Comparison of clinical parameters at week 24 and week 48
| Variable | Week | |||||||
|---|---|---|---|---|---|---|---|---|
| 24 | 48 | |||||||
| Groups | ||||||||
| ADA/MTX | PBO/MTX | adjdiff (95% CI) | p Value | ADA/MTX | PBO/MTX | adjdiff (95% CI) | p Value | |
| DAS28 | 3.0±1.2 | 3.6±1.4 | 0.53 (0.13 to 0.93) | 0.009 | 3.2±1.4 | 3.4±1.6 | 0.21 (−0.3 to 0.7) | 0.41 |
| TJC 0–28, mean±SD | 3.2±4.8 | 5.0±6 | 1.8 (0.22 to 3.4) | 0.025 | 3.4±5.1 | 5.0±6.5 | 1.6 (−0.19 to 3.3) | 0.080 |
| SJC 0–28, mean±SD | 1.4±2.2 | 3.6±4.9 | 2.0 (1.0 to 3.1) | 0.0002 | 1.5±2.4 | 2.9±4.3 | 1.3 (0.31 to 2.3) | 0.011 |
| ESR in mm/in first hour, mean±SD | 16.1±13.3 | 18.7±14.2 | 1.4 (−2.8 to 5.6) | 0.52 | 19.5±15.0 | 18.6±15.3 | −2.1 (−6.8 to 2.5) | 0.37 |
| CRP in mg/dl, mean±SD | 5.7±10.3 | 7.1±8.1 | 1.6 (−1.2 to 4.4) | 0.25 | 9.7±20.5 | 6.8±8.9 | −2.8 (−7.8 to 2.2) | 0.27 |
| DAS28 remission (%) | 47.9 | 29.5 | −18.4 (−32.1 to −3.8) | 0.021 | 42.4 | 36.8 | −5.6 (−19.9 to 9.1) | 0.47 |
| ACR20 response (%) | 79.0 | 67.6 | −11.4 (−24.1 to 1.9) | 0.10 | 66.0 | 74.9 | 8.9 (−4.7 to 22.2) | 0.21 |
| ACR50 response (%) | 63.8 | 48.7 | −15.1 (−29.3 to −0.3) | 0.049 | 52.6 | 51.4 | −1.2 (−16.0 to 13.6) | 0.88 |
| ACR70 response (%) | 48.0 | 26.8 | −21.2 (−37.7 to −6.8) | 0.006 | 40.5 | 34.0 | −6.5 (−20.6 to 8.0) | 0.40 |
| HAQ-DI, 1–3 scale, mean±SD | 0.49±0.6 | 0.72±0.6 | 0.26 (0.10 to 0.42) | 0.0014 | 0.61±0.6 | 0.66±0.6 | 0.082 (−0.11 to 0.27) | 0.40 |
| SF-36 mental score, mean±SD | 48.8±9.8 | 48.9±8.8 | 0.92 (−1.8 to 3.7) | 0.51 | 50.0±9.6 | 47.9±9.6 | −1.39 (−4.5 to 1.7) | 0.37 |
| SF-36 physical score, mean±SD | 44.0±11.1 | 39.8±9.9 | −6.0 (−9.1 to 2.9) | 0.0002 | 41.4±12.4 | 42.0±10.3 | −0.54 (−4.5 to 3.4) | 0.79 |
Values are means and SDs unless otherwise specified.
ACR, American College of Rheumatology; ADA, adalimumab; adjdiff, differences between groups adjusted for status at baseline; CRP, C reactive protein; DAS28, Disease Activity Score in 28 joints; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index, German version; MTX, methotrexate; PBO, placebo; SF-36, Short-Form Health Survey with 36 questions; SJC, swollen joint count; TJC, tender joint count.