Table 2.
Adverse Events
| Adverse events | Induction therapy (n=33) |
Maintenance therapy (n=31) |
|---|---|---|
| Treatment-emergent adverse events* | 15 (45.5) | 14 (45.2) |
| Adverse events considered related to infliximab | 1 (3.0) | 5 (16.1) |
| Treatment-emergent serious adverse events |
2 (6.1) | 4 (12.9) |
| Abdominal pain | 1 (3.0) | 3 (9.7) |
| Asthenia | 1 (3.0) | 0 |
| Angina pectoris | 0 | 1 (3.2) |
| Breast cancer | 0 | 1 (3.2) |
| Serious adverse events considered related to infliximab | 0 | 0 |
| Adverse events leading to early discontinuation | 0 | 2 (6.5) |
| Infusion reactions | 0 | 2 (6.5) |
| Pruritus | 0 | 1 (3.2) |
| Rash | 0 | 1 (3.2) |
| Paresthesia | 0 | 1 (3.2) |
| Dyspnea | 0 | 1 (3.2) |
| Infections | 3 (9.1) | 6 (19.4) |
| Onychomycosis | 1 (3.0) | 0 |
| Clostridium difficile infection | 1 (3.0) | 0 |
| Nasopharyngitis | 1 (3.0) | 4 (12.9) |
| Anal abscess | 0 | 1 (3.2) |
| Cystitis | 0 | 1 (3.2) |
Data are presented as number (%).
*A treatment-emergent adverse event was defined as any event that was not present prior to the initiation of infliximab or any already-present event that worsened in either intensity or frequency following exposure to infliximab, regardless of its relationship to infliximab.