Table 1.
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.