Table 1.
Baseline clinical characteristics for patients in the GO-FORWARD MRI substudy
| Group 1 | Group 2 | Golimumab+MTX | |||
|---|---|---|---|---|---|
| Characteristic | Placebo+MTX | Golimumab 100 mg+placebo | Group 3: 50 mg | Group 4: 100 mg | Groups 3 and 4 combined |
| Randomised MRI substudy patients | 72 | 72 | 47 | 49 | 96 |
| Women, n (%) | 61 (84.7%) | 56 (77.8%) | 41 (87.2%) | 42 (85.7%) | 83 (86.5%) |
| Age (years) | 52.4 | 52.5 (45.0 to 59.0) | 49.2 | 48.5 (41.5 to 57.5) | 50.7 | 52.0 (42.0 to 58.0) | 49.6 | 49.0 (44.0 to 53.0) | 50.1 | 51.0 (43.0 to 57.0) |
| Disease duration (years) | 9.3 | 6.5 (3.6 to 12.8) | 8.5 | 6.5 (3.2 to 12.5) | 8.0 | 5.3 (2.1 to 9.8) | 9.5 | 6.8 (2.3 to 14.5) | 8.8 | 6.1 (2.2 to 13.8) |
| Swollen joints (0–66) | 13.8 | 10.0 (7.5 to 18.5) | 13.6 | 10.0 (7.0 to 15.0) | 15.7 | 10.0 (8.0 to 22.0) | 12.7 | 11.0 (7.0 to 17.0) | 14.2 | 11.0 (7.5 to 18.0) |
| Tender joints (0–68) | 23.8 | 21.0 (13.5 to 32.0) | 22.3 | 21.5 (11.0 to 28.5) | 25.1 | 20.0 (11.0 to 38.0) | 22.0 | 21.0 (11.0 to 29.0) | 23.5 | 20.0 (11.0 to 32.5) |
| CRP (mg/dl) | 1.2 | 0.6 (0.3 to 1.9) | 2.1 | 1.0 (0.4 to 2.6) | 1.9 | 0.8 (0.3 to 2.0) | 1.5 | 0.9 (0.4 to 1.9) | 1.7 | 0.9 (0.4 to 2.0) |
| ESR (mm/h) | 35.3 | 35.5 (19.0 to 47.0) | 41.9 | 39.0 (22.5 to 56.5) | 41.2 | 38.0 (22.0 to 53.0) | 39.7 | 34.0 (25.5 to 50.0) | 40.5 | 36.0 (23.0 to 50.0) |
| vdH-S score (0–448) | 40.4 | 21.5 (2.0 to 54.0) | 39.1 | 17.3 (3.0 to 51.0) | 31.0 | 7.3 (2.0 to 55.0) | 31.1 | 13.5 (3.0 to 36.3) | 31.0 | 13.0 (2.5 to 49.5) |
| RAMRIS scores | |||||
| Synovitis (wrist plus MCP)* (0–21) | N=56, 6.7 | 6.8 (3.3 to 9.3) | N=53, 7.3 | 7.5 (2.5 to 10.5) | N=38, 7.6 | 7.8 (4.1 to 10.5) | N=39, 6.3 | 6.6 (3.0 to 8.5) | N=77, 7.0 | 7.0 (4.0 to 9.5) |
| Synovitis (wrist)* (0–9) | N=67, 3.9 | 4.0 (2.5 to 5.0) | N=62, 4.1 | 4.0 (2.0 to 6.5) | N=43, 4.3 | 4.5 (2.0 to 6.0) | N=44, 4.2 | 4.0 (2.5 to 6.0) | N=87, 4.2 | 4.0 (2.5 to 6.0) |
| Bone oedema (0–69) | N=67, 7.1 | 2.0 (0.0 to 12.0) | N=62, 6.9 | 2.3 (0.0 to 10.0) | N=43, 7.6 | 4.0 (0.5 to 12.5) | N=45, 6.0 | 2.0 (0.0 to 7.0) | N=88, 6.8 | 2.5 (0.0 to 11.8) |
| Bone erosion (0–230) | N=68, 25.5 | 12.8 (8.0 to 28.3) | N=62, 25.2 | 17.4 (5.5 to 35.5) | N=43, 23.9 | 11.0 (5.5 to 29.0) | N=45, 22.1 | 13.5 (6.0 to 20.7) | N=88, 23.0 | 12.5 (6.0 to 25.0) |
Data presented are n (%) or mean | median (IQR).
*
Due to an inability to obtain postgadolinium images of both the wrist and the metacarpophalangeal joints at the study site, 223 patients have RAMRIS synovitis scores of the wrist plus MCP joints and 240 patients have RAMRIS synovitis scores for the wrist joint only.
CRP, C reactive protein; ESR, erythrocyte sedimentation rate; MCP, metacarpophalangeal; MTX, methotrexate; RAMRIS, Rheumatoid Arthritis MRI Scoring system.