Efficacy variable | Baseline | Change during the study | |||||||
---|---|---|---|---|---|---|---|---|---|
SASP n=68 | MTX n=69 | SASP+ MTX n=68 | p value | SASP n=68 | MTX n=69 | SASP+ MTX n=69 | p value | ||
Symptomatic efficacy variable | |||||||||
Patient’s global assessment | 2.5 | 2.5 | 2.4 | NS | −0.9 | −0.9 | −0.8 | NS | |
Physician’s global assessment | 2.4 | 2.4 | 2.4 | NS | −0.7 | −0.7 | −0.6 | NS | |
Ritchie articular index | 17.6 | 16.5 | 18.9 | NS | −7.1 | −4.2 | −9.4 | 0.001 | |
Swollen joints | 10.5 | 9.4 | 9.4 | NS | −4.5 | −3.9 | −4.5 | NS | |
HAQ | 1.38 | 1.25 | 1.32 | NS | −0.74 | −0.73 | −0.70 | NS | |
Morning stiffness (min) | 78 | 92 | 95 | NS | −46 | −53 | −55 | NS | |
ESR (mm 1st h) | 42 | 46 | 38 | NS | −30 | −24 | −25 | NS | |
CRP (mg/l) | 30 | 37 | 29 | NS | −8 | −16 | −17 | NS | |
DAS | 4.23 | 4.13 | 4.24 | NS | −1.15 | −0.87 | −1.26 | 0.019 | |
Structural efficacy variable † | |||||||||
Erosion score | 2.77 | 3.78 | 4.28 | NS | +2.38 | +2.38 | +1.85 | NS | |
Narrowing score | 3.34 | 4.52 | 4.63 | NS | +2.26 | +2.12 | +1.61 | NS | |
Total damage score | 6.11 | 8.30 | 8.91 | NS | +4.64 | +4.50 | +3.46 | NS |
↵2-150 Values given are mean and p value is referred to the statistical significance using the inter-group comparison (analysis of variance), in the intention to treat analysis. †This analysis was performed in the completers with available radiographs (46, 49, and 49 patients in the SASP, MTX, and SASP + MTX groups, respectively).