Table 4.
Treatment-emergent adverse events
| Placebo (n = 87) | Adalimumab | |||
|---|---|---|---|---|
| 20 mg (n = 87) | 40 mg (n = 91) | 80 mg (n = 87) | ||
| AE | 71 (81.6) | 80 (92.0) | 90 (98.9)a | 81 (93.1)a |
| Serious AE | 8 (9.2) | 10 (11.5) | 17 (18.7) | 8 (9.2) |
| Severe AE | 5 (5.7) | 3 (3.4) | 4 (4.4) | 5 (5.7) |
| Infectious AE | 32 (36.8) | 30 (34.5) | 41 (45.1) | 37 (42.5) |
| Serious infectious AE | 1 (1.1) | 4 (4.6) | 6 (6.6) | 3 (3.4) |
| Injection site reaction | 2 (2.3) | 27 (31.0)a | 28 (30.8)a | 29 (33.3)a |
| Immunologic reaction | 0 (0.0) | 4 (4.6) | 2 (2.2) | 0 (0.0) |
| Malignancies | 2 (2.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Opportunistic infection including TB | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| AE leading to death | 0 (0.0) | 0 (0.0) | 1 (1.1) | 1 (1.1) |
| AE leading to early withdrawal | 4 (4.6) | 5 (5.7) | 12 (13.2) | 3 (3.4) |
| Probable or possibly related AEs | 32 (36.8) | 64 (73.6)a | 67 (73.6)a | 61 (70.1)a |
aP < 0.05 compared with placebo (Fisher exact test)
TB tuberculosis