ENBREL is the First Biologic to Publish Data Showing Safety and Sustained Efficacy for up to Nine Years in Patients with Moderate-to-Severe Rheumatoid Arthritis
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Nov. 12, 2006--Amgen
(NASDAQ:AMGN) today announced that Enbrel(R) (etanercept) is the first
biologic with published data to show improvements in multiple measures
of efficacy that were sustained in rheumatoid arthritis (RA) patients
completing up to nine years of therapy. These new data are being
presented at the American College of Rheumatology (ACR) Scientific
Meeting in Washington, D.C.
"The current data in Rheumatoid Arthritis suggest that Enbrel is
both effective and safe in long-term use," said Mark Genovese, M.D.,
Stanford University Medical Center, Palo Alto, California. "These
findings are significant because they provide a degree of reassurance
to both the patient and the physician that unexpected safety concerns
do not appear to be developing after nine years of use."
ENBREL continues to have a strong safety profile for extended
periods of use. In the studies presented at ACR, rates of serious
adverse events and serious infections remained low and were consistent
with controlled portions from the double-blind phases of the studies.
The overall number of observed malignancies (excluding nonmelanoma
skin cancers) were similar in type and number to what would be
expected in the general population.
Additionally, data showed that 77 early rheumatoid arthritis (ERA)
and 280 long-standing rheumatoid arthritis (LRA) patients who
completed ENBREL treatment for up to eight years experienced
substantial improvements in their ACR scores. Additionally, 73 LRA
patients who completed ENBREL treatment for up to nine years
experienced similar improvements. ACR scores are a composite measure
of improvement in RA symptoms, including joint swelling and
tenderness, pain, level of disability, overall patient and physician
assessment, and an objective marker of inflammation, such as
erythrocyte sedimentation rate.
Data being presented at ACR showed that ENBREL provided sustained
improvement in the signs and symptoms of RA, in those patients who
continued in the study, regardless of duration of disease. Following
eight years of ENBREL therapy: 75 percent of ERA patients and 76
percent of LRA patients achieved ACR 20; 60 percent of ERA patients
and 52 percent of LRA patients achieved ACR 50; 35 percent of ERA
patients and 26 percent of LRA patients achieved ACR 70. Further, for
those patients with LRA who received ENBREL treatment for nine years,
74 percent achieved ACR 20, 41 percent achieved ACR 50, and 22 percent
achieved ACR 70.
The ability to perform daily activities is an important goal for
many people with RA, and data presented at ACR showed that treatment
with ENBREL may help them achieve this goal. Through eight years of
treatment with ENBREL, data showed that 73 to 85 percent of patients
with ERA and 53 to 72 percent of patients with LRA achieved a
clinically significant improvement in the Health Assessment
Questionnaire (HAQ) score, a patient questionnaire that measures
disability. A clinically significant improvement in HAQ was defined as
at least a 0.22 improvement from baseline.
"Before I was diagnosed with RA, the pain, stiffness and fatigue
stopped me from doing many of the activities I enjoyed," said Gloria
Treece, a participant in the study. "Since starting ENBREL treatment
approximately nine years ago, I'm now able to take part in many
activities with my family."
These studies were designed to assess the safety and long-term
efficacy of ENBREL in adult LRA patients who have failed to respond to
at least one disease-modifying antirheumatic drug, and adult patients
with ERA (defined as less than or equal to three years of disease
duration). Patients with RA who participated in controlled clinical
trials of ENBREL were eligible to enroll in open-label extension
studies (LRA, N=644; ERA, N=207).
ABOUT RA
More than two million Americans suffer from RA, which can cause
stiffness, swelling, and limitation in the motion and function of
multiple joints. If RA is left untreated, patients can become disabled
from joint damage caused by the disease, limiting their ability to
function.
ABOUT ENBREL
ENBREL is a fully human soluble TNF receptor. ENBREL has more than
14 years of collective clinical experience.
ENBREL is indicated for:
-- reducing signs and symptoms, keeping joint damage from getting
worse, and improving physical function in patients with
moderate to severe rheumatoid arthritis. ENBREL can be taken
with methotrexate or used alone.
-- reducing signs and symptoms of moderate to severe
polyarticular-course juvenile rheumatoid arthritis in patients
who have failed one or more disease modifying anti-rheumatic
drugs (DMARDs).
-- reducing signs and symptoms, keeping joint damage of active
arthritis from getting worse, and improving physical function
in patients with psoriatic arthritis. ENBREL can be used with
methotrexate in patients who do not respond adequately to
methotrexate alone.
-- reducing signs and symptoms in patients with active ankylosing
spondylitis.
-- the treatment of adult patients (18 years or older) with
chronic moderate to severe plaque psoriasis who are candidates
for systemic therapy or phototherapy.
ENBREL is a type of protein called a tumor necrosis factor (TNF)
blocker that blocks the action of a substance your body's immune
system makes called TNF. People with an immune disease, such as
rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and
psoriasis, have too much TNF in their bodies. ENBREL can reduce the
amount of TNF in the body to normal levels, helping to treat your
disease. But, in doing so, ENBREL can also lower the ability of your
immune system to fight infections.
All medicines have side effects, including ENBREL. Possible side
effects of ENBREL include:
-- Serious infections
-- Many occurred in people prone to infection, such as those with
advanced or poorly controlled diabetes
-- Some serious infections have been fatal
-- Rare cases of tuberculosis have occurred
-- What not to do
-- Do not start ENBREL if you have an infection, such
as an open sore or the flu, or are allergic to
ENBREL or its components
-- What to do
-- Tell your doctor if you are prone to infection
-- Stop ENBREL if a serious infection occurs
-- Contact your doctor if you have questions about
ENBREL or develop an infection
-- Tell your doctor if you have ever been treated for
heart failure
-- 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
-- Rare reports of serious blood disorders (some fatal)
-- Contact your doctor immediately if you develop symptoms, such
as persistent fever, bruising, bleeding, or paleness
-- In medical studies of all TNF blockers, including ENBREL, a higher
rate of lymphoma (a type of cancer) was seen compared to the
general population. The risk of lymphoma may be up to several-fold
higher in rheumatoid arthritis and psoriasis patients
-- The role of TNF blockers, including ENBREL, in the development
of lymphoma is unknown
-- ENBREL can cause injection site reactions
-- In a medical study of patients with JRA, infections, headaches,
abdominal pain, vomiting, and nausea occurred more frequently than
in adults
-- The kinds of infections reported were generally mild and
similar to those usually seen in children
-- Other serious adverse reactions were reported rarely,
including serious infections (2%) and depression/personality
disorder (1%)
About Amgen and Wyeth
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market
ENBREL in North America. Wyeth markets ENBREL outside of North
America. Immunex Corporation, a wholly owned subsidiary of Amgen,
manufactures ENBREL. Additional information about ENBREL, including
full Prescribing Information, can be found on the Web site sponsored
by the companies at www.enbrel.com or by calling toll free 888-4ENBREL
(888-436-2735).
Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
first companies to realize the new science's promise by bringing safe
and effective medicines from lab, to manufacturing plant, to patient.
Amgen therapeutics have changed the practice of medicine, helping
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With a broad and deep pipeline of potential new medicines, Amgen
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vital medicines, visit www.amgen.com.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products
in the areas of women's health care, cardiovascular disease, central
nervous system, inflammation, transplantation, hemophilia, oncology,
vaccines and nutritional products. Wyeth is one of the world's largest
research-driven pharmaceutical and health care products companies. It
is a leader in the discovery, development, manufacturing and marketing
of pharmaceuticals, vaccines, biotechnology products and
non-prescription medicines that improve the quality of life for people
worldwide. The Company's major divisions include Wyeth
Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
Health.
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