| Characteristic Mean (SD) | Placebo/etanercept* | Etanercept/etanercept† | |||||
| First data | First data | ||||||
| Baseline of RCT | Point of OLE | End of OLE | Baseline of RCT | Point of OLE | End of OLE | ||
| N = (129) | N = (127) | N = (50) | N = (128) | N = (124) | N = (54) | ||
| PtGA‡ | 63.3 (18.1) | 33.0 (26.2) | 25.9 (23.2) | 63.2 (17.2) | 29.6 (25.6) | 19.7 (21.5) | |
| Total back pain‡ | 63.7 (20.2) | 33.6 (28.1) | 24.1 (23.5) | 61.7 (20.7) | 29.5 (27.4) | 18.8 (21.6) | |
| BASDAI | |||||||
| morning stiffness§ | 65.3 (20.2) | 30.4 (24.1) | 26.0 (23.3) | 60.9 (21.6) | 26.6 (26.0) | 19.0 (22.1) | |
| C-reactive protein (mg/dl) | 2.0 (2.4) | 0.6 (0.8) | 0.5 (0.7) | 1.8 (1.9) | 0.7 (1.8) | 0.3 (0.5) | |
| Swollen joint counts¶ | 3.7 (7.7) | 2.4 (7.7) | 2.8 (5.8) | 3.1 (5.5) | 1.1 (2.6) | 1.0 (2.7) | |
| Tender joint counts¶ | 8.7 (11.9) | 5.5 (11.5) | 4.9 (9.1) | 6.1 (10.1) | 2.9 (7.7) | 1.9 (4.2) | |
| Chest expansion (cm)¶ | 3.2 (1.8) | 3.3 (2.0) | 3.7 (2.4)** | 3.4 (2.2) | 3.9 (1.8) | 4.1 (1.9**) | |
| Modified Schober test (cm)¶ | 3.0 (1.6) | 3.0 (1.5) | 3.0 (1.5) | 3.1 (1.8) | 3.3 (1.7) | 3.5 (1.7) | |
| Occiput-to wall (cm)¶ | 5.0 (6.4) | 4.8 (7.0) | 5.4 (7.3) | 5.4 (5.7) | 4.2 (6.2) | 3.6 (5.9) | |
*Patients received placebo for 24 weeks during the RCT before being switched to etanercept in the 168- week OLE.
†Patients received etanercept in the RCT and OLE for a maximum exposure of 192 weeks of etanercept exposure.
‡Scored on 0–100 mm VAS.
§Average of the last two questions of the six-question BASDAI relating to morning stiffness.
¶Data collected at 24-week intervals rather than 12-week intervals. At the first data point of the OLE the number of patients analysed in the PBO/ETN group was (N = 122) patients and for the ETN/ETN group it was (N = 113).
**Last observation carried forward from week 144.