Table 2.
Intention-to-treat number of patients fulfilling primary and secondary response criteria at week 12
| Outcome parameter | Canakinumab | Placebo | P value | OR (95% CI) | ||
| Responder n (%) | 95% CI | Responder n (%) | 95% CI | |||
| DAS28(ESR) response | 12 (66.7) | 43.1 to 85.2 | 7 (41.2) | 20.1 to 65 | 0.18 | 2.86 (0.72 to 11.31) |
| DAS28(CRP) response | 12 (66.7) | 43.1 to 85.2 | 7 (41.2) | 20.1 to 65 | 0.18 | 2.86 (0.72 to 11.31) |
| ACR20 | 11 (61.1) | 37.7 to 81.1 | 7 (41.2) | 20.1 to 65 | 0.32 | 2.86 (0.72 to 11.31) |
| ACR30 | 11 (61.1) | 37.7 to 81.1 | 5 (29.4) | 11.7 to 53.7 | 0.09 | 2.24 (0.58 to 8.69) |
| ACR30 mod | 10 (55.6) | 32.7 to 76.8 | 4 (23.5) | 8 to 47.5 | 0.09 | 3.77 (0.92 to 15.44) |
| ACR50 | 9 (50) | 27.8 to 72.2 | 3 (17.6) | 4.7 to 40.9 | 0.08 | 4.06 (0.95 to 17.42) |
| ACR70 | 5 (27.8) | 11 to 51.3 | 2 (11.8) | 2 to 33.7 | 0.40 | 4.67 (0.99 to 22.03) |
| ACR90 | 2 (11.1) | 1.9 to 32.1 | 1 (5.9) | 0.3 to 25.8 | 1.0 | 2.88 (0.48 to 17.45) |
| EULAR response | 14 (77.8) | 54.7 to 92.5 | 9 (52.9) | 29.7 to 75.2 | 0.16 | 1.88 (0.16 to 22.83) |
| EULAR DAS(CRP) Resp. | 13 (72.2) | 48.7 to 89 | 8 (47.1) | 24.8 to 70.3 | 0.18 | 3.11 (0.72 to 13.44) |
Diff. response in % indicates difference between the response rates (in per cent)
EULAR response indicates good or moderate response according to the EULAR criterion based on disease activity score 28 (using erythrocyte sedimentation rate value) DAS28(ESR) or if specified on disease activity score 28 (using C-reactive protein value) DAS28(CRP).
ACR, American College of Rheumatology; ACR20, ACR 20% response; ACR30, ACR 30% response; ACR90, ACR 90% response; ACR30 mod, modified ACR 30 response; EULAR, European League Against Rheumatism; Resp, response.