Table 3.
Adverse events through study completion in patients with RA, PsA, and AS who received ≥ 1 administration of IV golimumab*
| RA trial | PsA trial | AS trial | Pooled golimumab | |
|---|---|---|---|---|
| Patients, N | 584 | 460 | 204 | 1248 |
| Mean follow-up, weeks (SD) | 95.9 (25.7) | 47.2 (13.0) | 51.8 (9.0) | 70.7 (30.7) |
| Patient years of follow-up | 1077 | 417 | 203 | 1697 |
| Patients who discontinued due to an AE | 41 (7.0) | 17 (3.7) | 4 (2.0) | 62 (5.0) |
| AEs | ||||
| Patients with ≥ 1 AE | 462 (79.1) | 234 (50.9) | 113 (55.4) | 809 (64.8) |
| Events/100 patient-years (95% CI) | 195.4 (187.2, 204.0) | 143.5 (132.3, 155.5) | 133.0 (117.6, 149.8) | 175.2 (169.0, 181.6) |
| Infections | ||||
| Patients with ≥ 1 infection | 287 (49.1) | 105 (22.8) | 67 (32.8) | 459 (36.8) |
| Events/100 patient-years (95% CI) | 59.9 (55.4, 64.7) | 34.0 (28.7, 40.1) | 49.8 (40.5, 60.5) | 52.3 (48.9, 55.9) |
| SAEs | ||||
| Patients with ≥ 1 SAE | 106 (18.2) | 24 (5.2) | 7 (3.4) | 137 (11.0) |
| Events/100 patient-years (95% CI) | 16.1 (13.8, 18.7) | 8.2 (5.6, 11.4) | 3.9 (1.7, 7.8) | 12.7 (11.0, 14.5) |
| Serious infections | ||||
| Patients with ≥ 1 serious infection | 36 (6.2) | 10 (2.2) | 3 (1.5) | 49 (3.9) |
| Events/100 patient-years (95% CI) | 4.0 (2.9, 5.4) | 2.6 (1.3, 4.7) | 1.5 (0.3, 4.3) | 3.4 (2.5, 4.4) |
| MACE | ||||
| Patients with ≥ 1 MACE | 9 (1.5) | 0 | 0 | 9 (0.7) |
| Events/100 patient-years (95% CI) | 0.8 (0.4, 1.6) | 0 (0.0, 0.7) | 0 (0.0, 1.5) | 0.5 (0.2, 1.0) |
| Malignancies | ||||
| Patients | 5 (0.9) | 2 (0.4) | 0 | 7 (0.6) |
| Events/100 patient-years (95% CI) | 0.5 (0.2, 1.1) | 0.5 (0.1, 1.7) | 0 (0.0, 1.5) | 0.4 (0.2, 0.9) |
| Deaths | ||||
| Patients | 5 (0.9) | 1 (0.2) | 0 | 6 (0.5) |
| Events/100 patient-years (95% CI) | 0.5 (0.2, 1.1) | 0.2 (0.0, 1.3) | 0 (0.0, 1.5) | 0.4 (0.1, 0.8) |
| Opportunistic infections | ||||
| Patients with ≥ 1 opportunistic infection | 4 (0.7) | 0 | 0 | 4 (0.3) |
| Events/100 patient-years (95% CI) | 0.4 (0.1, 1.0) | 0 (0.0, 0.7) | 0 (0.0, 1.5) | 0.2 (0.1, 0.6) |
| Active TB | ||||
| Patients | 3 (0.5) | 2 (0.4) | 1 (0.5) | 6 (0.5) |
| Events/100 patient-years (95% CI) | 0.3 (0.1, 0.8) | 0.5 (0.1, 1.7) | 0.5 (0.0, 2.7) | 0.4 (0.1, 0.8) |
| Infusion reaction | ||||
| Patients with ≥ 1 infusion reaction | 27 (4.6) | 4 (0.9) | 3 (1.5) | 34 (2.7) |
| Events/100 patient-years (95% CI) | 3.7 (2.7, 5.1) | 1.4 (0.5, 3.1) | 2.0 (0.5, 5.0) | 3.0 (2.2, 3.9) |
AE adverse event, AS ankylosing spondylitis, CI confidence interval, IV intravenous, MACE major adverse cardiovascular event, PsA psoriatic arthritis, RA rheumatoid arthritis, SAE serious adverse event, SD standard deviation, TB tuberculosis
*Data presented as n (%) unless otherwise noted