|
Clinical improvement as assessed by ACR criteria |
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| 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) |
||||
|
|
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| 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. | |||||||
Alten et al. Arthritis Research & Therapy 2008 10:R67 doi:10.1186/ar2438 |
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