Data Presented at 20th Annual World Congress of Dermatology Meeting Regarding
Use of ENBREL Monotherapy in Treatment of Psoriasis and Psoriatic Arthritis
PARIS, July 3 /PRNewswire-FirstCall/ -- Immunex Corporation (Nasdaq: IMNX)
and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced
they have initiated a second, global Phase 3 pivotal study assessing the
efficacy and tolerability of ENBREL(R) (etanercept) to treat moderate to
severe plaque psoriasis. The announcement was made at the 20th Annual World
Congress of Dermatology Meeting in Paris, France. In addition, Phase 2 study
results on psoriasis patients treated with ENBREL were presented.
"These Phase 2 results with ENBREL are encouraging as we continue to move
forward with this development program," said Daniel Burge, M.D., Immunex Vice
President of Clinical Development. "As we move through these studies, it's
important to note that ENBREL, a fully human soluble receptor, has several
years of experience in patients with moderately to severely active rheumatoid
arthritis demonstrating sustained efficacy and tolerability."
In this Phase 2 clinical study, 112 patients with moderate to severe
plaque psoriasis were randomized evenly to receive 25 mg of ENBREL or placebo
subcutaneously twice a week for 6 months. The primary endpoint of the study
was the proportion of patients achieving a 75 percent improvement in Psoriasis
Area and Severity Index (PASI 75) after 3 months.
"We're pleased with the results demonstrated to date with ENBREL in the
treatment of moderate to severe plaque psoriasis," said Burge. "TNF, or tumor
necrosis factor, is thought to be a dominant cytokine in the inflammatory
cascade and is found at high levels in psoriatic plaques. We've put science
into practice and have seen results such as the Physician Global Assessment
demonstrating that 53% of psoriasis patients treated with ENBREL were clear or
almost clear of skin lesions at 6 months, compared to 5% of patients treated
with placebo."
Patients treated with ENBREL(R) (etanercept) monotherapy experienced
continued improvement throughout the study. At 3 months, 30% of 57 patients
on ENBREL achieved PASI 75, compared with 2% of 55 patients on placebo
(P<0.0001). Fifty-six percent of patients treated with ENBREL achieved a PASI
75 at 6 months compared to 5% of patients receiving placebo.
Additionally, at 6 months 21% of patients receiving ENBREL achieved PASI
90 compared to none of those patients who received placebo, while 77% of
patients receiving ENBREL achieved a PASI 50 compared to 13% of those patients
who received placebo.
This Phase 2 study also assessed the impact of treatment with ENBREL on
health-related life quality of patients with moderate to severe plaque
psoriasis. Patients treated with ENBREL averaged a 64% mean improvement while
placebo patients exhibited a 7% mean improvement based on the Dermatology Life
Quality Index (DLQI). In addition, the average improvement in the patient
global assessment score was 62% for patients treated with ENBREL and 7% for
patients receiving placebo.
ENBREL was generally well tolerated in this study. Side effects seen
statistically more frequently in patients receiving ENBREL in this study were
limited to mild infections and injection site reactions. The majority of
infections observed were mild upper respiratory infections and sinusitis. The
overall tolerability profile in patients receiving ENBREL was similar to that
in the placebo group.
ENBREL: First and Only Therapy Approved To Treat Psoriatic Arthritis
Data were also presented regarding the use of ENBREL to treat psoriatic
arthritis. ENBREL is the first and only therapy approved by the U. S. Food
and Drug Administration for reducing signs and symptoms of active arthritis in
patients with psoriatic arthritis -- a life-impacting disease.
"The companies feel it is important to help raise awareness in the
dermatology community of the signs and symptoms of psoriatic arthritis as we
continue to see the evolution in treatment of this disease," said
Joseph Mahady, President, North America, Wyeth Pharmaceuticals."
The poster featured a previously presented 24-week, multicenter,
randomized, double-blind, placebo-controlled phase 3 study that assessed the
efficacy and tolerability of ENBREL (25-mg twice-weekly subcutaneous
injections) or placebo in 205 patients with psoriatic arthritis. The primary
endpoint was measured by the proportion of patients who met the American
College of Rheumatology preliminary criteria for improvement (ACR 20), which
includes tender and swollen joint counts, a patient as well as a physician
global assessment, patient assessment of pain, a disability index, and acute
phase reactant. In addition, a subset of clinical study patients was measured
by improvement in the PASI.
-- 59 percent of 101 patients receiving ENBREL achieved an ACR 20 response
compared to 15 percent of 104 patients receiving placebo, after
12 weeks of treatment; and
-- 38 percent of 101 patients receiving ENBREL achieved an ACR 50 response
compared to 4 percent of 104 patients receiving placebo after 12 weeks
of treatment
In a subset of patients with a predefined severity of psoriasis (greater
than 3% body surface area involved), responses increased over time, and at
6 months, the proportions of patients achieving a 50% or 75% improvement in
the PASI were 47% and 23%, respectively, in the ENBREL(R) (etanercept) group
(n=66) compared to 18% and 3%, respectively, in the placebo group (n=62).
Health-related quality of life was also assessed in this study. Sixty-two
percent of patients treated with ENBREL achieved clinically meaningful
improvement in the physical component summary of the SF-36 (a general quality
of life instrument), compared with 21% of placebo patients. Seventy percent of
patients receiving ENBREL achieved clinically meaningful improvement in their
EuroQol Feeling Thermometer score, compared with 38% of patients receiving
placebo.
Adverse events in the psoriatic arthritis trial were similar to those
reported in previous clinical trials of ENBREL in patients with rheumatoid
arthritis (RA). There was no increase in the number of serious adverse events
including serious infections occurring in psoriatic arthritis patients
receiving ENBREL compared with those receiving placebo. Only the rate of
injection site reactions (ISRs) in patients receiving ENBREL was statistically
different compared to placebo (36 percent vs. 9 percent). The most common
type of infection was upper respiratory infection (URI).
ABOUT PSORIASIS
Psoriasis is a non-contagious skin disease in which the skin grows four
times faster than normal and forms silvery layers, known as plaques, that
flake off with red, inflamed skin underneath. Up to 7,000,000 people in the
United States have been diagnosed with psoriasis, with 150,000 new cases
occurring each year.
ABOUT PSORIATIC ARTHRITIS
Psoriatic arthritis is an often painful chronic inflammatory disease that
is characterized by both joint disease and skin manifestations. People with
psoriatic arthritis may experience progressive joint pain and swelling,
similar to rheumatoid arthritis, coupled with the scaly red skin lesions
associated with psoriasis. Approximately 300,000 people in the United States
are affected with psoriatic arthritis.
ABOUT ENBREL
ENBREL is the only fully human TNF inhibitor approved for use without
methotrexate, a drug that has been the most commonly used disease-modifying
drug for RA. ENBREL is indicated for reducing the signs and symptoms and
inhibiting the progression of structural damage in patients with moderately to
severely active RA, in addition to the most recent indication as the first and
only approved treatment for reducing signs and symptoms of active arthritis in
patients with psoriatic arthritis.
ENBREL is the only TNF receptor on the market. It 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 and psoriatic arthritis. The
binding of ENBREL to TNF renders the bound TNF biologically inactive,
resulting in significant reduction in inflammatory activity.
Important Information
SINCE THE PRODUCT WAS FIRST INTRODUCED, SERIOUS INFECTIONS, SOME INVOLVING
DEATH, HAVE BEEN REPORTED IN PATIENTS USING ENBREL. MANY OF THESE INFECTIONS
OCCURRED IN PATIENTS WHO WERE PRONE TO INFECTIONS, SUCH AS THOSE WITH ADVANCED
OR POORLY CONTROLLED DIABETES. RARE CASES OF TUBERCULOSIS HAVE ALSO BEEN
REPORTED. ENBREL SHOULD BE DISCONTINUED IN PATIENTS WITH SERIOUS INFECTIONS.
DO NOT START ENBREL IF YOU HAVE AN INFECTION OF ANY TYPE OR IF YOU HAVE AN
ALLERGY TO ENBREL OR ITS COMPONENTS. ENBREL SHOULD BE USED WITH CAUTION IN
PATIENTS PRONE TO INFECTION. CONTACT YOUR PHYSICIAN IF YOU HAVE ANY QUESTIONS
ABOUT ENBREL OR INFECTIONS.
There have been reports of 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. There have also been rare reports of serious blood
disorders, some involving death. Contact your doctor immediately if you
develop symptoms such as persistent fever, bruising, bleeding, or paleness.
It is unclear if ENBREL has caused these nervous system or blood disorders.
If your doctor confirms serious blood problems, you may need to stop using
ENBREL.
The most frequent adverse events in placebo-controlled RA clinical trials
involving 349 adults were ISR's (37%), infections (35%), and headache (17%).
Only the rate of ISR was higher than that of placebo. The most frequent
adverse events in a methotrexate-controlled clinical trial of 415 adults with
early-stage RA were infections (64%), ISR (34%), and headache (24%). Of these,
only the rate of ISR was higher than that of methotrexate. In all 1,197 RA
patients studied, malignancies were rare (1%).
Adverse events in the psoriatic arthritis trial were similar to those
reported in RA clinical trials.
Immunex Corporation and Wyeth Pharmaceuticals, a division of Wyeth, market
ENBREL in North America. Other Wyeth affiliates market ENBREL outside of
North America. Immunex manufactures ENBREL. Additional information about
ENBREL, including full Prescribing Information, can be found on the
company-sponsored Web site at http://www.enbrel.com or by calling toll free
888-4ENBREL (888-436-2735).
Immunex Corporation is a leading biopharmaceutical company dedicated to
improving lives through immune system science innovations.
NOTE: Except for the historical information contained herein, this news
release contains forward-looking statements that involve substantial risks and
uncertainties. Among the factors that could cause actual results or timelines
to differ materially are risks associated with research and clinical
development, regulatory approvals, supply capabilities and reliance on
third-party manufacturers, product commercialization, competition, litigation,
and the other risk factors listed from time to time in reports filed by
Immunex with the Securities and Exchange Commission, including but not limited
to risks described under the caption "Important Factors That May Affect Our
Business, Our Results of Operation and Our Stock Price" within its most
recently filed Form 10-Q. The forward-looking statements contained in this
news release represent judgments of the management of Immunex as of the date
of this release. Immunex undertakes no obligation to publicly update any
forward-looking statements.
SOURCE Immunex Corporation
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Related links:
http://www.immunex.com
CONTACT:
media, Kris Greco, +1-206-265-4871, or
investors, Mark Leahy, +1-206-265-4363, both of Immunex
Corporation; or media, Doug Petkus of Wyeth Pharmaceuticals,
+1-610-902-7336
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