Table 4.
Measure |
Baseline |
Change from baseline to month 6 |
Remission at month 6 |
LDAS at month 6 |
||||
---|---|---|---|---|---|---|---|---|
N | Mean (SD) | N | Mean (95% CI) | N | Percent (95% CI) | N | Percent (95% CI) | |
|
Primary inefficacy |
|
||||||
DAS28 (ESR) |
129 |
5.6 (1.3) |
113 |
−1.5 (−1.7, –1.2) |
119 |
17.6 (10.8, 24.5) |
119 |
29.4 (21.2, 37.6) |
DAS28 (CRP) |
35 |
5.2 (1.3) |
26 |
−1.3 (−2.0, –0.7) |
32 |
12.5 (1.0, 24.0) |
32 |
34.4 (17.9, 50.8) |
CDAI |
140 |
32.1 (13.1) |
129 |
−13.9 (−16.3, –11.5) |
136 |
2.9 (0.1, 5.8) |
136 |
27.9 (20.4, 35.5) |
|
Secondary inefficacy |
|
||||||
DAS28 (ESR) |
249 |
5.6 (1.1) |
219 |
−1.4 (−1.6, –1.2) |
240 |
10.4 (6.6, 14.3) |
240 |
25.0 (19.5, 30.5) |
DAS28 (CRP) |
74 |
5.5 (1.3) |
55 |
−1.6 (−2.0, –1.3) |
68 |
20.6 (11.0, 30.2) |
68 |
38.2 (26.7, 49.8) |
CDAI |
295 |
32.5 (13.0) |
279 |
−15.4 (−17.1, –13.8) |
288 |
4.2 (1.9, 6.5) |
288 |
29.5 (24.2, 34.8) |
|
Safety and tolerability |
|
||||||
DAS28 (ESR) |
91 |
5.5 (1.3) |
84 |
−1.5 (−1.8, –1.2) |
98 |
18.4 (10.7, 26.0) |
98 |
29.6 (20.6, 38.6) |
DAS28 (CRP) |
27 |
4.8 (1.4) |
22 |
−1.5 (−2.2, –0.9) |
26 |
30.8 (13.0, 48.5) |
26 |
42.3 (23.3, 61.3) |
CDAI | 121 | 30.4 (13.4) | 115 | −15.2 (−17.6, –12.8) | 119 | 8.4 (3.4, 13.4) | 119 | 38.7 (29.9, 47.4) |
CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS, Disease Activity Score; ESR, erythrocyte sedimentation rate.