Patient demographic and baseline clinical characteristics*
| Parameter† | Adalimumab sc | Placebo (n = 110) | |||
|---|---|---|---|---|---|
| 20 mg | 40 mg | ||||
| Every other week (n = 106) | Weekly (n = 112) | Every other week (n = 113) | Weekly (n = 103) | ||
| *No statistically significant differences were noted in any demographic or baseline characteristic between the placebo group and the adalimumab dose groups and dose regimens (Kruskal-Wallis test for continuous variables and Pearson’s χ2 test for discrete variables); †results are shown as mean (SD) unless otherwise indicated; ‡0, no pain; 100, severe pain; §0, no disease activity; 100, extreme disease activity; ¶0, no difficulty; 3, unable to perform activity; **higher score indicates greater disease activity. | |||||
| sc, subcutaneous; RA, rheumatoid arthritis; DMARDs, disease modifying antirheumatic drugs; MTX, methotrexate; NSAIDs, non-steroidal anti-inflammatory drugs; DAS, disease activity score. | |||||
| Age (years) | 53.1 (12.2) | 54.4 (11.8) | 52.7 (13.3) | 51.8 (11.8) | 53.5 (13.2) |
| Female, No (%) | 84 (79.2) | 81 (72.3) | 90 (79.6) | 81 (78.6) | 85 (77.3) |
| RA duration (years) | 9.3 (6.4) | 11.3 (8.6) | 10.6 (6.9) | 11.9 (8.8) | 11.6 (9.3) |
| Previous treatments | |||||
| Number of traditional DMARDs | 3.7 (1.9) | 3.6 (1.7) | 3.8 (1.8) | 3.8 (2.0) | 3.6 (1.8) |
| Treatment failures, No (%) | |||||
| ⩾3 Traditional DMARDs | 75 (70.8) | 82 (73.2) | 84 (74.3) | 72 (69.9) | 76 (69.1) |
| MTX | 94 (88.7) | 105 (93.8) | 105 (92.9) | 90 (87.4) | 95 (86.4) |
| Concomitant treatments, No (%) | |||||
| NSAIDs | 86 (81.1) | 84 (75.0) | 93 (82.3) | 79 (76.7) | 92 (83.6) |
| Corticosteroids | 74 (69.8) | 76 (67.8) | 77 (68.1) | 84 (81.6) | 74 (67.3) |
| Disease activity | |||||
| Tender joint count (range 0–68) | 33.9 (14.4) | 35.3 (14.9) | 33.7 (15.9) | 33.8 (14.0) | 35.5 (14.2) |
| Swollen joint count (range 0–66) | 19.6 (8.7) | 19.8 (9.7) | 20.5 (10.6) | 19.3 (8.8) | 19.8 (9.3) |
| Patient assessment of pain (scale 0–100)‡ | 73.8 (18.2) | 71.1 (21.0) | 70.1 (19.9) | 71.2 (19.1) | 70.2 (18.1) |
| Patient global assessment of disease activity (scale 0–100)§ | 75.1 (18.2) | 74.0 (20.1) | 72.5 (19.3) | 74.2 (18.7) | 71.8 (19.9) |
| Physician global assessment of disease activity (scale 0–100)§ | 69.6 (17.6) | 68.1 (17.5) | 67.0 (16.7) | 67.7 (17.0) | 68.5 (18.2) |
| Health Assessment Questionnaire Disability Index (scale 0–3)¶ | 1.88 (0.60) | 1.88 (0.63) | 1.83 (0.59) | 1.84 (0.57) | 1.88 (0.64) |
| C reactive protein (mg/l) | 52.4 (52.1) | 47.2 (37.6) | 52.6 (37.4) | 49.3 (40.4) | 57.0 (49.0) |
| Erythrocyte sedimentation rate (mm/1st h) | 52.8 (27.9) | 51.5 (24.8) | 55.8 (27.0) | 51.1 (25.0) | 56.1 (28.0) |
| Rheumatoid factor positive, No (%) | 85 (80.2) | 94 (83.9) | 90 (79.6) | 85 (82.5) | 90 (81.8) |
| DAS28 (scale 2–10)** | 7.08 (0.92) | 7.09 (0.86) | 7.07 (0.86) | 7.02 (0.81) | 7.09 (0.87) |