ACTEMRA monotherapy provided rapid response for patients in the AMBITION trial 2
Randomized, double-blind, 24-week, Phase III clinical study in MTX-naïve/-free† patients with moderately to severely active RA. The primary endpoint was ACR20 response at week 24. Patients were treated with ACTEMRA 8 mg/kg IV* (every 4 weeks) or an escalating dose of MTX. MTX dose was initiated at 7.5 mg/week and increased to a maximum dose of 20 mg/week within 8 weeks.
*The recommended starting dose for ACTEMRA IV for adult patients is 4 mg/kg every 4 weeks followed by an increase to 8 mg/kg every 4 weeks based on clinical response.
†ACTEMRA is not indicated for the treatment of MTX-naïve patients with RA. ACTEMRA is indicated for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more DMARDs.
ACR=American College of Rheumatology; DMARD=disease-modifying antirheumatic drug; MTX=methotrexate; RA=rheumatoid arthritis.
SELECT IMPORTANT SAFETY INFORMATION
ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA.
Please see additional Important Safety Information below, and full Prescribing Information, including BOXED WARNING.
ACTEMRA also provided rapid response in TNF-IR patients 10
A Phase III, randomized, double-blind, placebo-controlled, parallel-group, 24-week study in RA patients who failed on at least one TNF antagonist. Randomly assigned patients received either ACTEMRA 8 mg/kg IV,* ACTEMRA 4 mg/kg, or placebo every 4 weeks while continuing background MTX (no other DMARDs were allowed).
Disease duration (ACTEMRA 8 mg/kg arm): 12.6 years; 50% of patients received at least 1 previous TNF therapy.
Disease duration (ACTEMRA 4 mg/kg arm): 11.0 years; 47% of patients received at least 1 previous TNF therapy.
ACR50 and ACR70 responses at week 24 were achieved by:
- 28.8% and 12.4% of patients in the ACTEMRA 8 mg/kg group
- 16.8% and 5.0% in the ACTEMRA 4 mg/kg group
- 3.8% and 1.3% in the placebo group
TNF=tumor necrosis factor; TNF-IR=inadequate response to TNF.