Patients With Severe Plaque Psoriasis Show Continued Improvement Over Six
Months of Therapy
SEATTLE, Aug. 20 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX) today
announced positive preliminary results from its first clinical study of
ENBREL(R) (etanercept) in psoriasis.
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
twice a week for six 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 12 weeks. Patients treated with ENBREL in
this study experienced significant improvement compared to those on placebo,
with 30 percent of patients on ENBREL achieving PASI 75 compared to 2 percent
of those on placebo.
Importantly, patients on ENBREL in this study continued to improve over
time. After six months of treatment, approximately half of the patients
receiving ENBREL achieved an improvement of 75 percent or better in the PASI
score, compared to 5 percent improvement for patients on placebo. In
addition, approximately 20 percent of patients receiving ENBREL for six months
improved by 90 percent or better, and no patients in the placebo group
achieved that level of response.
ENBREL was generally well tolerated in this study. Side effects seen more
frequently within the first 12 weeks of the study in patients receiving ENBREL
included mild infections (46 percent compared to 24 percent of placebo
patients). The majority of infections were upper respiratory infections
similar to colds.
Complete results of the study are expected to be presented at a scientific
meeting early next year.
"Patients in this study had lesions covering a third of their bodies on
average, and ENBREL provided significant relief," said Dan Burge, MD,
vice president for clinical research at Immunex. "We are very encouraged by
the outcome of this study and are embarking on a comprehensive clinical
program to study ENBREL in psoriasis."
This phase 2 study was designed to investigate the safety of and response
to ENBREL in psoriasis, following promising clinical results in patients with
psoriatic arthritis, a related condition. The data in psoriatic arthritis
have been filed with the U.S. Food and Drug Administration for review.
ABOUT PSORIASIS
Psoriasis is a chronic and painful skin disease that generally appears as
patches of raised red skin covered by a buildup of skin cells. Although the
exact cause is unknown, psoriasis is believed to be related to a malfunction
of the body's immune system that accelerates skin cell growth. There is no
known cure. According to the National Psoriasis Foundation, approximately
seven million Americans suffer from psoriasis, 80 percent with a form called
plaque psoriasis. Current treatments for severe psoriasis include
immunosuppressive drugs, retinoids and oral corticosteroids.
ABOUT ENBREL
ENBREL is currently approved for reducing signs and symptoms and
inhibiting the progression of structural damage in patients with moderately to
severely active RA. The FDA originally approved ENBREL on November 2, 1998,
to reduce signs and symptoms of moderately to severely active rheumatoid
arthritis in patients who have an inadequate response to one or more DMARDs.
ENBREL is the only TNF inhibitor that can be used both with methotrexate or
alone.
ENBREL acts by binding tumor necrosis factor (TNF). TNF is one of the
dominant cytokines or proteins that play an important role in normal immune
function and the cascade of reactions that cause the inflammatory process of
RA. ENBREL competitively inhibits binding of TNF molecules to the TNF
receptor (TNFR) sites. 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, 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 rare 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 clinical trials
involving 349 adults were injection site reactions (ISR) (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%). Only the rate of ISR was higher than that of
methotrexate. In all 1,197 RA patients studied, malignancies were rare (1%).
Additional information about ENBREL, including full prescribing
information, can be found 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, our supply capabilities and reliance on
third-party manufacturers, product commercialization, competition, litigation
and other risk factors listed from time to time in reports filed by Immunex
with the SEC, including but not limited to risks described under the caption
"Important Factors That May Affect Our Business, Our Results of Operations and
Our Stock Price" within our most recently filed Form 10-Q. The
forward-looking statements contained in this news release represent our
judgment as of the date of this release. Immunex undertakes no obligation to
publicly update any forward-looking statements. An electronic version of this
news release -- as well as additional information about Immunex of interest to
investors, customers, future employees and patients -- is available on the
Immunex home page at http://www.immunex.com.
SOURCE Immunex Corporation
 back to top
Related links:
http://www.immunex.com
Company News On-Call:
http://www.prnewswire.com/comp/434644.html
CONTACT:
Media, Robin Shapiro, +1-206-389-4040, or
Investors, Mark Leahy, +1-206-389-4363, both for Immunex
Corporation
|
