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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