New Two-Year Data Demonstrate That ENBREL Therapy Allowed Significantly More Rheumatoid Arthritis Patients to Achieve Clinical Remission
THOUSAND OAKS, Calif. & COLLEGEVILLE, Pa.---June
10, 2004--New results from TEMPO (Trial of Etanercept and Methotrexate
with Radiographic Patient Outcomes) demonstrated that Enbrel(R)
(etanercept) therapy allowed significantly more rheumatoid arthritis
(RA) patients to achieve clinical remission at two years compared to
patients treated with methotrexate alone. Building on the one-year
TEMPO results, this two-year data further supports the continued
efficacy of ENBREL therapy over time. Results were presented today
during the EULAR (European League Against Rheumatism) Annual European
Congress of Rheumatology in Berlin, Germany.
"The two-year data from the ongoing TEMPO trial show very good
results for the combination of etanercept and methotrexate. We are
particularly impressed by the high frequency of remission in patients
who have had both a long previous history of RA and high disease
activity at the start of the trial," said Lars Klareskog, M.D., Ph.D.,
principal investigator of the study from the rheumatology unit at the
Karolinska Institute/Karolinska University Hospital in Stockholm,
More than 40 percent of the 231 patients receiving combination
therapy of ENBREL and methotrexate achieved clinical remission as
assessed by the Disease Activity Score (DAS). Also, a significantly
higher percentage of the 223 patients receiving ENBREL alone (23.3
percent) achieved clinical remission, compared with the 228 patients
receiving methotrexate alone (15.8 percent). Clinical remission is
defined as having a DAS of less than 1.6, which measures tender and
swollen joints, erythrocyte sedimentation rate (ESR, an inflammatory
marker) and overall general health.
Nearly half (48.5 percent) of patients treated with the ENBREL
combination therapy achieved an American College of Rheumatology (ACR)
70 score compared with 27.4 percent of patients treated with ENBREL
and 20.6 percent of patients treated with methotrexate alone. ACR
scores measure improvement in RA disease activity, including joint
swelling and tenderness, pain, level of disability and overall
patient- and physician assessment. The ACR response is defined by the
level of improvement -- 20 percent, 50 percent, or 70 percent -- where
70 percent describes an improvement that is greatest in degree and,
therefore, most clinically meaningful.
Patients treated with ENBREL combination therapy also experienced
significant improvement in functionality after two years. Improvement
in functionality was significantly higher for the combination group as
assessed by patients' responses to the Health Assessment Questionnaire
(HAQ). Patients treated with ENBREL combination therapy experienced a
56 percent mean improvement in HAQ scores from baseline, compared to
39 percent mean improvement in patients treated with ENBREL alone and
36 percent mean improvement in patients treated with methotrexate
Also presented at the meeting were data from the first year of the
TEMPO study, showing that 80 percent of the combination-treated
patients experienced no progression of joint damage on radiographs at
one year as assessed by the van der Heijde-modified Total Sharp Score
(TSS), compared with 68 percent of the patients treated with ENBREL
monotherapy and 57 percent of patients treated with methotrexate
monotherapy. The TSS is an X-ray measurement of changes in joint
damage. "No progression" is defined as a unit change from baseline of
TSS less than or equal to 0.5.
The ENBREL TEMPO study randomized 682 patients with RA to one of
three treatment groups: ENBREL (25 mg twice weekly), methotrexate (up
to 20 mg once weekly), or ENBREL (25 mg twice weekly) plus
methotrexate. Patients in the ENBREL TEMPO trial had active RA and had
failed at least one disease-modifying antirheumatic drug (DMARD) other
Treatment with ENBREL or combination therapy was generally
well-tolerated. The safety profile was generally consistent with that
previously observed, and the combination did not result in increased
infections after two years of therapy.
More than two million Americans suffer from RA, which causes
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
ENBREL is the only fully human TNF receptor approved to reduce
signs and symptoms, improve physical function, and inhibit the
progression of structural damage in patients with moderately to
severely active RA, and to reduce the signs and symptoms and inhibit
the progression of structural damage of active arthritis in patients
with psoriatic arthritis. ENBREL is the only biologic therapy approved
in the U.S. for first-line treatment of RA patients, and can be used
alone or in combination with methotrexate. It is approved to reduce
the signs and symptoms of moderately to severely active
polyarticular-course juvenile rheumatoid arthritis (JRA) in patients
who have had an inadequate response to one or more DMARDs. It is also
the only biologic approved in the U.S. to treat 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 234,000 patients worldwide
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 that causes the
inflammatory process of RA, JRA, psoriatic arthritis, AS and
psoriasis. The binding of ENBREL to TNF renders the bound TNF
biologically inactive, resulting in significant reduction in
Since the product was first introduced, the following have been
reported in patients using ENBREL:
-- Serious infections
-- Many occurred in people prone to infection, such as those with
advanced or poorly controlled diabetes
-- Some serious infections were fatal
-- Rare cases of tuberculosis
-- What to do/not to do
-- Do not start ENBREL if you have an infection or are allergic
to ENBREL or its components.
-- 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
-- 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, a higher rate of lymphoma
(a type of cancer) was seen compared to the general population;
however, the risk of lymphoma may be up to several fold higher in
RA and psoriasis patients.
-- The role of TNF-blockers in the development of lymphoma is
-- The incidence of other cancers has not increased with exposure to
ENBREL and is similar to the expected rate.
-- ENBREL can also cause injection site reactions.
-- In a medical study of patients with JRA, infections, headaches,
abdominal pain, vomiting, and nausea occurred more frequently than
-- 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 percent) and
depression/personality disorder (1 percent).
Amgen Inc. 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
Amgen (Nasdaq:AMGN) is a global biotechnology company that
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Andrea Rothschild, 805-447-4587 (media)
Investor Relations, 805-447-1060
Jenifer Antonacci, 484-865-5220 (media)
Justin Victoria, 973-660-5340 (investors)