Variables | Placebo | Placebo → GOL, 2 mg/kg | GOL, 2 mg/kg | All GOL, 2 mg/kg* |
---|---|---|---|---|
Patients, n | 103 | 99 | 105 | 204 |
Mean duration of followup, weeks | 16.1 | 43.7 | 59.4 | 51.8 |
Patients who discontinued owing to AE | 0 | 1 (1.0) | 3 (2.9) | 4 (2.0) |
Patients with ≥ 1 AE | 24 (23.3) | 48 (48.5) | 65 (61.9) | 113 (55.4) |
Patients with ≥ 1 infection | 8 (7.8) | 25 (25.3) | 42 (40.0) | 67 (32.8) |
Patients with ≥ 1 infusion reaction | 0 | 0 | 3 (2.9) | 3 (1.5) |
Patients with ≥ 1 SAE | 0 | 1 (1.0) | 6 (5.7) | 7 (3.4) |
Serious infections | 0 | 0 | 3 (2.9) | 3 (1.5) |
Tuberculosis | 0 | 0 | 1 (1.0) | 1 (0.5) |
Opportunistic infections | 0 | 0 | 0 | 0 |
Demyelinating events | 0 | 0 | 0 | 0 |
Malignancies | 0 | 0 | 0 | 0 |
Deaths | 0 | 0 | 0 | 0 |
Data are presented as n (%) unless otherwise specified.
↵* Includes all 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; SAE: serious AE.