Differences in radiographic outcomes between patients with moderate and severe disease activity based on DAS28 at Month 12.
| TEMPO | ERA | |||
|---|---|---|---|---|
| Measure | Moderate | Severe | Moderate | Severe |
| TSS progression (annualized change), * mean (SD) | ||||
| MTX | 0.62 (1.94) | 2.95 (13.08) | 2.15 (6.27) | 1.71 (3.99) |
| ETN | –0.51 (1.04) | 0.55 (4.70) | –0.04 (1.36) | 0.89 (2.70) |
| ETN + MTX | –0.74 (1.43) | –0.53 (3.64) | ||
| No radiographic progression (annualized change in TSS ≤ 0),†** n (%) | ||||
| MTX | 7 (44) | 108 (51) | 15 (47) | 85 (49) |
| ETN | 6 (75) | 127 (59) | 22 (69) | 109 (65) |
| ETN + MTX | 14 (82) | 150 (71) | ||
ERA: Early Rheumatoid Arthritis; ETN: etanercept; MTX: methotrexate; TEMPO: Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes; TSS: Total Sharp Score.
↵* p values not determined using Mann-Whitney U test. Data not normally distributed. Mean (SD) shown here for descriptive purposes.
↵† If the expected number of patients was less than 5 in any treatment group per visit, then the 2-sided Fisher exact test was used; if the expected count in both moderate and severe was ≥ 5 per treatment group per visit, 2-sided chi-square test was used.
↵** Annualized change in TSS from baseline < 0.05 was categorized as no radiographic progression in the primary analysis.