American College of Rheumatology (ACR) core response criteria: baseline values and mean absolute changes from baseline to weeks 2 and 12*
| ACR criterion† | Placebo (n = 70)‡ | Adalimumab | |||
|---|---|---|---|---|---|
| 20 mg (n = 71)‡ | 40 mg (n = 70)‡ | 80 mg (n = 72)‡ | All doses (n = 213)‡ | ||
| VAS, visual analogue scale; HAQ, Health Assessment Questionnaire; CRP, C reactive protein; ESR, erythrocyte sedimentation rate; DAS28, disease activity score 28; ANCOVA, analysis of covariance. | |||||
| *A negative absolute change indicates a decrease in mean values from baseline to weeks 2 or 12 and an improvement in that parameter; a positive absolute change indicates an increase in mean values from baseline and a worsening in that parameter; †Results are shown as mean (SD); ‡group numbers indicate initial size of each group, with the exception of the adalimumab 20 mg group, which does not include the patient with Felty’s syndrome who was withdrawn after the first dose. Withdrawals and rescues were considered treatment failures; §p⩽0.001 v placebo (ANCOVA); ¶0 = no pain; 100 = severe pain; **0 = no disease activity, 100 = extreme disease activity; ††0 = no difficulty, 3 = unable to perform activity; ‡‡p⩽0.01 v placebo (ANCOVA); §§higher score indicates greater disease activity. | |||||
| Tender joint count (0–68), n | |||||
| Baseline | 30.9 (13.1) | 31.7 (13.2) | 31.0 (12.3) | 32.5 (12.8) | 31.7 (12.7) |
| Change from baseline* | |||||
| Week 2 | −1.0 (10.1) | −7.7 (11.1)§ | −9.5 (10.7)§ | −11.4 (12.0)§ | −9.5 (11.3)§ |
| Week 12 | −5.1 (17.8) | −14.0 (14.1)§ | −15.3 (11.6)§ | −15.2 (12.3)§ | −14.8 (12.7)§ |
| Swollen joint count (0–66), n | |||||
| Baseline | 20.2 (7.4) | 19.6 (9.0) | 18.7 (7.7) | 19.6 (8.3) | 19.3 (8.3) |
| Change from baseline* | |||||
| Week 2 | −0.9 (5.0) | −4.6 (7.2)§ | −5.0 (6.0)§ | −5.4 (7.6)§ | −5.0 (6.9)§ |
| Week 12 | −2.8 (7.3) | −8.1 (8.2)§ | −9.6 (7.1)§ | −10.7 (7.5)§ | −9.5 (7.6)§ |
| Patient assessment of pain (scale 0–100 mm on VAS)¶ | |||||
| Baseline | 72.4 (18.6) | 73.1 (18.0) | 73.4 (19.4) | 67.9 (23.1) | 71.5 (20.4) |
| Change from baseline* | |||||
| Week 2 | −1.7 (22.3) | −25.8 (26.4)§ | −26.0 (25.3)§ | −26.2 (20.8)§ | −26.0 (24.2)§ |
| Week 12 | −7.8 (26.9) | −31.8 (28.7)§ | −35.3 (29.4)§ | −30.1 (22.1)§ | −32.3 (26.7)§ |
| Patient global assessment of disease activity (scale 0–100 mm on VAS)** | |||||
| Baseline | 73.5 (19.3) | 74.0 (19.9) | 75.7 (19.5) | 69.3 (24.2) | 73.0 (21.4) |
| Change from baseline* | |||||
| Week 2 | −1.3 (20.5) | −24.2 (25.9)§ | −26.6 (29.6)§ | −26.8 (22.2)§ | −25.8 (24.6)§ |
| Week 12 | −6.9 (26.0) | −31.7 (28.0)§ | −37.6 (27.9)§ | −31.0 (23.7)§ | −33.3 (26.5)§ |
| Doctor global assessment of disease activity (scale 0–100 mm on VAS)** | |||||
| Baseline | 65.4 (17.8) | 65.6 (17.6) | 64.8 (18.2) | 63.9 (20.6) | 64.8 (18.8) |
| Change from baseline* | |||||
| Week 2 | −2.3 (18.4) | −19.6 (18.9)§ | −20.7 (22.8)§ | −24.3 (20.4)§ | −21.5 (20.7)§ |
| Week 12 | −5.0 (22.0) | −28.8 (23.3)§ | −35.7 (20.3)§ | −33.4 (21.1)§ | −32.6 (21.7)§ |
| Disability Index of the HAQ (scale 0–3)†† | |||||
| Baseline | 1.63 (0.67) | 1.79 (0.64) | 1.74 (0.66) | 1.66 (0.73) | 1.73 (0.68) |
| Change from baseline* | |||||
| Week 2 | +0.05 (0.38) | −0.34 (0.42)§ | −0.28 (0.33)§ | −0.30 (0.45)§ | −0.31 (0.40)§ |
| Week 12 | −0.04 (0.37) | −0.45 (0.46§ | −0.47 (0.43)§ | −0.48 (0.50)§ | −0.46 (0.46)§ |
| CRP, mg/l | |||||
| Baseline | 63 (44) | 57 (40) | 56 (39) | 60 (55) | 58 (4.5) |
| Change from baseline* | |||||
| Week 2 | −2 (35) | −30 (41)§ | −29 (30)§ | −35 (44)§ | −31 (39)§ |
| Week 12 | −1 (3.4) | −24 (3.1)§ | −32 (3.4)§ | −34 (35)§ | −30 (33)§ |
| ESR, mm/1st h | |||||
| Baseline | 53.6 (27.9) | 52.9 (0.7) | 51.7 (27.4) | 50.7 (24.8) | 51.8 (27.7) |
| Change from baseline* | |||||
| Week 2 | +2.5 (16.7) | −14.8 (20.8)§ | −14.3 (18.1)§ | −15.7 (18.1)§ | −14.9 (19.0)§ |
| Week 12 | −2.0 (20.1) | −14.2 (21.8)‡‡ | −17.9 (20.0)§ | −17.3 (20.6)§ | −16.4 (20.8)§ |
| DAS28 (scale, 2–10)§§ | |||||
| Baseline | 7.1 (0.8) | 7.0 (1.0) | 7.1 (0.8) | 7.0 (1.0) | 7.0 (0.9) |
| Change from baseline* | |||||
| Week 2 | −0.0 (0.7) | −1.1 (1.0)§ | −1.4 (1.1)§ | −1.5 (1.0)§ | −1.3 (1.0)§ |
| Week 12 | −0.5 (1.1) | −1.8 (1.4)§ | −2.1 (1.3)§ | −2.0 (1.2)§ | −2.0 (1.3)§ |