Table 2.
Baseline demographics and disease characteristics for patients in the MRI substudy and the study population overall
| Golimumab | ||||
|---|---|---|---|---|
| Characteristic | Placebo | 50 mg | 100 mg | Combined |
| MRI substudy population | ||||
| No of patients | 23 | 37 | 38 | 75 |
| Men | 18 (78.3%) | 26 (70.3%) | 29 (76.3%) | 55 (73.3%) |
| Age (years) | 46.0 (40.0, 55.0) | 38.0 (30.0, 45.0) | 37.0 (30.0, 43.0) | 37.0 (30.0, 44.0) |
| Years since inflammatory back pain first occurred | 20.0 (13.0, 30.0) | 10.0 (5.0, 14.0) | 11.0 (5.0, 18.0) | 10.0 (5.0, 18.0) |
| Years since diagnosis of AS | 16.9 (5.3, 23.7) | 4.5 (0.6, 11.5) | 4.8 (0.7, 15.8) | 4.5 (0.7, 13.5) |
| HLA-B27 positive | 20 (87.0%) | 29 (78.4%) | 30 (78.9%) | 59 (78.7%) |
| CRP (mg/dl) | 1.6 (0.3, 2.7) | 1.4 (0.6, 2.9) | 0.6 (0.3, 1.3) | 0.9 (0.3, 2.2) |
| ASDAS | 4.3 (3.6, 4.5) | 4.1 (3.3, 4.4) | 3.9 (3.3, 4.2) | 3.9 (3.3, 4.2) |
| BASDAI (0–10) | 7.0 (6.0, 7.7) | 6.2 (5.6, 7.8) | 7.1 (6.2, 8.3) | 6.7 (5.8, 8.0) |
| BASFI (0–10) | 5.5 (4.1, 6.9) | 5.4 (3.2, 6.8) | 6.2 (4.8, 7.2) | 5.8 (3.7, 7.1) |
| BASMI (0–10) | 4.0 (3.0, 7.0) | 3.0 (2.0, 4.0) | 3.0 (2.0, 5.0) | 3.0 (2.0, 5.0) |
| Total back pain (0–10) | 8.0 (6.9, 8.8) | 7.4 (5.5, 8.2) | 8.0 (7.1, 8.7) | 7.7 (6.4, 8.6) |
| Inflammation (0–10) | 7.1 (5.6, 8.6) | 6.4 (5.7, 8.1) | 7.6 (6.5, 9.2) | 7.4 (5.7, 8.7) |
| Morning stiffness (min) | 79.2 (54.0, 110.4) | 75.6 (60.0, 96.0) | 90.0 (60.0, 115.2) | 90.0 (60.0, 105.6) |
| History of extra-axial involvement | ||||
| Uveitis | 8 (34.8%) | 6 (16.2%) | 8 (21.1%) | 14 (18.7%) |
| Psoriasis | 3 (13.0%) | 2 (5.4%) | 9 (23.7%) | 11 (14.7%) |
| Inflammatory bowel disease | 2 (8.7%) | 6 (16.2%) | 2 (5.3%) | 8 (10.7%) |
| Dactylitis | 1 (4.3%) | 0 (0.0%) | 3 (7.9%) | 3 (4.0%) |
| Enthesitis | 7 (30.4%) | 9 (24.3%) | 20 (52.6%) | 29 (38.7%) |
| Peripheral arthritis | 5 (21.7%) | 9 (24.3%) | 11 (28.9%) | 20 (26.7%) |
| Total study population | ||||
| No of patients | 78 | 138 | 140 | 278 |
| Men | 55 (70.5%) | 102 (73.9%) | 98 (70.0%) | 200 (71.9%) |
| Age (years) | 41.0 (31.0, 50.0) | 38.0 (30.0, 47.0) | 38.0 (29.0, 46.0) | 38.0 (29.0, 46.0) |
| Years since inflammatory back pain first occurred | 16.0 (6.0, 24.0) | 11.0 (6.0, 19.0) | 11.0 (5.0, 18.5) | 11.0 (6.0, 19.0) |
| Years since diagnosis of AS | 7.3 (2.8, 18.6) | 5.2 (1.6, 11.6) | 5.2 (1.5, 13.3) | 5.2 (1.5, 12.3) |
| HLA-B27 positive | 66 (84.6%) | 112 (81.8%) | 118 (84.3%) | 230 (83.0%) |
| CRP (mg/dl) | 1.15 (0.30, 2.40) | 1.10 (0.50, 2.50) | 0.90 (0.40, 2.50) | 1.00 (0.40, 2.50) |
| BASDAI (0–10) | 6.6 (5.7, 7.7) | 6.6 (5.6, 7.6) | 7.0 (6.0, 7.9) | 6.8 (5.7, 7.7) |
| BASFI (0–10) | 4.9 (3.5, 6.8) | 5.0 (3.2, 6.7) | 5.4 (3.4, 7.3) | 5.2 (3.2, 6.9) |
| BASMI (0–10) | 4.0 (2.0, 5.0) | 3.0 (2.0, 4.0) | 3.0 (2.0, 5.0) | 3.0 (2.0, 5.0) |
| Total back pain (0–10) | 7.6 (6.6, 8.8) | 7.5 (5.7, 8.2) | 7.9 (6.5, 8.8) | 7.6 (6.1, 8.5) |
| Inflammation (0–10) | 7.1 (5.5, 8.3) | 7.1 (5.4, 8.1) | 7.6 (6.1, 9.0) | 7.3 (5.7, 8.5) |
| Morning stiffness (min) | 77.4 (45.6, 104.4) | 77.4 (52.8, 99.6) | 90.0 (60.0, 117.6) | 90.0 (60.0, 112.8) |
| History of extra-axial involvement | ||||
| Uveitis | 25 (32.1%) | 28 (20.3%) | 30 (21.4%) | 58 (20.9%) |
| Psoriasis | 8 (10.3%) | 7 (5.1%) | 16 (11.4%) | 23 (8.3%) |
| Inflammatory bowel disease | 8 (10.3%) | 11 (8.0%) | 7 (5.0%) | 18 (6.5%) |
| Dactylitis | 1 (1.3%) | 9 (6.5%) | 13 (9.3%) | 22 (7.9%) |
| Enthesitis | 24 (30.8%) | 50 (36.2%) | 57 (40.7%) | 107 (38.5%) |
| Peripheral arthritis | 28 (35.9%) | 49 (35.5%) | 44 (31.4%) | 93 (33.5%) |
Values are n (%) or median (IQR).
AS, ankylosing spondylitis; ASDAS, ankylosing spondylitis disease activity score; BASDAI, Bath ankylosing spondylitis disease activity index; BASFI, Bath ankylosing spondylitis functional index; BASMI, Bath ankylosing spondylitis metrology index; CRP, C-reactive protein; HLA, human leucocyte antigen.