72% of Patients Taking ENBREL Showed No Progression of Joint Erosion
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.
SINCE THE PRODUCT WAS FIRST INTRODUCED, SERIOUS INFECTIONS, SOME INVOLVING
DEATH, HAVE BEEN REPORTED IN PATIENTS USING ENBREL. MANY OF THESE EVENTS
OCCURRED IN PATIENTS WHO WERE PRONE TO INFECTIONS, SUCH AS THOSE WITH ADVANCED
OR POORLY CONTROLLED DIABETES. ENBREL SHOULD BE DISCONTINUED IN PATIENTS WITH
SERIOUS INFECTIONS. DO NOT START ENBREL IF YOU HAVE AN INFECTION OF ANY TYPE
OR IF YOU HAVE AN ALLERGY TO ENBREL OR ITS COMPONENTS. ENBREL SHOULD BE USED
WITH CAUTION IN PATIENTS PRONE TO INFECTION.
There have been rare reports of serious nervous system disorders such as
multiple sclerosis and/or inflammation of the nerves of the eyes. Tell your
doctor if you have ever had any of these disorders or if you develop them
after starting ENBREL. There have also been rare reports of serious blood
disorders, some involving death. Contact your doctor immediately if you
develop symptoms such as persistent fever, bruising, bleeding or paleness. It
is unclear if ENBREL has caused these nervous system or blood disorders. If
your doctor confirms serious blood problems, you may need to stop using
ENBREL.
The most frequent adverse events in placebo-controlled clinical trials
involving 349 adults were injection site reactions (ISR) (37%), infections
(35%), and headache (17%). Only the rate of ISR was higher than that of
placebo. The most frequent adverse events in a methotrexate-controlled
clinical trial of 415 adults with early-stage RA were infections (64%), ISR
(34%), and headache (24%). Only the rate of ISR was higher than that of
methotrexate. In all 1,197 RA patients studied, malignancies were rare (1%).
Immunex Corporation (Nasdaq: IMNX) and Wyeth-Ayerst Laboratories, a
division of American Home Products Corporation, market ENBREL in North
America. Other AHP affiliates will market ENBREL outside of North America.
Immunex manufactures ENBREL. Additional information about ENBREL, including
full prescribing information, can be found on the company-sponsored website at
(http://www.enbrel.com) or by calling toll-free 888-4ENBREL (888-436-2735).
Immunex Corporation is a biopharmaceutical company dedicated to improving
lives through immune system science innovations.
American Home Products Corporation's Wyeth Ayerst division is a major
research-oriented pharmaceutical company with leading products in the areas of
women's health care, cardiovascular disease therapies, central nervous system
drugs, anti-inflammatory agents, vaccines, oncology and hemophilia products
and generic pharmaceuticals.
American Home Products Corporation is one of the world's largest
research-based pharmaceutical and health care products companies. It is a
leader in the discovery, development, manufacturing, and marketing of
prescription drugs and over-the-counter medications. It also is a global
leader in vaccines, biotechnology and animal health care.
NOTE: This news release contains forward-looking statements that involve
risks and uncertainties, including risks associated with clinical development,
regulatory approvals, our reliance on third-party manufacturers, product
commercialization and other risks described from time to time in the SEC
reports filed by Immunex, including the most recently filed Form 10-Q. An
electronic version of this news release -- as well as additional information
about Immunex of interest to investors, customers, future employees and
patients -- is available on the Immunex home page at http://www.immunex.com.
SOURCE Immunex Corporation
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http://www.immunex.com
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http://www.prnewswire.com/comp/434644.html or fax,
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CONTACT:
Courtney Self of Immunex Corporation,
206-389-4142; or Doug Petkus of Wyeth-Ayerst Laboratories,
610-902-7336
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