Screening parameters | Placebo | Prednisolone 20 mg | Prednisolone 50 mg |
---|---|---|---|
Number of patients, n | 13 | 11 | 12 |
Age in years (mean±SD) | 43±16 | 35±8.3 | 42±8.5 |
Disease duration (years± SD) | 16±16 | 13±7.5 | 14±9.2 |
Gender (female %) | 23 | 18 | 8 |
HLA-B27 positivity (%) | 91 | 73 | 73 |
CRP mg/litre (mean±SD) | 27±21 | 19±13 | 32±47 |
CRP ≥10 mg/litre (%) | 77 | 64 | 58 |
Patients with peripheral arthritis (n) | 2 | 3 | 1 |
Patients with enthesitis according to Berlin enthesitis score (n) | 2 | 5 | 5 |
Patients with IBD (n) | 0 | 1 | 1 |
Patients with psoriasis (n) | 0 | 0 | 2 |
Patients with history of uveitis (n) | 1 | 0 | 0 |
BASDAI morning stiffness (mean±SD) | 6.8±2.5 | 7.1±2.3 | 7.0±1.6 |
BASFI (mean±SD) | 5.8±1.4 | 6.2±1.7 | 5.2±1.9 |
PG (mean±SD) | 7.2±1.6 | 7.9±1.3 | 7.4±2.1 |
Pain (mean±SD) | 7.6±1.6 | 8.1±1.0 | 7.6±1.8 |
BASMI (mean±SD) | 4.0±2.0 | 4.6±2.9 | 4.0±2.3 |
ASDAS (mean±SD) | 4.1±0.7 | 4.2±0.8 | 4.1±0.8 |
Baseline characteristics were not significantly different between the prednisolone and the placebo groups (Fisher's exact test, Wilcoxon test, significance level p=0.05).
ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI morning stiffness, mean of BASDAI question 5 and 6 for morning stiffness; 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 leukocyte antigen; IBD, inflammatory bowel disease; PG, patient global assessment.