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

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
Median follow-up, weeks 23.9   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)
Most common AEs (occurring in ≥5% of patients treated with SIMPONI ARIA® 2 mg/kg +/- MTX)
Alanine aminotransferase (ALT) increased 7.9 (19)   2.1 (5)
Aspartate aminotransferase (AST) increased 5.4 (13)   2.1 (5)

*Patients may appear in more than 1 column.

  • ALT elevations ≥5X the upper limit of normal occurred in 1.7% of SIMPONI ARIA®-treated patients and <1% of placebo-treated patients1
  • 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 groups1,2
  • No malignancies were reported in the SIMPONI ARIA® group compared to 2 malignancies in the placebo group (n=2)1,2

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

  • 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%)1
  • None of these infusion reactions were considered severe or serious1

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