Table 3.
Treatment‐emergent adverse events
| Adverse events, n (%) | During OLE by dose group, n (%) | During the trial | |
|---|---|---|---|
| pbo/ADA, N = 94 | ADA/ADA, N = 94 | All‐ADA,† N = 203 | |
| Any adverse event | 44 (46.8) | 47 (50.0) | 121 (59.6) |
| Events leading to study drug discontinuation | 0 | 0 | 6 (3.0) |
| Serious | 3 (3.2) | 3 (3.2) | 14 (6.9) |
| Infections | 25 (26.6) | 30 (31.9) | 77 (37.9) |
| Serious infection | 2 (2.1) | 1 (1.1) | 7 (3.4) |
| Diverticulitis | 1 (1.1) | 0 | 2 (1.0) |
| Bronchitis | 0 | 0 | 1 (0.5) |
| Endocarditis | 0 | 0 | 1 (0.5) |
| Erysipelas | 0 | 0 | 1 (0.5) |
| Influenza | 0 | 1 (1.1) | 1 (0.5) |
| Lung infection | 1 (1.1) | 0 | 1 (0.5) |
| Pneumonia | 0 | 1 (1.1) | 1 (0.5) |
| Special interest ‡ | |||
| Worsening/new onset of psoriasis | 4 (4.3) | 1 (1.1) | 7 (3.4) |
| Injection site reaction | 2 (2.1) | 2 (2.1) | 8 (3.9) |
| Allergic reaction including angio‐oedema/anaphylaxis | 1 (1.1) | 0 | 2 (1.0) |
| Any haematologic disorders including pancytopenia | 1 (1.1) | 0 | 2 (1.0) |
†Patients who received at least one dose of ADA during Period A plus any patient who received ADA in the OLE. ‡For ≥2 patients in any treatment group.
ADA, adalimumab; OLE, open‐label extension; pbo, placebo.