FOR ADULTS WITH ACTIVE AS

DEMONSTRATED SAFETY PROFILE

Adverse events (AEs) reported in the placebo-controlled phase (Week 16)1,2 :

  SIMPONI ARIA®   Placebo (saline)
Number of patients, n* 105   103
Median follow-up, weeks 16.1   16
Patients with 1 AE, % (n) 32.4 (34)   23.3 (24)
Patients with 1 serious AE, % (n) 1.9 (2)   0
Discontinuation rate due to AEs, % (n) 0   0
Patients with 1 infection, % (n) 11.4 (12)   7.8 (8)
Most common AEs (occurring in 5% of patients treated with SIMPONI ARIA® 2 mg/kg)
Nasopharyngitis 5.7 (6)   1.0 (1)

*Patients may appear in more than 1 column.

  • The adverse reactions were similar to those reported in patients with RA, with the exception of the higher incidence of ALT increased, which occurred in 2.9% of SIMPONI ARIA®-treated patients compared with none of the placebo-treated patients
  • No opportunistic infections, active tuberculosis, or malignancies were reported in the SIMPONI ARIA® and placebo groups1,2

 

The safety profile through Week 28 was similar to the safety profile during the first 16 weeks of the study.

Infusion reactions reported in the placebo-controlled phase (Week 16):