Canada's First Biologic Therapy for Rheumatoid Arthritis Provides New
Treatment Option for Patients
TORONTO, Dec. 8 /PRNewswire/ -- Health Canada has approved ENBREL(R)
(etanercept) for use in Canada. As Canada's first biologic therapy for
rheumatoid arthritis, ENBREL is approved in adults for reduction in signs and
symptoms of moderately to severely active rheumatoid arthritis in patients who
have had an inadequate response to one or more disease-modifying antirheumatic
drugs (DMARDs). In addition, ENBREL can be used in combination with
methotrexate in adult patients who do not respond adequately to methotrexate
alone. ENBREL vials will be commercially available for use in Canada
beginning March 2001 through a patient registry program that is accessible
through the patient's rheumatologist.
"ENBREL is a breakthrough treatment for Canadians with rheumatoid
arthritis," said Aldo Baumgartner, President and Chief Executive Office of
Wyeth-Ayerst Canada, Inc. "It brings the hope of effective treatment to many
patients for whom existing medications have failed."
In a Phase 3 trial of 234 rheumatoid arthritis patients, responses were
rapid, often appearing within one to two weeks after initiation of therapy,
and nearly always occurred within 3 months. At three months, study results
demonstrated that 62 percent of the patients receiving a 25 mg dose of ENBREL
reached the primary endpoint of 20 percent improvement by ACR criteria -- a
composite score of select measurements of RA symptoms including joint pain,
joint swelling, and patient and physician global assessment -- compared to
23 percent of the patients in the placebo group. At 6 months, the secondary
endpoints of this study demonstrated a 69 percent median improvement in pain
(vs. 2 percent for placebo), a 71 percent median improvement in tender joint
counts (vs. 6 percent for placebo), a 51 percent median improvement in swollen
joint counts (vs. 2 percent for placebo), and an 88 percent median reduction
in duration of morning stiffness (vs. 4 percent for placebo).
"ENBREL has given me my life back," says Rebecca McDonald. "Before
ENBREL, I could barely get out of bed, let alone climb a set of stairs. Now,
I'm able to run up a set of stairs, am active again with my family, and plan
to resume my teaching career." Individual responses to ENBREL may vary. In
medical studies, ENBREL worked for about two out of three people who used it.
In the United States, ENBREL is currently approved as first-line treatment
for reducing signs and symptoms and delaying structural damage in patients
with moderately to severely active rheumatoid arthritis. ENBREL is also
approved for the treatment of moderately to severely active
polyarticular-course juvenile rheumatoid arthritis (JRA) in patients who have
had an inadequate response to one or more disease-modifying medicines.
ENBREL is the only TNF inhibitor that can be used with or without
methotrexate.
In Canada, supplemental applications for polyarticular-course JRA and
first-line treatment of moderately to severely active rheumatoid arthritis in
adults will be filed soon with Health Canada.
"ENBREL works at the source of the inflammation, interrupting the disease
cycle and providing rapid and dramatic relief from the painful effects of
rheumatoid arthritis," said Dr. Ed Keystone, Director, Centre for Advanced
Therapeutics in Arthritis at Mount Sinai Hospital in Toronto, Canada, and a
rheumatologist who has been involved in studies of ENBREL. "Treatment with
ENBREL has provided these people with new hope -- where there was little
before -- to return to a more active and productive lifestyle."
About Rheumatoid Arthritis
According to the Arthritis Society of Canada, nearly 300,000 Canadians
have rheumatoid arthritis -- the most disabling form of arthritis that causes
pain, swelling, and severe limitations of movement that can lead to
disability.
Joint inflammation can destroy cartilage, tendons and ligaments, wear away
bone and subsequently cause joint deformity. People with rheumatoid arthritis
live on average 10 years less than those who do not suffer from rheumatoid
arthritis. Rheumatoid arthritis can affect people at any age, but most
commonly people ages 25 to 50. Women are three times more likely than men to
develop the disease.
ABOUT ENBREL
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%).
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%),
depression/personality disorder (1%), skin ulcer (1%), inflammation in parts
of the upper digestive tract (1%), group A streptococcal septic shock (1%),
type I diabetes mellitus (1%), and soft tissue and post-operative wound
infection (1% each).
Immunex Corporation 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
and records sales of ENBREL in the United States and Canada. Additional
information about ENBREL, including the U.S. 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 leading 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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CONTACT:
Doug Petkus of Wyeth-Ayerst Laboratories,
610-902-7336; or investors, Mark Leahy, 206-389-4363, or media,
Courtney Self, 206-389-4142, both of Immunex Corporation
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