Table 1.
Baseline demographics and disease characteristics by washout and direct-switch groups
| Washout patients (n = 449) | Direct-switch patients (n = 597) | Overall (n = 1046) | |
| Age, years | 56.1 (12.5) | 53.2 (12.3) | 54.4 (12.4) |
| Weight, kg | 78.9 (21.1) | 79.1 (20.0) | 79.0 (20.5) |
| Gender, female, n (%) | 359 (80.0) | 490 (82.1) | 849 (81.2) |
| Race, n (%) | |||
| White | 416 (92.7) | 551 (92.3) | 967 (92.4) |
| Black | 27 (6.0) | 33 (5.5) | 60 (5.7) |
| Other | 6 (1.3) | 13 (2.2) | 19 (1.8) |
| Duration of disease, years | 13.0 (10.0) | 10.6 (9.0) | 11.6 (9.5) |
| Previous anti-TNF therapy*, n (%) | |||
| Etanercept | 226 (50.3) | 366 (61.3) | 592 (56.6) |
| Infliximab | 281 (62.6) | 339 (56.8) | 620 (59.3) |
| Adalimumab | 193 (43.0) | 309 (51.8) | 502 (48.0) |
| Medications at day 1, n (%) | |||
| Methotrexate | 307 (68.4) | 423 (70.9) | 730 (69.8) |
| Azathioprine | 18 (4.0) | 25 (4.2) | 43 (4.1) |
| Gold | 4 (0.9) | 1 (0.2) | 5 (0.5) |
| Hydroxychloroquine/chloroquine | 71 (15.8) | 86 (14.4) | 157 (15.0) |
| Leflunomide | 66 (14.7) | 68 (11.4) | 134 (12.8) |
| Sulfasalazine | 32 (7.1) | 60 (10.1) | 92 (8.8) |
| Corticosteroids† | 280 (62.4) | 331 (55.4) | 611 (58.4) |
| Tender joints | 17.8 (5.9) | 17.8 (6.1) | 17.8 (6.0) |
| Swollen joints | 13.9 (5.6) | 13.5 (5.4) | 13.6 (5.5) |
| Patient global assessment, VAS 100 mm | 72.7 (16.7) | 73.1 (16.4) | 72.9 (16.5) |
| HAQ-DI | 1.7 (0.6) | 1.7 (0.6) | 1.7 (0.6) |
| DAS28 (CRP)‡ | 6.2 (0.7) | 6.2 (0.7) | 6.2 (0.7) |
| CRP (mg/dl)§ | 2.2 (3.0) | 2.1 (3.0) | 2.1 (3.0) |
| Rheumatoid factor positive, n (%) | 292 (65.0) | 349 (58.5) | 641 (61.3) |
| PPD positive, n (%) | 9 (2.0) | 17 (2.8) | 26 (2.5) |
Data are presented as mean (SD) unless otherwise indicated. *Patients could have previously received more than one prior anti-tumour necrosis factor (TNF) therapy; two patients, one in the washout and one in the direct-switch group, had received rituxmab more than 12 months before study entry. †Oral and/or injectable. ‡The joint count used was 28. §The upper limit of normal for high sensitivity C-reactive protein (CRP) was 3.00 mg/l. DAS28, disease activity score in 28 joints; HAQ-DI, health assessment questionnaire disability index; PPD, purified protein derivative; VAS, visual analogue scale.