Table 2

Pooled response rates; contrasts between treatment groups for placebo and active control trials expressed as risk ratios at 3 and 6 months; and the contrast (ratio of risk ratios) between 6 and 3 months.

Response rateRisk ratio*Mean (95% CI)p Value
ControlExperimental
Placebo control
ACR20
    3 Months0.260.552.1 (1.9 to 2.3)<0.001
        DMARD-IR†0.280.572.0 (1.8 to 2.3)<0.001
        TNF-IR‡0.180.472.6 (2.1 to 3.3)<0.001
    6 Months0.280.592.3 (1.9 to 2.8)<0.001
        DMARD-IR0.300.612.1 (1.8 to 2.5)<0.001
        TNF-IR0.140.513.6 (2.1 to 6.2)<0.001
    6 vs 3 Months1.1 (1.0 to 1.2)0.13
        DMARD-IR1.0 (0.9 to 1.2)0.36
        TNF-IR1.4 (1.0 to 2.0)0.08
ACR50
    3 Months0.070.283.8 (3.3 to 4.4)<0.001
        DMARD-IR0.070.293.7 (3.2 to 4.4)<0.001
        TNF-IR0.050.234.5 (2.1 to 9.5)<0.001
    6 Months0.100.363.6 (3.1 to 4.3)<0.001
        DMARD-IR0.100.373.4 (2.9 to 4.0)<0.001
        TNF-IR0.040.286.1 (3.7 to 10.1)<0.001
    6 vs 3 Months0.9 (0.8 to 1.1)0.42
        DMARD-IR0.9 (0.8 to 1.0)0.12
        TNF-IR1.4 (0.9 to 2.0)0.14
ACR70
    3 Months0.020.114.1 (3.1 to 5.3)<0.001
        DMARD-IR0.020.114.4 (3.3 to 5.8)<0.001
        TNF-IR0.020.075.2 (0.3 to 95.4)0.27
    6 Months0.030.185.8 (4.5 to 7.4)<0.001
        DMARD-IR0.030.185.6 (4.3 to 7.3)<0.001
        TNF-IR0.010.1210.6 (3.9 to 29.2)<0.001
    6 vs 3 Months1.4 (1.1 to 2.0)0.02
        DMARD-IR1.4 (1.1 to 1.7)0.001
        TNF-IR1.6 (0.1 to 29.3)0.75
Active control
ACR20
    3 Months0.530.591.1 (1.1 to 1.2)<0.001
    6 Months0.560.621.1 (1.0 to 1.2)0.003
    6 v 3 Months1.0 (1.0 to 1.0)0.30
ACR50
    3 Months0.240.311.3 (1.1 to 1.4)<0.001
    6 Months0.320.391.2 (1.1 to 1.3)<0.001
    6 v 3 Months0.9 (0.9 to 1.0)0.02
ACR70
    3 Months0.080.121.5 (1.1 to 1.8)0.002
    6 Months0.150.211.4 (1.3 to 1.6)<0.001
    6 v 3 Months1.0 (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.