Table 4.
Time point from baseline of the ATLAS study | |||||||
PRO measure | Week 24 | Week 36 | Week 52 | Week 76 | Week 104 | Week 128 | Week 156 |
BASDAI | |||||||
n | 288 | 278 | 274 | 270 | 262 | 242 | 236 |
Mean ± SD change | -3.1 ± 2.42 | -3.4 ± 2.41 | -3.5 ± 2.55 | -3.8 ± 2.33 | -3.9 ± 2.44 | -3.9 ± 2.39 | -3.9 ± 3.39 |
BASFI | |||||||
n | 288 | b | 274 | 270 | 261 | 242 | 236 |
Mean ± SD change | -2.2 ± 1.91 | b | -2.6 ± 2.04 | -2.8 ± 2.10 | -2.9 ± 2.14 | -2.9 ± 2.17 | -3.0 ± 2.10 |
SF-36 PCS | |||||||
n | 284 | b | 265 | 263 | 255 | 229 | 227 |
Mean ± SD change | 8.2 ± 9.01 | b | 10.19 ± 9.50 | 10.8 ± 9.88 | 11.0 ± 9.88 | 11.3 ± 9.68 | 11.6 ± 9.65 |
SF-36 MCS | |||||||
n | 284 | b | 265 | 263 | 255 | 229 | 227 |
Mean ± SD change | 4.8 ± 10.27 | b | 5.6 ± 10.35 | 5.1 ± 11.06 | 5.7 ± 10.96 | 4.1 ± 10.84 | 5.6 ± 11.59 |
SF-36 Physical Function | |||||||
n | 287 | b | 273 | 268 | 261 | 241 | 235 |
Mean ± SD change | 15.6 ± 20.99 | b | 19.5 ± 21.38 | 21.8 ± 21.79 | 21.9 ± 22.26 | 22.2 ± 22.34 | 23.3 ± 21.94 |
SF-36 Role–Physical | |||||||
n | 288 | b | 272 | 270 | 263 | 237 | 232 |
Mean ± SD change | 30.3 ± 40.48 | b | 37.2 ± 40.81 | 35.2 ± 40.72 | 39.1 ± 41.75 | 36.1 ± 42.39 | 37.8 ± 43.90 |
SF-36 Bodily Pain | |||||||
n | 288 | b | 274 | 270 | 263 | 237 | 233 |
Mean ± SD change | 24.0 ± 21.78 | b | 29.0 ± 22.96 | 29.7 ± 23.24 | 29.9 ± 23.74 | 31.8 ± 24.42 | 31.7 ± 24.33 |
SF-36 General Health | |||||||
n | 287 | b | 270 | 266 | 260 | 237 | 234 |
Mean ± SD change | 8.7 ± 17.37 | b | 11.3 ± 18.68 | 12.7 ± 19.25 | 12.5 ± 19.92 | 12.0 ± 18.84 | 12.7 ± 18.71 |
SF-36 Vitality | |||||||
n | 288 | b | 274 | 268 | 263 | 242 | 236 |
Mean ± SD change | 16.3 ± 19.82 | b | 19.5 ± 19.96 | 20.1 ± 19.65 | 20.4 ± 20.05 | 18.4 ± 19.85 | 20.1 ± 19.70 |
SF-36 Social Function | |||||||
n | 288 | b | 274 | 270 | 263 | 242 | 236 |
Mean ± SD change | 16.1 ± 23.88 | b | 19.7 ± 24.50 | 18.5 ± 23.73 | 20.6 ± 25.36 | 17.9 ± 26.01 | 22.3 ± 25.16 |
SF-36 Role–Emotional | |||||||
n | 286 | b | 271 | 268 | 260 | 235 | 230 |
Mean ± SD change | 17.2 ± 41.24 | b | 21.0 ± 44.40 | 19.5 ± 46.74 | 21.5 ± 46.01 | 16.9 ± 44.80 | 20.0 ± 46.06 |
SF-36 Mental Health | |||||||
n | 288 | b | 274 | 268 | 263 | 242 | 236 |
Mean ± SD change | 8.8 ± 16.52 | b | 10.1 ± 17.15 | 10.2 ± 17.50 | 10.6 ± 16.63 | 8.7 ± 16.96 | 10.5 ± 18.32 |
ASQOL | |||||||
n | 288 | b | 274 | 270 | 263 | 242 | 236 |
Mean ± SD change | -4.1 ± 4.23 | b | -4.8 ± 4.41 | -5.0 ± 4.32 | -5.4 ± 4.28 | -5.3 ± 4.35 | -5.4 ± 4.36 |
aAll values P < 0.001 compared with baseline 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; SD = standard deviation; SF-36 = Short Form-36 Health Survey.