- For US Healthcare Providers
- Full Prescribing Information
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: