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Table 2 Clinical improvement as assessed by ACR criteria

From: The human anti-IL-1β monoclonal antibody ACZ885 is effective in joint inflammation models in mice and in a proof-of-concept study in patients with rheumatoid arthritis

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

  1. 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.