Table 3.
Treatment-emergent adverse events (TEAEs) reported as related in at least 1% of patients in either treatment group, no (%)
| Related TEAEs reported in at least 1% of patients in either treatment group | CT-P13 3 mg/kg (N=301)* |
INX 3 mg/kg (N=301)* |
Total (N=602) |
|---|---|---|---|
| Alanine aminotransferase increased | 12 (4.0) | 11 (3.7) | 23 (3.8) |
| Aspartate aminotransferase increased | 8 (2.7) | 8 (2.7) | 16 (2.7) |
| γ-Glutamyltransferase increased | 2 (0.7) | 3 (1.0) | 5 (0.8) |
| Latent tuberculosis | 13 (4.3) | 14 (4.7) | 27 (4.5) |
| Upper respiratory tract infection | 4 (1.3) | 4 (1.3) | 8 (1.3) |
| Urinary tract infection | 4 (1.3) | 7 (2.3) | 11 (1.8) |
| Bronchitis | 4 (1.3) | 4 (1.3) | 8 (1.3) |
| Nasopharyngitis | 6 (2.0) | 4 (1.3) | 10 (1.7) |
| Gastroenteritis | 2 (0.7) | 3 (1.0) | 5 (0.8) |
| Herpes zoster | 1 (0.3) | 3 (1.0) | 4 (0.7) |
| Rhinitis | 0 | 3 (1.0) | 3 (0.5) |
| Tuberculosis | 3 (1.0) | 0 | 3 (0.5) |
| Infusion-related reaction | 20 (6.6) | 25 (8.3) | 45 (7.5) |
| Anaemia | 2 (0.7) | 3 (1.0) | 5 (0.8) |
| Neutropenia | 3 (1.0) | 2 (0.7) | 5 (0.8) |
| Leucopenia | 1 (0.3) | 3 (1.0) | 4 (0.7) |
| Headache | 4 (1.3) | 6 (2.0) | 10 (1.7) |
| Pyrexia | 0 | 3 (1.0) | 4 (0.7) |
| Rash | 1 (0.3) | 4 (1.3) | 5 (0.8) |
| Nausea | 1 (0.3) | 3 (1.0) | 4 (0.7) |
| Flare in RA activity | 7 (2.3) | 4 (1.3) | 11 (1.8) |
| Bone pain | 3 (1.0) | 0 | 6 (1.0) |
| Hypertension | 5 (1.7) | 3 (1.0) | 8 (1.3) |
The total number of treatment-emergent adverse events count included all related patient events. At each level of summarisation, a patient was counted once if he or she reported one or more related events. Only the most severe event was counted.
*Patients who received at least one (full or partial) dose of CT-P13 were included in the CT-P13 group for safety analyses, irrespective of their randomisation.
INX, innovator infliximab; RA, rheumatoid arthritis.