Study to Provide Insight into Practice Patterns, Utilization and Tolerability
Of Disease Modifying Anti Rheumatic Drugs (DMARDs) and Biologic Response
Modifiers
SEATTLE, Aug. 13 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX) and
Wyeth-Ayerst Laboratories, a division of American Home Products Corporation
(NYSE: AHP), announced today that they will sponsor a 10,000-patient
rheumatoid arthritis (RA) study. RADIUS (Rheumatoid Arthritis DMARD
Intervention and Utilization Study) is designed to gain more comprehensive
knowledge regarding current treatment for this chronic and debilitating
disease.
"This study is designed to analyze 'real world' treatment experience of
our patients with rheumatoid arthritis," said Allan Gibofsky, MD, JD,
Professor of Medicine and Public Health at Weill Medical College of Cornell
University and Attending Rheumatologist at The Hospital for Special Surgery in
New York City. "Given the size of the database, the study should yield
important clinical and safety information about our current treatment
regimens."
The RADIUS trial is specifically designed to collect data on:
* RA treatment practice patterns;
* Tolerability of RA therapies; and
* Efficacy of current disease modifying anti-rheumatic drugs (DMARDs) and
biologic response modifiers.
An independent advisory board comprised of academic and community-based
rheumatologists has provided input into the design and implementation of the
study. This board will also be involved in evaluating and interpreting data
collected in RADIUS.
"There are relatively few databases and little reliable data that can
provide a clear picture of how various therapies are used by community
physicians in patients with RA," said George Spencer-Green, MD, MS, franchise
medical director, Immunex Corporation. "This study is designed to provide a
better understanding of such use."
RADIUS STUDY DESIGN
RADIUS is divided into two parts:
* RADIUS 1 is a study of 5,000 adult patients who meet the ACR criteria
for RA diagnosis and currently require an introduction of a new DMARD to
RA therapy. This DMARD can be a change from, or an addition to, current
treatment regimen. This is a multi-center trial, and patients will be
recruited by approximately 600 investigators nationwide. RADIUS 1 is
scheduled to begin in the late summer of 2001 and data will be collected
for at least two years.
* RADIUS 2 will study an additional 5,000 adult patients who will begin
new treatment with ENBREL(R) (etanercept). These patients will meet the
same criteria as for RADIUS 1. This will also be a multi-center trial
and patients will be recruited by the same 600 investigators. RADIUS 2
is targeted to begin in 2002 when additional supplies of ENBREL become
available, and data will be collected for at least two years.
ABOUT ENBREL
An application for marketing approval of ENBREL was fast-tracked by the
U.S. Food and Drug Administration in 1998. Six months after the application
was submitted, the FDA approved ENBREL for reducing the signs and symptoms of
moderately to severely active RA in patients who have had an inadequate
response to one or more DMARDs. The following year, the FDA approved ENBREL
for reducing signs and symptoms of moderately to severely active
polyarticular-course juvenile rheumatoid arthritis in patients who have had an
inadequate response to DMARDs. In June 2000, the FDA approved ENBREL for
reducing signs and symptoms and inhibiting structural damage in patients with
moderately to severely active RA. ENBREL is the only TNF inhibitor approved
for use both with methotrexate or alone. It is also the only TNF inhibitor
approved for use as a first-line therapy for RA.
ENBREL acts by binding TNF, one of the dominant cytokines or regulatory
proteins that play an important role in both normal immune function and the
cascade of reactions that cause the inflammatory process of RA and psoriatic
arthritis. 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 INFECTIONS
OCCURRED IN PATIENTS WHO WERE PRONE TO INFECTIONS, SUCH AS THOSE WITH ADVANCED
OR POORLY CONTROLLED DIABETES. RARE CASES OF TUBERCULOSIS HAVE ALSO BEEN
REPORTED. 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. CONTACT YOUR PHYSICIAN IF YOU HAVE ANY QUESTIONS
ABOUT ENBREL OR INFECTIONS.
There have been rare reports of serious nervous system disorders such as
multiple sclerosis, seizures 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%).
In a study of 69 patients with JRA, infections (62%), headache (19%),
abdominal pain (19%), vomiting (13%), and nausea (9%) occurred more frequently
than in adults. The types of infections reported in JRA patients were
generally mild and consistent with those commonly seen in children. Serious
adverse reactions reported rarely were chicken pox (3%), gastroenteritis (3%),
serious infection (2%), depression/personality disorder (1%), skin ulcer (1%),
inflammation in parts of the upper digestive tract (1%), and diabetes (1%).
Immunex Corporation and Wyeth-Ayerst Laboratories, a division of American
Home Products (NYSE: AHP), market ENBREL in North America. Other AHP
affiliates market ENBREL outside of North America. Immunex manufactures
ENBREL. Additional information about ENBREL, including full prescribing
information, can be found on the company-sponsored Web site at
( http://www.enbrel.com ) or by calling toll-free 888-4ENBREL (888-436-2735).
Immunex Corporation is a leading biopharmaceutical company dedicated to
improving lives through immune system science innovations.
Wyeth-Ayerst Laboratories, a division of American Home Products, 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 gastrointestinal agents, vaccines,
oncology and hemophilia products.
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: Except for the historical information contained herein, this news
release contains forward-looking statements that involve substantial risks and
uncertainties. Among the factors that could cause actual results or timelines
to differ materially are risks associated with research and clinical
development, regulatory approvals, our supply capabilities and reliance on
third-party manufacturers, product commercialization, competition, litigation
and other risk factors listed from time to time in reports filed by Immunex
with the SEC, including but not limited to risks described under the caption
"Important Factors That May Affect Our Business, Our Results of Operations and
Our Stock Price" within our most recently filed Form 10-Q. The
forward-looking statements contained in this news release represent our
judgment as of the date of this release. Immunex undertakes no obligation to
publicly update any forward-looking statements.
SOURCE Immunex Corporation
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Related links:
http://www.immunex.com
http://www.enbrel.com
Company News On-Call:
http://www.prnewswire.com/comp/434644.html
CONTACT:
Media, Robin Shapiro of Immunex Corporation
+1-206-389-4040, or Doug Petkus of Wyeth-Ayerst, +1-610-902-7336,
or Investors, Mark Leahy of Immunex Corporation, +1-206-389-4363
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