Response rate | Risk ratio*Mean (95% CI) | p Value | ||
Control | Experimental | |||
Placebo control | ||||
ACR20 | ||||
3 Months | 0.26 | 0.55 | 2.1 (1.9 to 2.3) | <0.001 |
DMARD-IR† | 0.28 | 0.57 | 2.0 (1.8 to 2.3) | <0.001 |
TNF-IR‡ | 0.18 | 0.47 | 2.6 (2.1 to 3.3) | <0.001 |
6 Months | 0.28 | 0.59 | 2.3 (1.9 to 2.8) | <0.001 |
DMARD-IR | 0.30 | 0.61 | 2.1 (1.8 to 2.5) | <0.001 |
TNF-IR | 0.14 | 0.51 | 3.6 (2.1 to 6.2) | <0.001 |
6 vs 3 Months | 1.1 (1.0 to 1.2) | 0.13 | ||
DMARD-IR | 1.0 (0.9 to 1.2) | 0.36 | ||
TNF-IR | 1.4 (1.0 to 2.0) | 0.08 | ||
ACR50 | ||||
3 Months | 0.07 | 0.28 | 3.8 (3.3 to 4.4) | <0.001 |
DMARD-IR | 0.07 | 0.29 | 3.7 (3.2 to 4.4) | <0.001 |
TNF-IR | 0.05 | 0.23 | 4.5 (2.1 to 9.5) | <0.001 |
6 Months | 0.10 | 0.36 | 3.6 (3.1 to 4.3) | <0.001 |
DMARD-IR | 0.10 | 0.37 | 3.4 (2.9 to 4.0) | <0.001 |
TNF-IR | 0.04 | 0.28 | 6.1 (3.7 to 10.1) | <0.001 |
6 vs 3 Months | 0.9 (0.8 to 1.1) | 0.42 | ||
DMARD-IR | 0.9 (0.8 to 1.0) | 0.12 | ||
TNF-IR | 1.4 (0.9 to 2.0) | 0.14 | ||
ACR70 | ||||
3 Months | 0.02 | 0.11 | 4.1 (3.1 to 5.3) | <0.001 |
DMARD-IR | 0.02 | 0.11 | 4.4 (3.3 to 5.8) | <0.001 |
TNF-IR | 0.02 | 0.07 | 5.2 (0.3 to 95.4) | 0.27 |
6 Months | 0.03 | 0.18 | 5.8 (4.5 to 7.4) | <0.001 |
DMARD-IR | 0.03 | 0.18 | 5.6 (4.3 to 7.3) | <0.001 |
TNF-IR | 0.01 | 0.12 | 10.6 (3.9 to 29.2) | <0.001 |
6 vs 3 Months | 1.4 (1.1 to 2.0) | 0.02 | ||
DMARD-IR | 1.4 (1.1 to 1.7) | 0.001 | ||
TNF-IR | 1.6 (0.1 to 29.3) | 0.75 | ||
Active control | ||||
ACR20 | ||||
3 Months | 0.53 | 0.59 | 1.1 (1.1 to 1.2) | <0.001 |
6 Months | 0.56 | 0.62 | 1.1 (1.0 to 1.2) | 0.003 |
6 v 3 Months | 1.0 (1.0 to 1.0) | 0.30 | ||
ACR50 | ||||
3 Months | 0.24 | 0.31 | 1.3 (1.1 to 1.4) | <0.001 |
6 Months | 0.32 | 0.39 | 1.2 (1.1 to 1.3) | <0.001 |
6 v 3 Months | 0.9 (0.9 to 1.0) | 0.02 | ||
ACR70 | ||||
3 Months | 0.08 | 0.12 | 1.5 (1.1 to 1.8) | 0.002 |
6 Months | 0.15 | 0.21 | 1.4 (1.3 to 1.6) | <0.001 |
6 v 3 Months | 1.0 (0.9 to 1.0) | 0.40 |
*Risk ratio, the risk of a response in the experimental group versus that in the control group; and the ratio of risk ratios at 6 versus 3 months. Results >1 indicate a greater contrast between the treatment groups at 6 months. †DMARD-IR, patients with an incomplete response to disease-modifying drugs. ‡TNF-IR, patients with an incomplete response to anti-tumour necrosis factor agents.