New Phase 3 ENBREL Data Show Psoriasis Patients Achieved a Therapeutic Response From 'Step Down' Dosing Regimen
10 February 2004 - 12:02AM
PR Newswire (US)
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. Amgen's results may be affected
by its ability to successfully market both new and existing
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Discovery or identification of new product candidates cannot be
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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/
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