Overview of adverse events: all patients with at least 1 adalimumab injectiona.
| N = 553, n (%) | PY = 3089.2 Events (E/100 PY) | |
|---|---|---|
| Any AE | 536 (96.9) | 11,937 (386.4) |
| Serious AE | 271 (49.0) | 678 (21.9) |
| AE leading to discontinuation of study drug | 127 (23.0) | 179 (5.8) |
| Infectious AE | 448 (81.0) | 2873 (93.0) |
| Serious infectious AE | 85 (15.4) | 133 (4.3) |
| Opportunistic infection (excluding tuberculosis and oral candidiasis) | 8 (1.4) | 10 (0.3) |
| Tuberculosis | 2 (0.4) | 2 (< 0.1) |
| Malignant AE (excluding NMSC and lymphoma) | 30 (5.4) | 34 (1.1) |
| NMSC | 36 (6.5) | 45 (1.5) |
| Lymphoma | 5 (0.9) | 6 (0.2) |
| Demyelinating disease AE | 2 (0.4) | 2 (< 0.1) |
| Injection site reaction | 115 (20.8) | 258 (8.4) |
| Hepatic-related AE | 86 (15.6) | 165 (5.3) |
| Deathb | 24 (4.3) | 24 (0.8) |
↵a Any AE with an onset date on or after the day of the first ADA injection through 70 days after the last ADA injection in Year 10.
↵b Includes 6 deaths that were not treatment emergent (occurring > 70 days after last adalimumab injection). PY: patient-years; AE: adverse event; NMSC: nonmelanoma skin cancer.