Summary of adverse events
| Infliximab plus methotrexate (n=57) | Methotrexate (n=54) | |
|---|---|---|
| Treatment-emergent adverse events | No of subjects (%) | No of subjects (%) |
| Subjects with at least one AE | 33 (57.9) | 19 (35.2) |
| Subjects with serious AE | 2 (3.5) | 0 (0) |
| Subjects with severe AE | 1 (1.8) | 1 (1.9) |
| Subjects with AE leading to early withdrawal | 7 (12.3) | 2 (3.7) |
| Subjects with treatment-related AE | 26 (45.6) | 13 (24.1) |
| Nasopharyngitis | 2 (3.5) | 0 (0) |
| Upper abdominal pain | 0 (0) | 3 (5.6) |
| Infusion-related reaction | 2 (3.5) | 0 (0) |
| Fever | 2 (3.5) | 0 (0) |
| Headache | 3 (5.3) | 1 (1.9) |
| Leucopenia | 2 (3.5) | 0 (0) |
| Liver enzymes: mean change from baseline to week 16 (SD) | ||
| ALT | 13.8 (27.79) | 13.5 (30.74) |
| AST | 7.43 (14.71) | 3.69 (11.26) |
| GGT | –28.9 (202.78) | 35.18 (137.40) |
| Total bilirubin | 1.6 (3.70) | 0.7 (5.0) |
AE, adverse events; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, γ-glutamyltransferase