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
Mean follow-up, weeks16.1 16.0
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)
Patients with ≥1 serious infection, % (n)1.0% (1) 0% (0)
Patients with ≥1 infusion reaction, % (n)2.9% (3) 0% (0)
Most common AEs (occurring in ≥5% of patients treated with SIMPONI ARIA® 2 mg/kg)
Nasopharyngitis5.7 (6) 1.0 (1)

*Patients may appear in more than one 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

Infusion reactions reported in the placebo-controlled phase (Week 16)2:

safetygraph
safetygraph

ALT=alanine aminotransferase; AS=ankylosing spondylitis; RA=rheumatoid arthritis.

References: 1. SIMPONI ARIA® [Prescribing Information]. Horsham, PA: Johnson & Johnson. 2. Data on file. Johnson & Johnson.