Background
A. Activity index
| ||||||||
---|---|---|---|---|---|---|---|---|
High | Moderate | Low | Remission | |||||
DAS28 original# | > 5,1 | < 5,1 | < 3,2 | < 2,6 | ||||
DAS28 modified cut off # | > 5,5 | < 5,5 | < 3,6 | < 2,4 | ||||
SDAI## | > 26 | < 26 | < 11 | < 3,3 | ||||
CDAI### | > 22 | < 22 | < 10 | < 2,8 | ||||
B. Response criteria
| ||||||||
TJC | SJC | Patient global VAS | Patient pain VAS | Evaluator global | HAQ | ESR | CRP | |
ACR | yes | yes | yes/no | yes/no | yes/no | yes/no | yes/no | yes/no |
EULAR | yes | yes | yes | no | no | no | yes | no |
SDAI | yes | yes | yes | no | yes | no | no | yes |
CDAI | yes | yes | yes | no | yes | no | no | no |
Methods
Statistical methods
Results
All included N = 1789 | With 3 month data N = 1258 | Missing at 3 months N = 531 | ||||
---|---|---|---|---|---|---|
Mean | Std dev | Mean | Std dev | Mean | Std dev | |
Percent female | 77.2 | 77.8 | 77.8 | |||
Age | 55.9 | 13.4 | 55.6 | 13.2 | 56.3 | 13.7 |
Disease duration, years | 12.1 | 10.2 | 12.0 | 10.0 | 12.2 | 10.6 |
Ongoing DMARDs | 0.85 | 0.57 | 0.85 | 0.57 | 0.84 | 0.57 |
DAS28 (0–10) | 5.54 | 1.18 | 5.58 | 1.16 | 5.43 | 1.21 |
CDAI | 30.6 | 12.3 | 31.0 | 12.1 | 32.2 | 13.9 |
HAQ (0–3) | 1.34 | 0.64 | 1.36 | 0.64 | 1.29 | 0.62 |
CRP (mg/L) | 30.8 | 33.0 | 31.4 | 33.6 | 28.9 | 31.3 |
Baseline | |||||||
---|---|---|---|---|---|---|---|
Valid N
| DAS28 modified cut off | SDAI | CDAI | ||||
1657
|
1657
|
1681
| |||||
Reference criterion |
Valid N
| % | κ | % | κ | % | κ |
High disease activity
| |||||||
DAS28 original |
1657
| 52/35 |
0,73
| 60/27 |
0,69
| 61/24 |
0,65
|
DAS28 modified cut off |
1657
| 50/31 |
0,62
| 51/27 |
0,54
| ||
SDAI |
1672
| 67/26 |
0,83
| ||||
Moderate disease activity
| |||||||
DAS28 original |
1657
| 29/55 |
0,66
| 23/61 |
0,63
| 20/62 |
0,58
|
DAS28 modified cut off |
1657
| 25/52 |
0,52
| 21/53 |
0,42
| ||
SDAI |
1672
| 24/69 |
0,80
| ||||
Low disease activity
| |||||||
DAS28 original |
1657
| 2.7/94 |
0,64
| 1.3/96 |
0,55
| 1.3/96 |
0,54
|
DAS28 modified cut off |
1657
| 1.8/94 |
0,46
| 1.6/94 |
0,41
| ||
SDAI |
1672
| 1.7/97 |
0,81
| ||||
Remission
| |||||||
DAS28 original |
1657
| 0.6/99 |
0,91
| 0.1/99 |
0,15
| 0.1/99 |
0,15
|
DAS28 modified cut off |
1657
| 0.1/99 |
0,18
| 0.1/99 |
0,18
| ||
SDAI |
1672
| 0/100 |
1,00
| ||||
3 month
| |||||||
Valid N
|
1214
|
1224
|
1232
| ||||
High disease activity
| |||||||
DAS28 original |
1206
| 12/83 |
0,82
| 13/79 |
0,72
| 13/78 |
0.69
|
DAS28 modified cut off |
1214
| 11/82 |
0,72
| 11/80 |
0.67
| ||
SDAI |
1224
| 15/80 |
0,83
| ||||
Moderate disease activity
| |||||||
DAS28 original |
1206
| 34/50 |
0,67
| 32/46 |
0,55
| 30/45 |
0,49
|
DAS28 modified cut off |
1214
| 29/50 |
0,56
| 26/49 |
0,47
| ||
SDAI | 1224 | 35/55 |
0,79
| ||||
Low disease activity
| |||||||
DAS28 original | 1206 | 38/51 |
0,77
| 33/53 |
0,71
| 32/52 |
0,67
|
DAS28 modified cut off | 1214 | 39/47 |
0,71
| 37/46 |
0,66
| ||
SDAI | 1224 | 40/55 |
0,88
| ||||
Remission
| |||||||
DAS28 original | 1206 | 18/77 |
0,87
| 7.7/77 |
0,42
| 7.3/76 |
0,40
|
DAS28 modified cut off | 1214 | 7.1/80 |
0,47
| 6.7/80 |
0,44
| ||
SDAI | 1224 | 7.5/91 |
0,91
|
Reference criterion
| |||||||||
---|---|---|---|---|---|---|---|---|---|
EULAR | EULAR modified cut off | SDAI | CDAI | ||||||
Valid N | 1163 | 1163 | 1184 | 1195 | |||||
Valid N | % | κ | % | κ | % | κ | % | κ | |
Overall response
|
good+moderate
|
good+moderate
|
major+minor
|
major+minor
| |||||
ACR20 | 1234 | 61/22 |
0,61
| 59/24 |
0,62
| 62/19 |
0,54
| 61/19 |
0,54
|
EULAR | 1163 | 71/23 |
0,83
| 73/17 |
0,71
| 72/17 |
0,68
| ||
EULAR modified cut off | 1163 | 70/18 |
0,70
| 69/18 |
0,67
| ||||
SDAI | 1184 | 78/19 |
0,91
| ||||||
Moderate/minor response
|
moderate
|
moderate
|
minor
|
minor
| |||||
ACR50 | 1234 | 13/33 |
0,00
| 3.5/47 |
0,00
| 7.3/41 |
0,00
| 5.6/45 |
0,00
|
EULAR | 1163 | 14/54 |
0,27
| 13/43 |
0,04
| 10/46 |
0,03
| ||
EULAR modified cut off | 1163 | 11/65 |
0,31
| 8.7/68 |
0,28
| ||||
SDAI | 1184 | 20/70 |
0,74
| ||||||
Good/major response
|
good
|
good
|
major
|
major
| |||||
ACR70 | 1234 | 12/64 |
0,40
| 13/46 |
0,22
| 12/46 |
0,19
| 12/42 |
0,17
|
EULAR | 1163 | 31/43 |
0,49
| 25/38 |
0,27
| 26/36 |
0,27
| ||
EULAR modified cut off | 1163 | 45/39 |
0,69
| 47/37 |
0,69
| ||||
SDAI | 1184 | 51/42 |
0,86
|