Efficacy results at week 100 (extended population)
| SB4/SB4 (n=126) | ETN/SB4 (n=119) | |
| EULAR response, n/N* (%) | ||
| Good | 59/121 (48.8) | 63/115 (54.8) |
| Moderate | 54/121 (44.6) | 40/115 (34.8) |
| No response | 8/121 (6.6) | 12/115 (10.4) |
| DAS28 | ||
| Improvement from baseline, mean (SD) | 2.9 (1.5) | 3.0 (1.5) |
| Disease activity, n/N* (%) | ||
| Low (≤3.2) | 60/122 (49.2) | 63/115 (54.8) |
| Remission (<2.6) | 37/122 (30.3) | 40/115 (34.8) |
| SDAI score | ||
| Improvement from baseline, mean (SD) | 27.4 (15.5) | 28.7 (14.6) |
| Disease activity, n/N* (%) | ||
| Low (>3.3 and≤11) | 41/123 (33.3) | 44/115 (38.3) |
| Remission (≤3.3) | 38/123 (30.9) | 39/115 (33.9) |
| CDAI score | ||
| Improvement from baseline, mean (SD) | 26.8 (15.0) | 27.9 (14.1) |
| Disease activity, n/N* (%) | ||
| Low (>2.8 and≤10) | 38/123 (30.9) | 46/115 (40.0) |
| Remission (≤2.8) | 40/123 (32.5) | 33/115 (28.7) |
| Boolean-based remission, n/N* (%) | 31/123 (25.2) | 23/115 (20.0) |
| Radiographic results† | ||
| Change from baseline in JSN score, mean (SD) | 0.19 (1.98) | 0.39 (2.86) |
| Change from baseline in joint erosion score, mean (SD) | 0.28 (2.57) | 0.61 (3.08) |
| Change from baseline in mTSS, mean (SD) | 0.48 (4.05) | 1.0 (5.56) |
*Number of patients with available data at each time point.
†Based on number of patients who completed week 100 visit with available radiographic assessment results at weeks 0 and 100 (SB4/SB4, n=108; ETN/SB4, n=104).
CDAI, Clinical Disease Activity Index; DAS28, disease activity score based on a 28-joint count; ETN, reference etanercept; EULAR, European League Against Rheumatism; JSN, joint space narrowing; mTSS, modified Total Sharp Score; SDAI, Simplified Disease Activity Index.