Table 2.
Incidence of TEAEs reported by ≥ 5% of subjects in any treatment group (data are presented as n (%)
| TEAE | BAT2206 injection (n = 90) n (%) |
Ustekinumab (EU) (n = 89) n (%) |
Ustekinumab (USA) (n = 90) n (%) |
Total (n = 269) n (%) |
|---|---|---|---|---|
| Increased alanine aminotransferase | 10 (11.1) | 8 (9.0) | 7 (7.8) | 25 (9.3) |
| Increased aspartate aminotransferase | 7 (7.8) | 6 (6.7) | 4 (4.4) | 17 (6.3) |
| Increased blood bilirubin | 7 (7.8) | 11 (12.4) | 5 (5.6) | 23 (8.6) |
| Decreased neutrophil count | 5 (5.6) | 2 (2.2) | 4 (4.4) | 11 (4.1) |
| Increased neutrophil count | 5 (5.6) | 3 (3.4) | 4 (4.4) | 12 (4.5) |
| Increased white blood cell count | 5 (5.6) | 3 (3.4) | 4 (4.4) | 12 (4.5) |
| Increased blood creatine phosphokinase | 3 (3.3) | 7 (7.9) | 3 (3.3) | 13 (4.8) |
| Hypertriglyceridemia | 15 (16.7) | 17 (19.1) | 11 (12.2) | 43 (16.0) |
| Hyperglycemia | 9 (10.0) | 7 (7.9) | 11 (12.2) | 27 (10.0) |
| Hyperuricemia | 8 (8.9) | 6 (6.7) | 8 (8.9) | 22 (8.2) |
| Hematuria | 10 (11.1) | 4 (4.5) | 6 (6.7) | 20 (7.4) |
| Proteinuria | 5 (5.6) | 6 (6.7) | 4 (4.4) | 15 (5.6) |
EU European Union, N number of TEAEs, n% incidence of subjects reporting TEAEs, TEAE treatment-emergent adverse event