32 (30.5) |
| Dose***, mg/day | 7.0 (2.5) | 7.0 (2.5) | 7.6 (2.5) | 7.4 (2.6) | 6.1 (2.5) | 7.8 (2.7) |
| NSAIDs, n (%) | 156 (79.2) | 323 (81.8) | 167 (69.9) | 173 (71.8) | 90 (87.4) | 94 (89.5) |
AS ankylosing spondylitis, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BMI body mass index, CRP C-reactive protein, IV intravenous, NSAID non-steroidal anti-inflammatory drug, PsA psoriatic arthritis, RA rheumatoid arthritis, SD standard deviation
*Data presented as mean (SD) unless otherwise noted
**Among patients with investigator-assessed spondylitis in addition to peripheral arthritis as their primary presentation of PsA
***Prednisone or equivalent