Table 6 |
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|
Mean change in PRO measures from week 24 to each follow-up visit |
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|
PRO measure |
Time point from baseline of the ATLAS study |
|||||
|
|
||||||
|
Week 36 |
Week 52 |
Week 76 |
Week 104 |
Week 128 |
Week 156 |
|
|
|
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|
BASDAI |
||||||
|
n |
278 |
274 |
270 |
262 |
242 |
236 |
|
Mean change ± SD |
-0.2 ± 1.41 |
-0.4 ± 1.59 |
-0.5 ± 1.65 |
-0.6 ± 1.87 |
-0.6 ± 1.80 |
-0.5 ± 2.88 |
|
P-valuea |
0.004 |
< 0.001 |
< 0.001 |
< 0.001 |
< 0.001 |
0.009 |
|
BASFI |
||||||
|
n |
278 |
274 |
270 |
261 |
242 |
236 |
|
Mean change ± SD |
-1.1 ± 10.68 |
-3.1 ± 13.07 |
-4.4 ± 14.22 |
-5.0 ± 15.90 |
-4.6 ± 15.87 |
-5.5 ± 14.27 |
|
P-valuea |
0.100 |
< 0.001 |
< 0.001 |
< 0.001 |
< 0.001 |
< 0.001 |
|
SF-36 PCS |
||||||
|
n |
b |
268 |
267 |
259 |
232 |
231 |
|
Mean change ± SD |
b |
1.8 ± 6.71 |
2.2 ± 7.35 |
2.4 ± 7.60 |
2.5 ± 8.54 |
2.6 ± 7.94 |
|
P-valuea |
b |
< 0.001 |
< 0.001 |
< 0.001 |
< 0.001 |
< 0.001 |
|
SF-36 MCS |
||||||
|
n |
b |
268 |
267 |
259 |
232 |
231 |
|
Mean change ± SD |
b |
0.7 (7.55) |
0.1 (7.50) |
0.6 (7.37) |
-1.2 (8.60) |
0.2 (8.29) |
|
P-valuea |
b |
0.150 |
0.892 |
0.176 |
0.033 |
0.718 |
|
ASQOL |
||||||
|
n |
b |
274 |
270 |
263 |
242 |
236 |
|
Mean change ± SD |
b |
-0.5 (2.73) |
-0.7 (2.78) |
-1.0 (3.01) |
-0.8 (3.43) |
-1.0 (3.07) |
|
P-valuea |
b |
0.002 |
< 0.001 |
< 0.001 |
< 0.001 |
< 0.001 |
|
|
||||||
|
aP-values based on paired Student t-test. bMeasure not assessed at this time point. ASQOL = AS Quality of Life Questionnaire; ATLAS = Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS; BASDAI = Bath AS Disease Activity Index; BASFI = Bath AS Functional Index; MCS = Mental Component Summary; PCS = Physical Component Summary; PRO = patient-reported outcome; SF-36 = Short Form-36 Health Survey. |
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|
van der Heijde et al. Arthritis Research & Therapy 2009 11:R124 doi:10.1186/ar2790 |
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