Data from two Phase III studies
showed that patients who suffer from the debilitating and painful effects
of rheumatoid arthritis (RA) achieved significant improvements in signs and
symptoms when treated with ACTEMRA(R) (tocilizumab) alone or in combination
with methotrexate compared with methotrexate alone. The final results of
both studies will be presented as oral presentations, along with 13 other
abstracts which evaluate ACTEMRA in patients with moderately to severely
active RA, at the American College of Rheumatology (ACR) Annual Scientific
Meeting in San Francisco, October 24-29.
Results of the RADIATE study, which evaluated difficult-to-treat
patients who failed to respond to prior anti-tumor necrosis factor
(TNF)-alpha therapies, demonstrated that half of patients treated with
ACTEMRA (8 mg/kg) in combination with methotrexate achieved a 20 percent
reduction (ACR20)(1) in RA signs and symptoms, compared with 10 percent of
patients treated with methotrexate alone.
"Despite treatment with existing therapies, many patients with RA
continue to experience symptoms of joint pain and stiffness," said Mark
Genovese, M.D., Professor of Medicine at Stanford University School of
Medicine. "The compelling results of these studies further support the
efficacy and safety of ACTEMRA as a potential new treatment option for
managing the chronic signs and symptoms of this debilitating disease."
The AMBITION study, which examined the effects of ACTEMRA (8 mg/kg) as
monotherapy, showed that 70 percent of patients receiving ACTEMRA achieved
a 20 percent improvement in their signs and symptoms (ACR20), compared with
53 percent of patients receiving methotrexate alone. The study not only
successfully met its primary endpoint of non-inferiority in patients with
moderate to severe RA, but also demonstrated superiority over the standard
effective dose regimen of methotrexate alone.
In both studies, nearly one-third of all ACTEMRA (8 mg/kg) patients
achieved disease remission (as defined by DAS28
Treatment with ACTEMRA and methotrexate showed significant clinical
benefits even in the subgroup analysis of difficult-to-treat patients who
received up to three anti-TNF-alpha therapies that failed.
The most common adverse reactions reported most frequently in the
ACTEMRA arms of the RADIATE study were diarrhea, upper abdominal pain, rash
and dizziness.
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