STOCKHOLM, Sweden, June 14 /PRNewswire-FirstCall/ --
Immunex Corporation (Nasdaq: IMNX) announced today that data on patients
receiving ENBREL(R) (etanercept) and experiencing improvement in physical
functioning measurements as assessed by a validated health assessment
questionnaire (HAQ) for rheumatoid arthritis (RA) will be presented at the 3rd
Annual European League Against Rheumatism meeting this week.
"We are seeing results that support what we have thought for some time
-- that early, aggressive treatment in the disease process is critical to
inhibiting the progression of joint damage," said Daniel Burge, M.D., Immunex
vice president of clinical development. "Improvement in physical function
goes to the heart of what patients need ... being able to hold and care for a
child, being able to brush your hair, being able to have enough energy to
work, these are the things that deeply impact people's lives."
Multiple poster presentations are scheduled regarding improvement in
physical functioning for patients treated with ENBREL. A study conducted by
Roy M. Fleischmann, M.D., Metroplex Clinical Research Center in Dallas, TX,
demonstrated rapid and sustained improvement in disability in 769 RA patients
treated with ENBREL based on disability scores measured by the Stanford Health
Assessment Questionnaire (HAQ) over three years. The study compared HAQ
scores in two groups of patients treated with ENBREL: 207 patients with early
disease (mean RA duration one year) and 562 patients with long-standing
disease who had failed multiple disease modifying antirheumatic drugs (DMARDS)
(mean RA duration was 12 years). HAQ scores are determined by improvement in
various physical functions such as dressing, grooming, eating, and walking.
"While ENBREL significantly improved HAQ scores for patients treated with
early and long-standing RA, patients who received ENBREL earlier in the
disease experienced greater benefit with 56% improvement versus a 35%
improvement for patients with long-standing disease using ENBREL," said Dr.
Fleischmann. "This difference in improvement could be attributed to the fact
that once joint damage occurs, it cannot be reversed."
At three years, patients with early disease had experienced a 56%
reduction in HAQ scores compared to a 35% improvement in patients with
long-standing disease. Twenty six percent of patients with early RA achieved
a zero HAQ score (no measurable disability), while only 14% of patients with
established RA achieved a zero HAQ score.
ABOUT ENBREL
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 cause 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.
ENBREL is indicated for reducing signs and symptoms and inhibiting the
progression of structural damage in patients with moderately to severely
active rheumatoid arthritis.
Important Treatment Considerations
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(R) (etanercept). 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 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%). Of these, only the rate of ISR was higher than that
of methotrexate. In all 1,197 RA patients studied, malignancies were rare
(1%).
Immunex Corporation and Wyeth Pharmaceuticals, a division of Wyeth,
(NYSE: WYE), 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-K. 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
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