Summary of safety through weeks 16 and 24 in all randomised patients who received at least one injection of study agent
| Week 16 | |||||||
|---|---|---|---|---|---|---|---|
| Group 1: Placebo+MTX | Group 2: Golimumab 50 mg+MTX | Group 3: Golimumab 100 mg+MTX | Combined Groups 2 and 3 | ||||
| Number of patients | 88 | 86 | 87 | 173 | |||
| Patients with AEs | 64 (72.7%) | 65 (75.6%) | 68 (78.2%) | 133 (76.9%) | |||
| Patients with SAEs | 1 (1.1%) | 1 (1.2%) | 2 (2.3%) | 3 (1.7%) | |||
| Patients with AEs causing study agent d/c | 1 (1.1%) | 3 (3.5%) | 6 (6.9%) | 9 (5.2%) | |||
| Patients with infections | 35 (39.8%) | 33 (38.4%) | 29 (33.3%) | 62 (35.8%) | |||
| Patients with serious infections | 0 (0.0%) | 0 (0.0%) | 1 (1.1%) | 1 (0.6%) | |||
| Patients with injection site reactions* | 6 (6.8%) | 7 (8.1%) | 9 (10.3%) | 16 (9.2%) | |||
| Patients with: | |||||||
| Neoplasia | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |||
| Malignancy | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |||
| Week 24 | |||||||
|---|---|---|---|---|---|---|---|
| Group 1: Placebo+MTX | Group 2: Golimumab 50 mg+MTX | Group 3: | Combined | All | |||
| With or without EE Placebo+MTX | With EE Placebo+MTX→ Golimumab 50 mg+MTX | With or without EE Golimumab 50 mg+MTX | With EE Golimumab 50 mg→100 mg+MTX | Golimumab 100 mg+MTX | Groups 2 and 3 | Golimumab +MTX | |
| Number of patients | 88 | 28 | 86 | 9 | 87 | 173 | 201 |
| Patients with AEs | 67 (76.1%) | 14 (50.0%) | 70 (81.4%) | 1 (11.1%) | 72 (82.8%) | 142 (82.1%) | 156 (77.6%) |
| Patients with SAEs | 1 (1.1%) | 0 (0.0%) | 2 (2.3%) | 0 (0.0%) | 3 (3.4%) | 5 (2.9%) | 5 (2.5%) |
| Patients with AEs leading to d/c of study agent | 1 (1.1%) | 0 (0.0%) | 4 (4.7%) | 0 (0.0%) | 7 (8.0%) | 11 (6.4%) | 11 (5.5%) |
| Patients with infections | 39 (44.3%) | 4 (14.3%) | 36 (41.9%) | 0 (0.0%) | 34 (39.1%) | 70 (40.5%) | 74 (36.8%) |
| Patients with serious infections | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.1%) | 1 (0.6%) | 1 (0.5%) |
| Patients with injection site reactions* | 7 (8.0%) | 3 (10.7%) | 8 (9.3%) | 0 (0.0%) | 10 (11.5%) | 18 (10.4%) | 21 (10.4%) |
| Patients with: | |||||||
| Neoplasia | 0 (0.0%) | 0 (0.0%) | 2 (2.3%)† | 0 (0.0%) | 0 (0.0%) | 2 (1.2%) | 2 (1.0%) |
| Malignancy | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
Data shown are number (%) of patients.
↵* Injection site reactions were defined as any adverse reaction at a subcutaneous study agent injection site. In the placebo column the reactions are to a placebo injection; in all other columns the reactions are to a golimumab injection.
† The neoplasias included were a non-serious benign breast neoplasm and a serious bone neoplasm determined by histopathological examination to be ‘borderline’ malignant.
AE, adverse event; d/c, discontinuation; EE, early escape; MTX, methotrexate; SAE, serious adverse event.