Table 2.
Treatment-emergent adverse events (TEAEs) that were reported in at least 1% of patients in GB242 and INF group, # (%)
| TEAEs | GB242 (N = 283) n (%)* |
INF (N = 283) n (%) |
Total (N = 566) n (%) |
|---|---|---|---|
| Any TEAEs, patients (%) | 166 (58.7%) | 174 (61.5%) | 340 (60.1%) |
| Upper respiratory tract infection | 60 (21.2) | 68 (24.0) | 128 (22.6) |
| White blood cell count increased | 20 (7.1) | 30 (10.6) | 50 (8.8) |
| Urinary tract infection | 18 (6.4) | 23 (8.1) | 41 (7.2) |
| Anemia | 16 (5.7) | 14 (4.9) | 30 (5.3) |
| Hyperlipemia | 14 (4.9) | 4 (1.4) | 18 (3.2) |
| Abnormal liver function test | 14 (4.9) | 19 (6.7) | 33 (5.8) |
| Weight increase | 11 (3.9) | 8 (2.8) | 19 (3.4) |
| Aspartate aminotransferase increased | 11 (3.9) | 11 (3.9) | 22 (3.9) |
| Pyrexia | 11 (3.9) | 10 (3.5) | 21 (3.7) |
| Alanine aminotransferase increased | 10 (3.5) | 13 (4.6) | 23 (4.1) |
| Toothache | 9 (3.2) | 1 (0.4) | 10 (1.8) |
| Cough | 9 (3.2) | 16 (5.7) | 25 (4.4) |
| Hyperuricemia | 7 (2.5) | 5 (1.8) | 12 (2.1) |
| Drug-induced hypersensitivity reaction | 7 (2.5) | 1 (0.4) | 8 (1.4) |
| Neutrophil count decreased | 6 (2.1) | 7 (2.5) | 13 (2.3) |
| Pneumonia | 6 (2.1) | 5 (1.8) | 11 (1.9) |
| Rash | 6 (2.1) | 4 (1.4) | 10 (1.8) |
| Dizziness | 6 (2.1) | 5 (1.8) | 11 (1.9) |
| Rheumatoid arthritis | 4 (1.4) | 7 (2.5) | 11 (1.9) |
| Hypertension | 4 (1.4) | 6 (2.1) | 10 (1.8) |
| Lymphocyte count decreased | 3 (1.1) | 6 (2.1) | 9 (1.6) |
| Nausea | 3 (1.1) | 7 (2.5) | 10 (1.8) |
| Allergic dermatitis | 2 (0.7) | 7 (2.5) | 9 (1.6) |
| Chest discomfort | 2 (0.7) | 6 (2.1) | 8 (1.4) |
| Infusion-related reactions | 27 (9.5) | 23 (8.1) | 50 (8.8) |
The total number of treatment-emergent adverse events count included all related patient events
*In the GB242 group, safety analyses included patients who received at least one (full or partial) dose of GB242, irrespective of their randomization. INF infliximab, RA rheumatoid arthritis