Table 3.
Treatment-emergent adverse events (safety population)
| CT-P17 (N = 324) | EU-adalimumab (N = 324) | |
|---|---|---|
| Subjects with ≥ 1 TEAE, n (%) | 169 (52.2) | 184 (56.8) |
| Study drug-related | 88 (27.2) | 99 (30.6) |
| TEAEs reported in ≥ 5% of subjects in either treatment group | ||
| ISR | 16 (4.9) | 22 (6.8) |
| Nasopharyngitis | 17 (5.2) | 20 (6.2) |
| Upper respiratory tract infection | 17 (5.2) | 20 (6.2) |
| Neutropenia | 14 (4.3) | 17 (5.2) |
| Subjects with ≥ 1 TESAE, n (%) | 10 (3.1) | 16 (4.9) |
| Subjects with ≥ 1 TEAE leading to study drug discontinuation, n (%) | 5 (1.5) | 8 (2.5) |
| Subjects with ≥ 1 TEAE classified as hypersensitivity/allergic reactions, n (%) | 2 (0.6) | 4 (1.2) |
| Subjects with ≥ 1 TEAE classified as ISR, n (%) | 16 (4.9) | 22 (6.8) |
| Subjects with ≥ 1 TEAE classified as infection, n (%) | 97 (29.9) | 103 (31.8) |
| Subjects with ≥ 1 TEAE classified as malignancy, n (%) | 1 (0.3)a | 0 |
| Total number of TEAEs leading to death | 0 | 0 |
Note: There were no significant differences between the CT-P17 and EU-adalimumab groups for any parameter (p > 0.05)
aBreast cancer that was considered unrelated to study drug; the subject’s family history of breast cancer was considered a risk factor by the investigator
TEAE treatment-emergent adverse event, EU-adalimumab European Union-approved adalimumab, ISR injection-site reaction, TESAE treatment-emergent serious adverse event