Table 2.
Adverse events during the placebo-controlled periods of studies of IV golimumab in patients with RA, PsA, and AS*
| RA trial, weeks 0–24 | PsA trial, weeks 0–24 | AS trial, weeks 0–16 | Pooled | |||||
|---|---|---|---|---|---|---|---|---|
| Placebo | Golimumab | Placebo | Golimumab | Placebo | Golimumab | Placebo | Golimumab | |
| Patients, N | 197 | 395 | 239 | 240 | 103 | 105 | 539 | 740 |
| Mean follow-up, weeks | 20.9 | 23.6 | 23.2 | 23.9 | 16.0 | 16.1 | 21.0 | 22.6 |
| Patients who discontinued due to an AE | 1 (0.5) | 12 (3.0) | 3 (1.3) | 5 (2.1) | 0 | 0 | 4 (0.7) | 17 (2.3) |
| Patients with ≥ 1 AE | 98 (49.7) | 227 (57.5) | 97 (40.6) | 111 (46.3) | 24 (23.3) | 34 (32.4) | 219 (40.6) | 372 (50.3) |
| Patients with ≥ 1 infection | 48 (24.4) | 119 (30.1) | 37 (15.5) | 45 (18.8) | 8 (7.8) | 12 (11.4) | 93 (17.3) | 176 (23.8) |
| Patients with ≥ 1 SAE | 5 (2.5) | 19 (4.8) | 8 (3.3) | 7 (2.9) | 0 | 2 (1.9) | 13 (2.4) | 28 (3.8) |
| Patients with ≥ 1 serious infection | 0 | 4 (1.0) | 2 (0.8) | 1 (0.4) | 0 | 1 (1.0) | 2 (0.4) | 6 (0.8) |
| Patients with malignancy | 0 | 1 (0.3) | 2 (0.8) | 0 | 0 | 0 | 2 (0.4) | 1 (0.1) |
| Deaths | 1 (0.5) | 0 | 2 (0.8) | 0 | 0 | 0 | 3 (0.6) | 0 |
| Patients with ≥ 1 infusion reaction | 1 (0.5) | 14 (3.5) | 0 | 4 (1.7) | 0 | 3 (2.9) | 1 (0.2) | 21 (2.8) |
| Common AEs** | ||||||||
| Upper respiratory tract infection | 15 (7.6) | 29 (7.3) | 3 (1.3) | 7 (2.9) | 1 (1.0) | 3 (2.9) | 19 (3.5) | 39 (5.3) |
| Increased ALT | 7 (3.6) | 11 (2.8) | 5 (2.1) | 19 (7.9) | 0 | 3 (2.9) | 12 (2.2) | 33 (4.5) |
| Headache | 5 (2.5) | 20 (5.1) | 5 (2.1) | 5 (2.1) | 1 (1.0) | 4 (3.8) | 11 (2.0) | 29 (3.9) |
| Nasopharyngitis | 5 (2.5) | 10 (2.5) | 13 (5.4) | 8 (3.3) | 1 (1.0) | 6 (5.7) | 19 (3.5) | 24 (3.2) |
| Increased AST | 3 (1.5) | 7 (1.8) | 5 (2.1) | 13 (5.4) | 0 | 0 | 8 (1.5) | 20 (2.7) |
| Hypertension | 4 (2.0) | 14 (3.5) | 4 (1.7) | 4 (1.7) | 0 | 1 (1.0) | 8 (1.5) | 19 (2.6) |
| Bronchitis | 2 (1.0) | 12 (3.0) | 4 (1.7) | 1 (0.4) | 0 | 0 | 6 (1.1) | 13 (1.8) |
| Urinary tract infection | 6 (3.0) | 12 (3.0) | 0 | 0 | 1 (1.0) | 0 | 7 (1.3) | 12 (1.6) |
| Worsening rheumatoid arthritis | 12 (6.1) | 9 (2.3) | 0 | 0 | 0 | 0 | 12 (2.2) | 9 (1.2) |
| Neutropenia | 0 | 0 | 5 (2.1) | 9 (3.8) | 0 | 0 | 5 (0.9) | 9 (1.2) |
AE adverse event, AS ankylosing spondylitis, ALT alanine aminotransferase, AST aspartate aminotransferase, IV intravenous, PsA psoriatic arthritis, RA rheumatoid arthritis, SAE serious adverse event
*Data presented as n (%) unless otherwise noted
**AEs occurring in ≥ 3% of patients in any treatment group