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New Phase 3 ENBREL Data Show Psoriasis Patients Achieved a Therapeutic Response
From 'Step Down' Dosing Regimen
THOUSAND OAKS, Calif. and COLLEGEVILLE, Pa., Feb. 7 /PRNewswire/ -- A global
Phase 3 study of Enbrel(R) (etanercept) demonstrated that asignificant number
of psoriasis patients given initial loading doses of ENBREL for three months
rapidly achieved psoriasis clearing and then maintained the response while
receiving half the drug dose. These data were presented at the American Academy
of Dermatology annual meeting in Washington, D.C.
In this double-blind, placebo-controlled study, 583 patients with moderate to
severe psoriasis were randomized to receive placebo (n=193), 25 mg of ENBREL
twice weekly (n=196), or a loading dose of 50 mg of ENBREL twice weekly (n=194),
for 12 weeks. Following this initial period, patients then continued treatment
for an additional 12 weeks. During the second 12 weeks, those taking the
loading dose of ENBREL were "stepped down" to half the dose (25 mg twice
weekly), while patients taking 25 mg twice weekly continued with the same dose.
Patients initially taking placebo were started on 25 mg ENBREL twice weekly. As
previously reported, patients in both groups initially receiving ENBREL
experiencedimprovement in psoriasis in as early as two weeks.
The new data show that during the second 12 weeks of the study, ENBREL continued
to provide significant relief of psoriasis symptoms in all groups. Forty-nine
percent of patients treated with the loading dose achieved 75 percent
improvement in the Psoriasis Area Severity Index (also known as PASI 75) in the
first 12 weeks of the study as compared to 34 percent of patients taking 25 mg
twice weekly and three percent of patients taking placebo. A large majority (77
percent) of the patients treated with the loading dose who had achieved a PASI
75 response at week 12 maintained this response through week 24 while receiving
the stepped down dose. In addition, at week 24, the percentage of step down
patients achieving PASI 75 increased to 54 percent.
"In this study, more step down patients achieved the clinical milestone of PASI
75 by week 12," said Craig Leonardi, M.D., clinical associate professor of
dermatology at Saint Louis University. "It was very exciting to see that a
large majority of these patients maintained the effect while receiving half the
loading dose."
Psoriasis Patients Treated with ENBREL Stopped And Re-Started Treatment Without
Serious Side Effects From Their Psoriasis
In another presented Phase 3 study not involving step down therapy, 409 patients
who had achieved at least a PASI 50 response at the conclusion of 24 weeks
stopped treatment and were monitored for relapse. Patients withdrawn from
ENBREL treatment did not have serious adverse events due to psoriasis including
disease flares, hospitalizations or transformation of psoriasis to a more severe
form of the disease. After discontinuing ENBREL, the median time to relapse
(loss of half of PASI improvement achieved while on ENBREL) was approximately
three months.
After patients relapsed, they were retreated with the same dose they had
received at the end of the double-blind period of the study. Overall PASI 75
response rates at both week 12 and 24 of re-treatment (n=297 and n=174,
respectively) were similar to those seen after initial treatment in all groups.
"Psoriasis is a chronic condition and patients must sometimes stop treatment due
to life circumstances such as pregnancy or surgery," said Alice Gottlieb, M.D.,
Ph.D., director of the Clinical Research Center at University of Medicine and
Dentistry of New Jersey-Robert Wood Johnson Medical School. "These data show
that ENBREL was stopped and restarted without severe side effects due to
psoriasis or loss of efficacy."
ENBREL was generally well tolerated in both Phase 3 studies. Adverse events
were similar to those reported in previous clinical trials, with injection site
reactions occurring more frequently than in the placebo group.
ABOUT PSORIASIS
An estimated 4.5 million people in the United States suffer from psoriasis and
1.5 million have moderate to severe plaque psoriasis. The disease is
characterized by chronic inflammation of the skin. This inflammation drives the
formation of red, itchy skin plaques that are painful and disfiguring. Tumor
necrosis factor (TNF) is found at high levels in psoriatic plaques, and plays a
critical role in their formation and maintenance.
ENBREL is currently approved for the treatment of moderately to severely active
psoriatic arthritis and is currently under review by the U.S. Food and Drug
Administration for the treatment of psoriasis.
ABOUT ENBREL
ENBREL is the only fully human TNF receptor approved to reduce signs and
symptoms, improve physicalfunction, and inhibit the progression of structural
damage in patients with moderately to severely active rheumatoid arthritis (RA),
and to reduce the signs and symptoms and inhibit the progression of structural
damage 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 or in combination with methotrexate. It is 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 one or more disease-modifying antirheumatic drugs (DMARDs). It is
also the first biologic approved to treat the signs and symptoms in patients
with active ankylosing spondylitis (AS).
ENBREL has been used by more than 215,000 patients worldwide across indications
since becoming commercially available more than five 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 RA, JRA,
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:
* 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 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
* 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 patients.
The role of TNF-inhibitors in the development of lymphoma is unknown.
* The incidence of other cancers 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 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 http://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.
WyethPharmaceuticals, 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.
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, 2002, 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 we project.
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and existing products domestically and internationally, sales growth of recently
launched products, difficulties or delays in manufacturing its products, and
regulatory developments (domestic or foreign) involving current and future
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governments, private insurance plans and managed care providers, and may be
affected by domestic and international trends toward managed care and healthcare
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 Amgen's products. Furthermore,
Amgen's research, testing, pricing, marketing and other operations are subject
to extensive regulation by domestic and foreign government regulatory
authorities. Amgen or others could identify side effects or manufacturing
problems with its products after they are on the market.
In addition, Amgen competes with other companies with respect to some of its
marketed products as well as for the discovery and development of new products.
Discovery or identification of new product candidates cannot be guaranteed and
movement from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate will be successful and become a
commercial product.
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. Further, some raw
materials, medical devices and component parts for Amgen's products are supplied
by sole third party suppliers.
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 pharmaceutical research, product development,
manufacturing, and commercialization, and economic conditions, including
interest and currency exchange rate fluctuations, the impact of competitive or
generic products, product liability and other types of lawsuits, the impact of
legislative and regulatory compliance and obtaining approvals, and patents, and
other risks and uncertainties, including those detailed from time to time in
Wyeth's periodic reports, including 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. Wyeth
assumes no obligation to publicly update any forward-looking statements, whether
as a result of new information, future events or otherwise.
CONTACT:
Amgen:
Andrea Rothschild (media)
805-447-6287
818-681-8660 (cell)
Cary Rosansky (investors)
805-447-1060
Wyeth Pharmaceuticals:
Douglas Petkus (media)
484-865-5140
Justin Victoria (investors)
973-660-5340
DATASOURCE: Amgen
CONTACT: Media, Andrea Rothschild, +1-805-447-6287, or cell,
+1-818-681-8660, or Investors, Cary Rosansky, +1-805-447-1060, both of Amgen;
or media, Douglas Petkus, +1-484-865-5140, or investors, Justin Victoria,
+1-973-660-5340, both of Wyeth Pharmaceuticals
Web site: http://www.enbrel.com/
Web site: http://www.amgen.com/