American College of Rheumatology response rates, safety, and immunogenicity during the open label extension period of study NCT01895309 that examined switching of etanercept to SB4 versus maintenance of SB4
| ACR response, n/n’ | Timepoint | SB4/SB4 (n=126) | ETN/SB4 (n=119) |
| ACR20 | Week 52 | 99/125 (79.2%) | 98/119 (82.4%) |
| Week 76 | 102/125 (81.6%) | 90/117 (76.9%) | |
| Week 100 | 95/122 (77.9%) | 91/115 (79.1%) | |
| ACR50 | Week 52 | 65/125 (52.0%) | 64/119 (53.8%) |
| Week 76 | 74/125 (59.2%) | 62/117 (53.0%) | |
| Week 100 | 73/122 (59.8%) | 70/115 (60.9%) | |
| ACR70 | Week 52 | 48/125 (38.4%) | 39/119 (32.8%) |
| Week 76 | 49/125 (39.2%) | 44/117 (37.6%) | |
| Week 100 | 52/122 (42.6%) | 48/115 (41.7%) | |
| No of patients with, n (%) | SB4/SB4 (n=126) | ETN/SB4 (N=119) | |
| ≥1 TEA | 60 (47.6%) | 58 (48.7%) | |
| ≥1 SAE | 6 (4.8%) | 2 (1.7%) | |
| Serious infection | 1 (0.8%) | 1 (0.8%) | |
| Active tuburculosis | 0 (0.0%) | 0 (0.0%) | |
| Injection site reactions* | 0 (0.0%) | 0 (0.0%) | |
| Malignancy† | 1 (0.8%) | 0 (0.0%) | |
| Death† | 1 (0.8%) | 0 (0.0%) | |
| ADA positive‡ | 1 (0.8%) | 1 (0.9%)§ | |
*Defined as high level group in terms of administration site reactions.†Hepatic cancer was reported in SB4/SB4. ‡Defined as at least one ADA positive up to week 100 after week 52. §Percentage is based on the number of patients with ADA results (117 patients). ADA, anti drug antibody; SAE, serious adverse event; TEA, treatment emergent adverse event.