Response for secondary outcome end points at week 26
| 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) | ||
| *Results shown as mean value (SD) unless stated otherwise; †a negative absolute or percentage change indicates an improvement in that ACR response criterion; last observation carried forward; ‡p value for adalimumab absolute change versus placebo absolute change (by analysis of covariance; for C reactive protein and erythrocyte sedimentation rate, Wilcoxon and Mann-Whitney test); §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. | |||||
| Tender joint count (range 0–68) | |||||
| Mean baseline value | 33.7 (14.3) | 35.3 (14.9) | 33.9 (15.8) | 33.8 (14.0) | 35.5 (14.2) |
| Absolute change† | −11.2 (14.9) | −14.9 (15.7) | −13.6 (18.7) | −17.1 (15.5) | −6.6 (16.6) |
| Percentage change† | −35.5 | −42.4 | −37.4 | −48.0 | −9.5 |
| p Value‡ | ⩽0.01 | ⩽0.001 | ⩽0.001 | ⩽0.001 | |
| Swollen joint count (range 0–66) | |||||
| Mean baseline value | 19.4 (8.6) | 19.8 (9.7) | 20.5 (10.6) | 19.4 (8.8) | 19.8 (9.3) |
| Absolute change† | −5.7 (10.5) | −7.2 (11.0) | −8.5 (10.6) | −8.3 (10.8) | −2.4 (9.5) |
| Percentage change† | −28.0 | −34.6 | −37.0 | −40.1 | −7.4 |
| p Value‡ | ⩽0.01 | ⩽0.001 | ⩽0.001 | ⩽0.001 | |
| Patient assessment of pain (scale 0–100)§ | |||||
| Mean baseline value | 73.8 (18.2) | 71.1 (21.0) | 70.3 (19.9) | 71.4 (19.1) | 70.2 (18.1) |
| Absolute change† | −20.1 (30.3) | −25.2 (30.8) | −27.6 (31.1) | −32.0 (31.3) | −11.0 (26.7) |
| Percentage change† | −26.4 | −33.4 | −37.7 | −42.4 | −11.4 |
| p Value‡ | – | ⩽0.001 | ⩽0.001 | ⩽0.001 | |
| Patient global assessment of disease activity (scale 0–100)¶ | |||||
| Mean baseline value | 75.1 (18.2) | 74.0 (20.1) | 72.6 (19.3) | 74.4 (18.6) | 71.8 (19.9) |
| Absolute change† | −19.5 (29.9) | −26.5 (31.6) | −27.9 (30.5) | −35.0 (31.5) | −10.6 (27.8) |
| Percentage change† | −25.1 | −33.9 | −38.9 | −44.1 | −7.9 |
| p Value‡ | – | ⩽0.001 | ⩽0.001 | ⩽0.001 | |
| Physician global assessment of disease activity (scale 0–100) ¶ | |||||
| Mean baseline value | 69.6 (17.6) | 68.1 (17.5) | 67.3 (16.6) | 68.0 (16.8) | 68.5 (18.2) |
| Absolute change† | −20.5 (27.0) | −26.4 (28.8) | −27.3 (28.8) | −32.5 (27.3) | −10.9 (25.4) |
| Percentage change† | −29.1 | −38.9 | −38.8 | −45.5 | −12.9 |
| p Value‡ | ⩽0.001 | ⩽0.001 | ⩽0.001 | ⩽0.001 | |
| Health Assessment Questionnaire Disability Index (scale 0–3)** | |||||
| Mean baseline value | 1.88 (0.60) | 1.88 (0.63) | 1.83 (0.59) | 1.83 (0.57) | 1.88 (0.64) |
| Absolute change† | −0.29 (0.63) | −0.39 (0.62) | −0.38 (0.60) | −0.49 (0.54) | −0.07 (0.49) |
| Percentage change† | −14.7 | −18.5 | −21.3 | −28.7 | +1.8 |
| p Value‡ | ⩽0.01 | ⩽0.001 | ⩽0.001 | ⩽0.001 | |
| C reactive protein (mg/l) | |||||
| Median baseline value | 37.6 | 37.6 | 46.2 | 41.9 | 39.2 |
| Absolute change† | −4.3 | −10.7 | −19.5 | −16.7 | +3 |
| Percentage change† | −18.5 | −38.8 | −42.8 | −54.4 | +0.4 |
| p Value‡ | – | ⩽0.01 | ⩽0.001 | ⩽0.001 | |
| Erythrocyte sedimentation rate (mm/1st h) | |||||
| Median baseline value | 45.0 | 48.0 | 54.0 | 49.0 | 50.5 |
| Absolute change† | −2.5 | −5.5 | −12.0 | −12.0 | −2.0 |
| Percentage change† | −5.9 | −12.7 | −28.8 | −29.4 | −4.4 |
| p Value‡ | – | ⩽0.05 | ⩽0.001 | ⩽0.001 | |
| DAS28 (scale 2–10)†† | |||||
| Mean baseline value | 7.1 (0.9) | 7.1 (0.9) | 7.1 (0.8) | 7.0 (0.8) | 7.1 (0.9) |
| Absolute change† | −1.3 (1.6) | −1.6 (1.7) | −1.7 (1.6) | −2.0 (1.6) | −0.7 (1.3) |
| Percentage change† | −18.2 | −23.3 | −23.8 | −28.4 | −9.1 |
| p Value‡ | ⩽0.01 | ⩽0.001 | ⩽0.001 | ⩽0.001 | |