Table 4

Efficacy outcomesa from the extension phase of the study: weeks 12 to 82 (intention-to-treat population)

Parameter

W12

W24

W36

W48

W60

W72

W84


ACR, number (percentage) of patients

n = 27

n = 7

n = 9

n = 8

n = 8

n = 9

n = 8

ACR20b

15 (56%)

6 (86%)

7 (78%)

5 (63%)

6 (75%)

6 (67%)

7 (88%)

ACR50b

9 (33%)

2 (27%)

4 (44%)

3 (38%)

6 (75%)

3 (33%)

5 (63%)

ACR70

3 (11%)

1 (14%)

2 (22%)

1 (13%)

3 (38%)

2 (22%)

2 (25%)

ACR90

0 (0%)

0 (0%)

1 (11%)

0 (0%)

2 (25%)

1 (11%)

1 (13%)

ACRn

n = 27

n = 7

n = 9

n = 8

n = 8

n = 9

n = 8

Mean ± SD

31.6 ± 33.5

36.0 ± 29.0

45.9 ± 32.3

30.9 ± 36.7

58.3 ± 31.4

35.6 ± 41.3

50.9 ± 38.0

Median

42.9

40.7

45.5

40.0

64.9

39.7

55.0

Range

-40.0–87.5

-16.7–73.0

-3.8–93.3

-20.0–70.9

10.0–93.3

-27.8–97.4

-17.6–98.8

CRP, number (percentage) of patients

n = 28

n = 7

n = 12

n = 9

n = 7

n = 9

n = 8

Improvement > 50%

14 (50%)

5 (71%)

9 (75%)

6 (67%)

3 (43%)

6 (68%)

5 (63%)

25% < improvement ≤ 50%

3 (11%)

0 (0%)

1 (8%)

0 (0%)

3 (43%)

1 (11%)

1 (13%)

0% < improvement ≤ 25%

5 (18%)

1 (14%)

1 (8%)

1 (11%)

1 (14%)

1 (11%)

1 (13%)

Stable

3 (11%)

1 (14%)

1 (8%)

0 (0%)

0 (0%)

0 (0%)

0 (0%)

Deterioration

3 (11%)

0 (0%)

0 (0%)

2 (22%)

0 (0%)

1 (11%)

1 (13%)

DAS28

n = 24

n = 4

n = 5

n = 6

n = 7

n = 7

n = 4

Mean ± SD

4.6 ± 1.3

5.2 ± 1.7

4.4 ± 1.9

4.7 ± 2.1

3.3 ± 1.5

3.5 ± 1.5

3.1 ± 1.6

Median

4.4

4.9

4.1

4.4

2.6

3.0

2.5

Range

0.5–7.0

3.6–7.5

2.3–7.5

2.7–8.7

1.7–5.3

1.6–6.1

1.9–5.5

DAS28 < 2.6, number (percentage) of patients

1 (4%)

0 (0%)

1 (20%)

0 (0%)

4 (57%)

1 (14%)

2 (50%)

DAS28 ≤ 3.2, number (percentage) of patients

1 (4%)

0 (0%)

1 (20%)

2 (33%)

4 (57%)

4 (57%)

3 (75%)


aResults from extension phase are preliminary. bPrimary efficacy outcome. American College of Rheumatology (ACR) results are presented as the cumulative number of patients reaching each ACR level. ACR20/50/70/90, American College of Rheumatology 20%/50%/70%/90% improvement criteria; ACRn, index of improvement in rheumatoid arthritis; DAS28, disease activity score using 28 joint counts; CRP, C-reactive protein; SD, standard deviation; W, week.

Tebib et al. Arthritis Research & Therapy 2009 11:R95   doi:10.1186/ar2740

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