Baseline demographics and disease characteristics for the full analysis set and subgroups of patients fulfilling the imaging or clinical arms of the Assessment of Spondyloarthritis international Society axial SpA criteria
| All | Imaging (MRI+)* | Clinical (HLA-B27+, MRI−)† | ||||
|---|---|---|---|---|---|---|
| Placebo N=94 | Adalimumab N=91 | Placebo N=43 | Adalimumab N=46 | Placebo N=48 | Adalimumab N=45 | |
| Demographics | ||||||
| Female, n (%) | 54 (57) | 47 (52) | 22 (51) | 26 (57) | 29 (60) | 21 (47) |
| White, n (%) | 91 (97) | 91 (100) | 41 (95) | 46 (100) | 47 (98) | 45 (100) |
| Age (years) | 38.4 (10.4) | 37.6 (11.3) | 38.9 (8.7) | 36.8 (9.9) | 38.1 (11.7) | 38.5 (12.6) |
| Disease characteristics | ||||||
| Symptom duration (years) | 10.1 (8.8) | 10.1 (9.0) | 10.1 (7.2) | 9.3 (9.0) | 10.2 (10.1) | 11.0 (9.1) |
| Duration since diagnosis (years) | 3.0 (3.8) | 2.7 (4.2) | 3.2 (4.4) | 2.4 (3.9) | 3.0 (3.4) | 3.1 (4.6) |
| Concomitant DMARD use, n (%) | 16 (17) | 17 (19) | 6 (14) | 5 (11) | 9 (19) | 12 (27) |
| Concomitant NSAID use, n (%) | 74 (79) | 72 (79) | 32 (74) | 38 (83) | 40 (83) | 34 (76) |
| History of SpA features, n (%) | ||||||
| Inflammatory back pain | 91 (97) | 88 (97) | 41 (95) | 43 (93) | 47 (98) | 45 (100) |
| HLA-B27 positive | 70 (74) | 75 (82) | 22 (51) | 30 (65) | 48 (100) | 45 (100) |
| Good prior response to NSAIDs | 70 (74) | 64 (70) | 34 (79) | 32 (70) | 34 (71) | 32 (71) |
| Arthritis (past or present) | 49 (52) | 32 (35) | 22 (51) | 16 (35) | 24 (50) | 16 (36) |
| Elevated CRP‡ | 36 (38) | 36 (40) | 15 (35) | 21 (46) | 19 (40) | 15 (33) |
| Heel enthesitis (past or present) | 38 (40) | 36 (40) | 19 (44) | 17 (37) | 19 (40) | 19 (42) |
| Family history of SpA | 23 (25) | 28 (31) | 6 (14) | 9 (20) | 17 (36) | 19 (42) |
| Anterior uveitis (past or present) | 10 (11) | 12 (13) | 6 (14) | 5 (11) | 4 (8) | 7 (16) |
| Dactylitis (past or present) | 10 (11) | 10 (11) | 7 (16) | 6 (13) | 3 (6) | 4 (9) |
| Inflammatory bowel disease (past or present) | 6 (6) | 4 (4) | 3 (7) | 3 (7) | 3 (6) | 1 (2) |
| BASDAI (0–10) | 6.5 (1.6) | 6.4 (1.5) | 6.4 (1.3) | 6.2 (1.6) | 6.6 (1.7) | 6.6 (1.4) |
| ASDAS | 3.4 (0.8) | 3.2 (0.8) | 3.2 (0.6) | 3.3 (0.9) | 3.4 (0.9) | 3.2 (0.7) |
| Patient global assessment of disease activity (0–10 cm VAS) | 6.8 (1.9) | 6.8 (1.8) | 6.7 (1.9) | 6.8 (1.9) | 6.8 (1.8) | 6.7 (1.7) |
| Total back pain (0–10 cm VAS) | 7.0 (1.7) | 6.9 (1.8) | 6.9 (1.8) | 7.0 (1.9) | 6.9 (1.7) | 6.8 (1.7) |
| BASFI (0–10 cm VAS) | 4.9 (2.3) | 4.5 (1.9) | 4.6 (2.3) | 4.4 (2.1) | 5.0 (2.3) | 4.6 (1.8) |
| Inflammation/morning stiffness§ (0–10) | 6.7 (2.1) | 6.5 (2.0) | 6.5 (1.9) | 6.3 (2.0) | 6.8 (2.3) | 6.6 (1.9) |
| CRP¶ (mg/l) | 7.6 (10.2) | 6.8 (11.8) | 6.3 (9.1) | 7.4 (9.7) | 8.8 (11.3) | 6.2 (13.8) |
| Elevated baseline CRP, n (%) | 37 (39) | 29 (32) | 15 (35) | 18 (39) | 20 (42) | 11 (24) |
| MASES (0–13) | 3.9 (3.4) | 3.5 (3.6) | 3.6 (3.4) | 4.0 (3.8) | 4.2 (3.5) | 2.8 (3.5) |
| BASMIlin (0–10) | 2.7 (1.2) | 2.7 (1.3) | 2.6 (1.1) | 2.6 (1.3) | 2.7 (1.1) | 2.8 (1.2) |
| SF-36 PCS (0–100) | 33.1 (8.3) | 33.9 (7.7) | 32.9 (7.9) | 34.0 (7.5) | 33.3 (8.6) | 33.8 (8.0) |
| HAQ-S (0–3) | 1.1 (0.6) | 1.0 (0.6) | 1.1 (0.6) | 1.0 (0.6) | 1.1 (0.5) | 1.0 (0.5) |
| SPARCC MRI sacroiliac joint score (0–72) | 4.7 (9.9) | 5.1 (9.5) | 7.3 (12.9) | 8.5 (12.1) | 2.5 (5.7) | 1.6 (3.5) |
| SPARCC MRI spinal score (0–108) | 4.6 (6.3) | 4.1 (5.3) | 4.4 (6.5) | 4.5 (6.3) | 4.6 (6.2) | 3.6 (3.9) |
All values are mean (SD) unless otherwise indicated.
N: ASDAS, 91/87 placebo/adalimumab; BASFI, 90 adalimumab; BASMI, 90 adalimumab; SPARCC SI, 91 placebo, SPARCC spine, 90 placebo.
*Past or present sacroiliitis on MRI suggestive of axial SpA6 based on assessment by the local radiologist/rheumatologist.
†Patients who did not have past or present sacroiliitis on MRI based on assessment by the local radiologist/rheumatologist but were HLA-B27 positive; after randomisation, three patients were found to have neither a positive MRI nor a positive HLA-B27.
‡Based on data obtained in the medical history for the presence of CRP concentration above upper normal limit in the presence of back pain.
§Mean of BASDAI questions 5 and 6.
¶Combined CRP levels including both standard CRP that has been converted to mg/l units and high-sensitivity CRP values.
ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMIlin, Bath Ankylosing Spondylitis Metrology Index-linear; CRP, C-reactive protein; DMARD, disease-modifying anti-rheumatic drug; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; MRI, magnetic resonance imaging; NSAIDs, nonsteroidal anti-inflammatory drugs; SpA, spondyloarthritis; SPARCC, Spondyloarthritis Research Consortium of Canada; VAS, visual analogue scale.