Table 5 Adverse events summarized by corticosteroid use at baseline in patients with RA, PsA, and AS*
Occurrence during placebo-controlled periods, n (%) | ||||||||||||||||
RA trial | PsA trial | AS trial | Pooled | |||||||||||||
PBO | Golimumab | PBO | Golimumab | PBO | Golimumab | PBO | Golimumab | |||||||||
Corticosteroid use at baseline | + | - | + | − | + | − | + | − | + | − | + | − | + | − | + | − |
Treated patients, N | 134 | 63 | 251 | 144 | 67 | 172 | 66 | 174 | 23 | 80 | 32 | 73 | 224 | 315 | 349 | 391 |
Mean follow-up, weeks | 21.1 | 20.4 | 23.5 | 23.9 | 22.7 | 23.3 | 23.4 | 24.0 | 15.9 | 16.0 | 16.0 | 16.1 | 21.0 | 20.9 | 22.8 | 22.5 |
≥ 1 infection | 34 (25.4) | 14 (22.2) | 79 (31.5) | 40 (27.8) | 9 (13.4) | 28 (16.3) | 13 (19.7) | 32 (18.4) | 0 | 8 (10.0) | 2 (6.3) | 10 (13.7) | 43 (19.2) | 50 (15.9) | 94 (26.9) | 82 (21.0) |
≥ 1 SAE | 5 (3.7) | 0 | 16 (6.4) | 3 (2.1) | 3 (4.5) | 5 (2.9) | 1 (1.5) | 6 (3.4) | 0 | 0 | 0 | 2 (2.7) | 8 (3.6) | 5 (1.6) | 17 (4.9) | 11 (2.8) |
≥ 1 serious infection | 0 | 0 | 3 (1.2) | 1 (0.7) | 2 (3.0) | 0 | 1 (1.5) | 0 | 0 | 0 | 0 | 1 (1.4) | 2 (0.9) | 0 | 4 (1.1) | 2 (0.5) |
Events/100 patient-years through study completion** | ||||||||||||||||
RA trial | PsA trial | AS trial | Pooled | |||||||||||||
Golimumab | Golimumab | Golimumab | Golimumab | |||||||||||||
Corticosteroid use at baseline | + | − | + | − | + | − | + | − | ||||||||
Patients, N | 381 | 203 | 126 | 334 | 55 | 149 | 562 | 686 | ||||||||
Total PY of follow-up | 697 | 379 | 112 | 306 | 57 | 146 | 865 | 832 | ||||||||
SAE | 16.4 (13.5, 19.6) | 15.6 (11.8, 20.1) | 4.5 (1.5, 10.5) | 9.5 (6.4, 13.6) | 0 (0.0, 5.3) | 5.5 (2.4, 10.8) | 13.8 (11.4, 16.5) | 11.5 (9.4, 14.1) | ||||||||
Serious infections | 3.6 (2.3, 5.3) | 4.7 (2.8, 7.5) | 3.6 (1.0, 9.2) | 2.3 (0.9, 4.7) | 0.0 (0.0, 5.3) | 2.1 (0.4, 6.0) | 3.4 (2.2, 4.8) | 3.4 (2.2, 4.9) | ||||||||