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New Two-Year Data Demonstrate That ENBREL Therapy Allowed Significantly More Rheumatoid Arthritis Patients to Achieve Clinical Remission
THOUSAND OAKS, Calif. & COLLEGEVILLE, Pa.---June 10, 2004--New results from TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) demonstrated that Enbrel(R) (etanercept) therapy allowed significantly more rheumatoid arthritis (RA) patients to achieve clinical remission at two years compared to patients treated with methotrexate alone. Building on the one-year TEMPO results, this two-year data further supports the continued efficacy of ENBREL therapy over time. Results were presented today during the EULAR (European League Against Rheumatism) Annual European Congress of Rheumatology in Berlin, Germany.
"The two-year data from the ongoing TEMPO trial show very good results for the combination of etanercept and methotrexate. We are particularly impressed by the high frequency of remission in patients who have had both a long previous history of RA and high disease activity at the start of the trial," said Lars Klareskog, M.D., Ph.D., principal investigator of the study from the rheumatology unit at the Karolinska Institute/Karolinska University Hospital in Stockholm, Sweden.
More than 40 percent of the 231 patients receiving combination therapy of ENBREL and methotrexate achieved clinical remission as assessed by the Disease Activity Score (DAS). Also, a significantly higher percentage of the 223 patients receiving ENBREL alone (23.3 percent) achieved clinical remission, compared with the 228 patients receiving methotrexate alone (15.8 percent). Clinical remission is defined as having a DAS of less than 1.6, which measures tender and swollen joints, erythrocyte sedimentation rate (ESR, an inflammatory marker) and overall general health.
Nearly half (48.5 percent) of patients treated with the ENBREL combination therapy achieved an American College of Rheumatology (ACR) 70 score compared with 27.4 percent of patients treated with ENBREL and 20.6 percent of patients treated with methotrexate alone. ACR scores measure improvement in RA disease activity, including joint swelling and tenderness, pain, level of disability and overall patient- and physician assessment. The ACR response is defined by the level of improvement -- 20 percent, 50 percent, or 70 percent -- where 70 percent describes an improvement that is greatest in degree and, therefore, most clinically meaningful.
Patients treated with ENBREL combination therapy also experienced significant improvement in functionality after two years. Improvement in functionality was significantly higher for the combination group as assessed by patients' responses to the Health Assessment Questionnaire (HAQ). Patients treated with ENBREL combination therapy experienced a 56 percent mean improvement in HAQ scores from baseline, compared to 39 percent mean improvement in patients treated with ENBREL alone and 36 percent mean improvement in patients treated with methotrexate alone.
Also presented at the meeting were data from the first year of the TEMPO study, showing that 80 percent of the combination-treated patients experienced no progression of joint damage on radiographs at one year as assessed by the van der Heijde-modified Total Sharp Score (TSS), compared with 68 percent of the patients treated with ENBREL monotherapy and 57 percent of patients treated with methotrexate monotherapy. The TSS is an X-ray measurement of changes in joint damage. "No progression" is defined as a unit change from baseline of TSS less than or equal to 0.5.
The ENBREL TEMPO study randomized 682 patients with RA to one of three treatment groups: ENBREL (25 mg twice weekly), methotrexate (up to 20 mg once weekly), or ENBREL (25 mg twice weekly) plus methotrexate. Patients in the ENBREL TEMPO trial had active RA and had failed at least one disease-modifying antirheumatic drug (DMARD) other than methotrexate.
Treatment with ENBREL or combination therapy was generally well-tolerated. The safety profile was generally consistent with that previously observed, and the combination did not result in increased infections after two years of therapy.
More than two million Americans suffer from RA, which causes 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 fully human TNF receptor approved to reduce signs and symptoms, improve physical function, and inhibit the progression of structural damage in patients with moderately to severely active RA, and to reduce the signs and symptoms and inhibit the progression of structural damage of active arthritis in patients with psoriatic arthritis. ENBREL is the only biologic therapy approved in the U.S. for first-line treatment of RA patients, and can be used alone or in combination with methotrexate. It is approved to reduce the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients who have had an inadequate response to one or more DMARDs. It is also the only biologic approved in the U.S. to treat 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 234,000 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 that causes the inflammatory process of RA, JRA, psoriatic arthritis, AS and psoriasis. The binding of ENBREL to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity.
Since the product was first introduced, the following have been reported in patients using ENBREL:
-- Serious infections -- Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes -- Some serious infections were fatal -- Rare cases of tuberculosis -- What to do/not to do -- Do not start ENBREL if you have an infection or are allergic to ENBREL or its components. -- 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, a higher rate of lymphoma (a type of cancer) was seen compared to the general population; however, the risk of lymphoma may be up to several fold higher in RA and psoriasis patients. -- The role of TNF-blockers in the development of lymphoma is unknown. -- The incidence of other cancers has not increased with exposure to ENBREL and is similar to the expected rate. -- ENBREL can also 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).
Amgen Inc. 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 (Nasdaq:AMGN) is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
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, hemophilia, oncology and vaccines. 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.
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2003, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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Andrea Rothschild, 805-447-4587 (media)
Investor Relations, 805-447-1060
Jenifer Antonacci, 484-865-5220 (media)
Justin Victoria, 973-660-5340 (investors)