FOR ADULTS WITH ACTIVE PsA

DEMONSTRATED SAFETY PROFILE

Adverse events (AEs) reported in the placebo-controlled phase (Week 24)1-3:

 SIMPONI
ARIA® + MTX		 Placebo
(saline) + MTX
Number of patients, n*240 239
Mean follow-up, weeks23.9 23.2
Patients with ≥1 AE, % (n)46.3 (111) 40.6 (97)
Patients with ≥1 serious AE, % (n)2.9 (7) 3.3 (8)
Discontinuation rate due to AEs, % (n)2.1 (5) 1.3 (3)
Patients with ≥1 infection, % (n)18.8 (45) 15.5 (37)
Patients with ≥1 serious infection, % (n)0.4% (1) 0.8% (2)
Patients with ≥1 infusion reaction, % (n)0.8% (2) 0% (0)
Most common AEs (occurring in ≥5% of patients treated with SIMPONI ARIA® 2 mg/kg + MTX)
Alanine aminotransferase (ALT) increased7.9 (19) 2.1 (5)
Aspartate aminotransferase (AST) increased5.4 (13) 2.1 (5)

*Patients may appear in more than one column.

  • ALT elevations ≥5X the upper limit of normal occurred in 1.7% of SIMPONI ARIA®–treated patients and <1% of placebo-treated patients1,2
  • Adverse reactions were similar to those observed in patients with RA, with the exception of psoriasis (new onset or worsening, palmar/plantar, and pustular), which occurred in <1% of SIMPONI ARIA®–treated patients2
  • The incidence of the adverse reactions reported in Trial PsA were similar to Trial RA with the exception of higher incidence in SIMPONI ARIA® for ALT increased (7.9% vs 2.1% in placebo), AST increased (5.4% vs 2.1% in placebo), and neutrophil count decreased (4.6% vs 2.1% in placebo)2
  • No opportunistic infections or active tuberculosis were reported in the SIMPONI ARIA® or placebo groups1
  • No malignancies were reported in the SIMPONI ARIA® group compared to 2 malignancies in the placebo group (n=2)1

Infusion reactions reported in the placebo-controlled phase (Week 24)1,3:

safetygraph
safetygraph
  • Infusion reactions reported for the SIMPONI ARIA® group included blood glucose increase (2 subjects, 0.8% [2/240]), headache (1 patient, 0.4% [1/240]) and infusion-related reaction (infusion reaction tightness of the chest, infusion reaction anxiety, and infusion reaction dyspnea; 1 patient, 0.4% [1/240])1
  • None of these infusion reactions were considered severe or serious1

MTX=methotrexate; PsA=psoriatic arthritis.