Safety findings through the end of IV golimumab dosing in the main study and during the LTE enrollment period (including early escape and dose regimen adjustments) and throughout the LTE of SC golimumab. Note that data are summarized by actual treatment received, with adverse events being attributed to the treatment received at the time of the event. Thus, some patients are included in more than 1 column. Data are n (%) unless otherwise indicated.
| IV Study Agent (Main Study Week 0 Through LTE-0) | SC Golimumab (LTE-0 through LTE-40) | |||||
|---|---|---|---|---|---|---|
| IV Placebo + MTX | All IV Golimumab Combined | All IV Golimumab + MTX Combined | SC Golimumab 50 mg | SC Golimumab 50 mg + MTX | All SC Golimumab Combined | |
| Patients treated, n | 129 | 254 | 469 | 117 | 419 | 508 |
| Average duration of followup, wks | 24.4 | 47.6 | 59.5 | 33.4 | 38.2 | 39.2 |
| Average no. of IV administrations | 2.9 | 5.2 | 5.4 | — | — | — |
| Average no. of SC administrations | — | — | — | 6.0 | 6.5 | 6.8 |
| Patients with ≥ 1 AE | 93 (72.1) | 201 (79.1) | 393 (83.8) | 78 (66.7) | 286 (68.3) | 353 (69.5) |
| Patients with ≥ 1 SAE | 7 (5.4) | 25 (9.8) | 71 (15.1) | 8 (6.8) | 38 (9.1) | 46 (9.1) |
| Patients who died | 0 (0.0) | 4 (1.6) | 2 (0.4) | 0 (0.0) | 2 (0.5) | 2 (0.4) |
| Patients who discontinued IV/SC study agent due to AE | 4 (3.1) | 17 (6.7) | 32 (6.8) | 5 (4.3) | 5 (1.2) | 10 (2.0) |
| Patients with ≥ 1 neoplasm* | 2 (1.6) | 3 (1.2) | 17 (3.6) | 0 (0.0) | 2 (0.5) | 2 (0.4) |
| Patients with ≥ 1 infection | 48 (37.2) | 115 (45.3) | 238 (50.7) | 41 (35.0) | 149 (35.6) | 187 (36.8) |
| Patients with ≥ 1 serious infection | 2 (1.6) | 12 (4.7) | 26 (5.5) | 2 (1.7) | 16 (3.8) | 18 (3.5) |
| Infusions/injections with infusion/injection reaction | 7/368 (1.9) | 18/1311 (1.4) | 24/2483 (1.0) | 5/700 (0.7) | 14/2743 (0.5) | 19/3443 (0.6) |
| Patients with ≥ 1 infusion/injection reaction | 7 (5.4) | 15 (5.9) | 19 (4.1) | 4 (3.4) | 8 (1.9) | 12 (2.4) |
↵* Including benign, malignant, and unspecified growths (including cysts and polyps). AE: adverse event; IV: intravenous; LTE: longterm extension; MTX: methotrexate; SAE: serious adverse event; SC: subcutaneous.