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Data Show ENBREL Significantly Improved Nail Psoriasis in Patients with Moderate to Severe Plaque Psoriasis
Vienna, Austria (ots/PRNewswire) -
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced new data that showed that, in moderate to severe plaque psoriasis patients, ENBREL(R) (etanercept) reduced the severity of nail psoriasis by more than 28 percent at 12 weeks and reduced the signs and symptoms of plaque psoriasis. Nail psoriasis occurs in up to half of psoriasis patients and can range in severity from minor cosmetic concerns to severe pain and disability. These data and other findings from an ongoing randomized, open-label trial were presented at the European Academy of Dermatology and Venereology Congress, the leading European dermatovenereology meeting, in Vienna, Austria.
"Despite the prevalence of nail psoriasis and its clinical impact, it is believed to be very difficult or impossible to treat," said Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. "This is particularly disheartening because in addition to the psychological stress associated with the cosmetic aspects of the disease, severe pain and limited dexterity can affect patients' ability to perform even the simplest tasks, such as buttoning their clothes. These data demonstrate that ENBREL may improve nail psoriasis in moderate to severe plaque psoriasis patients."
These data are part of an ongoing trial that involved 708 patients with moderate to severe plaque psoriasis who received ENBREL continuously or intermittently over the first 12 weeks of the study. In this study, patients were assessed on the most severely involved (target) fingernail at baseline at Week 12, according to the Nail Psoriasis Severity Index (NAPSI), a numeric tool for evaluating the severity of nail-bed psoriasis and nail matrix psoriasis by area of involvement in the nail unit (on a scale of 0 to 8).
Of the 708 patients enrolled in the study, 73.3 percent (n=519) had nail psoriasis. At baseline, the mean NAPSI was 4.6, but after 12 weeks of treatment with ENBREL, the mean NAPSI was 3.3 (p<0.0001) -- an approximate 28 percent reduction in the severity of nail psoriasis. ENBREL treatment also significantly improved mean Psoriasis Area Severity Index from a baseline of 22.3 to 8.6 (p<0.0001) at Week 12.
Plaque psoriasis, the most common form of psoriasis, is a non-contagious chronic disease in which the immune system causes the skin to grow at an accelerated rate. Plaque psoriasis once was considered just an inflammatory skin disorder of unknown cause that primarily was a cosmetic nuisance. However, based on medical knowledge, it now may be more accurately described as a dynamic, genetic, immunological, systemic disorder manifesting on the body surface as well as in the joints in a significant proportion of patients. According to the World Psoriasis Day Consortium, plaque psoriasis affects an estimated 125 million people, or 3 percent of the world's population.
The disease occurs among people of all ages, although it is most commonly diagnosed in early adulthood. Due to genetic factors, certain people are more likely to develop plaque psoriasis, but a trigger usually is necessary for symptoms to appear. These triggers may include emotional stress, injury to the skin, some types of infection or reaction to certain drugs.
Wyeth Pharmaceuticals markets ENBREL outside North America. ENBREL was discovered by Immunex Corporation, now part of Amgen Inc. (Nasdaq: AMGN), and was jointly developed with Wyeth Pharmaceuticals. The two companies co-promote ENBREL in North America.
In the European Union, ENBREL is approved for the treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including cyclosporine, methotrexate or PUVA. ENBREL also is approved in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. ENBREL can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. ENBREL also is indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. In patients with rheumatoid arthritis, ENBREL used alone or in combination with methotrexate has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. ENBREL also is approved for the treatment of active polyarticular juvenile idiopathic arthritis in children aged four to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. ENBREL has not been studied in children aged less than four years. ENBREL also is approved for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. ENBREL has been shown to improve physical function in patients with psoriatic arthritis and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. ENBREL also is approved for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Physicians have become familiar with the benefits and long-term tolerability profile of ENBREL since it became commercially available seven years ago. Almost 500,000 patients have been treated worldwide across approved indications. ENBREL acts by binding tumor necrosis factor (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 processes of psoriasis, psoriatic arthritis and rheumatoid arthritis. The binding of ENBREL to TNF renders the bound TNF biologically inactive, which can result in significant reduction in inflammatory activity.
Since the product first was introduced, serious infections, some involving death, have been reported in patients using ENBREL. Patients should tell their doctor if they currently have an infection or are prone to getting infections. Patients should not start ENBREL if they have an infection of any type or an allergy to ENBREL or its components. ENBREL should be used with caution in patients prone to infection.
There have been reports of serious nervous system disorders such as multiple sclerosis and/or inflammation of the nerves of the eyes. Patients should inform their doctor if they ever have had any of these disorders or if they develop them after starting ENBREL. Patients also should tell their doctor if they ever have been treated for heart failure. There also have been rare reports of serious blood disorders, some involving death.
Patients should contact their doctor immediately if they develop symptoms such as persistent fever, bruising, bleeding or paleness. It is unclear if ENBREL has caused these nervous system or blood disorders. If a patient's doctor confirms serious blood problems, patients may need to stop using ENBREL.
The most common adverse events observed during the double-blind, placebo-controlled portions of three clinical trials in patients with psoriasis were infections (27 percent to 29 percent of patients), injection-site reactions (14 percent to 16 percent), headaches (9 percent to 12 percent), and injection-site ecchymoses (6 percent to 8 percent). There were no reports of opportunistic infections or tuberculosis during 662 patient exposure years.
Twenty-three malignancies were reported in patients with plaque psoriasis treated with ENBREL in double-blind and open-label studies of up to 15 months involving 1,261 patients treated with ENBREL.
The most frequent adverse events in five double-blind, controlled clinical trials in patients with rheumatoid arthritis were infections (49 percent of patients), injection-site reactions (31 percent), headaches (12 percent) and respiratory disorders (10 percent). Malignancies were rare.
The types of adverse events observed in the psoriatic arthritis and ankylosing spondylitis trials were similar to those reported in rheumatoid arthritis clinical trials.
In a study of patients with juvenile idiopathic arthritis, infections (62 percent of patients), headache (19 percent), abdominal pain (19 percent), vomiting (13 percent) and nausea (9 percent) occurred more frequently than in adults. Serious adverse reactions reported rarely were chicken pox (3 percent), gastroenteritis (3 percent), serious infections (2 percent), depression/personality disorder (1 percent), skin ulcer (1 percent), inflammation in parts of the upper digestive tract (1 percent) and diabetes (1 percent).
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, 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.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our period reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
ots Originaltext: Wyeth Pharmaceuticals
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Media, Candace Steele, of Wyeth Pharmaceuticals,
+1-484-865-5428, or Gill Markham, of Wyeth Europa, +44(0)1628-692536,
+44(0)7770-827753, or Investors, Justin Victoria of Wyeth,