Patient demographics and baseline disease characteristics
| ADA+2.5 mg MTX (N=98) | ADA+5 mg MTX (N=100) | ADA+10 mg MTX (N=99) | ADA+20 mg MTX (N=98) | |
|---|---|---|---|---|
| Age, years | 52.0±13.2 | 49.7±13.1 | 52.1±12.9 | 53.8±14.4 |
| Age distribution, n (%) | ||||
| <65 years | 84 (85.7) | 89 (89.0) | 85 (85.9) | 77 (78.6) |
| ≥65 years | 14 (14.3) | 11 (11.0) | 14 (14.1) | 21 (21.4) |
| Female, n (%) | 70 (71.4) | 78 (78.0) | 78 (78.8) | 74 (75.5) |
| RA duration, years | 0.35±0.84 | 0.29±0.22 | 0.33±0.30 | 0.31±0.41 |
| Concomitant medications, n (%) | ||||
| NSAIDs | 69 (70.4) | 61 (61.0) | 69 (69.7) | 59 (60.2) |
| Corticosteroids | 31 (31.6) | 27 (27.0) | 39 (39.4) | 31 (31.6) |
| TJC68 | 27.4±14.7 | 29.0±15.4 | 26.4±14.7 | 25.8±13.7 |
| SJC66 | 18.9±12.7 | 19.7±13.2 | 16.4±11.7 | 17.1±11.8 |
| TJC28 | 16.6±6.4 | 17.0±6.9 | 14.7±6.4 | 15.4±6.2 |
| SJC28 | 12.7±6.6 | 13.0±6.3 | 11.1±6.3 | 11.8±5.7 |
| PGA disease activity (VAS 0–100 mm) | 66.5±15.4 | 68.4±16.0 | 65.6±15.7 | 64.7±18.1 |
| PtGA disease activity (VAS 0–100 mm) | 70.6±21.7 | 71.6±20.4 | 67.7±20.2 | 65.5±22.9 |
| PtGA pain (VAS 0–100 mm) | 70.0±20.2 | 69.2±18.7 | 66.3±18.5 | 66.5±20.2 |
| mTSS | 9.8±12.9 | 8.6±8.9 | 10.8±13.0 | 10.6±12.9 |
| Estimated annual mTSS progression* | 28.0 | 29.7 | 32.6 | 34.0 |
| ESR (mm/h) | 41.7±15.4 | 50.3±23.4 | 42.9±18.9 | 47.7±20.9 |
| CRP (mg/dL) | 2.0±2.5 | 2.7±3.0 | 2.3±3.2 | 2.5±3.6 |
| ACPA positive, n (%) | 76 (77.6) | 77 (77.0) | 81 (81.8) | 81 (82.7) |
| RF positive, n (%) | 85 (86.7) | 83 (83.0) | 82 (82.8) | 80 (81.6) |
| DAS28(CRP)† | 6.10±0.92 | 6.22±0.94 | 5.86±0.97 | 5.91±1.01 |
| SDAI | 45.3±14.2 | 46.5±14.6 | 41.4±15.0 | 42.7±14.9 |
| CDAI | 43.3±13.6 | 43.8±13.8 | 39.1±13.5 | 40.2±12.8 |
| HAQ-DI | 1.49±0.74 | 1.57±0.62 | 1.62±0.67 | 1.58±0.65 |
Data are mean±SD unless indicated otherwise.
*Calculated by dividing mean baseline mTSS by mean disease duration at baseline.
†N values=96, 98, 95 and 97 for ADA+2.5, 5, 10 and 20 mg, respectively.
ACPA, anticitrullinated peptide antibody; ADA, adalimumab; CDAI, clinical disease activity index; CRP, C reactive protein; DAS28, 28-joint count disease activity score; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; mTSS, modified total Sharp score; MTX, methotrexate; NSAIDs, non-steroidal anti-inflammatory drugs; PGA, physician's global assessment; PtGA, patient's global assessment; RA, rheumatoid arthritis; RF, rheumatoid factor; SDAI, simple disease activity index; TJC, tender joint count; SJC, swollen joint count; VAS, visual analogue scale.