Ongoing Study Supports Benefit of Early, Aggressive Treatment of Rheumatoid
Arthritis
58% of Patients Treated With 25 mg of ENBREL Have No Radiographic Progression
Through 3 Years
STOCKHOLM, Sweden, June 14 /PRNewswire-FirstCall/ --
Immunex Corporation (Nasdaq: IMNX) today announced that data supporting the
efficacy, tolerability and science of ENBREL(R) (etanercept) will be discussed
at the 3rd Annual European League Against Rheumatism Meeting this week in
approximately 35 oral and poster presentations. Data on ENBREL, the only
fully human, TNF soluble receptor, will include the longest study to date of
patients on a continuous therapy to inhibit tumor necrosis factor (TNF) in
rheumatoid arthritis (RA).
"What we have seen over time is a consistent and sustained response to
this RA therapy, with more than 70% of patients responding," said Daniel
Burge, M.D., Immunex vice president of clinical development. "Consistent
response, defined as having achieved an ACR 20 response, has been seen when
ENBREL is used as monotherapy (without other disease modifying anti-rheumatic
drugs), whether patients are young or old, whether patients have long-standing
disease or are newly diagnosed with moderate to severe disease."
Data was presented from an ongoing study of 629 patients using ENBREL(R)
(etanercept) as monotherapy and who had failed other DMARDs (disease-modifying
anti-rheumatic agents). These patients were observed in an open-label follow
up study. The following data were presented for 119 patients who have now
completed five years of therapy with ENBREL:
-- 71% patients achieved the ACR 20
-- 48% patients achieved the ACR 50
-- 27% patients achieved the ACR 70
"In addition to seeing sustained efficacy through five years of follow up,
ENBREL has demonstrated a consistent tolerability profile," said Dr. Burge.
"In short-term studies of people being treated with ENBREL, the serious
infection rate was comparable to those receiving placebo, and did not change
with long-term experience. In addition, post-marketing reports of serious
infections including tuberculosis, occur at rates comparable to the expected
U.S. background incidence."
ENBREL was generally well tolerated over the five years of this study. In
the study, no significant differences in the type or rate of adverse events
were seen in patients treated with ENBREL over time. Serious adverse events
occurred at a rate of 0.14 per patient-year in this long-term study compared
to 0.13 in the patients treated with ENBREL and 0.20 in placebo patients in
the previous controlled studies. Likewise, serious infection (associated with
hospitalization or IV antibiotics) occurred at a rate of 0.04 per patient year
in the long-term study, compared to 0.04 per patient year in the patients
treated with ENBREL and 0.05 in placebo patients in the controlled studies.
The number of malignancies reported in patients treated with ENBREL was
similar to the expected number calculated from the National Cancer Institute
SEER database (30 observed vs. 31 predicted). No opportunistic infections
have been observed in patients treated with ENBREL in the long-term study.
Treatment with ENBREL(R) (etanercept) is Effective for Patients with Early
Erosive Rheumatoid Arthritis (ERA) -- Three Year Study Demonstrating 58% of
Patients Receiving 25 mg. of ENBREL Demonstrated no Radiographic Progression
A second study, conducted by Joan Bathon, M.D., John Hopkins University,
assessed 161 ERA patients treated with ENBREL as part of an ongoing open-label
extension study (three years of etanercept therapy total).
"The study underscores the importance of the treating RA as early as
possible with medicine that has been shown to inhibit the progression of
structural damage," said Barry Labinger, Immunex senior vice president and
general manager, commercial operations. "Over a three year period in this
study, a majority (58%) of patients receiving 25 mg of ENBREL twice weekly,
showed no radiographic progression of their RA, as measured by a total Sharp
score."
Patients in the open-label study had previously participated in a 2-year,
multicenter study of ERA patients assessing the efficacy of ENBREL or
methotrexate. The open-label study includes those patients randomized to
receive ENBREL 25 mg twice weekly in the original study who continued this
dose (n=161), and 143 patients previously receiving methotrexate who chose to
receive ENBREL. The results for the 161 patients receiving ENBREL
continuously for three years were:
-- 77% of patients achieved an ACR 20
-- 58% of patients demonstrated no radiographic progression
In this study, there was no increase of serious infections (requiring
hospitalization or IV antibiotics), malignancies, or significant adverse
events in the ENBREL group compared to the methotrexate group from the
original controlled study.
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 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.
ENBREL is the only TNF inhibitor approved by the U.S. Food and Drug
Administration to treat newly diagnosed RA patients with moderate to severe
disease.
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%).
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, (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
 back to top
Related links:
http://www.immunex.com
CONTACT:
media, Kris Greco, +1-206-265-4871, or
investors, Mark Leahy, +1-206-265-4363, both for Immunex
Corporation
|
