Adverse events through Week 28. Data presented as n (%) unless otherwise noted.
| Variables | Weeks 0–16 | Weeks 0–28 | |
|---|---|---|---|
| Placebo | GOL, 2 mg/kg | Combined GOL, 2 mg/kg* | |
| Patients, n | 103 | 105 | 204 |
| Mean duration of followup, weeks | 16.0 | 16.1 | 20.2 |
| Patients who discontinued because of an AE | 0 | 0 | 1 (0.5) |
| Patients with ≥ 1 AE | 24 (23.3) | 34 (32.4) | 71 (34.8) |
| Patients with ≥ 1 infection | 8 (7.8) | 12 (11.4) | 35 (17.2) |
| Patients with ≥ 1 infusion reaction | 0 | 3 (2.9) | 3 (1.5) |
| Patients with ≥ 1 SAE | 0 | 2 (1.9) | 2 (1.0) |
| Serious infections | 0 | 1 (1.0) | 1 (0.5) |
| Malignancies | 0 | 0 | 0 |
| Deaths | 0 | 0 | 0 |
↵* The combined GOL group includes patients randomized to the placebo group who crossed over to GOL at Week 16 and patients randomized to the GOL group at baseline. GOL: golimumab; AE: adverse event; SAE: serious AE.