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Treatment Has Demonstrated Improvement in Physical Function and Kept Joint Damage from Progressing at Three YearsENBREL Plus Methotrexate: First Treatment Regimen to Demonstrate Ability to Inhibit Radiographic Progression of Joint Damage for Three Consecutive Years
THOUSAND OAKS, Calif. & COLLEGEVILLE, Pa., Nov 13, 2005 (BUSINESS WIRE) -- Amgen (Nasdaq:AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), today announced data from a long-term blinded study of anti-TNF agent in patients with rheumatoid arthritis (RA) demonstrated that more than three quarters of patients treated with Enbrel(R) (etanercept) plus methotrexate combination therapy experienced no progression of joint damage at three years. These new results from the TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study will be presented at the American College of Rheumatology's (ACR) Annual Scientific Meeting in San Diego, California.
"Rheumatoid arthritis is a chronic condition requiring long-term treatment. It is critical to provide patients with treatment options that not only reduce the signs and symptoms of the disease, but also inhibit the progression of joint damage," said Desiree van der Heijde, M.D., professor of rheumatology, University of Maastricht in the Netherlands. "The TEMPO results reinforce the benefits of ENBREL and methotrexate combination therapy and underscore the importance of effective treatment."
At three years, the majority of patients taking ENBREL and methotrexate combination therapy had no progression of joint damage(1). These results were significantly better than those achieved in ENBREL monotherapy and methotrexate monotherapy-treated patients. Patients receiving ENBREL monotherapy also had significantly better results than patients receiving methotrexate monotherapy. Total Sharp Score was calculated by assessing changes in joint space narrowing and bone erosion as captured by radiographic imaging.
Further, additional data presented at ACR showed that improvement in physical function was higher for the ENBREL combination group than for either therapy alone. Patients treated with ENBREL combination therapy experienced a 56 percent mean improvement in Health Assessment Questionnaire (HAQ) scores from baseline, compared to 37 percent mean improvement in patients treated with ENBREL alone and 33 percent mean improvement in patients treated with methotrexate alone. HAQ scores measure a patient's ability to perform activities of daily living such as dressing, walking, and grooming.
The ENBREL TEMPO study randomized 686 patients with RA, of which 638 were included in the three-year radiographic analysis. Patients received either ENBREL (25 mg twice weekly), methotrexate (up to 20 mg once weekly), or ENBREL (25 mg twice weekly) plus methotrexate once weekly. Patients in the ENBREL TEMPO trial had active RA and an inadequate response to at least one disease-modifying antirheumatic drug (DMARD) other than methotrexate. The primary radiographic endpoint was the change from baseline in the van der Heijde-modified TSS at one year. Secondary radiographic endpoints included changes in total erosions, changes in total joint space narrowing, number of eroded joints, and percent of patients with no radiographic progression.
ENBREL was generally well tolerated.
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 the only soluble tumor necrosis factor (TNF) receptor approved to reduce signs and symptoms, induce major clinical response, improve physical function, and inhibit the progression of structural damage in patients with moderately to severely active rheumatoid arthritis (RA). ENBREL can be used alone or in combination with methotrexate.
ENBREL is the only treatment indicated to reduce the signs and symptoms, inhibit the progression of structural damage of active arthritis, and improve physical function in patients with psoriatic arthritis. It is approved to reduce the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients four years of age or older who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). It is also the first biologic approved to reduce 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 308,000 patients worldwide across indications.
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 involved in the inflammatory process of RA, JRA, psoriasis, psoriatic arthritis, and AS. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.
What important information do I need to know about taking 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, 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 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
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 website sponsored by the companies at www.ENBREL.com or by calling toll-free 1-888-4ENBREL (1-888-436-2735).
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 (NYSE:WYE), 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 nonprescription 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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Amgen Christine Cassiano, 805-447-4587 (media) Laura Biswas, 805-447-1060 (investors) or Wyeth Pharmaceuticals Candace Steele, 484-865-5428 (media) Justin Victoria, 973-660-5340 (investors)