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).
ABOUT WYETH
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.
Media, Candace Steele, of Wyeth Pharmaceuticals, +1-484-865-5428, or Gill Markham, of Wyeth Europa, +44(0)1628-692536, or Mobile, +44(0)7770-827753, or Investors, Justin Victoria of Wyeth, +1-973-660-5340
