Week 16 and week 24 safety results
| Placebo-controlled period | Placebo crossover period | Cumulative | ||||||
|---|---|---|---|---|---|---|---|---|
| Weeks 0–16 | Weeks 16–24 | Weeks 0–24 | ||||||
| Group 1: Placebo | Group 2: Golimumab 50 mg | Group 3: Golimumab 100 mg | Group 1: Placebo→Golimumab 50 mg | Group 2: Golimumab 50 mg | Group 3: Golimumab 100 mg | Group 2: Golimumab 50 mg | Group 3: Golimumab 100 mg | |
| Patients, n | 105 | 101 | 102 | 92 | 96 | 100 | 101 | 102 |
| Patients with AEs | 67 (63.8) | 63 (62.4) | 62 (60.8) | 31 (33.7) | 34 (35.4) | 33 (33.0) | 72 (71.3) | 72 (70.6) |
| Patients with SAEs | 2 (1.9) | 1 (1.0) | 2 (2.0) | 0 (0) | 3 (3.1) | 2 (2.0) | 4 (4.0) | 4 (3.9) |
| Patients with AEs leading to discontinuation of study agent | 3 (2.9) | 2 (2.0) | 1 (1.0) | 0 (0) | 2 (2.1) | 1 (1.0) | 4 (4.0) | 2 (2.0) |
| Patients with infections | 25 (23.8) | 27 (26.7) | 29 (28.4) | 5 (5.4) | 11 (11.5) | 7 (7.0) | 33 (32.7) | 34 (33.3) |
| Patients with serious infections | 1 (1.0) | 0 (0) | 1 (1.0) | 0 (0) | 1 (1.0) | 0 (0) | 1 (1.0) | 1 (1.0) |
| Patients with abnormal LFTs | 3 (2.9) | 0 (0) | 4 (3.9) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 4 (3.9) |
| Patients with injection-site reactions | 7 (6.7) | 8 (7.9) | 8 (7.8) | 3 (3.3) | 6 (6.3) | 5 (5.0) | 12 (11.9) | 10 (9.8) |
| Patients with neoplasms (benign, malignant and unspecified) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (2.1) | 1 (1.0) | 2 (2.0) | 1 (1.0) |
| Breast cancer | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (1.0) | 0 (0) | 1 (1.0) |
| Skin papilloma | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (1.0) | 0 (0) | 1 (1.0) | 0 (0) |
| Ovarian neoplasm | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (1.0) | 0 (0) | 1 (1.0) | 0 (0) |
Data are presented as n (%) unless otherwise noted.
AEs, adverse events; LFT, liver function test; SAEs, serious adverse events.