Related treatment-emergent adverse events reported in at least 1% of patients in either treatment group, no (%)
| CT-P13 5 mg/kg (N=128) | INX 5 mg/kg (N=122) | Total (N=250) | |
|---|---|---|---|
| Alanine aminotransferase increased | 14 (10.9) | 13 (10.7) | 27 (10.8) |
| Aspartate aminotransferase increased | 12 (9.4) | 10 (8.2) | 22 (8.8) |
| γ-glutamyltransferase increased | 4 (3.1) | 5 (4.1) | 9 (3.6) |
| Latent tuberculosis* | 5 (3.9) | 4 (3.3) | 9 (3.6) |
| Upper respiratory tract infection | 3 (2.3) | 2 (1.6) | 5 (2.0) |
| Nasopharyngitis | 3 (2.3) | 2 (1.6) | 5 (2.0) |
| Pharyngitis | 2 (1.6) | 3 (2.5) | 5 (2.0) |
| Urinary tract infection | 5 (3.9) | 0 | 5 (2.0) |
| Bacteriuria | 0 | 2 (1.6) | 2 (0.8) |
| Tonsillitis | 0 | 2 (1.6) | 2 (0.8) |
| Tuberculosis | 2 (1.6) | 1 (0.8) | 3 (1.2) |
| Infusion-related reaction | 5 (3.9) | 6 (4.9) | 11 (4.4) |
| Serum creatinine phosphokinase increased | 4 (3.1) | 1 (0.8) | 5 (2.0) |
| Neutropenia | 2 (1.6) | 2 (1.6) | 4 (1.6) |
| Leukopenia | 0 | 2 (1.6) | 2 (0.8) |
| Pyrexia | 2 (1.6) | 1 (0.8) | 3 (1.2) |
| Headache | 3 (2.3) | 1 (0.8) | 4 (1.6) |
| Rash | 0 | 3 (2.5) | 3 (1.2) |
| Urticaria | 0 | 2 (1.6) | 2 (0.8) |
| Nausea | 1 (0.8) | 2 (1.6) | 3 (1.2) |
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.
*Latent tuberculosis (TB) as an AE refers to patients who originally had a negative TB test and became positive subsequently. These cases were considered as an AE as patients were treated for the reasons related to latent TB.
INX, innovator infliximab.