| Assessment | Baseline value at randomisation | Duration of adalimumab exposure | ||||||||
| 12 Weeks | 24 Weeks | 1 Year | 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 | |
| Patient’s global assessment of disease activity, 0–10 cm VAS | ||||||||||
| Baseline value | 6.5 (2.0) | 6.3 (2.2) | 6.2 (2.3) 303 | 6.2 (2.3) 309 | 6.2 (2.3) 291 | 6.2 (2.3) 309 | 6.2 (2.3) 275 | 6.2 (2.3) 309 | 6.3 (2.1) 172 | 6.2 (2.3) 309 |
| Visit value | 3.6 (2.8) 303 | 3.7 (2.8) 309 | 3.1 (2.6) 291 | 3.2 (2.7) 309 | 2.8 (2.6) 275 | 3.1 (2.8) 309 | 2.3 (2.5) 172 | 2.9 (2.8) 309 | ||
| Total back pain, 0–10 cm VAS | ||||||||||
| Baseline value | 6.7 (2.2) | 6.4 (2.2) | 6.2 (2.4) 304 | 6.2 (2.4) 310 | 6.2 (2.4) 292 | 6.2 (2.4) 310 | 6.2 (2.4) 276 | 6.2 (2.4) 310 | 6.4 (2.1) 173 | 6.2 (2.4) 310 |
| Visit value | 3.7 (2.9) 304 | 3.8 (2.9) 310 | 3.1 (2.7) 292 | 3.2 (2.7) 310) | 2.7 (2.6) 276 | 3.1 (2.8) 310 | 2.2 (2.5) 173 | 2.9 (2.9) 310 | ||
| BASFI, 0–10 cm VAS | ||||||||||
| Baseline value | 5.6 (2.2) | 5.2 (2.2) | 5.2 (2.4) 292 | 5.2 (2.4) 310 | 5.2 (2.3) 292 | 5.2 (2.4) 310 | 5.2 (2.4) 276 | 5.2 (2.4) 310 | 5.3 (2.2) 173 | 5.2 (2.4) 310 |
| Visit value | 3.5 (2.6) 305 | 3.6 (2.6) 310 | 3.1 (2.5) 292 | 3.2 (2.5) 310 | 2.8 (2.5) 276 | 3.1 (2.6) 310 | 2.4 (2.3) 173 | 2.9 (2.5) 310 | ||
| Inflammation (mean of questions 5 and 6 of the BASDAI), 0–10 cm VAS | ||||||||||
| Baseline value | 6.7 (1.9) | 6.7 (2.0) | 6.4 (2.3) 304 | 6.4 (2.3) 310 | 6.4 (2.3) 292 | 6.4 (2.3) 310 | 6.3 (2.3) 276 | 6.4 (2.3) 310 | 6.7 (2.0) 173 | 6.4 (2.3) 310 |
| Visit value | 3.5 (2.7) 304 | 3.6 (2.8) 310 | 2.8 (2.4) 292 | 3.0 (2.5) 310 | 2.5 (2.4) 276 | 2.8 (2.6) 310 | 2.1 (2.3) 173 | 2.7 (2.6) 310 | ||
| BASDAI, 0–10 cm VAS | ||||||||||
| Baseline value | 6.3 (1.7) | 6.3 (1.7) | 6.0 (2.0) 304 | 6.0 (2.0) 310 | 6.0 (2.0) 292 | 6.0 (2.0) 310 | 5.9 (2.0) 276 | 6.0 (2.0) 310 | 6.3 (1.7) 173 | 6.0 (2.0) 310 |
| Visit value | 3.6 (2.5) 304 | 3.6 (2.5) 310 | 3.0 (2.4) 292 | 3.2 (2.5) 310 | 2.7 (2.3) 276 | 3.0 (2.5) 310 | 2.4 (2.3) 173 | 2.9 (2.5) 310 | ||
| C-reactive protein, mg/dl‡ | ||||||||||
| Baseline value | 2.2 (2.9) | 1.8 (2.2) | 1.8 (2.3) 299 | 1.8 (2.3) 307 | 1.9 (2.4) 286 | 1.8 (2.3) 307 | 1.9 (2.4) 270 | 1.8 (2.3) 307 | 1.8 (2.4) 84 | 1.8 (2.3) 307 |
| Visit value | 0.5 (1.1) 299 | 0.6 (1.3) 307 | 0.6 (1.3) 286 | 0.6 (1.4) 307 | 0.6 (1.1) 270 | 0.6 (1.3) 307 | 0.5 (0.9) 84 | 0.7 (1.4) 307 | ||
| BASMI, 0–10 | ||||||||||
| Baseline value | 4.2 (2.1) | 3.8 (2.2) | 3.9 (2.2) 296 | 3.9 (2.2) 309 | 4.0 (2.2) 255 | 3.9 (2.2) 310 | 3.9 (2.2) 273 | 3.9 (2.2) 310 | 3.9 (2.2) 173 | 3.9 (2.2) 310 |
| Visit value | 3.5 (2.3) 296 | 3.5 (2.3) 309 | 3.4 (2.4) 255 | 3.3 (2.4) 310 | 3.2 (2.2) 273 | 3.2 (2.3) 310 | 3.1 (2.2) 173 | 3.3 (2.3) 310 | ||
| Chest expansion, cm | ||||||||||
| Baseline value | 3.0 (1.9) | 3.4 (1.8) | 3.4 (1.9) 277 | 3.4 (1.9) 306 | 3.4 (1.8) 237 | 3.4 (1.9) 306 | 3.4 (1.9) 234 | 3.4 (1.9) 306 | 4.1 (2.1) 260 | 3.4 (1.9) 306 |
| Visit value | 3.8 (2.2) 277 | 3.8 (2.2) 277 | 3.7 (2.0) 237 | 3.7 (2.1) 306 | 4.1 (6.7) 234 | 4.0 (5.9) 306 | 4.1 (2.1) 260 | 4.0 (2.1) 306 | ||
| MASES, 0–13 | ||||||||||
| Baseline value | 6.7 (7.5) | 6.4 (6.8) | 5.9 (7.0) 308 | 5.9 (7.0) 308 | 5.8 (6.9) 294 | 5.9 (7.0) 309 | 5.7 (6.9) 279 | 5.9 (7.0) 309 | 6.0 (7.1) 217 | 5.9 (7.0) 309 |
| Visit value | 3.7 (6.0) 308 | 3.7 (6.0) 308 | 2.8 (5.1) 294 | 3.0 (5.3) 309 | 2.4 (4.6) 279 | 2.8 (5.6) 309 | 2.2 (4.4) 217 | 2.7 (5.5) 309 | ||
| Swollen joint count, 0–44 | ||||||||||
| Baseline value | 1.4 (2.8) | 1.5 (3.3) | 1.4 (3.1) 297 | 1.3 (3.0) 311 | 1.4 (3.1) 292 | 1.3 (3.0) 311 | 1.3 (3.1) 264 | 1.3 (3.0) 311 | 1.5 (3.2) 216 | 1.3 (3.0) 311 |
| Visit value | 1.1 (3.1) 297 | 1.2 (3.3) 311 | 1.0 (2.5) 292 | 1.1 (2.8) 311 | 0.9 (2.7) 264 | 1.1 (3.2) 311 | 0.8 (3.1) 216 | 0.9 (3.4) 311 | ||
| Tender joint count, 0–46 | ||||||||||
| Baseline value | 5.6 (6.8) | 5.1 (7.4) | 5.1 (7.5) 297 | 5.1 (7.7) 311 | 4.8 (7.1) 292 | 5.1 (7.7) 311 | 4.4 (6.5) 264 | 5.1 (7.7) 311 | 4.9 (7.2) 218 | 5.1 (7.7) 311 |
| Visit value | 4.0 (7.8) 297 | 4.0 (7.8) 311 | 3.4 (7.0) 292 | 3.8 (7.3) 311 | 2.7 (5.8) 264 | 3.6 (7.2) 311 | 2.7 (6.1) 218 | 3.5 (7.5) 311 | ||
*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. ‡Normal range using a ultrasensitive C-reactive protein assay is 0.007–0.49 mg/dl. BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; VAS, visual analogue scale.