Table 3.
Adverse events through week 52
Golimumab-IV | Infliximab | |
---|---|---|
Patients, N | 685 | 585 |
Mean follow-up, weeks | 41.3 | 41.3 |
Patients with ≥ 1 AE | 348 (50.8) | 356 (60.9) |
Patients with ≥ 1 serious AE | 66 (9.6) | 60 (10.3) |
Patients with ≥ 1 infection or infestation | 156 (22.8) | 155 (26.5) |
Patients with ≥ 1 opportunistic infection | 10 (1.5) | 9 (1.5) |
Patients with ≥ 1 serious infection | 21 (3.1) | 20 (3.4) |
Patients with ≥ 1 malignancy | 13 (1.9) | 10 (1.7) |
Latent tuberculosis | 0 | 1 (0.2) |
Most common AEs (occurring in ≥ 5% of either regimen) | ||
Nausea | 20 (2.9) | 38 (6.5) |
Worsening of rheumatoid arthritis | 23 (3.4) | 32 (5.5) |
Upper respiratory tract infection | 28 (4.1) | 30 (5.1) |
Pruritus | 10 (1.5) | 30 (5.1) |
Data presented as n (%) unless otherwise noted
AE adverse event, IV intravenous