Table 1.
Baseline characteristics of the 198 patients randomized to receive golimumab or placeboa
| Characteristic | Golimumab (n = 98) | Placebo (n = 100) |
|---|---|---|
| Male sex | 61 (62.2) | 52 (52.0) |
| Age, mean ± SD years | 30.7 ± 7.1 | 31.7 ± 7.2 |
| White race | 98 (100.0) | 100 (100.0) |
| Geographic region | ||
| Eastern Europe | 52 (53.1) | 53 (53.0) |
| Western Europe and US | 46 (46.9) | 47 (47.0) |
| BMI, mean ± SD kg/m2 | 25.6 ± 4.7 | 25.1 ± 4.9 |
| Disease duration since diagnosis | ||
| 1 year | 67 (68.4) | 65 (65.0) |
| 1–2 years | 20 (20.4) | 19 (19.0) |
| 3–5 years | 11 (11.2) | 16 (16.0) |
| BASDAI, mean ± SD (10‐cm VAS) | 6.6 ± 1.6 | 6.4 ± 1.5 |
| BASFI, mean ± SD (10‐cm VAS) | 5.3 ± 2.4 | 4.8 ± 2.5 |
| SPARCC SI MRI score, mean ± SD (range 0–72)b | 9.9 ± 12.3 | 12.7 ± 15.4 |
| MRI‐positive for sacroiliitisc | 66 (67.3) | 66 (66.0) |
| ASDAS, mean ± SD | 3.6 ± 0.9 | 3.5 ± 0.8 |
| CRP concentration, mean ± SD mg/dl | 1.5 ± 2.9 | 1.3 ± 2.0 |
| CRP > upper limit of normal | 40 (40.8) | 41 (41.0) |
| HLA–B27 positive | 81 (82.7) | 82 (82.0) |
a
Except where indicated otherwise, values are the number (%) of patients. BMI = body mass index; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; VAS = visual analog scale; BASFI = Bath Ankylosing Spondylitis Functional Index; ASDAS = Ankylosing Spondylitis Disease Activity Score; CRP = C‐reactive protein.
b
The Spondyloarthritis Research Consortium of Canada magnetic resonance imaging index for sacroiliac joint inflammation (SPARCC SI MRI) score was determined in 91 patients in the golimumab group and 96 patients in the placebo group.
c
A central reader reported the presence or absence of active inflammation of SI joints.