Study Showed Half of Patients Treated with Enbrel(R) (etanercept) Plus Methotrexate Can Achieve DAS Clinical Remission and 80 Percent Had No Progression of Joint Damage in Active Early Rheumatoid Arthritis
2008-07-15 17:46:00
Data Demonstrated Benefits of Early Treatment in Patients with
Moderate-to-Severe Rheumatoid Arthritis (RA)
COLLEGEVILLE, Pa. & THOUSAND OAKS, Calif.–(EMWNews)–Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) and Amgen
(NASDAQ:AMGN) today announced the publication of data from the COMET
(COmbination of Methotrexate and ETanercept in Active Early Rheumatoid
Arthritis) trial demonstrating that half of patients treated with the
combination of ENBREL and methotrexate achieved Disease Activity Score
(DAS) clinical remission and nearly all had no progression of joint
damage. These findings were published online on July 15 by The Lancet,
a leading global medical journal.
According to study results at one year, 50 percent of patients (n = 265)
with active early moderate–to-severe
rheumatoid arthritis who received a combination of ENBREL and
methotrexate therapy achieved DAS clinical remission (DAS28 <
2.6) versus 28 percent (n = 263) of those treated with methotrexate
alone. DAS28 is a measure of joint swelling and tenderness (based on 28
joints), as well as overall disease activity measured by a global health
assessment and an objective marker of inflammation (erythrocyte
sedimentation rate). DAS28 is a modified measure of the DAS44, which is
a validated tool used in clinical trials and serves as the basis for the
European League Against Rheumatism (EULAR) response criteria.
“We hope that these data encourage physicians
to use clinical remission as a new standard for evaluating symptom
control in the treatment of early RA,” said
Paul Emery, M.D., lead COMET trial investigator and Professor of
Rheumatology, University of Leeds, UK. “Clinical
remission is highly relevant to patients’
daily lives as they cope with their symptoms.”
Additionally, at one year, 80 percent of patients (n = 246) receiving
ENBREL and methotrexate had no evidence of progression of joint damage
as seen on x-ray, compared to 59 percent (n = 230) of those treated with
methotrexate alone.
Combination therapy with ENBREL plus methotrexate also helped patients
remain more functionally active. Based on the Health Assessment
Questionnaire (used to assess certain daily life activities), 61 percent
(n = 256) of patients treated with combination therapy demonstrated
improvement in their functionality versus 44 percent (n = 241) of those
treated with only methotrexate. Further, the COMET trial showed that
patients who were treated with combination therapy had a nearly
three-fold reduction in work stoppage compared with those who received
methotrexate alone.
“It’s important for
people living with a chronic disease like moderate to severe rheumatoid
arthritis to be able to continue with their daily life activities,”
said Dr. Emery. “These data show that if
patients receive combination treatment early, they are more likely to be
able to continue with their daily activities, including going to work,
than those treated with methotrexate alone.”
American College of Rheumatology (ACR) scores were also assessed in the
COMET study and were comparable to the DAS clinical remission data.
Nearly half of patients receiving ENBREL plus methotrexate achieved an
ACR 70 score, versus 28 percent of the methotrexate-only group. The
percentage of patients who achieve an ACR 70 score represent those who
achieve a 70 percent improvement in select RA symptoms, including joint
swelling and tenderness, pain, level of disability, overall patient and
physician disease assessment, and an objective marker of inflammation,
such as erythrocyte sedimentation rate.
The COMET study is a 24-month, double-blind, randomized, parallel group,
multicenter, outpatient study. The data published in The Lancet
represent the results of the first year of treatment, in which patients
were randomly assigned to receive combination ENBREL 50 mg plus
methotrexate therapy, or methotrexate alone, once a week for 52 weeks.
The population under study had less than two years (median seven months)
of moderately to severely active disease.
At one year, there were no differences in rates of serious infections or
malignancies among patients in the ENBREL plus methotrexate group
compared with the methotrexate-only group. No cases of tuberculosis or
demyelinating disease were reported. No new safety signals were
identified.
In other RA clinical trials of ENBREL, the most common adverse events
were injection site reaction, infection, and headache. Rare cases of
tuberculosis and demyelinating diseases have been reported in
post-marketing surveillance.
To view the abstract of this manuscript, please visit the following Web
site: www.thelancet.com/journals/lancet.
ABOUT ENBREL
ENBREL is a soluble form of a fully human tumor necrosis factor (TNF)
receptor and has 16 years of collective clinical experience with an
established safety profile. ENBREL was first approved in 1998 for
moderate to severe rheumatoid arthritis and was later approved to treat
children and adolescents with juvenile rheumatoid arthritis (now called
juvenile idiopathic arthritis) in 1999. ENBREL was approved in 2004 to
treat moderate to severe plaque psoriasis in adults.
ENBREL indications in the U.S.:
-
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.
-
ENBREL is indicated for reducing the signs and symptoms of moderately
to severely active polyarticular juvenile idiopathic arthritis in
patients ages 2 and older.
-
ENBREL is indicated for reducing signs and symptoms, keeping joint
damage from getting worse, and improving physical function in patients
with psoriatic arthritis. ENBREL can be used in combination with
methotrexate in patients who do not respond adequately to methotrexate
alone.
-
ENBREL is indicated for reducing signs and symptoms in patients with
active ankylosing spondylitis.
-
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.
Important Safety Information
What important safety information do I need to know about taking
prescription 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,
juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic
arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can
reduce the amount of active 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.
Serious infections, including tuberculosis (TB), have happened in
patients taking ENBREL. Some of these serious infections have been
fatal. Many serious infections occurred in people prone to infection.
Serious infections have also occurred in patients with advanced or
poorly controlled diabetes. Do not start ENBREL if you have an infection
or are allergic to ENBREL or its components. Once on ENBREL, if you get
an infection or have any sign of an infection, including fever, cough,
or flu-like symptoms, or have open sores, tell your doctor. Your doctor
should test you for TB before starting ENBREL and should monitor you
closely for signs and symptoms of TB.
Serious nervous system disorders, such as multiple sclerosis, seizures,
or inflammation of the nerves of the eyes have been reported. There have
been rare reports of serious blood disorders (some fatal).
In medical studies, more cases of lymphoma (a type of cancer) were seen
in patients taking TNF blockers compared to similar patients who were
not taking TNF blockers. The risk of lymphoma may be several-fold higher
in people with rheumatoid arthritis and psoriasis; the role of TNF
blockers in the development of malignancies is unknown.
Tell your doctor if you:
-
Think you have, are being treated for, have signs of, or are prone to
infection
-
Have any open sores
-
Have or have had TB or hepatitis B
-
Have ever been treated for heart failure
-
Have ever had or develop a serious nervous system disorder
-
Develop symptoms such as persistent fever, bruising, bleeding, or
paleness while taking ENBREL
Common side effects in adult clinical trials were injection site
reaction, infection and headache.
In a medical study of patients with JIA, infection, headache, 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,
including serious infection and depression/personality disorder.
If you have any questions about this information, be sure to discuss
them with your doctor. You are encouraged to report negative side
effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
Please visit www.enbrel.com or call
1-888-4ENBREL to request additional information, including the full U.S.
Prescribing Information and Medication Guide.
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.
Amgen discovers, develops, manufactures 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
millions of people around the world in the fight against cancer, kidney
disease, rheumatoid arthritis, and other serious illnesses. With a deep
and broad pipeline of potential new medicines, Amgen remains committed
to advancing science to dramatically improve people’s lives. To learn
more about our pioneering science and our vital medicines, visit www.amgen.com.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women’s health care, infectious disease, gastrointestinal
health, 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. To learn more, visit www.wyeth.com.
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Amgen, Thousand Oaks Shutter, 805-447-1060 (investors) Halstrom, 484-865-2020 (media) (investors) |
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