Table 6.
PRO measure | Time point from baseline of the ATLAS study | |||||
Week 36 | Week 52 | Week 76 | Week 104 | Week 128 | Week 156 | |
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.