Phase 3 Psoriatic Arthritis Data for ENBREL(R) (etanercept) Announced at a National Scientific Meeting

[Guest guest]

Phase 3 Psoriatic Arthritis Data for ENBREL®

(etanercept) Announced at a National Scientific

Meeting

Application for ENBREL Granted Priority Review

by FDA as First Product

To Be Considered for Treatment of

Psoriatic Arthritis

SAN FRANCISCO, Nov. 11 /PRNewswire/ -- Phase 3

results of ENBREL®

(etanercept) studied in patients with psoriatic

arthritis will be presented

this week at the 65th Annual American College of

Rheumatology National

Scientific Meeting in San Francisco.

" Psoriatic arthritis is a devastating disease

for which there are

currently no approved treatments, " says Philip

Mease, MD, Seattle Rheumatology

Associates, Swedish Medical Center Division of

Clinical Research and Clinical

Professor, University of Washington. " These data,

currently under review by

the FDA, indicate that ENBREL can significantly

improve the signs and symptoms

of psoriatic arthritis in many patients. "

This 24-week, multicenter, randomized,

double-blind, placebo-controlled

study assessed the efficacy and tolerability of

ENBREL (25-mg twice-weekly

subcutaneous injections) or placebo in 205

patients with psoriatic arthritis.

The primary endpoint was measured by the

proportion of patients who met the

American College of Rheumatology preliminary

criteria for improvement (ACR20),

which includes duration of morning stiffness,

tender and swollen joint counts

and a patient as well as a physician global

assessment. In addition, two

other measurements were utilized to study aspects

of both the joint and skin

manifestations of psoriatic arthritis: 1) The

Psoriatic Arthritis Response

Criteria (PsARC) measures improvement in tender

and swollen joint score, along

with a series of global assessments; and 2) a

subset of clinical study

patients was measured by improvement in the

psoriasis area and severity index

(PASI). PASI measures improvement in both the

amount of psoriatic plaque

throughout the body, as well as the severity of

the disease.

Results from the study include:

-- 59 percent of 101 patients receiving

ENBREL® (etanercept) achieved

an ACR20 response compared to 15 percent

of 104 patients receiving

placebo, after 12 weeks of treatment.

-- 72 percent of patients receiving ENBREL

achieved a treatment response

compared to 31 percent of patients

receiving placebo after 12 weeks of

treatment, using the PsARC measurement.

-- 54 percent of patients receiving ENBREL

for 24 weeks were assessed as

having clear or almost clear skin

manifestations, as measured by the

dermatologists' global assessment,

compared to 23 percent of patients

receiving placebo. At baseline, 20

percent of patients in each group

were clear or almost clear of skin

disease.

Also in this study, a subset (62 patients

receiving ENBREL and 66 patients

receiving placebo who had greater than 3 percent

of their body covered by

psoriatic plaque) were evaluated for psoriasis

activity. Results showed that:

-- 23 percent of patients receiving ENBREL

improved by 75 percent or

better compared to 3 percent of patients

receiving placebo, as

measured by the psoriasis area and

severity index (PASI) score.

Adverse events were similar to those reported

in previous trials of ENBREL

in patients with rheumatoid arthritis. There was

no increase in the number of

serious adverse events occurring in patients

receiving ENBREL as compared with

those receiving placebo. Only the rate of

injection site reactions (ISRs) in

patients receiving ENBREL was statistically

different compared to placebo

(36 percent vs. 9 percent).

These data are currently being reviewed by the

U.S. Food & Drug

Administration (FDA) for potential approval of

ENBREL for the treatment of

psoriatic arthritis. In September, the FDA

granted " priority review " status

requiring that the FDA act on the supplemental

Biologics License Application

(sBLA) within six months of submission date.

Immunex submitted its sBLA for

ENBREL on July 16, 2001. ENBREL is the first

product to be reviewed by the

FDA for the treatment of psoriatic arthritis.

" We are working with the FDA on this priority

review of the application

because we know the need for treatment is great, "

says Garrison, M.D.,

M.P.H, senior vice president of clinical research

and development for Immunex

Corporation (Nasdaq: IMNX

<http://alliance.marketwatch.com/custom/alliance/i

nteractivechart.asp?symb=IMNX & astyle=0,0,0,0,0,0,0

,10,0,0 & c=179 & urlpull= & logourl= & post=0>).

ABOUT PSORIATIC ARTHRITIS

Like rheumatoid arthritis (RA), psoriatic

arthritis is a chronic

inflammatory disease of the joints and connective

tissue. The disease causes

joint pain and swelling that can lead to crippling

along with inflamed and

irritated scaly red patches of skin throughout the

body. It is a progressive

and debilitating disease and because there are no

treatments specifically

approved for psoriatic arthritis, doctors often

use therapies approved for RA,

including nonsteroidal anti-inflammatory drugs

(NSAIDs) and disease modifying

anti-rheumatic drugs (DMARDs). However, no DMARDs

are currently approved for

use in psoriatic arthritis. There are

approximately 300,000 patients with

psoriatic arthritis in the United States and the

disease affects both men and

women most commonly between the ages 30 and 50.

Psoriatic arthritis patients

are generally treated by rheumatologists and

dermatologists.

ABOUT ENBREL

An application for marketing approval of

ENBREL® (etanercept) to treat

RA was fast-tracked by the U.S. Food and Drug

Administration in 1998. Six

months after the application was submitted, the

FDA approved ENBREL for

reducing the signs and symptoms of moderately to

severely active RA in

patients who have had an inadequate response to

one or more DMARDs. The

following year, the FDA approved ENBREL for

reducing signs and symptoms of

moderately to severely active polyarticular-course

juvenile rheumatoid

arthritis in patients who have had an inadequate

response to DMARDs. In

June 2000, the FDA approved ENBREL for reducing

signs and symptoms and

inhibiting the progression of structural damage in

patients with moderately to

severely active RA. ENBREL is the only tumor

necrosis factor (TNF) inhibitor

approved for use without methotrexate. It is also

the only TNF inhibitor

approved for use as a first-line therapy for RA.

ENBREL acts by binding TNF, one of the

dominant 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. ENBREL competitively inhibits binding

of TNF molecules to the TNF

receptor sites. The binding of ENBREL to TNF

renders the bound TNF

biologically inactive, resulting in significant

reduction in inflammatory

activity.

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 rare 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. 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® (etanercept) 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 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 treated with ENBREL

with early-stage RA were

infections (64%), ISR (34%), and headache (24%).

Only the rate of ISR was

higher than that of methotrexate. In all 1,197 RA

patients studied,

malignancies were rare (1%).