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SIMPONI ARIA® Safety Profile: Psoriatic Arthritis | HCP | HCP
  1. Safety
  2. PSA - Safety - Placebo Uncontrolled Phase

FOR ADULTS WITH ACTIVE PsA

DEMONSTRATED SAFETY PROFILE AT WEEK 60

Controlled and uncontrolled phase (Week 60)1

  Combined SIMPONI ARIA® + MTX*
Number of patients, n 460
Mean follow-up, weeks 47.2
Patients with ≥1 AE, % (n) 50.9 (234)
Patients with ≥1 serious AE, % (n) 5.2 (24)
Discontinuation rate due to AEs, % (n) 3.7 (17)
Deaths, % (n) 0.2 (1)
Patients with ≥1 infection, % (n) 22.8 (105)
Patients with ≥1 serious infection, % (n) 2.2 (10)
Patients with active TB, % (n) 0.4 (2)
Patients with ≥malignancy, % (n) 0.4 (2)
Patients with ≥demyelinating event, % (n) 0.2 (1)
Most common AEs occurring in ≥5% of patients treated with SIMPONI ARIA® +/- MTX, %(n): nasopharyngitis 5.0 (23), ALT increased 8.3 (38), and AST increased 6.7 (31)

*Patients may appear in more than 1 column.

  • No opportunistic infections were reported1
  • Four newly diagnosed malignancies were reported through Week 60: 2 patients in the SIMPONI ARIA® group and 2 patients in the placebo group1
  • Three deaths were reported through Week 60: 2 patients in the placebo group and 1 patient in the SIMPONI ARIA® group1

INFUSION REACTIONS WITH SIMPONI ARIA® vs PLACEBO-CONTROLLED PATIENTS THROUGH WEEK 60

  • Infusion reactions reported for the SIMPONI ARIA® group included headache (1 patient, 0.4%) and infusion-related reaction (infusion reaction tightness of the chest, infusion reaction anxiety, and infusion reaction dyspnea; 1 patient, 0.4%)2
  • None of these infusion reactions were considered severe or serious2

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