Differences in clinical outcomes between patients with moderate and severe disease activity based on DAS28 at Month 12. Values are mean (SD).
| Measure | TEMPO | ERA | ||
|---|---|---|---|---|
| Moderate | Severe | Moderate | Severe | |
| DAS28 remission (based on DAS28 < 2.6), n (%) | ||||
| MTX | 7 (44) | 32 (15)* | 11 (33) | 26 (15)* |
| ETN | 3 (38) | 36 (17) | 15 (47) | 24 (14)** |
| ETN + MTX | 13 (77) | 73 (35)** | ||
| DAS28 low disease activity (DAS28 ≤ 3.2), n (%) | ||||
| MTX | 9 (56) | 59 (28)* | 18 (55) | 49 (28)* |
| ETN | 5 (63) | 67 (31) | 18 (56) | 44 (26)** |
| ETN + MTX | 14 (82) | 105 (50)* | ||
| DAS28 change in mean scores (SD) from baseline | ||||
| MTX | 1.6 (0.3) | 2.6 (0.1)* | 1.2 (0.2) | 2.4 (0.1)** |
| ETN | 1.5 (0.4) | 2.7 (0.1)* | 1.7 (0.2) | 2.4 (0.1)* |
| ETN + MTX | 2.5 (0.3) | 3.5 (0.1)* | ||
| ACR20 response, n (%) | ||||
| MTX | 12 (75) | 158 (75) | 18 (55) | 116 (65) |
| ETN | 6 (75) | 163 (76) | 21 (66) | 119 (70) |
| ETN + MTX | 14 (82) | 179 (85) | ||
| ACR50 response, n (%) | ||||
| MTX | 5 (31) | 91 (43) | 13 (39) | 72 (40) |
| ETN | 2 (25) | 106 (50) | 17 (53) | 81 (47) |
| ETN + MTX | 12 (71) | 145 (69) | ||
| ACR70 response, n (%) | ||||
| MTX | 2 (13) | 40 (19) | 6 (18) | 38 (21) |
| ETN | 1 (13) | 53 (25) | 7 (22) | 41 (24) |
| ETN + MTX | 11 (65) | 85 (40)* | ||
| HAQ score, mean (SD) | ||||
| MTX | 0.6 (0.1) | 1.1 (0.1)* | 0.6 (0.1) | 0.8 (0.0) |
| ETN | 0.6 (0.2) | 1.0 (0.1) | 0.4 (0.1) | 0.8 (0.1)* |
| ETN + MTX | 0.4 (0.2) | 0.8 (0.0)* | ||
| HAQ ≤ 0.5, n (%) | ||||
| MTX | 8 (50) | 69 (33) | 19 (58) | 78 (44) |
| ETN | 4 (50) | 72 (34) | 24 (75) | 71 (42)** |
| ETN + MTX | 14 (82) | 86 (41)** | ||
| HAQ change in mean scores (SD) from baseline | ||||
| MTX | 0.29 (0.12) | 0.68 (0.05)* | 0.44 (0.09) | 0.77 (0.05)* |
| ETN | 0.42 (0.21) | 0.74 (0.05) | 0.45 (0.09) | 0.75 (0.05)* |
| ETN + MTX | 0.74 (0.18) | 1.00 (0.05) | ||
If the patient numbers were < 5 in any treatment group per visit, the Fisher exact test 2-sided p value was used; if the expected count in both moderate and severe frequencies was ≥ 5 in any frequency table cell, then chi-square p value was used.
↵* p < 0.05;
↵** p < 0.001. ACR: American College of Rheumatology; DAS28: Disease Activity Score including 28-joint count; ERA: Early Rheumatoid Arthritis; ETN: etanercept; HAQ: Health Assessment Questionnaire; MTX: methotrexate; TEMPO: Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes.