Table 2.
Efficacy results at week 52 in FAS with no imputation
| Result | SB4 50 mg (n = 299) | ETN 50 mg (n = 297) |
| ACR response | ||
| ACR20 | 210/259 (81.1) | 195/246 (79.3) |
| Maintenance of response among week 24 responders | 183/201 (91.0) | 176/200 (88.0) |
| Response among week 24 non-responders | 27/58 (46.6) | 19/46 (41.3) |
| ACR50 | 143/259 (55.2) | 125/246 (50.8) |
| Maintenance of response among week 24 responders | 98/118 (83.1) | 86/108 (79.6) |
| Response among week 24 non-responders | 45/141 (31.9) | 39/138 (28.3) |
| ACR70 | 91/259 (35.1) | 73/246 (29.7) |
| Maintenance of response among week 24 responders | 49/64 (76.6) | 44/55 (80.0) |
| Response among week 24 non-responders | 42/195 (21.5) | 29/191 (15.2) |
| ACR-N, mean (s.d.) | 52.08 (30.277) | 49.17 (30.299) |
| Major clinical responsea | 54/259 (20.8) | 45/246 (18.3) |
| DAS28-ESR | ||
| Improvement from baseline, mean (s.d.) | 2.91 (1.360) | 2.80 (1.288) |
| Disease activity | ||
| Low (≤3.2) | 109/260 (41.9) | 86/246 (35.0) |
| Remission (<2.6) | 69/260 (26.5) | 47/246 (19.1) |
| EULAR response | ||
| Good | 108/259 (41.7) | 85/246 (34.6) |
| Moderate | 132/259 (51.0) | 139/246 (56.5) |
| No response | 19/259 (7.3) | 22/246 (8.9) |
| HAQ-DI | ||
| Improvement from baseline, mean (s.d.) | 0.73 (0.582) | 0.70 (0.623) |
| SDAI score | ||
| Improvement from baseline, mean (s.d.) | 28.7 (13.32) | 27.69 (13.740) |
| Disease activity | ||
| Low (>3.3 and ≤11) | 93/260 (35.8) | 92/245 (37.6) |
| Remission (≤3.3) | 62/260 (23.8) | 50/245 (20.4) |
| CDAI score | ||
| Improvement from baseline, mean (s.d.) | 27.9 (12.94) | 26.8 (13.56) |
| Disease activity | ||
| Low (>2.8 and ≤10) | 94/260 (36.2) | 82/246 (33.3) |
| Remission (≤2.8) | 57/260 (21.9) | 48/246 (19.5) |
| Boolean-based remissionb | 40/260 (15.4) | 33/245 (13.5) |
| Radiographic resultsc | ||
| Change from baseline in JSN score, mean (s.d.) | 0.18 (1.142) | 0.43 (2.096) |
| Change from baseline in joint erosion score, mean (s.d.) | 0.26 (1.608) | 0.31 (1.677) |
| Change from baseline in mTSS, mean (s.d.) | 0.45 (2.497) | 0.74 (3.356) |
| Patients with change from baseline in mTSS > 0 | 75/250 (30.0) | 78/228 (34.2) |
| Patients with progression based on the SDCd | 21/250 (8.4) | 32/228 (14.0) |
Values are the number of patients/total number (%) unless indicated otherwise.
a
ACR70 response for 6 consecutive months.
b
Defined as SJC ≤1, TJC ≤1, CRP ≤1 mg/dl and patient global VAS ≤1 using a 0–10 scale.
c
Based on patients with available radiographic results at weeks 0 and 52 (SB4, n = 250; ETN, n = 228).
d
SDC = 2.3 for change in mTSS.
ETN: reference etanercept; JSN: joint space narrowing.