Enbrel Combination Therapy Inhibited Progression of Joint Damage and Offered Significant Rheumatoid Arthritis Symptom Relief in New Clinical Study
FOR IMMEDIATE RELEASE
THOUSAND OAKS, Calif., and COLLEGEVILLE, Pa., June 20, 2003 - Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced results of a new study assessing the efficacy of combination treatment with ENBREL. (etanercept) and methotrexate in rheumatoid arthritis (RA) patients, compared with ENBREL or methotrexate alone. One-year results of TEMPO, (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes), were presented today at a satellite symposium during the European League Against Rheumatism meeting in Lisbon, Portugal.
Eighty percent of patients treated with combination therapy experienced no radiographic progression through one year, compared to 68 percent of patients treated with ENBREL alone and 57 percent of patients treated with methotrexate.
Both combination therapy and ENBREL monotherapy provided significant inhibition of joint damage (-0.5 mean change and 0.5 mean change from baseline in total Sharp score, respectively), compared with methotrexate alone (2.8 mean change in total Sharp score). A Sharp score is an X-ray measurement of changes in total joint damage as assessed by bone erosions and joint space narrowing.
"The radiographic data in this study demonstrate that ENBREL in combination or alone had a more significant impact on the progression of structural damage in RA versus methotrexate alone," said Dr. Désirée van der Heijde, professor of rheumatology, University of Maastricht in the Netherlands. "In fact, the combination of ENBREL and methotrexate provided some of best radiographic responses noted to date. This is especially important considering the characteristics of RA as a chronic, progressively disabling disease."
Other responses were evaluated by 20 percent, 50 percent and 70 percent ACR score improvements in the signs and symptoms of RA (known as ACR20, ACR50 and ACR70 scores).
After 52 weeks of treatment, an ACR20 score was achieved by 85 percent of patients treated with the ENBREL and methotrexate combination, 76 percent of patients treated with ENBREL alone and 75 percent of patients treated with methotrexate.
Sixty-nine percent of patients on combination therapy reached an ACR50 score at one year, versus 48 percent and 43 percent with ENBREL alone and methotrexate respectively. ACR70 scores were 43 percent, 24 percent and 19 percent with the ENBREL combination, ENBREL alone, and methotrexate respectively.
"These data provide new, compelling evidence of the importance of ENBREL as a first-line therapy," said Dr. Victoria Kusiak, vice president of global medical affairs and North American medical director of Wyeth Pharmaceuticals. "Since its approval in 1998, physicians have experienced the flexibility and efficacy of using ENBREL alone or in combination with methotrexate."
The multi-center, double-blind, Phase 3 study randomized 682 patients with RA for a period of one year to receive ENBREL (25 mg twice weekly) plus methotrexate (mean dose of 17 mg once weekly), ENBREL (25 mg twice weekly) plus placebo capsules once weekly, or methotrexate (mean dose of 17 mg once weekly) plus placebo injections twice weekly.
"This study shows that ENBREL, either in combination with methotrexate or alone, provided patients not only symptomatic relief but significant inhibition of joint damage," said Dr. Beth Seidenberg, Amgen senior vice president of development.
Adverse events were similar to those reported in previous clinical trials of ENBREL in patients with RA.
The most frequent adverse events in placebo-controlled RA clinical trials (n=349) were injection site reactions (ISR) (37%), infections (35%), and headache (17%). Only the rate of ISR was higher than that of placebo. The most frequent adverse events in a methotrexate-controlled trial (n=415) were infections (64%), ISR (34%), and headache (24%). Only the rate of ISR was higher than that of methotrexate.
Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. If left untreated or improperly treated, RA can produce serious destruction of one or more joints, which frequently leads to permanent disability, significantly impacting quality of life.
ENBREL is the only fully human, soluble TNF receptor approved to reduce the signs and symptoms and inhibit the structural damage in patients with moderately to severely active RA, and to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis. ENBREL is the only biologic therapy approved for first line treatment of RA patients, and can be used alone. It is also 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 disease-modifying medicines.
Physicians have become familiar with the benefits and proven long-term tolerability profile of ENBREL. It has been used to treat over 180,000 patients worldwide since becoming commercially available four years ago.
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 psoriatic arthritis and RA. 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:
- 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
- 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
• 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
• The incidence of cancer has not increased with extended 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%) and depression/personality disorder (1%)
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 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, 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.
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