Table 4 |
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|
Efficacy outcomesa from the extension phase of the study: weeks 12 to 82 (intention-to-treat population) |
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|
Parameter |
W12 |
W24 |
W36 |
W48 |
W60 |
W72 |
W84 |
|
|
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|
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%) |
|
|
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|
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. |
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|
Tebib et al. Arthritis Research & Therapy 2009 11:R95 doi:10.1186/ar2740 |
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