Table 1

Summary of safety findings for the OLE (week 52 to week 204)

Open-label infliximab plus methotrexate (N=78)
Average weeks of follow-up114.1
Adverse events71 (91.0%)
Common adverse events (>20% of patients)
 Upper respiratory tract infection31 (39.7%)
 Pharyngitis30 (38.5%)
 Headache19 (24.4%)
 Fever18 (23.1%)
 Rhinitis18 (23.1%)
 Vomiting17 (21.8%)
Patients with adverse events leading to discontinuation of study agent Adverse events leading to discontinuation11 (14.1%)
 Infusion syndrome5 (6.4%)
 Pneumonia2 (2.6%)
 Anaphylactoid reaction1 (1.3%)
 Chills1 (1.3%)
 Coughing1 (1.3%)
 Fever1 (1.3%)
 Urticaria1 (1.3%)
 Uveitis1 (1.3%)
 Unintended pregnancy1 (1.3%)
 Vomiting1 (1.3%)
Serious adverse events*17 (21.8%)
Infections57 (73.1%)
Common infections (≥10% of patients)
 Upper respiratory infection25 (32.1%)
 Pharyngitis23 (29.5%)
 Rhinitis12 (15.4%)
 Bronchitis8 (10.3%)
 Fever8 (10.3%)
No of infusions with infusion reactions†60/1079 (5.6%)
 Positive for antibody to infliximab‡48/359 (13.4%)
 Negative for antibody to infliximab‡7/317 (2.2%)
 Inconclusive for antibody to infliximab‡3/364 (0.8%)
No of patients with infusion reactions†25/78 (32.1%)
 Positive for antibody to infliximab‡15/26 (57.7%)
 Negative for antibody to infliximab‡5/22 (22.7%)
 Inconclusive for antibody to infliximab‡3/23 (13.0%)
Serious infusion reaction2 (2.6%)
 Possible delayed hypersensitivity reaction0 (0.0%)
 Possible anaphylactic reaction1 (1.3%)
Antinuclear antibodies (titre ≥1:320)
 Newly positive from weeks 52 to 20415/58 (25.9%)
Antibody to double-stranded DNA
 Newly positive from weeks 52 to 2044/61 (6.6%)
  • * A serious adverse event was any adverse event that resulted in death, a life-threatening event, inpatient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability/incapacity, or congenital anomaly/birth defect.

  • An infusion reaction was any adverse event that occurred during an infusion or within 1 h after the completion of an infusion.

  • Any positive antibody response was classified as positive, regardless of the presence or absence of infliximab in the last serum sample(s) evaluated following an infusion; negative antibody responses were classified as negative if the patient had no measurable concentrations of infliximab in the sample(s) or inconclusive if infliximab was detected in the sample(s). In this analysis of infusion reactions by antibody status, the occurrence of infusion reactions was assessed among the 71 patients with appropriate samples for testing antibody to infliximab.

  • OLE, open-label extension.