Table 2 Response criteria: LS mean between-treatment difference for canakinumab vs placebo at week 12
Variable | Canakinumab 150 mg SC q4wk, n = 69 | Canakinumab 300 mg SC q2wk, n = 64 | Canakinumab 300 mg SC q2wk + 600 mg IV loading dose, n = 71 |
|---|---|---|---|
Number of tender joints | |||
Baseline, mean (SD) | 15.6 (6.00) | 15.2 (6.00) | 16.8 (6.20) |
Difference vs. placebo in LS mean change (95% CI) | -1.7 (-4.1, 0.6) | -0.3 (-2.7, 2.2) | 0.2 (-2.1, 2.6) |
p-value | 0.152 | 0.837 | 0.839 |
Number of swollen joints | |||
Baseline, mean (SD) | 11.8 (4.29) | 11.9 (4.39) | 12.4 (4.95) |
Difference vs. placebo in LS mean change (95% CI) | -1.8 (-3.6, -0.1) | -1.9 (-3.7, -0.1) | -1.2 (-3.0, 0.6) |
p-value | 0.040* | 0.039* | 0.178 |
RA pain intensity, VAS in mm | |||
Baseline, mean (SD) | 61.6 (18.00) | 59.7 (19.82) | 65.0 (16.21) |
Difference vs. placebo in LS mean change (95% CI) | -6.5 (-14.0, 1.1) | -4.7 (-12.3, 3.0) | 0.2 (-2.1, 2.6) |
p-value | 0.091 | 0.233 | 0.336 |
Physicians' global assessment of disease activity, VAS in mm | |||
Baseline, mean (SD) | 65.4 (15.14) | 60.1 (17.46) | 64.7 (12.93) |
Difference vs. placebo in LS mean change (95% CI) | -8.8 (-16.6, -0.9) | -6.4 (-14.4, 1.7) | -4.0 (-11.8, 3.8) |
p-value | 0.029* | 0.121 | 0.316 |
Patients' global assessment of disease activity, VAS in mm | |||
Baseline, mean (SD) | 63.4 (16.97) | 63.6 (20.67) | 67.8 (15.94) |
Difference vs. placebo in LS mean change (95% CI) | -7.5 (-14.7, -0.3) | -7.4(-14.7, 0.0) | -4.5 (-11.7, 2.8) |
p-value | 0.041* | 0.049* | 0.226 |
hsCRP, mg/L | |||
Baseline, mean (SD) | 16.62 (18.735) | 16.60 (17.050) | 6.59 (20.785) |
Difference vs. placebo in LS mean change (95% CI) | -7.3 (-12.5, -2.1) | -2.7 (-8.1, 2.6) | -4.9 (-10.1, 0.3) |
p-value | 0.007* | 0.313 | 0.065 |