Summary of safety profile during the transition period
| INF/SB2 (n=94) | INF/INF (n=101) | SB2/SB2 (n=201) | |
| At least one TEAE | 34 (36.2) | 36 (35.6) | 81 (40.3) |
| Frequently reported TEAEs (≥2% in any treatment group) | |||
| Latent tuberculosis | 7 (7.4) | 4 (4.0) | 11 (5.5) |
| Nasopharyngitis | 2 (2.1) | 4 (4.0) | 11 (5.5) |
| Rheumatoid arthritis | 2 (2.1) | 4 (4.0) | 7 (3.5) |
| ALT increased | 4 (4.3) | 1 (1.0) | 5 (2.5) |
| AST increased | 4 (4.3) | 2 (2.0) | 4 (2.0) |
| Upper respiratory tract infection | 3 (3.2) | 5 (5.0) | 1 (0.5) |
| Bronchitis | 1 (0.5) | 2 (2.0) | 5 (2.5) |
| Pharyngitis | 2 (2.1) | 0 (0.0) | 1 (0.5) |
| Tonsillitis | 2 (2.1) | 1 (1.0) | 0 (0.0) |
| Headache | 2 (2.1) | 0 (0.0) | 1 (0.5) |
| Antinuclear antibody positive | 0 (0.0) | 2 (2.0) | 0 (0.0) |
| Any serious TEAE | 6 (6.4) | 3 (3.0) | 7 (3.5) |
| Serious infection | 2 (2.1) | 1 (1.0) | 1 (0.5) |
| Infusion-related reaction* | 3 (3.2) | 2 (2.0) | 7 (3.5) |
| Malignancy† | 2 (2.1) | 1 (1.0) | 0 (0.0) |
Values represent n (%) of patients. Latent tuberculosis was diagnosed as having a newly positive QuantiFERON test that was negative at week 0.
*There were two serious infusion-related reactions (drug hypersensitivity in INF/SB2 group, anaphylactic reaction in SB2/SB2 group), which led to discontinuation of the investigational product.
†See text for details.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; INF, reference infliximab; TEAE, treatment-emergent adverse event.