Table 3.
Changes and discontinuations due to AEs, overall and by treatment line
| CT-P13 (N = 105) | Reference infliximab (N = 92) | |||||
|---|---|---|---|---|---|---|
| Overall (N = 105) | First line (n = 82) | Subsequent line (n = 23) | Overall (N = 92) | First line (n = 62) | Subsequent line (n = 30) | |
| Patients changing biologic or discontinuing therapy due to an AE, n | ||||||
| Total | 13 | 9 | 4 | 17 | 13 | 4 |
| Changed biologic | 8 | 5 | 3 | 5 | 4 | 1 |
| Discontinued therapy | 5 | 4 | 1 | 12 | 9 | 3 |
| AEs leading to changed biologic or discontinued therapy, n | ||||||
| Changed biologic | ||||||
| Infusion/injection reaction | 5 | 2 | 3 | 5 | 4 | 1 |
| Uveitis | 1 | 1 | ||||
| Skin rash | 3 | 3 | 1 | 1 | ||
| Discontinued therapy | ||||||
| Infusion/injection reaction | 2 | 1 | 1 | 2 | 1 | 1 |
| Mycobacterium tuberculosis infection pulmonary | 1 | 1 | 4 | 4 | ||
| Headache | 2 | 2 | ||||
| Other infection | 1 | 1 | ||||
| Transaminitis only | 1 | 1 | ||||
| Psoriasis | 1 | 1 | ||||
| Uveitis | 1 | 1 | ||||
| Gastric ulcer | 1 | 1 | ||||
| Acute kidney injury | 1 | 1 | ||||
| Unknown | 1 | 1 | ||||
AE adverse event