About the AMBITION Study
AMBITION (Actemra versus Methotrexate double-Blind Investigative Trial In mONotherapy), a two-arm, randomized, double-blind, placebo-controlled study, was designed to evaluate the non-inferiority and subsequent superiority of ACTEMRA monotherapy in patients with RA compared with methotrexate alone at 24 weeks. Patients who had not received methotrexate for at least six months beforehand were randomized to receive either ACTEMRA (8 mg/kg) intravenously every four weeks plus placebo capsules weekly or placebo infusions every four weeks plus methotrexate weekly. The study evaluated 673 patients from 252 sites in 18 countries, including the United States.
In the AMBITION study, 70 percent, 44 percent and 28 percent of patients in the ACTEMRA (8 mg/kg) arm achieved ACR20, ACR50 and ACR70, respectively, compared with 53 percent, 34 percent and 15 percent, respectively, of patients treated with methotrexate alone. Disease remission (DAS28 <2.6) was demonstrated in 34 percent of ACTEMRA patients compared with 12 percent of patients in the control group. A higher proportion of ACTEMRA (8 mg/kg) patients achieved a significant EULAR response(3) as early as the second week in the study. Levels of C-reactive protein (CRP), a marker of inflammation, and hemoglobin levels showed rapid normalization in as early as two weeks in ACTEMRA (8 mg/kg) patients in the AMBITION study, compared with patients treated with methotrexate alone.
ACTEMRA was generally well tolerated and the adverse event rates were similar in the group treated with ACTEMRA compared with patients treated with methotrexate alone (80 percent and 78 percent, respectively).
In both studies, patients treated with ACTEMRA alone or with methotrexate achieved greater improvements in quality-of-life measures, including fatigue, pain, and physical and mental functions, compared with methotrexate.
About ACTEMRA(R) (tocilizumab)
ACTEMRA is the fir
|SOURCE Hoffmann-La Roche Inc.|
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