Adalimumab | Placebo | Difference in change score from baseline to week 6, P value | |||
Baseline (n=25) | Change at week 6 (n=24) | Baseline (n=24) | Change at week 6 (n=23) | ||
CANDEN spine total inflammation score | 10.2 (13) | −5.7 (9.2) | 7.3 (10) | −0.8 (3.0) | 0.03 |
Vertebral body subscore | 9.5 (12) | −5.2 (8.3) | 6.9 (9.9) | −0.9 (2.6) | 0.03 |
Anterior corner subscore | 3.9 (5.6) | −2.0 (3.8) | 3.3 (4.3) | −0.3 (1.2) | 0.21 |
Posterior corner subscore | 1.5 (2.6) | −0.9 (1.8) | 1.3 (2.4) | 0.0 (0.4) | 0.01 |
Non-corner subscore | 1.5 (3.2) | −0.3 (0.8) | 0.9 (2.4) | −0.2 (0.8) | 0.21 |
Lateral corner subscore | 2.5 (3.8) | −1.9 (3.2) | 1.5 (2.5) | −0.4 (1.8) | 0.03 |
Posterior elements subscore | 0.7 (2.3) | −0.5 (1.7) | 0.4 (0.8) | 0.1 (0.6) | 0.16 |
SPARCC MRI spine index (23-DVU) | 11.0 (14) | −6.3 (10) | 8.7 (13) | −1.5 (3.7) | 0.05 |
CANDEN spine erosion score | 0.7 (1.7) | 0.0 (0.2) | 0.6 (0.9) | 0.0 (0.1) | 0.58 |
Fat Spondyloarthritis Spine Score | 7.8 (11) | 0.7 (2.7) | 3.2 (5.5) | 0.1 (0.6) | 0.35 |
CANDEN new bone formation score | 9.3 (26) | 0.2 (0.6) | 5.7 (12) | 0.3 (0.9) | 0.92 |
mSASSS | 8.0 (15) | NA | 6.3 (12) | NA | NA |
BASDAI | 6.3 (1.2) | −2.4 (2.2) | 6.4 (1.5) | −0.6 (1.8) | 0.01 |
All values as mean (SD). Significance tests for difference in change scores at week 6 between groups were calculated by Mann-Whitney U tests with continuity correction. Two patients in the adalimumab group had missing BASDAI values at week 6 and were excluded from the BASDAI results. MRI scores were the average of the two readers. Lateral corner subscore is the sum of antero-lateral and postero-lateral lesion scores.
BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CANDEN, Canada-Denmark; DVU, discovertebral unit; mSASSS, modified Stoke Ankylosing Spondylitis Spine Score; NA, not available; PE, posterior elements; SPARCC, Spondyloarthritis Research Consortium of Canada.