Patients with ankylosing spondylitis have reported that their
condition has negatively impacted their ability to perform daily
activities including exercising, rising from a seated position and
climbing stairs without aid. Overall, patients treated with ENBREL
achieved a 46 percent improvement in physical function, as measured
by the Bath Ankylosing Spondylitis Functional Index (BASFI), and
these results were sustained through 160 weeks. The BASFI is a 10-question,
patient self-assessment instrument consisting of 8 specific questions
regarding physical function in AS and 2 questions reflecting the
patient's ability to cope with everyday life. Each question is answered
on a 10 cm horizontal visual analog scale, the mean of which gives
the BASFI score (0-10).
ENBREL was generally well tolerated over 148 to 160 weeks of therapy.
This study was designed to assess the safety and long-term efficacy
of ENBREL in patients with AS, using clinical measures to assess
disease activity, physical function, improvement in AS symptoms,
and ongoing surveillance to assess the incidence of adverse events.
The study is a 96-week open-label, multinational, phase 4 extension
study in 59 patients with AS who completed each of two earlier trials,
a 12-week randomized, double-blind, placebo-controlled study and
a 96-week open-label study. The data presented at ACR is from the
first 52-weeks of an ongoing 96-week extension study (total ENBREL
treatment 148 - 160 weeks).
Enbrel received FDA approval to treat the signs and symptoms of
active AS in 2003 following a randomized, double-blind, placebo-controlled
phase 3 study in 277 patients with active ankylosing spondylitis.
Treatment with ENBREL (n=138) resulted in significant clinical improvements
through 24 weeks, compared to placebo (n=139). At 12 weeks, the
ASAS 20 response was achieved by 60 percent of patients receiving
ENBREL, compared to 27 percent of patients receiving placebo (p
less than or equal to 0.0001, ENBREL vs. placebo). These results
were maintained through 24 weeks. Patients in this study were between
18 and 70 years of age and had ankylosing spondylitis as defined
by the modified New York Criteria for Ankylosing Spondylitis. Patients
with complete ankylosis of the spine were excluded from study participation.
Patients taking hydroxychloroquine, sulfasalazine, methotrexate,
or prednisone (less than or equal to 10 mg/day) could continue these
drugs at stable doses for the duration of the study. Doses of 25
mg ENBREL or placebo were administered subcutaneously twice a week
for 6 months. The primary measure of efficacy was a 20 percent improvement
in the Assessment in Ankylosing Spondylitis (ASAS) response criteria.
ABOUT AS
Ankylosing spondylitis, which affects up to half a million people
in the United States, is a chronic, painful and progressive inflammatory
disease affecting joints and ligaments that normally allow a person's
back to move and flex. The disease most often occurs in the lower
back but can affect the upper spine, chest and neck. In more advanced
disease, the spine can fuse, causing loss of motion and a permanent
stooped-over posture. AS may also involve other joints, such as
the hips, shoulders, knees and ankles. Unlike other forms of arthritis,
AS frequently affects individuals between the ages of 17 and 35.
It tends to affect more men than women.
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 http://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
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have changed the practice of medicine, helping millions of people
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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,
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marketing of pharmaceuticals, vaccines, biotechnology products and
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