Summary of adverse events to week 52 for patients who received golimumab by early escape status
| Group 1: placebo+MTX → golimumab 50 mg+MTX* | Group 2: golimumab 100 mg+placebo | Group 3: golimumab 50 mg+MTX | |||||
|---|---|---|---|---|---|---|---|
| Early escape (weeks 16–52) | Crossover (weeks 24–52) | 100 mg + placebo only | Early escape (weeks 16–52) 100 mg → 100 mg+MTX | 50 mg+MTX only | Early escape (weeks 16–52) 50 mg+ MTX → 100 mg+MTX | Group 4: golimumab 100 mg+MTX | |
| Patients treated with golimumab | 41 | 82 | 133 | 36 | 89 | 15 | 89 |
| Average duration of follow-up | 35.0 | 27.7 | 40.6 | 34.3 | 45.3 | 36.0 | 49.5 |
| Average exposure (no of administrations) | 8.7 | 6.8 | 9.8 | 8.1 | 11.1 | 8.9 | 11.9 |
| Patients with one or more adverse events (%) | 35 (85.4) | 55 (67.1) | 105 (78.9) | 31 (86.1) | 77 (86.5) | 13 (86.7) | 77 (86.5) |
| Patients with one or more serious adverse events (%) | 5 (12.2) | 3 (3.7) | 16 (12.0) | 7 (19.4) | 9 (10.1) | 3 (20.0) | 16 (18.0) |
| Patients who discontinued subcutaneous study medication because of an adverse event (%) | 1 (2.4) | 2 (2.4) | 10 (7.5) | 2 (5.6) | 4 (4.5) | 0 (0) | 7 (7.9) |
| Patients with one or more infections (%) | 20 (48.8) | 34 (41.5) | 67 (50.4) | 13 (36.1) | 44 (49.4) | 9 (60.0) | 52 (58.4) |
| Patients with one or more serious infections (%) | 2 (4.9) | 0 (0) | 5 (3.8) | 3 (8.3) | 2 (2.2) | 0 (0) | 7 (7.9) |
| Patients with one or more injection-site disorders (%) | 1 (2.4) | 2 (2.4) | 15 (11.3) | 2 (5.6) | 7 (7.9) | 3 (20.0) | 8 (9.0) |
| Patients with one or more malignancies (%) | 0 (0) | 1 (1.2) | 1 (0.8) | 0 (0) | 1 (1.1) | 0 (0) | 3 (3.4) |
Adverse events are categorised according to the treatment the patient was receiving at the time of the event.
↵* Only patients who received at least one dose of golimumab (to early escape or crossover) are included. Patients who discontinued treatment before week 16 received placebo injections only. One patient who discontinued study treatment before week 16 returned for study visits and was included in the efficacy analysis. This patient did not receive golimumab and therefore was not included in the safety analysis.
MTX, methotrexate.