Mean change from baseline (LOCF) | |||||||
---|---|---|---|---|---|---|---|
Patient's VAS disease activity | Patient's VAS pain | HAQ-DI | FACIT | SF-36 PCS | SF-36 MCS | ||
DARWIN 1 | |||||||
PBO (N=86) | Wk12 | −16.7 | −16.9 | −0.38 | 5.6 | 3.2 | 4.3 |
Wk24 | −17.9 | −17 | −0.37 | 6.0 | 2.8 | 4.7 | |
200mg qd (N=86) | Wk12 | −34.2*** | −31.4** | −0.75*** | 11.4*** | 8.9*** | 8.1 |
Wk24 | −34.9** | −34.6*** | −0.82*** | 11.6** | 9.7*** | 7.2 | |
100mg bid (N=84) | Wk12 | −35.6*** | −37.9*** | −0.84*** | 11.3*** | 10.5*** | 6.2 |
Wk24 | −39.1*** | −37.9*** | −0.90*** | 12.8*** | 11.6*** | 7.1 | |
DARWIN 2 | |||||||
PBO (N=72) | Wk12 | −11.5 | −13.3 | −0.23 | 3.9 | 3.0 | 2.7 |
Wk24 | – | – | – | – | – | – | |
200mg qd (N=69) | Wk12 | −28.2*** | −31.3*** | −0.74*** | 11.2*** | 8.6*** | 6.8** |
Wk24 | −35.1 | −37.7 | −0.85 | 13.7 | 9.7 | 8.5 |
*p<0.05; **p<0.01; ***p<0.001 vs. PBO. Subjects who switched at wk 12 were handled as if they discontinued at wk 12. In DARWIN 2 statistical comparison vs. PBO is not possible after wk 12.