Table 4.
Adverse events, including clinical laboratory abnormalities, summarized by methotrexate 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 | |||||||
| Methotrexate use at baseline | + | + | + | − | + | − | + | − | + | − | + | − | + | − |
| Treated patients, N | 197 | 395 | 173 | 66 | 163 | 77 | 21 | 82 | 16 | 89 | 391 | 148 | 574 | 166 |
| Mean follow-up, weeks | 20.9 | 23.6 | 23.2 | 23.1 | 23.8 | 24.0 | 15.9 | 16.0 | 16.1 | 16.1 | 21.6 | 19.2 | 23.5 | 19.7 |
| ≥ 1 infection | 48 (24.4) | 119 (30.1) | 26 (15.0) | 11 (16.7) | 26 (16.0) | 19 (24.7) | 2 (9.5) | 6 (7.3) | 2 (12.5) | 10 (11.2) | 76 (19.4) | 17 (11.5) | 147 (25.6) | 29 (17.5) |
| ≥ 1 SAE | 5 (2.5) | 19 (4.8) | 4 (2.3) | 4 (6.1) | 5 (3.1) | 2 (2.6) | 0 | 0 | 0 | 2 (2.2) | 9 (2.3) | 4 (2.7) | 24 (4.2) | 4 (2.4) |
| ≥ 1 serious infection | 0 | 4 (1.0) | 1 (0.6) | 1 (1.5) | 1 (0.6) | 0 | 0 | 0 | 0 | 1 (1.1) | 1 (0.3) | 1 (0.7) | 5 (0.9) | 1 (0.6) |
| Baseline ALT ≤ ULN, n | 182 | 357 | 144 | 60 | 135 | 74 | 18 | 76 | 15 | 83 | 344 | 136 | 507 | 157 |
| ALT ≥ 3 to < 5× ULN | 2 (1.1) | 4 (1.1) | 1 (0.7) | 0 | 2 (1.5) | 1 (1.4) | 0 | 0 | 0 | 1 (1.2) | 3 (0.9) | 0 | 6 (1.2) | 2 (1.3) |
| ALT ≥ 5× ULN | 0 | 3 (0.8) | 0 | 1 (1.7) | 0 | 1 (1.4) | 0 | 1 (1.3) | 0 | 0 | 0 | 2 (1.5) | 3 (0.6) | 1 (0.6) |
| Baseline ALT > ULN, n | 14 | 34 | 25 | 4 | 27 | 3 | 3 | 4 | 1 | 6 | 42 | 8 | 62 | 9 |
| ALT ≥ 3 to < 5× ULN | 3 (21.4) | 4 (11.8) | 0 | 0 | 3 (11.1) | 1 (33.3) | 0 | 0 | 0 | 0 | 3 (7.1) | 0 | 7 (11.3) | 1 (11.1) |
| ALT ≥ 5× ULN | 0 | 0 | 0 | 0 | 3 (11.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (4.8) | 0 |
| Events/100 patient-years through study completion** | ||||||||||||||
| RA trial | PsA trial | AS trial | Pooled | |||||||||||
| Golimumab | Golimumab | Golimumab | Golimumab | |||||||||||
| Methotrexate use at baseline | + | + | − | + | − | + | − | |||||||
| Patients, N | 584 | 323 | 137 | 36 | 168 | 943 | 305 | |||||||
| Total PY of follow-up | 1077 | 290 | 127 | 35 | 168 | 1402 | 295 | |||||||
| Serious infections | 4.0 (2.9, 5.4) | 3.8 (1.9, 6.8) | 0 (0.0, 2.4) | 0 (0.0, 8.5) | 1.8 (0.4, 5.2) | 3.9 (2.9, 5.0) | 1.0 (0.2, 3.0) | |||||||
| ALT ≥ 3 to < 5× ULN | 3.5 (2.5, 4.8) | 21.0 (16.1, 27.0) | 7.9 (3.8, 14.5) | 2.8 (0.1, 15.8) | 2.4 (0.7, 6.1) | 7.1 (5.8, 8.7) | 4.8 (2.6, 8.0) | |||||||
| ALT ≥ 5× ULN | 2.0 (1.3 ,3.1) | 3.1 (1.4, 5.9) | 3.2 (0.9, 8.1) | 0 (0.0, 8.5) | 1.2 (0.1, 4.3) | 2.2 (1.5, 3.1) | 2.0 (0.8, 4.4) | |||||||
| Patients positive for antibodies to golimumab***, n/N (%) | 129/552 (23.4) | 60/316 (19.0) | 39/134 (29.1) | 4/36 (11.1) | 37/167 (22.2) | 193/904 (21.3) | 76/301 (25.2) | |||||||
“+” indicates with methotrexate; “−” indicates without methotrexate
AE adverse event, ALT alanine aminotransferase, AS ankylosing spondylitis, CI confidence interval, PBO placebo, PsA psoriatic arthritis, PY patient-years, RA rheumatoid arthritis, SAE serious adverse event, ULN upper limit of normal
*Data presented as n (%), n/N (%), or events /100 PY (95% CI), unless otherwise noted
**The three trials ranged from 60 to 112 weeks in duration (Fig. 1). Time-adjusted incidence of AEs (events/100 PY) are shown
***Antibodies to golimumab were assessed using a drug-tolerant enzyme immunoassay at 52 weeks for all three trials