- News & Events
- Contact Us
Treatment with ENBREL Had a Positive Effect on Activities of Daily Living for Patients with Psoriasis
THOUSAND OAKS, Calif. & MADISON, N.J.--(BUSINESS WIRE)--Feb. 18, 2005--
Data Also Show Many ENBREL Patients Experienced Improvements in
Symptoms and the Impact of the Disease on Their Daily Life
At three months, nearly 30 percent of 311 patients with moderate-to-severe psoriasis who were taking Enbrel(R) (etanercept) reported that they were "not at all" bothered by their psoriasis, as indicated by their achieving a "zero" score on the Dermatology Life Quality Index (DLQI) measure. The data will be presented at the American Academy of Dermatology annual meeting in New Orleans, Louisiana.
The DLQI is a patient questionnaire widely used in clinical practice which measures the impact of their disease on patient's feelings, daily activities, leisure activities, work, school and personal relationships, as well as how they feel about treatment and their symptoms. The best possible DLQI score to achieve is zero, indicating that psoriasis did not interfere with their lives at all.
Many patients treated with ENBREL experienced improvements in their symptoms and how they felt about their disease as early as one week. Additionally, many patients also reported that the condition of their skin no longer affected social or leisure activities, prevented them from working or studying, or restricted intimacy. The group of patients on ENBREL therapy continued to experience improvements in their activities of daily living over the course of the 12-week study.
In addition to its significant physical symptoms, moderate-to-severe psoriasis can also affect people's feelings, behaviors and experiences. People with psoriasis often are fatigued, and feel depressed, self conscious and socially isolated.
"People with moderate-to-severe psoriasis may face a lifetime of physical and emotional challenges that can have a devastating impact on their personal lives, even leading to extreme embarrassment and social isolation," said Alice Gottlieb, M.D., of the UMDNJ-Robert Wood Johnson Medical School in New Brunswick, New Jersey. "We know that ENBREL can be extremely effective in treating the physical symptoms of the disease, and it is impressive to see that ENBREL treatment also helped improve important aspects of patients' personal lives."
In addition to DLQI data, statistically significant improvements were seen in many people treated with ENBREL across a variety of measurements including mean improvement from baseline in the Psoriasis Area and Severity Index (PASI), a measure of disease severity and in the patient's assessment of psoriasis and itching. These new psoriasis data on ENBREL are consistent with previous studies showing that ENBREL treatment provided significant relief of psoriasis symptoms.
In the Phase 3, double-blind, placebo-controlled, multicenter study conducted at 39 sites in the United States and Canada 620 patients were randomized to receive either 50 mg subcutaneous injections of ENBREL twice a week or placebo twice a week. Before study entry, patients had to discontinue previous psoriasis therapies. Patients were stratified at randomization into two groups: patients who previously received phototherapy or systemic psoriasis therapy, and patients who received neither therapy. The primary endpoint for this study was achievement of a 75 percent or greater improvement from baseline in the PASI 75 after 12 weeks of double-blind treatment. Secondary endpoints at week 12 included the DLQI response, a zero score in DLQI, the subject's assessment of itching, and improvements from baseline in skin pain. After 12 weeks, the double-blind phase was followed by an open-label treatment period where all patients received 50 mg of ENBREL twice a week.
ENBREL was generally well-tolerated during the 12-week double-blind portion of the study. The most commonly reported adverse event was injection site reaction.
Up to seven million people in the United States have psoriasis and 1.5 million have moderate-to-severe plaque psoriasis. The disease is characterized by chronic inflammation of the skin. This inflammation helps drive the formation of red, itchy skin plaques that are often painful and disfiguring. Tumor necrosis factor (TNF) is found at increased levels in psoriatic plaques and plays a critical role in their formation and continued existence.
ENBREL is the only soluble 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 initiated in combination with methotrexate or used alone.
ENBREL is the only treatment indicated to reduce the signs and symptoms and inhibit the progression of structural damage of active arthritis 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 280,000 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.
Since the product was first introduced, the following have been reported in patients using Enbrel(R) (etanercept): -- 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 inhibitors, 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 inhibitors 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 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, 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.
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, 2004, 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.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes even adequately, modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied, and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships, and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify side effects or manufacturing problems with Amgen's products after they are on the market.
In addition, sales of Amgen's products are affected by the availability of reimbursement and the reimbursement policies imposed by third-party payors, including governments, private insurance plans, and managed care providers, and may be affected by domestic and international trends toward managed care and health care cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage, and pricing of our products. In addition, Amgen competes with other companies with respect to some of Amgen's marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates, or new indications for existing products, may face competition when and as they are approved and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's ability to obtain or maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.
The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Health care professionals should refer to and rely upon the FDA-approved labeling for the products and not the information discussed in this news release.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing, commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, wars or terrorist acts, product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Nurha Hindi (media), 805-447-4587; 818-522-8411 (cell)
Arvind Sood (investors), 805-447-1060
Candace Steele (media), 484-865-5428
Justin Victoria (investors), 973-660-5340