Table 2.

Summary of key safety findings through Week 104. Data presented are number (%) of patients unless specified otherwise.

Golimumab + MTX
Placebo1, Wks 0–24Golimumab 100 mg + PlaceboGolimumab 50 mg + MTXGolimumab 100 mg + MTXAll Golimumab + MTXAll Golimumab
Golimumab-treated pts2125132212239387434
Average no. golimumab injections16.418.414.819.421.6
Average followup time (wks)66.076.658.878.389.9
Average cumulative golimumab dose (mg)1634.5919.31466.81407.01699.9
Total pt-yrs of followup51.4167.6312.3270.4582.7750.3
AE109 (82.6)181 (85.4)154 (64.4)314 (81.1)388 (89.4)
Common AE3
  Upper respiratory tract infection21 (15.9)40 (18.9)35 (14.6)74 (19.1)93 (21.4)
  Cough13 (9.8)25 (11.8)20 (8.4)45 (11.6)58 (13.4)
  Nasopharyngitis13 (9.8)20 (9.4)22 (9.2)42 (10.9)55 (12.7)
  Bronchitis11 (8.3)26 (12.3)16 (6.7)42 (10.9)50 (11.5)
  Headache8 (6.1)19 (9.0)19 (7.9)37 (9.6)45 (10.4)
Discontinuation of SC study agent because of AE(s)13 (9.8)14 (6.6)15 (6.3)29 (7.5)41 (9.4)
Serious AE26 (19.7)33 (15.6)41 (17.2)73 (18.9)98 (22.6)
Death
  No. patients0 (0.0)3 (2.3)0 (0.0)1 (0.4)1 (0.3)4 (0.9)
  Incidence (95% CI) per 100 pt-yrs0.00 (0.00, 5.83)1.79 (0.37, 5.23)0.00 (0.00, 0.96)0.37 (0.01, 2.06)0.17 (0.00, 0.96) 0.53 (0.15, 1.37)
Any infection75 (56.8)131 (61.8)103 (43.1)227 (58.7)293 (67.5)
  Treated infection(s)58 (43.9)98 (46.2)83 (34.7)177 (45.7)229 (52.8)
  Serious infection(s)0 (0.0)8 (6.1)7 (3.3)14 (5.9)21 (5.4)29 (6.7)
  Incidence (95% CI) per 100 pt-yrs0.00 (0.00, 5.83)4.77 (2.06, 9.41)2.24 (0.90, 4.62)5.18 (2.83, 8.69)3.60 (2.23, 5.51) 3.87 (2.59, 5.55)
Malignancies4
  No. patients2 (1.6)3 (2.3)6 (2.8)5 (2.1)11 (2.8)14 (3.2)
  Incidence (95% CI) per 100 pt-yrs3.89 (0.47, 14.05)1.79 (0.37, 5.23)1.92 (0.71, 4.18)1.85 (0.60, 4.32)1.89 (0.94, 3.38) 1.87 (1.02, 3.13)
  SIR (95% CI) vs SEER50.00 (0.00, 8.40)0.00 (0.00, 2.91)1.04 (0.13, 3.76)1.85 (0.38, 5.41)1.41 (0.46, 3.29) 1.09 (0.35, 2.54)
Injection site reactions6
  Reaction to golimumab injection14 (10.6)10 (4.7)12 (5.0)22 (5.7)36 (8.3)
  Reaction to placebo injection9 (6.8)6 (2.8)7 (2.9)13 (3.4)21 (4.8)
  • 1 Because of vast differences in length of followup for placebo versus golimumab treatment, incidence by length of followup is provided for AE of interest, i.e., death, serious infection, malignancy.

  • 2 Patients may appear in more than 1 column. Thus, treatment groups are not mutually exclusive.

  • 3 Absolute numbers and percentages of patients with 1 or more AE reported in 10% or more of golimumab-treated patients. The Medical Dictionary for Regulatory Activities (MedDRA) preferred terms are sorted by decreasing frequency in the “All Golimumab” group.

  • 4 Two (1.5%) additional patients in the placebo + MTX group had malignancies through Week 52, yielding a total of 16 patients with malignancy.

  • 5 SIR: standardized incidence ratio, i.e., observed/expected incidences of malignancy (excluding nonmelanoma skin cancer).

  • 6 Injection site reactions were defined as any adverse reaction at a subcutaneous study agent injection site. MTX: methotrexate; pt-yrs: patient-years; SC: subcutaneous; SEER: Surveillance, Epidemiology and End Results; AE: adverse events.