Assessment | Baseline value at randomisation | Duration of adalimumab exposure | ||||||||||||
24 Weeks | 1 Year | 1.5 Years | 2 Years† | |||||||||||
Placebo N = 107 (SD) | Adalimumab N = 208 (SD) | Observed (SD) n | LOCF (SD) n | Observed (SD) n | LOCF (SD) n | Observed (SD) n | LOCF (SD) n | Observed (SD) n | LOCF (SD) n | |||||
ASQoL, 0–18‡ | ||||||||||||||
Baseline value | 10.6 (4.0) | 10.2 (4.0) | 9.6 (4.6) 242 | 10.0 (4.6) 310 | 9.9 (4.6) 281 | 10.0 (4.6) 310 | 9.5 (4.6) 232 | 10.0 (4.6) 310 | 10.5 (4.3) 218 | 10.0 (4.6) 310 | ||||
Visit value | 5.9 (5.1) 242 | 6.3 (5.2) 310 | 5.6 (5.0) 281 | 6.1 (5.3) 310 | 5.2 (4.8) 232 | 6.0 (5.2) 310 | 5.2 (4.9) 218 | 5.8 (5.2) 310 | ||||||
SF-36 PCS score§ | ||||||||||||||
Baseline value | 31.8 (8.0) | 32.9 (8.0) | 33.8 (8.4) 237 | 33.1 (8.4) 304 | 33.1 (8.4) 278 | 33.2 (8.5) 308 | 33.8 (8.6) 227 | 33.2 (8.5) 308 | 32.1 (7.9) 214 | 33.2 (8.5) 308 | ||||
Visit value | 41.1 (10.2) 237 | 40.2 (10.3) 304 | 42.2 (10.7) 278 | 41.5 (10.7) 308 | 43.5 (10.5) 227 | 41.8 (10.8) 308 | 43.2 (10.8) 214 | 41.9 (10.9) 308 | ||||||
SF-36 MCS score§ | ||||||||||||||
Baseline value | 44.4 (12.0) | 43.4 (12.0) | 44.7 (11.5) 237 | 44.4 (11.7) 304 | 44.6 (11.4) 278 | 44.4 (11.6) 308 | 45.2 (11.2) 227 | 44.4 (11.6) 308 | 43.9 (11.1) 214 | 44.4 (11.6) 308 | ||||
Visit value | 48.9 (10.6) 237 | 48.5 (10.8) 304 | 49.2 (10.4) 278 | 48.3 (10.9) 308 | 49.5 (10.5) 227 | 48.3 (11.2) 308 | 49.3 (10.5) 214 | 48.6 (11.3) 308 |
*All values are the mean (SD). For observed and last observation carried forward (LOCF) analyses, the baseline value is the last observation before the first dose of adalimumab. †The majority of patients treated with placebo for the first 24 weeks of the ATLAS study did not have 2 years of exposure to adalimumab at the time of this analysis. ‡The minimum clinically important difference for the ankylosing spondylitis quality of life (ASQoL) questionnaire was a reduction of at least 1.8 points. §The minimum clinically important difference for both the Short Form 36 (SF-36) physical component summary (PCS) and mental component summary (MCS) scores was an improvement (increase) of at least 3 points. HRQoL, health-related quality of life.