U.S. Study Results Provide Data Following Patients on ENBREL for As Long As
43 Months
NICE, France, June 23 /PRNewswire/ -- Patients with active rheumatoid
arthritis who responded to ENBREL(R), (etanercept) experienced sustained
reduction of joint pain and swelling for as long as 43 months of treatment,
according to results from an on-going long-term open-label study.
Approximately two thirds of the patients in this study responded to ENBREL as
measured by ACR20. Interim results of this study were presented at the 15th
Annual Meeting of the European League Against Rheumatism (EULAR) today by Dr.
Larry Moreland of the University of Alabama, Birmingham. These data have not
been submitted to the U.S. Food and Drug Administration.
ENBREL was generally well tolerated for up to 43 months. In the study, no
significant differences in the rate or type of adverse events were seen in
patients treated with ENBREL over time. Injection site reactions occurred in
43 percent of patients; less than 0.5 percent of patients withdrew from the
study due to injection site reactions. A total of 16 percent of patients have
discontinued treatment: five percent due to adverse events and four percent
due to lack of efficacy. No opportunistic infections have been observed.
Adverse events resulting in hospitalization and/or treatment with IV
antibiotics observed in long-term follow-up have occurred at rates similar to
those seen in placebo and etanercept groups in controlled trials. There were
ten malignancies reported, of various types, similar to the number (11.5)
expected in the general population (calculated from the NCI SEER database).
U.S. Data -
Additional highlights from the U.S. long-term study of ENBREL include:
-- Decreased use of corticosteroids was seen in 56 percent of
383 patients. Discontinuation of corticosteroids was seen in
26 percent of the patients while 9 percent increased steroid use.
-- The numbers of tender and swollen joints rapidly declined from a median
of 30 and 25 to 8 and 10 at three months and continued to decline to
4 and 5 at 30 months (n=139).
-- After 30 months of treatment (n=139), no tender joints were seen in
28 percent of patients and no swollen joints were seen in 27 percent of
patients.
-- 553 patients on ENBREL have been followed for more than one year and
500 have been followed for over 18 months. 373 patients on ENBREL were
followed for two years and 139 have been followed for 30 months.
53 patients on ENBREL were followed for 36 to 43 months. All patients
in this trial had moderately to severely active rheumatoid arthritis
and had failed treatment with one or more disease modifying
anti-rheumatic drugs prior to starting ENBREL.
European Data -
In a second trial, a European three-year study with 549 patients, all of
whom have already participated in an ENBREL European double-blind trial, have
received etanercept for up to 15 months thus far. The participants are being
treated with 25 mg of ENBREL twice weekly at 58 centers throughout Europe.
All patients previously had an inadequate response to DMARDs and the majority
are receiving NSAIDS and corticosteroids.
In the European study, after three months of open-label treatment, mean
number of painful joints was reduced by 64 percent (swollen joints by
66 percent) from the baseline of the preceding double-blind study, indicating
maintenance of the therapeutic response. The most frequent adverse events
reported were upper respiratory infection and injection site reaction. The
occurrence of serious infections and malignancies appeared stable over the
current exposure period. 84 percent of patients will continue in the study.
Lack of efficacy (5 percent) and adverse reactions (7 percent) account for the
majority of patient discontinuations.
ENBREL is now considered to be a first-line treatment for moderately to
severely active rheumatoid arthritis. After careful review of clinical data,
the U.S. Food and Drug Administration on June 6, 2000 confirmed that ENBREL
not only reduces signs and symptoms but also delays structural joint damage in
patients with moderately to severely active rheumatoid arthritis (RA).
Approximately five million people in Europe and North America suffer from
the crippling effects of rheumatoid arthritis, a chronic disorder that causes
the body's immune system to attack the lining of the joints, resulting in
pain, swelling, fatigue and disability. The exact cause of the disease is
unknown although biotechnology research has advanced understanding of the role
of genes and factors causing inflammation.
ABOUT ENBREL
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. The most frequent adverse events in
placebo-controlled trials in rheumatoid arthritis (n=349) were injection site
reactions (ISR) (37%), infections (35%) and headache (17%). Only the rate of
ISR was higher than placebo. The most frequent adverse events in the
methotrexate-controlled trial (n=415) were infection (64%), ISR (34%) and
headache (24%). Only the rate of ISR was higher than methotrexate. In all RA
patients treated in clinical trials (n= 1197), 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 will 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
888-4ENBREL (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, central nervous system
drugs, anti-inflammatory agents, vaccines and generic pharmaceuticals.
AHP 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 release contains forward-looking statements that involve risks
and uncertainties, including risks associated with clinical development,
regulatory approvals, patent litigation, product commercialization and other
risks described from time to time in the SEC reports filed by Immunex,
including the most recently filed 10-K and 10-Q forms. For more information,
please refer to http://www.immunex.com.
SOURCE Immunex Corporation
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Related links:
http://www.immunex.com
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http://www.prnewswire.com/comp/434644.html or fax,
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CONTACT:
Tim Warner of Immunex Corporation,
206-470-4193; or Doug Petkus of Wyeth-Ayerst Laboratories,
610-971-4980
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