Table 3.
Difference in adjusted ACR response rates (PP population, N = 230)
| Treatment | N | Adjusted response rate (%) | Comparison | Difference in percent adjusted response rate (95% CI) | |
|---|---|---|---|---|---|
| ACR20 | DRL_RI | 82 | 72.0 | DRL_RI–RTX-US | 2.8 (−11.18 to 16.81) |
| RTX-US | 81 | 69.1 | DRL_RI–RTX-EU | 3.6 (−10.54 to 17.73) | |
| RTX-EU | 79 | 68.4 | RTX-US–RTX-EU | 0.8 (−13.58 to 15.15) | |
| ACR50 | DRL_RI | 82 | 43.9 | DRL_RI–RTX-US | 4.4 (−10.73 to 19.52) |
| RTX-US | 81 | 39.5 | DRL_RI–RTX-EU | 0.9 (−14.45 to 16.18) | |
| RTX-EU | 79 | 43.0 | RTX-US–RTX-EU | −3.5 (−18.78 to 11.72) | |
| ACR70 | DRL_RI | 82 | 17.1 | DRL_RI–RTX-US | 2.3 (−8.97 to 13.49) |
| RTX-US | 81 | 14.8 | DRL_RI–RTX-EU | 1.9 (−9.47 to 13.24) | |
| RTX-EU | 79 | 15.2 | RTX-US–RTX-EU | −0.4 (−11.44 to 10.69) |
Adjusted response rates for the treatment arms using the logistic regression analysis including treatment, gender, and region as fixed effects and patients as a random effect in the model
ACR20, ACR50, and ACR70: proportion of the patients with at least 20%, 50%, or 70% improvement in counts of tender and swollen joints and in 3 of the following: patient’s assessment of pain, patient’s global assessment of disease activity, patient’s assessment of physical function, the physician’s global assessment of disease activity, and acute phase reactant
Percentages = (number of responders/number of patients in the corresponding visit) × 100
ACR American College of Rheumatology, CI confidence interval, PP per-protocol, RTX-EU MabThera®, RTX-US Rituxan®