Table 3

Construct validity as assessed by change in scores from baseline to week 6 in adalimumab group compared with placebo group

AdalimumabPlaceboDifference 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 score10.2 (13)−5.7 (9.2)7.3 (10)−0.8 (3.0)0.03
 Vertebral body subscore9.5 (12)−5.2 (8.3)6.9 (9.9)−0.9 (2.6)0.03
  Anterior corner subscore3.9 (5.6)−2.0 (3.8)3.3 (4.3)−0.3 (1.2)0.21
  Posterior corner subscore1.5 (2.6)−0.9 (1.8)1.3 (2.4)0.0 (0.4)0.01
  Non-corner subscore1.5 (3.2)−0.3 (0.8)0.9 (2.4)−0.2 (0.8)0.21
   Lateral corner subscore2.5 (3.8)−1.9 (3.2)1.5 (2.5)−0.4 (1.8)0.03
 Posterior elements subscore0.7 (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 score0.7 (1.7)0.0 (0.2)0.6 (0.9)0.0 (0.1)0.58
Fat Spondyloarthritis Spine Score7.8 (11)0.7 (2.7)3.2 (5.5)0.1 (0.6)0.35
CANDEN new bone formation score9.3 (26)0.2 (0.6)5.7 (12)0.3 (0.9)0.92
mSASSS8.0 (15)NA6.3 (12)NANA
BASDAI6.3 (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.