Clinical, functional and imaging endpoints at week 12
| Variable | Placebo N=94 | Adalimumab N=91 | p Value |
|---|---|---|---|
| Mean change from baseline | Mean change from baseline | ||
| BASDAI (0–10) | −1.0 | −1.9 | 0.004 |
| ASDAS | −0.3 | −1.0 | <0.001 |
| 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 | −1.1 | 0.053 |
| Inflammation/morning stiffness | −1.1 | −2.2 | <0.001 |
| CRP (mg/l) | −0.3 | −4.3 | <0.001 |
| BASMIlin (0–10)* | −0.1 | −0.1 | 0.828 |
| MASES (0–13)* | −0.8 | −0.6 | 0.962 |
| HAQ-S Disability index (0–3)* | −0.1 | −0.3 | 0.025 |
| SF-36 PCS (0–100)* | 2.0 | 5.5 | 0.001 |
| SPARCC MRI SI score (0–72)* | −0.6 | −3.2 | 0.003 |
| SPARCC MRI spinal score (0–108)* | −0.2 | −1.8 | 0.001 |
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.