Table 1.
Demographics and baseline disease characteristics
| Etanercept (EMBARK) N = 163a |
Control (DESIR) N = 76a |
P value | Control (DESIR) excludedb N = 22 |
|
|---|---|---|---|---|
| Age, y | 31.7 (7.9) | 31.7 (7.5) | 0.94c | 31.9 (6.7) |
| Male, n/N (%) | 105/163 (64.4) | 45/76 (59.2) | 0.44d | 12/22 (54.5) |
| Symptom duration, years | 2.4 (1.8) | 1.5 (0.9) | < 0.001c | 1.5 (0.9) |
| Current smoker, n/N (%) | 37/163 (22.7) | 29/75 (38.7) | 0.01d | 5/22 (22.7) |
| HLA-B27(+), n/N (%) | 121/157 (77.1) | 66/76 (86.8) | 0.08d | 17/22 (77.3) |
| BASDAI (0–10) | 6.0 (1.8) | 3.4 (2.0) | < 0.001c | 4.5 (2.1) |
| ASDAS | 3.0 (1.0) | 2.1 (0.9) | < 0.001c | 2.6 (0.9) |
| BASFI (0–10 cm VAS) | 4.1 (2.4) | 2.0 (1.9) | < 0.001c | 3.1 (2.9) |
| CRP, mg/L | 7.4 (11.5) | 6.0 (8.1) | 0.19c | 7.1 (13.0) |
| Erosion SSS (0–40)f | 2.2 (3.0) | 2.8 (3.5) | 0.12c | 0.6 (1.5), 2.4 (4.7), 1.5 (2.6) |
| Backfill SSS (0–20) | 0.5 (1.3) | 0.3 (0.7) | 0.50c | NA |
| Fat metaplasia SSS (0–40)f | 0.6 (1.7) | 0.5 (1.8) | 0.91c | 1.5 (3.2), 1.8 (3.7), 1.7 (3.9) |
| Ankylosis SSS (0–20)f | 0.3 (1.3) | 0.2 (1.1) | 0.11c | 0.1 (0.6), 0.1 (0.3), 0.2 (0.7) |
| SPARCC MRI SIJ inflammation score (0–72)f | 8.5 (11.0) | 6.0 (9.4) | 0.003c | 4.5 (6.5), 3.3 (4.0), 2.7 (3.9) |
| SPARCC MRI SIJ inflammation score ≥ 2, n/N (%)f | 99/161 (61.5) | 33/76 (43.4) | 0.009d | 11/20 (55.0), 9/19 (47.4), 9/21 (42.9) |
| Total SIJ score (mNY grade 0–8)f | 1.5 (1.3) | 1.6 (1.6) | 0.76c | 1.5 (2.2), 1.4 (2.0), 1.7 (1.6) |
| SIJ radiograph met mNY criteria (%)e, f | 19/156 (12.2) | 10/68 (14.7) | 0.61d | 7/22 (31.8), 5/20 (25.0), 4/21 (19.0) |
aPatients with week 104 MRI data
bNot included in the analysis because a week 104 MRI was not available. Included in the table for comparison only
cWilcoxon rank-sum
dMantel-Haenszel
eRadiographs from EMBARK and DESIR cohorts were assessed by 3 central readers who were not the same readers that conducted assessment of radiographs at screening for inclusion in the EMBARK trial
fFor the patients from DESIR who were excluded from this analysis, we have included 3 scores because there were 3 sets of central readers in 3 independent reading campaigns
Values are mean (standard deviation) unless otherwise noted
ASDAS Ankylosing Spondylitis Disease Activity Score, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BASFI Bath Ankylosing Spondylitis Functional Index, CRP C-reactive protein, HLA human leukocyte antigen, mNY modified New York, NA not available, SPARCC MRI SIJ inflammation score Spondyloarthritis Research Consortium of Canada Magnetic Resonance Imaging Sacroiliac Joint score (a score of MRI bone marrow edema), SSS SIJ Structural Score, VAS visual analog scale