| |
Week 76*
|
Week 128*
|
| Etanercept + Methotrexate |
DMARD + Methotrexate |
Etanercept + Methotrexate |
DMARD + Methotrexate |
| n=260 |
n=126 |
n=241 |
n=120 |
| Clinical Endpoints/Outcomes |
| Tender joint count, mean change (SD) |
-21.1 (12.4) |
-22.9 (12.8) |
-21.4 (12.1) |
-24.0 (13.3) |
| Swollen joint count, mean change (SD) |
-16.6 (9.0) |
-17.7 (10.3) |
-16.6 (9.0) |
-18.5 (11.2) |
| Physician global assessment, mean change (SD) |
-5.2 (2.0) |
-5.0 (1.8) |
-5.2 (2.1) |
-5.2 (2.0) |
| Duration of morning stiffness, mean change (SD) |
-98.8 (202.6) |
-91.5 (181.7) |
-118.8 (294.7) |
-90.9 (206.6) |
| Patient-Reported Outcomes |
| Subject global assessment, mean change (SD) |
-3.9 (3.0) |
-3.4 (2.8) |
-4.3 (2.7) |
-3.8 (2.8) |
| VAS general health (0-100 mm), mean change (SD) |
-33.3 (28.4) |
-33.1 (27.1) |
-36.3 (27.1) |
-36.4 (27.6) |
| VAS pain (0-100 mm), mean change (SD) |
-40.4 (28.9) |
-37.2 (27.1) |
-42.0 (28.6) |
-40.6 (26.8) |
| VAS fatigue (0-100 mm), mean change (SD) |
-29.4 (31.5) |
-28.2 (28.2) |
-30.5 (31.3) |
-30.4 (30.7) |
* Treatment modification was permitted at the start of the extension (i.e., after week 24); during the extension, 259/260 patients in the ETN + MTX group continued to receive etanercept and 105/126 patients in the DMARD + MTX group received etanercept.
DMARD, disease-modifying anti-rheumatic drug; LOCF, last observation carried forward; SD, standard deviation; VAS, visual analog scale.