Treatment Has Demonstrated Improvement in Physical Function and Kept Joint Damage from Progressing at Three Years
ENBREL Plus Methotrexate: First Treatment Regimen to Demonstrate Ability to Inhibit Radiographic Progression of Joint Damage for Three Consecutive Years
THOUSAND OAKS, Calif. & COLLEGEVILLE, Pa., Nov 13, 2005 (BUSINESS WIRE) --
Amgen (Nasdaq:AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE),
today announced data from a long-term blinded study of anti-TNF agent in patients
with rheumatoid arthritis (RA) demonstrated that more than three quarters of
patients treated with Enbrel(R) (etanercept) plus methotrexate combination therapy
experienced no progression of joint damage at three years. These new results
from the TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient
Outcomes) study will be presented at the American College of Rheumatology's
(ACR) Annual Scientific Meeting in San Diego, California.
"Rheumatoid arthritis is a chronic condition requiring long-term
treatment. It is critical to provide patients with treatment options
that not only reduce the signs and symptoms of the disease, but also
inhibit the progression of joint damage," said Desiree van der Heijde,
M.D., professor of rheumatology, University of Maastricht in the
Netherlands. "The TEMPO results reinforce the benefits of ENBREL and
methotrexate combination therapy and underscore the importance of
effective treatment."
At three years, the majority of patients taking ENBREL and
methotrexate combination therapy had no progression of joint
damage(1). These results were significantly better than those achieved
in ENBREL monotherapy and methotrexate monotherapy-treated patients.
Patients receiving ENBREL monotherapy also had significantly better
results than patients receiving methotrexate monotherapy. Total Sharp
Score was calculated by assessing changes in joint space narrowing and
bone erosion as captured by radiographic imaging.
Further, additional data presented at ACR showed that improvement in physical
function was higher for the ENBREL combination group than for either therapy
alone. Patients treated with ENBREL combination therapy experienced a 56 percent
mean improvement in Health Assessment Questionnaire (HAQ) scores from baseline,
compared to 37 percent mean improvement in patients treated with ENBREL alone
and 33 percent mean improvement in patients treated with methotrexate alone.
HAQ scores measure a patient's ability to perform activities of daily living
such as dressing, walking, and grooming.
The ENBREL TEMPO study randomized 686 patients with RA, of which 638 were included
in the three-year radiographic analysis. Patients received either ENBREL (25
mg twice weekly), methotrexate (up to 20 mg once weekly), or ENBREL (25 mg twice
weekly) plus methotrexate once weekly. Patients in the ENBREL TEMPO trial had
active RA and an inadequate response to at least one disease-modifying antirheumatic
drug (DMARD) other than methotrexate. The primary radiographic endpoint was
the change from baseline in the van der Heijde-modified TSS at one year. Secondary
radiographic endpoints included changes in total erosions, changes in total
joint space narrowing, number of eroded joints, and percent of patients with
no radiographic progression.
ENBREL was generally well tolerated.
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 the only soluble tumor necrosis factor (TNF) receptor
approved to reduce signs and symptoms, induce major clinical response,
improve physical function, and inhibit the progression of structural
damage in patients with moderately to severely active rheumatoid
arthritis (RA). ENBREL can be used alone or in combination with
methotrexate.
ENBREL is the only treatment indicated to reduce the signs and
symptoms, inhibit the progression of structural damage of active
arthritis, and improve physical function in patients with psoriatic
arthritis. It is approved to reduce the signs and symptoms of
moderately to severely active polyarticular-course juvenile rheumatoid
arthritis (JRA) in patients four years of age or older who have had an
inadequate response to one or more disease-modifying antirheumatic
drugs (DMARDs). It is also the first biologic approved to reduce the
signs and symptoms in patients with active ankylosing spondylitis
(AS). ENBREL is indicated for 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 has been used by more than 308,000 patients worldwide
across indications.
ENBREL acts by binding TNF, one of the dominant inflammatory
cytokines or regulatory proteins that play an important role in both
normal immune function and the cascade of reactions involved in the
inflammatory process of RA, JRA, psoriasis, psoriatic arthritis, and
AS. The binding of ENBREL to TNF renders the bound TNF biologically
inactive, resulting in significant reduction in inflammatory activity.
What important information do I need to know about taking ENBREL?
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 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
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 website sponsored by
the companies at www.ENBREL.com or by calling toll-free 1-888-4ENBREL
(1-888-436-2735).
Amgen discovers, develops and delivers innovative human
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products in the areas of women's health care, cardiovascular disease,
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SOURCE: Amgen
Amgen
Christine Cassiano, 805-447-4587 (media)
Laura Biswas, 805-447-1060 (investors)
or
Wyeth Pharmaceuticals
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