ENBREL(R) Only TNF Receptor With Five Years Sustained Data In Treatment of Rheumatoid Arthritis

[Guest guest]

ENBREL® Only TNF Receptor With Five Years Sustained Data In Treatment of

Rheumatoid Arthritis

Majority of Patients Treated With ENBREL

Have No Radiographic Progression After Three Years

THOUSAND OAKS, Calif. and RADNOR, Pa., Oct. 25 /PRNewswire-FirstCall/ --

New data from multiple studies evaluating the use of ENBREL® (etanercept),

the only fully human TNF receptor, in patients with long-standing disease,

as

well as newly diagnosed patients, will be presented this week as part of the

66th American College of Rheumatology Annual Scientific Meeting in New

Orleans. These data include results from a study evaluating up to five

years

of ENBREL monotherapy to treat patients with rheumatoid arthritis (RA) who

have previously failed a disease modifying anti-rheumatic drug (DMARD)

therapy.

ENBREL is indicated for reducing signs and symptoms and inhibiting the

progression of structural damage in patients with moderately to severely

active rheumatoid arthritis.

" The consistent and sustained efficacy and long-term tolerability of

ENBREL continue to distinguish it as an important therapeutic option

available

for people suffering from the often debilitating effects of RA, " said Dr.

Mark

Genovese, assistant professor of medicine at Stanford University School of

Medicine, and lead investigator in the early RA trial.

LONG-TERM MONOTHERAPY STUDY OF ENBREL TO TREAT RA

During a poster session, data will be presented from an ongoing study

involving 629 adult patients with moderate to severe RA who have failed at

least one DMARD and are being treated with ENBREL monotherapy. Three

hundred

and nineteen patients have been observed for between four and five years,

and

68 of these patients have been observed for five years or more.

The poster includes data supporting the sustained response demonstrated

for those patients observed for five years.

-- 71% of patients achieved the ACR 20

-- 48% of patients achieved the ACR 50

-- 27% of patients achieved the ACR 70

-- 24% of patients had no tender or swollen joints

-- 16% had no disability as measured by the Health Assessment

Questionnaire

ENBREL was generally well tolerated in this study. No increased rate of

serious adverse events was observed 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 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 0.05 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 previous 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 (16 observed vs. 20 predicted). No opportunistic

infections have been observed in patients treated with ENBREL in this long-

term study.

NEW RADIOGRAPHIC DATA FROM ONGOING 4-YEAR STUDY OF ENBREL TO TREAT EARLY

EROSIVE RHEUMATOID ARTHRITIS

New data from an ongoing study of patients with early-erosive rheumatoid

arthritis (ERA) was presented during a poster session at ACR demonstrating

that ENBREL provided sustained improvement in signs and symptoms over 4

years.

Additionally, 58% of 142 patients who remained on ENBREL for 3 years had no

radiographic progression of their disease.

" We're pleased that the data from this trial continue to support

long-term

improvement in both signs and symptoms of early erosive rheumatoid

arthritis,

in addition to demonstrating no progression of bone and joint damage in the

majority of these patients, " said Dr. Burge, Amgen's vice president

of

clinical research. " It is significant to note that at year four 73% of 49

patients treated with corticosteroids were able to reduce or discontinue

corticosteroid therapy when treated with ENBREL, while 81% of 124 patients

originally treated with methotrexate have discontinued or reduced use of

methotrexate. "

Patients in the ongoing open-label study initially participated in a

2-year, double-blind, multicenter trial assessing the efficacy of ENBREL or

methotrexate to treat ERA. The open-label study includes those patients

randomized to receive ENBREL (25 mg twice weekly subcutaneous) in the

original

study who continued this dose (n=161), and 143 patients previously receiving

methotrexate who chose to receive ENBREL.

Response was sustained for patients originally treated with ENBREL 25 mg

twice weekly (n=109) observed at 4 years:

-- 79% of patients achieved the ACR 20

-- 58% of patients achieved the ACR 50

-- 31% of patients achieved the ACR 70

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 receptor approved for use to reduce

the

signs and symptoms of active arthritis in patients with psoriatic arthritis,

and to reduce the signs and symptoms and inhibit the structural damage in

patients with moderately to severely active RA. ENBREL is the only biologic

therapy approved to treat newly diagnosed RA patients, and can be used

alone.

Approved since 1998, ENBREL has been used to treat more than 129,000

patients.

ENBREL 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

psoriatic

arthritis and RA. The binding of ENBREL to TNF renders the bound TNF

biologically inactive, resulting in significant reduction in inflammatory

activity.

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® (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. Patients have been observed in clinical trials for

over

3 years. The incidence of malignancies has not increased with extended

exposure to ENBREL and is similar to the projected background rate.

Adverse events in the psoriatic arthritis trial were similar to those

reported in RA clinical trials.

In a study of 69 patients with JRA, infections (62%), headache (19%),

abdominal pain (19%), vomiting (13%), and nausea (9%) occurred more

frequently

than in adults. The types of infections reported in JRA patients were

generally mild and consistent with those commonly seen in children. Serious

adverse reactions reported rarely were chicken pox (3%), gastroenteritis

(3%),

serious infection (2%), depression/personality disorder (1%), skin ulcer

(1%),

inflammation in parts of the upper digestive tract (1%), and diabetes (1%).

Please see full Product Information.

Amgen and Wyeth Pharmaceuticals, a division of Wyeth, (NYSE: WYE),

market

ENBREL in North America. Other Wyeth affiliates market ENBREL outside of

North America. Immunex Corporation, a wholly-owned subsidiary of Amgen,

manufactures ENBREL. Additional information about ENBREL, including full

Prescribing Information, can be found on the Web site sponsored by the

companies at http://www.enbrel.com or by calling toll free 888-4ENBREL

(888-436-2735).

Amgen is a global biotechnology company that discovers, develops,

manufactures and markets important human therapeutics based on advances in

cellular and molecular biology.

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the

areas of women's health care, cardiovascular disease, central nervous

system,

inflammation, hemophilia, oncology and vaccines. Wyeth (NYSE: WYE) is one of

the world's largest research-driven pharmaceutical and health care products

companies. It is a leader in the discovery, development, manufacturing, and

marketing of pharmaceuticals, vaccines, biotechnology products and non-

prescription medicines that improve the quality of life for people

worldwide.

The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer

Healthcare and Fort Dodge Animal Health.

CONTACT: Amgen Wyeth Pharmaceuticals

Hamm (media) Petkus (media)

805/447-3872 610/902-7336

Cary nsky (investors) (investors)

805/447-4634 973/660-5340

EDITOR'S NOTE: An electronic version of this news release may be

accessed

via http://www.amgen.com . Visit the Corporate Center and click on Amgen

News.

Journalists and media representatives may sign up to receive all news

releases

electronically at time of announcement by filling out a short form.

Data in this release refer to Abstracts # 1427 (Board # 387) and #1419

(Board # 344) being presented at the poster session, Monday, October 28,

8:00 a.m. - 4:00 p.m. CT

http://www.prnewswire.com/cgi-bin/stories.pl