FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE RA, IN COMBINATION WITH MTX

DEMONSTRATED SAFETY PROFILE

Adverse events (AEs) through Week 1121,2:

SIMPONI ARIA® + MTX
Number of patients, n584
Mean follow-up, weeks95.9
Patients with ≥1 AE, % (n)79.1 (462)
Patients with ≥1 serious AE, % (n)18.2 (106)
Discontinuation rate due to AEs, % (n)7.0 (41)
Patients with ≥1 infection, % (n)49.1 (287)
Patients with ≥1 serious infection, % (n)6.2 (36)
Patients with ≥1 infusion reaction3.9% (23)
Most common AEs (occurring in ≥5% of patients), % (n)
Upper respiratory tract infection11.5 (67)
Bronchitis8.9 (52)
RA8.7 (51)
Hypertension6.7 (39)
Nasopharyngitis6.7 (39)
Urinary tract infection6.5 (38)
ALT increase6.5 (38)
Headache5.8 (34)
Pharyngitis5.8 (34)

Incidence per 100 patient-years for patients treated with SIMPONI ARIA® + MTX (n=584) in the controlled and uncontrolled phases1,2*:

  • Active TB: 0.28 (3 events; 95% CI [0.06, 0.81])
  • Opportunistic infections: 0.37 (4 events; 95% CI [0.10, 0.95])
  • Total malignancies: 0.47 (5 events; 95% CI [0.15, 1.09])

*Total patient-years of follow-up were 958 for active TB and opportunistic infections and 955 for total malignancies. During the controlled and uncontrolled phase, 6 malignancies were reported in 5 patients treated with SIMPONI ARIA® + MTX.

Infusion reactions reported in the controlled and uncontrolled phases (~Week 112) 1,2

safetygraph
safetygraph

ALT=alanine aminotransferase; MTX=methotrexate; TB=tuberculosis.

References: 1. Data on file. Johnson & Johnson. 2. Bingham CO III, Mendelsohn AM, Kim L, et al. Maintenance of clinical and radiographic benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: week-112 efficacy and safety results of the open-label long-term extension of a phase III, double-blind, randomized, placebo-controlled trial. Arthritis Care Res (Hoboken). 2015;67(12):1627-1636.