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
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
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
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
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;
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compliance; risks and uncertainties associated with global operations
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detailed from time to time in our period reports filed with the
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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
Im Internet recherchierbar: http://www.presseportal.ch
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,