Table 1.
Baseline characteristics of the overall study population and the biomarker substudy population
| Placebo | Golimumab 50 mg | Golimumab 100 mg | |
|---|---|---|---|
| Overall study population | |||
| N | 78 | 138 | 140 |
| Age (years) | 40.6 ± 12.7 | 39.2 ± 12.5 | 38.6 ± 11.3 |
| Sex (% men) | 71 | 74 | 70 |
| Race (% Caucasian) | 73 | 75 | 73 |
| Years of inflammatory back pain | 16.1 ± 11.5 | 13.6 ± 10.4 | 13.2 ± 10.4 |
| Serum CRP (μg/ml) | 1.9 ± 2.3 | 1.8 ± 1.8 | 1.8 ± 2.1 |
| HLA-B27 positive (%) | 85 | 82 | 84 |
| Back pain (10-cm VAS) | 7.5 ± 1.6 | 7.1 ± 1.5 | 7.6 ± 1.6 |
| BASDAI score (0–10) | 6.6 ± 1.5 | 6.5 ± 1.6 | 6.9 ± 1.5 |
| BASFI score (0–10) | 5.1 ± 2.3 | 5.0 ± 2.4 | 5.2 ± 2.6 |
| Biomarker substudy population | |||
| N | 24 | 37 | 39 |
| Age (years) | 42.3 ± 11.2 | 39.2 ± 12.7 | 40.4 ± 11.8 |
| Sex (% men) | 67 | 76 | 64 |
| Race (% Caucasian) | 88 | 95 | 95 |
| Years of inflammatory back pain | 18.1 ± 10.3 | 13.7 ± 10.0 | 16.7 ± 12.5 |
| Serum CRP (μg/ml) | 1.2 ± 1.2 | 1.9 ± 1.7 | 1.8 ± 2.0 |
| HLA-B27 positive (%) | 83 | 73 | 82 |
| Back pain (10-cm VAS) | 7.7 ± 1.4 | 7.6 ± 1.3 | 7.6 ± 1.4 |
| BASDAI score (0–10) | 6.7 ± 1.6 | 7.2 ± 1.3 | 7.1 ± 1.3 |
| BASFI score (0–10) | 5.9 ± 2.0 | 6.3 ± 2.2 | 5.8 ± 2.2 |
Data shown are mean ± SD or percentage of patients.
BASDAI, Bath ankylosing spondylitis disease activity index; BASFI, Bath ankylosing spondylitis functional index; CRP, C-reactive protein; HLA, human leucocyte antigen; VAS, visual analogue scale.