Summary of safety through week 268
| Golimumab* | ||||
|---|---|---|---|---|
| 50 mg only | 50 and 100 mg | 100 mg only | Total | |
| Number of golimumab-treated pts | 139 | 146 | 109 | 394 |
| Mean weeks of follow-up | 190.0 | 242.1 | 217.3 | 216.9 |
| Mean number of administrations | 44.3 | 56.9 | 51.1 | 50.9 |
| Pts with ≥1 AE (%) | 121 (87.1) | 126 (86.3) | 100 (91.7) | 347 (88.1) |
| Pts with ≥1 serious AE (%) | 29 (20.9) | 29 (19.9) | 25 (22.9) | 83 (21.1) |
| Pts who discontinued study (%) agent because of AE | 21 (15.1) | 9 (6.2) | 19 (17.4) | 49 (12.4) |
| Pts with ≥1 infection (%) | 94 (67.6) | 100 (68.5) | 87 (79.8) | 281 (71.3) |
| Death | ||||
| Pts with event (%) | 2 (1.4) | 0 | 3 (2.8) | 5 (1.3) |
| Incidence/100 pt-yrs (95% CI) | 0.39 (0.05 to 1.42) | 0.00 (0.00 to 0.44) | 0.66 (0.14 to 1.92) | 0.30 (0.10 to 0.71) |
| Serious infection | ||||
| Pts with event (%) | 5 (3.6) | 4 (2.7) | 6 (5.5) | 15 (3.8) |
| Number of serious infections | 5 | 7 | 7 | 19 |
| Incidence/100 pt-yrs (95% CI) | 0.98 (0.32 to 2.30) | 1.03 (0.41 to 2.12) | 1.54 (0.62 to 3.17) | 1.16 (0.70 to 1.81) |
| MACE† | ||||
| Pts with event (%) | 4 (2.9) | 4 (2.7) | 3 (2.8) | 11 (2.8) |
| Number of MACE | 5 | 4 | 4 | 13 |
| Incidence/100 pt-yrs (95% CI) | 0.98 (0.32 to 2.30) | 0.59 (0.16 to 1.51) | 0.88 (0.24 to 2.25) | 0.79 (0.42 to 1.35) |
| All malignancies | ||||
| Pts with event | 8 | 5 | 8 | 21 |
| Incidence/100 pt-yrs (95% CI) | 1.58 (0.68 to 3.12) | 0.74 (0.24 to 1.72) | 1.77 (0.77 to 3.49) | 1.28 (0.80 to 1.96) |
| SIR (95% CI) relative to SEER (excluding NMSC) | 1.85 (0.60 to 4.32) | 0.57 (0.07 to 2.05) | 1.42 (0.39 to 3.64) | 1.22 (0.61 to 2.18) |
| Type of malignancies | ||||
| Pts with lymphoma | 0 | 0 | 0 | 0 |
| Pts with NMSC | 3 | 3 | 4 | 10 |
| Incidence/100 pt-yrs (95% CI) | 0.59 (0.12 to 1.73) | 0.44 (0.09 to 1.29) | 0.88 (0.24 to 2.25) | 0.61 (0.29 to 1.12) |
| Pts with other malignancies (excluding NMSC) | 5 | 2 | 4 | 11 |
| Incidence/100 pt-yrs (95% CI) | 0.99 (0.32 to 2.30) | 0.29 (0.04 to 1.06) | 0.88 (0.24 to 2.26) | 0.67 (0.34 to 1.20) |
| SIR (95% CI) relative to SEER | 1.94 (0.63 to 4.52) | 0.60 (0.07 to 2.16) | 1.49 (0.41 to 3.81) | 1.28 (0.64 to 2.28) |
| Golimumab injection-site reactions | ||||
| Pts with reactions (%) | 14 (10.1) | 8 (5.5) | 15 (13.8) | 37 (9.4) |
| Injections with reactions (%) | 51/6158 (0.8) | 11/8314 (0.1) | 31/5572 (0.6) | 93/20044 (0.5) |
| Number of pts with >1 markedly abnormal postbaseline value for most commonly observed abnormalities through wk256 | 139 | 146 | 109 | 394 |
| Elevated eosinophil count‡ (%) | 3 (2.2) | 3 (2.1) | 2 (1.8) | 8 (2.0) |
| Elevated total bilirubin§ (%) | 5 (3.6) | 5 (3.4) | 1 (0.9) | 11 (2.8) |
Data shown are number (%) of patients, unless otherwise specified.
*With or without methotrexate.
†MACE were defined as cardiovascular deaths or cardio/cerebrovascular serious AEs and included acute myocardial infarction/ischemia, aphasia, carotid artery stenosis/disease/occlusion, death.
‡Markedly increased eosinophil count defined as ≥100% increase and value >0.8×103/µL.
§Markedly elevated total bilirubin value defined as ≥100% increase and value >1.5 mg/dL.
AE, adverse event; MACE, major adverse cardiovascular event; NMSC, non-melanoma skin cancer; pt(s), patient(s); pt-yrs, patient-years; SEER, Surveillance, Epidemiology and End Results database; SIR, standardised incidence ratio (observed/expected based on the SEER database (2004)), adjusted for age, gender, and race).