|
FAS, n (%)
|
PPS, n (%)
|
---|
ACR70
|
ACR50
|
ACR20
|
ACR70
|
ACR50
|
ACR20
|
---|
TLHS 4.8 g
|
6 (10.2)
|
24 (40.7)**,****
|
45 (76.3)*,***
|
6 (11.3)
|
23 (43.4)**,****
|
44 (83.0)**,****
|
TLHS 3.6 g
|
2 (3.4)
|
14 (23.7)
|
43 (72.9)*
|
2 (3.7)
|
14 (25.9)
|
42 (77.8)*,***
|
TLHS 2.4 g
|
1 (1.7)
|
9 (15.3)
|
33 (55.9)
|
1 (1.8)
|
9 (15.8)
|
33 (57.9)
|
Placebo
|
3 (5.1)
|
8 (13.6)
|
32 (54.2)
|
3 (5.8)
|
8 (15.4)
|
29 (55.8)
|
-
ACR American College of Rheumatology response criteria, FAS full analysis set, PPS per protocol set
- *P < 0.05 versus the placebo group
- **P < 0.01 versus the placebo group
- ***P < 0.05 versus the 2.4 g group
- ****P < 0.01 versus the 2.4 g group