Display of adverse events
| SB2 (N=290) | INF (N=293) | |
|---|---|---|
| n (%) | n (%) | |
| Any TEAEs, patients (%) | 167 (57.6) | 170 (58.0) |
| Latent tuberculosis | 17 (5.9) | 20 (6.8) |
| Alanine aminotransferase increased | 23 (7.9) | 8 (2.7) |
| Headache | 16 (5.5) | 13 (4.4) |
| Nasopharyngitis | 14 (4.8) | 15 (5.1) |
| Rheumatoid arthritis | 16 (5.5) | 9 (3.1) |
| Aspartate aminotransferase increased | 12 (4.1) | 8 (2.7) |
| Bronchitis | 9 (3.1) | 11 (3.8) |
| Upper respiratory tract infection | 10 (3.4) | 9 (3.1) |
| Back pain | 7 (2.4) | 9 (3.1) |
| Arthralgia | 8 (2.8) | 7 (2.4) |
| Pneumonia | 7 (2.4) | 7 (2.4) |
| Hypertension | 6 (2.1) | 8 (2.7) |
| Urinary tract infection | 7 (2.4) | 5 (1.7) |
| Cough | 6 (2.1) | 6 (2.0) |
| Rash | 6 (2.1) | 5 (1.7) |
| Pharyngitis | 4 (1.4) | 6 (2.0) |
| Pyrexia | 2 (0.7) | 7 (2.4) |
| Dyspepsia | 1 (0.3) | 6 (2.0) |
| Any SAEs | 26 (9.0) | 26 (8.9) |
| Serious infections or tuberculosis | 9 (3.1) | 6 (2.0) |
| Pneumonia | 3 (1.0) | 2 (0.7) |
| Pneumonia bacterial | 1 (0.3) | 0 (0.0) |
| Pyelonephritis | 1 (0.3) | 0 (0.0) |
| Soft tissue infection | 1 (0.3) | 0 (0.0) |
| Tuberculous pleurisy | 1 (0.3) | 0 (0.0) |
| Urinary tract infection | 1 (0.3) | 0 (0.0) |
| Enteritis | 1 (0.3) | 0 (0.0) |
| Cellulitis | 0 (0.0) | 1 (0.3) |
| Erysipelas | 0 (0.0) | 1 (0.3) |
| Pulmonary tuberculosis | 0 (0.0) | 1 (0.3) |
| Wound infection | 0 (0.0) | 1 (0.3) |
| Infusion related reactions | 15 (5.2) | 13 (4.4) |
TEAEs are listed for reported events of at least a frequency ≥2% in either study group in the safety population (SAF). Latent tuberculosis was reported when a positive Quantiferon test seroconversion occurred after randomisation. The incidence rate for any infections was 47 cases/100-person years for SB2 and 64 cases/100 person-years for INF.
INF, infliximab reference product; SAE, serious adverse event; TEAE, treatment-emergent adverse event.