FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE RA, IN COMBINATION WITH MTX

DEMONSTRATED SAFETY PROFILE

Adverse events (AEs) through Week 241,2 :

  SIMPONI ARIA® + MTX   Placebo (saline) + MTX
Number of patients, n* 463   197
Median follow-up, weeks 24.0   23.9
Patients with 1 AE, % (n) 52.9 (245)   49.2 (97)
Patients with 1 serious AE, % (n) 4.1 (19)   2.0 (4)
Discontinuation rate due to AEs, % (n) 3.5 (16)   0.5 (1)
Patients with 1 infection, % (n) 26.6 (123)   24.4 (48)
Patients with 1 serious infection, % (n) 0.9 (4)   0.0 (0)
Most common AE (occurring in 5% of patients treated with SIMPONI ARIA® 2 mg/kg + MTX)
Upper respiratory tract infection, % (n) 6.5 (30)   7.6 (15)

*Patients may appear in more than 1 column.

Incidence per 100 patient-years for patients treated with SIMPONI ARIA® + MTX (n=584) in the controlled and uncontrolled phase1,2:

  • Active tuberculosis (TB): 0.28 (3 events; 95% CI [0.06, 0.81])
  • Opportunistic infections: 0.37 (4 events; 95% CI [0.10, 0.95])
  • Total malignancies: 0.47 (5 events; 95% CI [0.15, 1.09])

During the controlled and uncontrolled phase, 6 malignancies were reported in 5 patients treated with SIMPONI ARIA® + MTX

*Total patient-years of follow-up for patients receiving golimumab + MTX were 1077 for active TB and opportunistic infections and 1073 for total malignancies.

Infusion reactions reported through Week 241: