Enbrel Safety Data for up to Eight Years In Patients with Juvenile Rheumatoid Arthritis Being Presented at EULAR
THOUSAND OAKS, Calif. and COLLEGEVILLE, Pa.- Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced the presentation of additional data that showed that the safety profile of Enbrel® (etanercept) was maintained with long-term use in patients with moderate-to-severe juvenile rheumatoid arthritis (JRA) who completed up to eight years of therapy. JRA is a chronic autoimmune disease of childhood that is sometimes difficult to diagnose. ENBREL is the only biologic medicine currently approved to treat the signs and symptoms of JRA in patients who have previously tried a traditional disease modifying antirheumatic drug (DMARD). The study results will be presented at the European League Against Rheumatism (EULAR) Annual Congress, an international rheumatology meeting, in Barcelona, Spain.
Approximately 50,000 children in the United States have JRA. Symptoms of JRA include fatigue, joint pain and stiffness following sleep or inactivity, fever and associated muscle weakness. There are differing presentations of the signs and symptoms of JRA and there is no specific test for diagnosis.
“Early diagnosis and treatment are crucial to managing symptoms of JRA,” says Andreas O. Reiff, M.D., head of Rheumatology and Rehabilitation at Children’s Hospital Los Angeles and study investigator, who will be presenting the data at EULAR. "The ENBREL data are important for both physicians and parents because they demonstrate the safety profile has remained consistent after long-term use in this patient population.”
The study, which was designed to assess the long-term safety of ENBREL in people with JRA, found that the overall rate of serious adverse events did not increase with long-term use of ENBREL. No deaths, lymphomas or other malignancies, tuberculosis or other opportunistic infections were reported. Sixty-one percent of patients studied (n=42) entered their fourth year of continuous ENBREL treatment. Further, 38 percent (n=26) of patients studied entered their eighth year of continuous ENBREL treatment and experienced a similar safety profile.
Patients with JRA who participated previously in a double-blind, randomized controlled trial of ENBREL (n=69) were eligible to enroll in this multicenter open-label extension study (n=58). Safety assessments included the incidence of serious adverse events, deaths, lymphomas, malignancies, opportunistic infections and medically important infections.
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 of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more DMARDs.
* 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 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.
What important information do I need to know about taking prescription Enbrel® (etanercept)?
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
o Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes
o Some serious infections have been fatal
o 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 or have had hepatitis B
# 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
o 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)
o 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
o The role of TNF blockers, including ENBREL, in the development of lymphoma is unknown
* ENBREL can cause injection site reaction
* In a medical study of patients with JRA, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adults
o The kinds of infections reported were generally mild and similar to those usually seen in children
o Other serious adverse reactions were reported rarely, including serious infection (2%) and depression/personality disorder (1%)
If you have any questions about this information, be sure to discuss them with your doctor. Please see full Prescribing Information at www.enbrel.com or call 1-888-4ENBREL.
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