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Table 2 Key secondary endpoints: rates of CDAI and SDAI LDA and remission, ACR responses, improvements in HAQ-DI (primary analysis set; LOCF imputation)

From: Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etanercept in patients with moderately active rheumatoid arthritis despite DMARD therapy

 

Placebo-etanercept (N = 104)

Etanercept-etanercept (N = 106)

CDAI LDA (score ≤10), n (%)

  

 Week 2

9 (9.1)

13 (12.3)

 Week 8

16 (15.4)

31 (29.2)

 Week 12

22 (21.2)

27 (25.5)

 Week 24

43 (41.3)

49 (46.2)

CDAI remission (score ≤2.8), n (%)

  

 Week 2

1 (1.0)

2 (1.9)

 Week 8

0 (0.0)

3 (2.8)

 Week 12

1 (1.0)

4 (3.8)

 Week 24

4 (3.8)

9 (8.5)

SDAI LDA (score ≤11), n (%)

  

 Week 2

8 (8.2)

13 (12.4)

 Week 8

15 (14.4)

32 (30.2)

 Week 12

22 (21.2)

25 (23.6)

 Week 24

41 (39.4)

48 (45.3)

SDAI remission (score ≤3.3), n (%)

  

 Week 2

1 (1.0)

1 (1.0)

 Week 8

0 (0.0)

6 (5.7)

 Week 12

2 (1.9)

6 (5.7)

 Week 24

7 (6.7)

11 (10.4)

ACR20 response, n (%)

  

 Week 2

15 (14.9)

30 (28.6)

 Week 8

24 (23.1)

53 (50.0)

 Week 12

30 (28.8)

43 (40.6)

 Week 24

48 (46.2)

53 (50.0)

ACR50 response, n (%)

  

 Week 2

3 (3.0)

6 (5.7)

 Week 8

5 (4.8)

21 (19.8)

 Week 12

13 (12.5)

22 (20.8)

 Week 24

30 (28.8)

35 (33.0)

ACR70 response, n (%)

  

 Week 2

0 (0.0)

2 (1.9)

 Week 8

0 (0.0)

6 (5.7)

 Week 12

1 (1.0)

6 (5.7)

 Week 24

13 (12.5)

17 (16.0)

Change from baseline in HAQ-DI, mean score change (SD)

  

 Week 2

−0.09 (0.39)

−0.27 (0.43)

 Week 8

−0.21 (0.42)

−0.37 (0.47)

 Week 12

−0.20 (0.43)

−0.39 (0.54)

 Week 24

−0.45 (0.52)

−0.48 (0.58)

  1. CDAI: Clinical Disease Activity Index; SDAI: Simplified Disease Activity Index; LDA: low disease activity; ACR: American College of Rheumatology; HAQ-DI: Health Assessment Questionnaire Disability Index; LOCF: last observation carried forward; SD: standard deviation.