Baseline demographics and clinical characteristics of the study patients by treatment arm
Golimumab+MTX (N=26) | Placebo+MTX (N=25) | |
Age, years | 47.5 (11.8) | 45.8 (11.0) |
Gender (male:female) | 18:8 | 20:5 |
Disease duration arthritis, years | 0.5 (0.5–1.8) | 0.5 (0.4–3.0) |
Disease duration skin, years | 6.0 (1–20) | 11 (4–19) |
Prior use of csDMARD (leflunomide) | 1 | 0 |
Concomitant use of topical psoriasis treatment | 6 | 13 |
Concomitant use of fumaric acid (N) | 1 | 2 |
Concomitant use of sulfasalazine (N) | 0 | 1 |
Concomitant NSAID use at baseline (N) | 16 | 17 |
Concomitant corticosteroid use at baseline (N) | 0 | 0 |
DAS CRP | 2.3 (1.03) | 2.46 (0.87) |
Swollen joint count (median (IQR)) | 7 (4–8.25) | 5 (4–9.5) |
Tender joint count (median (IQR)) | 9.5 (4–15.25) | 10 (5.5–17) |
PASI score (median (IQR)) | 1.6 (0.32–3.3) | 2.3 (0.3–6.8) |
No of patients with baseline PASI >2.5 | 10 | 10 |
No of patients with enthesitis | 4 | 7 |
No of patients with dactylitis | 9 | 8 |
No of patients reporting inflammatory axial symptoms at baseline | 4 | 2 |
ESR (mm/h) | 20.5 (6.5–33.3) | 15.0 (5.0–29) |
No of patients with raised ESR (>20 mm/h) | 13 | 14 |
CRP (mg/dL) | 4.5 (1.23–13.3) | 7.0 (2–15.9) |
No of patients with raised CRP (>5 mg/dL) | 14 | 9 |
VAS patient global (mm) | 44.7 (24.7) | 39.3 (23.4) |
VAS patient pain (mm) | 43.5 (24.2) | 41.3 (28.4) |
VAS physician (mm) | 44.5 (14.5) | 47 (19.7) |
Morning stiffness (min) | 44 (32.5) | 42.3 (33.3) |
BASDAI | 41.0 (18.6) | 41.3 (23.3) |
Values are mean (SD), N or median (p25, p75).
BASDAI, Bath ankylosing spondylitis disease activity index; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; MTX, Methotrexate; NSAID, non steroidal anti inflammatory drug; PASI, psoriasis activity and severity index; VAS, visual analogue scale on a 0-100mm scale.