Table 2.
Assessor (time point) | Response | ACZ885 | Placebo (n = 15) | P value (10 mg/kg versus placebo) | |||
0.3 mg/kg (n = 6) | 1.0 mg/kg (n = 6) | 3.0 mg/kg (n = 6) | 10 mg/kg (n = 19/20a) | ||||
Blinded observer (day 43) | ACR20 | 1 (17%) | 0 (0%) | 4 (67%) | 6 (32%) | 1 (7%) | 0.085 |
ACR50 | 0 (0%) | 0 (0%) | 1 (17%) | 3 (16%) | 0 (0%) | 0.162 | |
ACR70 | 0 (0%) | 0 (0%) | 0 (0%) | 2 (11%) | 0 (0%) | 0.305 | |
Investigator (any time within 6 weeks of treatment start) | ACR20 | 3 (50%) | 2 (33%) | 4 (67%) | 10 (50%) | 3 (20%) | 0.070 |
ACR50 | 0 (0%) | 0 (0%) | 2 (33%) | 4 (20%) | 0 (0%) | 0.093 | |
ACR70 | 0 (0%) | 0 (0%) | 0 (0%) | 3 (15%) | 0 (0%) | 0.174 |
Shown are the number and percentage of patients achieving 20%, 50%, or 70% improvement in terms of American College of Rheumatology (ACR) criteria (ACR20, ACR50 and ACR70, respectively) at day 43 as assessed by a blinded observer and at any time point within 6 weeks of treatment start as assessed by the investigator. aNote that for one patient in the 10 mg/kg treatment group, the ACR criteria assessment by a blinded observer was not conducted at day 43.