70 Percent of Patients Treated With ENBREL Had No Progression of Joint Erosion
Over Two Years Compared to 58 Percent of Methotrexate-Treated Patients
PHILADELPHIA, Oct. 30 /PRNewswire/ -- For the first time ever, two-year
data are available for ENBREL(R) (etanercept) as a first-line treatment of
moderately to severely active rheumatoid arthritis, which will be presented at
the 64th Annual Scientific American College of Rheumatology Meeting in
Philadelphia. Using clinical and radiographic endpoints, this two-year study
compared ENBREL (n=207) with methotrexate (n=217) in patients with early,
active rheumatoid arthritis (RA), and will be presented by Mark Genovese, MD
of Stanford University. Results from this study support the use of ENBREL as
first-line treatment for moderately to severely active RA, to reduce joint
pain and swelling, and to delay joint damage.
The following results from the study will be presented by Dr. Genovese:
* 72 percent of patients treated with ENBREL achieved an ACR 20 at two
years compared with 59 percent of methotrexate-treated patients.
* 70 percent of patients treated with ENBREL had no radiographic
progression of joint erosions over two years compared to 58 percent of
methotrexate-treated patients.
* ENBREL was generally well tolerated with continuous treatment in
patients with early, active rheumatoid arthritis. The most frequently
reported adverse events that were statistically different between the
two treatments were injection-site reactions (35%) for patients treated
with ENBREL, and for patients treated with methotrexate, nausea (31%),
mouth ulcers (17%), hair loss (12%) and lung toxicity (2%).
* When assessing their own health status, 55 percent of patients treated
with ENBREL compared to 37 percent of methotrexate-treated patients
reported at least 0.5 unit improvement in a composite score, called the
health assessment questionnaire (HAQ).
"The data from the ENBREL early rheumatoid arthritis (ERA) trial show
great promise for those suffering from early and active rheumatoid arthritis,"
says Dr. Mark Genovese, MD, Assistant Professor of Medicine, Division of
Immunology and Rheumatology, Stanford University School of Medicine and
presenter of the ENBREL ERA two-year study. "Early and aggressive treatment
of rheumatoid arthritis is important to help minimize the debilitating effects
of the disease."
Dr. Genovese's conclusions were drawn from radiographic and clinical
results of the ENBREL ERA trial -- a phase III randomized, multi-center trial
that included 632 adults who had early stage RA (less than three years and had
never been treated previously with methotrexate). The trial was divided into
two parts: the first was double-blind and lasted until all patients had
received at least 12 months of treatment. After this, patients continued in
an open-label phase that lasted until all patients completed at least
24 months of treatment. The physicians who analyzed the x-rays were blinded
to the study treatments for the entire study. Seventy-four percent of ENBREL
patients and 59% of methotrexate patients completed 2 years on study. ACR
responses were analyzed based on patients' last observation carried forward.
The data from the first year of this trial were submitted to the U.S. Food
and Drug Administration, and led to FDA approval on June 6, 2000 for use of
ENBREL as first-line treatment for moderately to severely active RA to reduce
signs and symptoms and to delay radiographic progression of joint damage.
The 632 participants in the ENBREL "ERA" study were randomized to receive
either 25 mg or 10 mg of ENBREL, or up to 20 mg of methotrexate per week for
24 months. To ensure blinding of study treatments during the first part of
the study, patients received both injections and pills: ENBREL by injection
twice weekly plus placebo pills weekly, or methotrexate pills weekly plus
placebo injections twice weekly. Patients enrolled in this study had RA for a
relatively short time (mean of one year), and had active disease (mean tender
and swollen joint counts of 30 and 24, respectively, and reported four hours
of morning stiffness). All patients had risk factors for rapidly progressive,
erosive RA including the presence of rheumatoid factor and/or erosions on
baseline x-rays of the hands, wrists and feet. The data presented herein are
for these patients who received 25 mg of ENBREL.
ABOUT ENBREL
The U.S. Food and Drug Administration (FDA) has approved ENBREL as a
first-line treatment of moderately to severely active rheumatoid arthritis.
ENBREL is indicated for reducing signs and symptoms and delaying structural
damage in patients with moderately to severely active rheumatoid arthritis.
IN POSTMARKETING USE, SERIOUS INFECTIONS AND SEPSIS, INCLUDING FATALITIES,
HAVE BEEN REPORTED. MANY OF THESE EVENTS OCCURRED IN PATIENTS PREDISPOSED TO
INFECTIONS, SUCH AS THOSE WITH ADVANCED OR POORLY CONTROLLED DIABETES.
DISCONTINUE ENBREL IN PATIENTS WITH SERIOUS INFECTIONS OR SEPSIS. DO NOT
START ENBREL IN THE PRESENCE OF SEPSIS, INFECTION (INCLUDING CHRONIC OR
LOCALIZED), OR ALLERGY TO ENBREL OR ITS COMPONENTS. USE CAUTION IN PATIENTS
PREDISPOSED TO INFECTION.
Rare cases of central nervous system (CNS) demyelinating disorders have
been reported, although the causal relationship to ENBREL remains unclear.
Exercise caution when considering ENBREL for patients with these disorders.
Rare cases of pancytopenia, including aplastic anemia, some fatal, have been
reported in RA patients. Exercise caution in patients who have a previous
history of significant hematologic abnormalities. Although the causal
relationship to ENBREL remains unclear, advise patients to seek immediate
medical attention if they develop signs or symptoms of blood dyscrasias or
infection. If significant hematologic abnormalities are confirmed, consider
discontinuing ENBREL.
The most frequent adverse events in placebo-controlled clinical trials
with ENBREL (n=349) 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 the methotrexate-controlled
trial (n=415) were infections (64%), ISR (34%), and headache (24%). Only the
rate of ISR was higher than that of MTX. In all RA patients treated in
clinical trials (n=1,197), malignancies were rare (1%).
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 the 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.
Immunex Corporation (Nasdaq: IMNX) and Wyeth-Ayerst Laboratories, division
of American Home Products Corporation (NYSE: AHP), market ENBREL in North
America. Other American Home Products Corporation 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 website at (http://www.enbrel.com) or by calling toll-free
1-888-4ENBREL (1-888-436-2735).
Immunex Corporation is a biopharmaceutical company dedicated to improving
lives through immune system science innovations.
American Home Products Corporation's Wyeth-Ayerst division is a major
research-oriented pharmaceutical company with leading products in the areas of
women's health care, cardiovascular disease therapies, CNS drugs, anti-
inflammatory agents, vaccines and generic pharmaceuticals.
American Home Products Corporation owns a majority interest in Immunex.
AHP is one of the world's largest research-based pharmaceutical and health
care products companies. It is a leader in the discovery, development,
manufacturing and marketing of prescription drugs, including biotechnological
and vaccine products, animal health care products and over-the-counter
medications.
NOTE: This news release contains forward-looking statements that involve
risks and uncertainties, including risks associated with clinical development,
regulatory approvals, our reliance on third-party manufacturers, product
commercialization and other risks described from time to time in the SEC
reports filed by Immunex, including the most recently filed Form 10-Q. 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 or fax,
800-758-5804, ext. 434644
CONTACT:
Courtney Self, 206-972-3775, or Tim Warner,
206-470-4193, both of Immunex Corporation; or Doug Petkus of
Wyeth-Ayerst, 610-902-7336
|
