Overall safety and AEs of interest by treatment (safety population)
| ABP 501 (n=264) | Adalimumab (n=262) | |
| Number of patients, n (%) | Number of patients, n (%) | |
| Any TEAE | 132 (50.0) | 143 (54.6) |
| Serious AEs | 10 (3.8) | 13 (5.0) |
| AEs leading to discontinuation of IP | 5 (1.9) | 2 (0.8) |
| AEs leading to study discontinuation | 7 (2.7) | 2 (0.8) |
| AEs of interest | ||
| Any | 80 (30.3) | 94 (35.9) |
| Infections | 61 (23.1) | 68 (26.0) |
| Malignancies | 1 (0.4) | 1 (0.4) |
| Hypersensitivity | 14 (5.3) | 10 (3.8) |
| Haematological reactions | 5 (1.9) | 5 (1.9) |
| Heart failure | 1 (0.4) | 2 (0.8) |
| Liver enzyme elevations | 13 (4.9) | 10 (3.8) |
| Injection-site reactions | 6 (2.3) | 13 (5.0) |
For each category, patients were included only once even if they had multiple events in that category. AEs coded using MedDRA V.17.1.
AE, adverse event; IP, investigational product; TEAE, treatment-emergent adverse event.