Enbrel first biologic with up to 9 years rheumatoid arthritis safety, sustained efficacy data
THOUSAND OAKS, Calif., November 12, 2006 -- Amgen (NASDAQ: AMGN) today announced that Enbrel? (etanercept) is the first biologic with published data to show improvements in multiple measures of efficacy that were sustained in rheumatoid arthritis (RA) patients completing up to nine years of therapy. These new data are being presented at the American College of Rheumatology (ACR) Scientific Meeting in Washington, D.C.
"The current data in Rheumatoid Arthritis suggest that Enbrel is both effective and safe in long-term use," said Mark Genovese, M.D., Stanford University Medical Center, Palo Alto, California. "These findings are significant because they provide a degree of reassurance to both the patient and the physician that unexpected safety concerns do not appear to be developing after nine years of use."
ENBREL continues to have a strong safety profile for extended periods of use. In the studies presented at ACR, rates of serious adverse events and serious infections remained low and were consistent with controlled portions from the double-blind phases of the studies. The overall number of observed malignancies (excluding nonmelanoma skin cancers) were similar in type and number to what would be expected in the general population.
Additionally, data showed that 77 early rheumatoid arthritis (ERA) and 280 long-standing rheumatoid arthritis (LRA) patients who completed ENBREL treatment for up to eight years experienced substantial improvements in their ACR scores. Additionally, 73 LRA patients who completed ENBREL treatment for up to nine years experienced similar improvements. ACR scores are a composite measure of improvement in RA symptoms, including joint swelling and tenderness, pain, level of disability, overall patient and physician assessment, and an objective marker of inflammation, such as erythrocyte sedimentation rate.
Data being presented at ACR showed that ENBREL provided sustained improvement in the signs and symptoms of RA, in those patients who continued in the study, regardless of duration of disease. Following eight years of ENBREL therapy: 75 percent of ERA patients and 76 percent of LRA patients achieved ACR 20; 60 percent of ERA patients and 52 percent of LRA patients achieved ACR 50; 35 percent of ERA patients and 26 percent of LRA patients achieved ACR 70. Further, for those patients with LRA who received ENBREL treatment for nine years, 74 percent achieved ACR 20, 41 percent achieved ACR 50, and 22 percent achieved ACR 70.
The ability to perform daily activities is an important goal for many people with RA, and data presented at ACR showed that treatment with ENBREL may help them achieve this goal. Through eight years of treatment with ENBREL, data showed that 73 to 85 percent of patients with ERA and 53 to 72 percent of patients with LRA achieved a clinically significant improvement in the Health Assessment Questionnaire (HAQ) score, a patient questionnaire that measures disability. A clinically significant improvement in HAQ was defined as at least a 0.22 improvement from baseline.
"Before I was diagnosed with RA, the pain, stiffness and fatigue stopped me from doing many of the activities I enjoyed," said Gloria Treece, a participant in the study. "Since starting ENBREL treatment approximately nine years ago, I'm now able to take part in many activities with my family."
These studies were designed to assess the safety and long-term efficacy of ENBREL in adult LRA patients who have failed to respond to at least one disease-modifying antirheumatic drug, and adult patients with ERA (defined as less than or equal to three years of disease duration). Patients with RA who participated in controlled clinical trials of ENBREL were eligible to enroll in open-label extension studies (LRA, N=644; ERA, N=207).
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.
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:
- 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
- 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 percent) and depression/personality disorder (1 percent)
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 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 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 broad and deep 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, cardiovascular disease, 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.
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