Table 4.

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 + MTXAll IV Golimumab CombinedAll IV Golimumab + MTX CombinedSC Golimumab 50 mgSC Golimumab 50 mg + MTXAll SC Golimumab Combined
Patients treated, n129254469117419508
Average duration of followup, wks24.447.659.533.438.239.2
Average no. of IV administrations2.95.25.4
Average no. of SC administrations6.06.56.8
Patients with ≥ 1 AE93 (72.1)201 (79.1)393 (83.8)78 (66.7)286 (68.3)353 (69.5)
Patients with ≥ 1 SAE7 (5.4)25 (9.8)71 (15.1)8 (6.8)38 (9.1)46 (9.1)
Patients who died0 (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 AE4 (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 infection48 (37.2)115 (45.3)238 (50.7)41 (35.0)149 (35.6)187 (36.8)
Patients with ≥ 1 serious infection2 (1.6)12 (4.7)26 (5.5)2 (1.7)16 (3.8)18 (3.5)
Infusions/injections with infusion/injection reaction7/368 (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 reaction7 (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.