Table 2

Clinical, functional and imaging endpoints at week 12

VariablePlacebo N=94Adalimumab N=91p Value
Mean change from baselineMean change from baseline
BASDAI (0–10)−1.0−1.90.004
Patient global assessment of disease activity (0–10 cm VAS)−0.9−2.2<0.001
Total back pain (0–10 cm VAS)−1.1−2.3<0.001
BASFI (0–10 cm VAS)−0.6−1.10.053
Inflammation/morning stiffness−1.1−2.2<0.001
CRP (mg/l)−0.3−4.3<0.001
BASMIlin (0–10)*−0.1−0.10.828
MASES (0–13)*−0.8−0.60.962
HAQ-S Disability index (0–3)*−0.1−0.30.025
SF-36 PCS (0–100)*
SPARCC MRI SI score (0–72)*−0.6−3.20.003
SPARCC MRI spinal score (0–108)*−0.2−1.80.001
  • p Value for between-group comparisons based on ANCOVA adjusted for baseline; last observation carried forward analyses unless otherwise noted.

  • N placebo/adalimumab: BASFI, 94/90; ASDAS, 91/87.

  • *Observed analyses (N placebo/adalimumab): BASMIlin (93/90); MASES (93/91); HAQ-S (90/88); SF-36 PCS (93/91); SPARCC MRI SI (84/84); SPARCC MRI spine (83/85).

  • ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMIlin, linear Bath Ankylosing Spondylitis Metrology Index; CRP, C-reactive protein; HAQ-S, Health Assessment Questionnaire modified for Spondyloarthropathies; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; MRI, magnetic resonance imaging; SF-36 PCS, Short Form-36, V.2, Health Status Survey, Physical Component Summary Score; SI, sacroiliac; SPARCC, Spondyloarthritis Research Consortium of Canada.