FOR ADULTS WITH ACTIVE PsA

DEMONSTRATED SAFETY PROFILE AT WEEK 60

Controlled and uncontrolled phase (Week 60)1,2

Combined SIMPONI ARIA®
+/- MTX
Number of patients, n460
Mean follow-up, weeks47.2
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 ≥1 infusion reaction, % (n)0.9 (4)
Patients with active tuberculosis, % (n)0.4 (2)
Patients with ≥1 malignancy, % (n)0.4 (2)
Patients with ≥1 demyelinating event, % (n)0.2 (1)
Most common AEs occurring in ≥5% of patients treated with SIMPONI ARIA® +/- MTX, %(n)
Nasopharyngitis5.0 (23)
ALT increased8.3 (38)
AST increased6.7 (31)
  • No opportunistic infections were reported1
  • Active tuberculosis was observed in 0.4% (2)2
  • Four newly diagnosed malignancies were reported through Week 60: 2 subjects in the SIMPONI ARIA® group and 2 subjects in the placebo group1
  • Three deaths were reported through Week 60: 2 subjects in the placebo group and 1 subject in the SIMPONI ARIA® group1

INFUSION REACTIONS WITH SIMPONI ARIA® vs PLACEBO-CONTROLLED PATIENTS THROUGH WEEK 601,2

safetygraph
  • Infusion reactions reported for the SIMPONI ARIA® group included headache (1 patient, 0.2%), infusion-related reaction (infusion reaction tightness of the chest, infusion reaction anxiety, and infusion reaction dyspnea; 1 patient, 0.2%), fatigue (1 patient, 0.2%), and throat irritation (1 patient, 0.2%)1
  • None of these infusion reactions were considered severe or serious1,2

AE=adverse events; ALT=alanine aminotransferase; AST=aspartate aminotransferase; MTX=methotrexate; PsA=psoriatic arthritis.

References: 1. Data on file. Johnson & Johnson. 2. Husni ME, Kavanaugh A, Murphy F, et al. Efficacy and safety of intravenous golimumab through one year in patients with active psoriatic arthritis. Arthrit Care Res. 2006;45(6):885-889.