Longitudinal clinical data
| Variable | Adalimumab (N=30) | Placebo (N=30) | p Value |
|---|---|---|---|
| AUSCAN pain | 5.4 (9.8) | 1.7 (13.1) | 0.063 |
| AUSCAN stiffness | 0.4 (2.1) | 0.1 (3.0) | 0.721 |
| AUSCAN function | 1.2 (18.5) | 2.0 (17.9) | 0.133 |
| No of tender joints | 0.7 (2.3) | 1.4 (4.8) | 0.238 |
| No of joints with palpable effusion | |||
| Maximal grip strength (kg) | 1.7 (2.7) | 1.0 (2.4) | 0.814 |
| Dominant hand | 0.8 (1.2) | 1.2 (1.8) | 0.231 |
| Maximal grip strength | |||
| Non-dominant hand | 0.9 (1.3) | 0.2 (1.1) | 0.281 |
Data shown are mean differences (SD) in changes of scores from baseline to week 52.
Safety results are reported in table 4. More adverse events were reported in the adalimumab group (N=13) than in the placebo group (N=8), although more infectious adverse events were seen in the placebo group (four vs only two in the adalimumab group). Three infections required antibiotics. All adverse events were graded as mild to moderate in severity and only one case required withdrawal from the study. This patient withdrew consent after experiencing vertigo and hypertension 9 months after baseline. This patient was treated with placebo. No serious adverse events or malignancies occurred. Biological routine safety blood tests revealed no problems.