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SIMPONI ARIA® (golimumab) Controlled & Uncontrolled Phase: AS | HCP

FOR ADULTS WITH ACTIVE AS

DEMONSTRATED SAFETY PROFILE AT WEEK 60

Adverse events (AEs) through Week 601,2

  SIMPONI ARIA®
Number of patients, n* 204
Median follow-up, weeks 51.8
Patients with 1 AE, % (n) 55.4% (113)
Patients with 1 serious AE, % (n) 3.4% (7)
Discontinuation rate due to AEs, % (n) 2.0% (4)
Patients with 1 infection, % (n) 32.8% (67)
Patients with 1 serious infection, % (n) 1.5% (3)
Patients with 1 infusion reaction, % (n) 1.5% (3)

Most common AEs (occurring in 5% of patients treated with SIMPONI ARIA®)

Nasopharyngitis, 11.8% (24)
Upper respiratory tract infection, 7.4% (15)
Alanine aminotransferase (ALT) increased, 5.9% (12)

*Patients may appear in more than one column.

  • 1 case of active tuberculosis was reported
  • No opportunistic infections or malignancies were reported
  • No deaths were reported

Infusion reactions reported through Week 601,2