SEATTLE, Nov. 29 /PRNewswire/
-- Data from a clinical study published in the current issue of the New
England Journal of Medicine demonstrate that ENBREL(R) (etanercept) can
delay progression of structural joint damage in patients with moderately
to severely active rheumatoid arthritis (RA), even in patients with the
earliest stages of the disease. Patients were included in the study only
if they had been diagnosed with active RA within three years, however,
on average, patients included in the study had disease for just one
year.
The study showed that
ENBREL was effective in delaying joint damage in early RA patients, with
72 percent of 207 patients taking ENBREL having no progression of joint
erosion measured by x-ray at one year, compared to 60% of 217 patients
taking methotrexate.
"This study is
important because it showed that ENBREL alone compared favorably to
methotrexate, which is the current standard of care," said Barbara
Finck, Medical Director at Immunex and one of the lead authors on the
New England Journal of Medicine article. "In addition to being
effective for reducing signs and symptoms in patients with long-standing
moderately to severely active disease, we now know that ENBREL is
effective in delaying structural damage in patients with early RA. This
is especially important because 70% of RA patients show erosions within
2 years of diagnosis."
ENBREL "ERA"
Study
The Early RA, or ERA,
trial was a Phase 3 randomized, double-blind, multi-center study that
included 632 adults who had RA for less than three years and had never
been treated with methotrexate. Patients were randomized to receive
either 25 mg or 10 mg of ENBREL by subcutaneous (under the skin)
injection or up to 20 mg of methotrexate per week for 12 months.
Patients enrolled in this study had RA for a relatively short time (mean
of one year), and had active disease (mean tender and swollen joint
counts of 30 and 24, respectively, and reported four hours of morning
stiffness). All patients had risk factors for rapidly progressive,
erosive RA including the presence of rheumatoid factor and/or erosions
on baseline x-rays of the hands, wrists and feet.
ABOUT ENBREL
Based on the data from
the ERA trial, the U.S. Food and Drug Administration approved ENBREL for
reducing signs and symptoms and delaying structural damage in patients
with moderately to severely active RA on June 6, 2000 as part of a
supplemental biologics license application (sBLA). The FDA originally
approved ENBREL on November 2, 1998 to reduce signs and symptoms of
moderately to severely active rheumatoid arthritis in patients who have
an inadequate response to one or more disease modifying anti-rheumatic
drugs (DMARDs). ENBREL is the only TNF inhibitor that can be used with
or without methotrexate.
ENBREL acts by binding
tumor necrosis factor (TNF). TNF is one of the dominant cytokines or
proteins that play an important role in normal immune function and the
cascade of reactions that cause the inflammatory process of RA. ENBREL
competitively inhibits binding of TNF molecules to the TNF receptor (TNFR)
sites. The binding of ENBREL to TNF renders the bound TNF biologically
inactive, resulting in significant reduction in inflammatory activity.
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