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

DEMONSTRATED SAFETY PROFILE

Adverse events (AEs) through Week 1121,2 :

  SIMPONI ARIA® + MTX
Number of patients, n* 584
Median follow-up, weeks 95.9
Patients with 1 AE, % (n) 79.1 (462)
Patients with 1 serious AE, % (n) 18.2 (106)
Discontinuation rate due to AEs, % (n) 7.0 (41)
Patients with 1 infection, % (n) 49.1 (287)
Patients with 1 serious infection, % (n) 6.2 (36)
Most common AEs (occurring in 5% of patients), % (n)
Upper respiratory tract infection, 11.5 (67); bronchitis, 8.9 (52); RA, 8.7 (51); hypertension, 6.7 (39); nasopharyngitis, 6.7 (39); urinary tract infection, 6.5 (38); ALT increase, 6.5 (38); headache, 5.8 (34); pharyngitis, 5.8 (34) 

Incidence per 100 patient-years for patients treated with SIMPONI ARIA® + MTX (n=584) in the controlled and uncontrolled phases1,2:

  • 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

 

Infusion reactions reported in the controlled and uncontrolled phrases (≈Week 92)1: