Table 3.
Safety summary by patient type at 2 years
| Safety parameters | Cohort 1: Patients with seropositive, erosive, early RA | Cohort 2: Patients with RA | ||
|---|---|---|---|---|
| Abatacept SC (n = 38) | Adalimumab SC (n = 45) | Abatacept SC (n = 280) | Adalimumab SC (n = 283) | |
| Deaths | 0 (0) | 0 (0) | 1 (0.4) | 1 (0.4) |
| SAEs | 6 (15.8) | 7 (15.6) | 38 (13.6) | 47 (16.6) |
| Related SAEs | 0 (0) | 0 (0) | 11 (3.9) | 20 (7.1) |
| Discontinuations due to SAEs | 0 (0) | 2 (4.4) | 5 (1.8) | 14 (4.9) |
| Serious infections and infestations | 2 (5.3) | 0 (0) | 6 (2.1) | 12 (4.2) |
| AEs | 37 (97.4) | 39 (86.7) | 258 (92.1) | 261 (92.2) |
| Related AEs | 10 (26.3) | 18 (40.0) | 122 (43.8) | 146 (51.6) |
| Discontinuations due to AEs | 1 (2.6) | 5 (11.1) | 11 (3.9) | 26 (9.2) |
| Malignancies | 0 (0) | 0 (0) | 5 (1.8) | 5 (1.8) |
| Autoimmune events | 1 (2.6) | 1 (2.2) | 11 (3.9) | 4 (1.4) |
| Local injection-site reactions | 1 (2.6) | 6 (13.3) | 9 (3.2) | 26 (9.2) |
Data are presented as the number of patients with adverse events, with the percentage given in parenthesis
AEs adverse events, RA rheumatoid arthritis, SAEs serious adverse events, SC subcutaneous