Table 3

Longitudinal clinical data

VariableAdalimumab (N=30)Placebo (N=30)p Value
AUSCAN pain5.4 (9.8)1.7 (13.1)0.063
AUSCAN stiffness0.4 (2.1)0.1 (3.0)0.721
AUSCAN function1.2 (18.5)2.0 (17.9)0.133
No of tender joints0.7 (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 hand0.8 (1.2)1.2 (1.8)0.231
Maximal grip strength
Non-dominant hand0.9 (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.