ACTEMRA HAS PROVEN EFFICACY AT 2 DOSING STRENGTHS 1,12
ACTEMRA 8 mg/kg IV* + MTX and ACTEMRA 4 mg/kg IV + MTX demonstrated greater efficacy compared to MTX alone
1-year, double-blind treatment phase followed by a second year of open-label therapy, and optional 3-year open-label extension phase; a Phase III trial. In year 1, patients received ACTEMRA 8 mg/kg IV* + MTX, ACTEMRA 4 mg/kg IV + MTX, or placebo + MTX every 4 weeks. The primary endpoint was ACR20 response at week 24. The primary endpoint was achieved in 56% of patients with ACTEMRA 8 mg/kg + MTX and 51% of patients with ACTEMRA 4 mg/kg + MTX, vs 27% of patients with placebo + MTX at week 24.
*The recommended starting dose for ACTEMRA IV is 4 mg/kg every 4 weeks followed by an increase to 8 mg/kg every 4 weeks based on clinical response.
ACR=American College of Rheumatology; MTX=methotrexate; MTX-IR=inadequate response to MTX.