Adalimumab (N=30) | Placebo (N=30) | p Value | ||
---|---|---|---|---|
Demographics | ||||
Women (%) | 86.7 | 83.3 | 0.704 | |
BMI (kg/m2) | ±SD | 24.8±3.6 | 26.5±4.4 | 0.122 |
Age at baseline (years) | ±SD | 61.9±6.1 | 60.7±6.9 | 0.769 |
Disease duration (years) | ±SD | 9.6±6.1 | 14.4±8.8 | 0.016 |
Clinical data | ||||
AUSCAN pain | ±SD | 20.4±9.0 | 25.1±11.1 | 0.008 |
AUSCAN stiffness | ±SD | 5.1±2.3 | 5.5±2.6 | 0.322 |
AUSCAN function | ±SD | 48.4±20.2 | 54.1±21.0 | 0.006 |
No of tender joints* | ±SD | 3.3±2.7 | 5.0±3.7 | 0.014 |
No of palpable effusions* | ±SD | 3.2±3.0 | 2.5±2.5 | 0.201 |
Maximal grip strength | ||||
Dominant hand (kg) | ±SD | 18.4±9.6 | 19.4±10.1 | 0.398 |
Non-dominant hand (kg) | ±SD | 17.2±7.4 | 18.3±9.4 | 0.258 |
Analgesics and NSAID intake (N) (%) | 9.0 (30.0%) | 8.0 (26.7%) | 0.104 | |
Radiological data | ||||
Phases at baseline† (N=960) | ||||
‘N’/‘S’ (%) (N) | 81.7% (392/480) | 83.3% (400/480) | 0.201 | |
‘J’ (%) (N) | 5.6% (27/480) | 6.0% (29/480) | 0.658 | |
‘E’ (%) (N) | 7.7% (37/480) | 6.4% (31/480) | 0.456 | |
‘R’ (%) (N) | 5.0% (24/480) | 4.0% (19/480) | 0.587 | |
‘F’ (%) (N) | 0.0% (0/480) | 0.2% (1/480) | 0.920 | |
Thumb base osteoarthritis‡ | ||||
None (N) | 6 | 7 | 0.902 | |
Mild (N) | 13 | 11 | 0.811 | |
Moderate/severe (N) | 11 | 12 | 0.935 |
↵* Sixteen joints were assessed (proximal interphalangeal 2–5 and distal interphalangeal 2–5 of both hands; interphalangeal P1 is excluded).
↵† Nine-hundred and sixty joints were assessed in 60 patients.
↵‡ Thumb base osteoarthritis: none: if absent in both hands; mild–moderate/severe: if present in at least one hand; ‘E’ erosive; ‘F’ fusion; ‘J’ joint space loss; ‘N’ normal; ‘R’ remodelled; ‘S’ stationary non-erosive osteoarthritis.
Except where indicated otherwise, data shown are mean values; AUSCAN data scales: pain 0–50; stiffness: 0–10; function: 0–90.
BMI, body mass index; NSAID, non-steroidal anti-inflammatory drug.